Import Alert 99-39

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 99-39
Published Date: 03/04/2024
Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded

Reason for Alert:

NOTE: The revision to this Import Alert dated 9/4/2020 updates the guidance section with addition of instructions for releasing entries subject to DWPE, updating charge section, and PAF section. Changes are noted and bracketed by asterisks(***).

Section 801(a)(3) of the FD&C Act authorizes FDA to detain an article of food offered for import based on information that causes an article to appear to be misbranded in violation of the FD&C Act. This Import Alert is intended to primarily address imported food products that appear to be misbranded within the meaning of specific provisions of section 403 of the FD&C Act (sections 403(a)(1), 403(e)(1), 403(e)(2), 403(f), 403(g)(1), 403(g)(2), 403(h)(1), 403(h)(2), 403(i)(1), 403(i)(2), 403(k), 403(q), 403(r)(1)(A)/(B), 403(s)(2)(A), 403(s)(2)(B), 403(s)(2)(C), or 403(y)), and which are not covered by other existing Import Alerts (see note).

Note: There are several foods-related Import Alerts which address other specific misbranding provisions of the FD&C Act. Firms/products should be listed on the Red List for those other Import Alerts if they are covered by those alerts. If firms/products are also covered by this Import Alert (i.e., products appear to be misbranded under sections 403(a)(1), 403(e)(1), 403(e)(2), 403(f), 403(g)(1), 403(g)(2), 403(h)(1), 403(h)(2), 403(i)(1), 403(i)(2), 403(k), 403(q), 403(r)(1)(A)/(B), 403(s)(2)(A), 403(s)(2)(B), 403(s)(2)(C), or 403(y) of the FD&C Act), such firms/products should be listed on the RED LISTS for both alerts.

Guidance:

***Divisions may detain, without physical examination, shipments of the products identified on the Red List of this Alert.***

In accordance with Chapter 9 of the Regulatory Procedures Manual, recommendations for detention without physical examination for specific product(s) from an individual manufacturer or shipper may be made after one violative entry if the entry represents a potentially significant health hazard and all other appropriate criteria are satisfied.

Recommendations for detention without physical examination for specific product(s) from an individual manufacturer or shipper for violations that do not pose a potentially significant public health hazard may be made if there have been at least three (3) detentions in a recent six-month period or less and these detentions represent at least 25 percent of the total shipments of that product examined in the applicable time period if all other appropriate criteria are satisfied.

Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Food Safety and Applied Nutrition (CFSAN) will evaluate regulatory packages on a case-by-case basis.

For additional information concerning FDA's food labeling requirements, refer to 21 CFR Part 101 or other applicable provisions of Title 21 of the Code of Federal Regulations.

***Release of Articles Subject to Detention without Physical Examination under this Import Alert:
In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide all relevant information supporting the request for release to the appropriate FDA Division compliance office.***

***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."***

If a firm/product is listed on the Red List on this Import Alert and is also subject to DWPE for the same underlying violation on another misbranding-related Import Alert referred to above for the same underlying violation, then a request can be made to the Division of Import Operations that the firm or product be removed from the Red List for both Import Alerts based on the same information.

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

                                                                                                                                                                       

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Dietary Supplements and Labeling Assessment Branch at CFSANEnforcement@fda.hhs.gov

Product Description:

Various Food Products

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded, Section 403(a)(1)]

OASIS Charge Code: FALSE

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. [Misbranded, Section 403(e)(1)]

OASIS Charge Code: LACKS FIRM

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act. [Misbranded, Section 403(e)(2)]

OASIS Charge Code: LACKS N/C

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). [Misbranded, Section 403(f)]

OASIS Charge Codes: NO ENGLISH or INCONSPICU

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. [Misbranded, Section 403(g)(1)]

OASIS Charge Code: STD IDENT

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided under Section 401 of the FD&C Act and the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation. [Misbranded, Section 403(g)(2)]

OASIS Charge Code: STD NAME

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(h)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a standard of quality has been prescribed by regulation as provided by Section 401 of the FD&C Act, and its quality falls below such standard and its label does not bear a statement that it falls below such standard in such manner and form as such regulations specify. [Misbranded, Section 403(h)(1)]

OASIS Charge Code: STD QUALIT

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(h)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations as provided by Section 401 of the FD&C Act and the article falls below the applicable standard of fill and its label does not bear a statement that it falls below such standard in such manner and form as such regulations specify. [Misbranded, Section 403(h)(2)]

OASIS Charge Code: STD FILL

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be. [Misbranded, Section 403(i)(1)]

OASIS Charge Code: USUAL NAME

And/Or

***The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. [Misbranded, Section 403(i)(2)]

OASIS Charge Code: LIST INGRE***

And/Or

*** The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein. [Misbranded, Section 403(i)(2)]

OASIS Charge Code: JUICE %***

And/Or

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function). [Misbranded, Section 403(k)]

OASIS Charge Code: PRESRV LBL***

And/Or

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. [Misbranded, 403(k)]

OASIS Charge Code: FLAVR LBLG***

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. [Misbranded, Section 403 (q)]

OASIS Charge Code: NUTRIT LBL

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim. [Misbranded, Section 403(r)(1)(A)/(B)]

OASIS Charge Code: HEALTH C

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend. [Misbranded, Section 403(s)(2)(A)]

OASIS Charge Code: DIETARYING

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. [Misbranded, Section 403(s)(2)(B)]

OASIS Charge Code: DIETARYLBL

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. [Misbranded, Section 403(s)(2)(C)]

OASIS Charge Code: PLANT PART

And/Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. [Misbranded, Section 403(y)]



OASIS Charge Codes "NCONTACT"

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


AFGHANISTAN


HAJI BASHIR AHMAD LTD
Date Published : 02/03/2017
Charagh Ali Market , Kabul, AF-KAB AFGHANISTAN
21 H - - 01 Apricot, Dried or Paste
Date Published: 02/03/2017

Desc: Whole Apricot
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient . Section 403(f) of the FD&C Act in that the product label contains information in foreign languages but does not present all information required by the Act in all languages.

21 H - - 14 Plum, Dried or Paste
Date Published: 02/03/2017

Desc: Dried Plum
Notes: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.


ALGERIA


CEBON SARL
Date Published : 01/25/2022
#129 Cete Meridji Fouka , W Tepiza, DZ-16 ALGERIA
36 A - - 99 Sugar Products, N.E.C.
Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7.

36 B - - 08 Sugar Syrup, Beet and Cane (Liquid Sucrose, Simple Syrup)
Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7.

36 C - - 04 Honey
Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7.

Cebon El Mordjene
Date Published : 01/25/2022
129, Cite Meridji, Fouka , Wilaya, Tipaza ALGERIA
36 A - - 99 Sugar Products, N.E.C.
Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7.

36 B - - 08 Sugar Syrup, Beet and Cane (Liquid Sucrose, Simple Syrup)
Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7.

36 C - - 04 Honey
Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7.


ARMENIA


ARSSI ALLIANCE LLC
Date Published : 08/25/2023
24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/25/2023

Desc: Immune Booster Antiviral
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/25/2023

Desc: Immune Booster Antiviral
Notes: he article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.


AUSTRALIA


Natural Vitality
Date Published : 06/09/2017
11 Aldinga St , Brendale, Queensland AUSTRALIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/09/2017

Desc: Body Brilliance
Notes: The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/09/2017

Desc: Male Testo Dietary Supplement
Notes: The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.


AUSTRIA


APO Fruchtsaefte GmbH
Date Published : 10/02/2015
Gossering 1 , Millstatt, Karnten AUSTRIA
29 B - T 99 Carbonated Soft Drink, N.E.C., Packaged Food (Not Commercially Sterile)
Date Published: 10/02/2015

Desc: MitoChon Energy Drink
Notes: ***Charges: 403(i)(2), 403(q)(5)(F), 403(y). The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of Federal Food, Drug and Cosmetic Act (the Act) in that it is fabricated from two or more ingredients, but the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36. Specifically: In the "other" section of the product's ingredient list, the product lists "Trade Secret Stabilization Process" and "Solubilized in water from the Austrian Alps." While these may be true statements, the former is not appropriate to list in the ingredients section of the product and the latter is not the common or usual name for "water." Additionally, ingredients such as NADH, Q10H2, Pyridoxal- 5'-PO43, and Vitamin B2 RSP must be spelled out or listed by their common and usual names. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act in that your "Supplement Facts" panel is not in an appropriate format as required by 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (y) [21 U.S.C. § 343(y)] of the Act. The label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 [21 U.S.C. § 379aa-1] of the Act, may receive a report of a serious adverse event with such dietary supplement. ***

Rey GmbH
Date Published : 10/02/2015
Hauptstrase 33 , St.Michael i.Obersteiermark, Steiermark AUSTRIA
29 B - T 99 Carbonated Soft Drink, N.E.C., Packaged Food (Not Commercially Sterile)
Date Published: 10/02/2015

Desc: MitoChon Energy Drink
Notes: ***                                                                                                                                                                                                                                Charges: 403(i)(2), 403(q)(5)(F), 403(y). The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of Federal Food, Drug and Cosmetic Act (the Act) in that it is fabricated from two or more ingredients, but the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36. Specifically: In the "other" section of the product's ingredient list, the product lists "Trade Secret Stabilization Process" and "Solubilized in water from the Austrian Alps." While these may be true statements, the former is not appropriate to list in the ingredients section of the product and the latter is not the common or usual name for "water." Additionally, ingredients such as NADH, Q10H2, Pyridoxal- 5'-PO43, and Vitamin B2 RSP must be spelled out or listed by their common and usual names. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act in that your "Supplement Facts" panel is not in an appropriate format as required by 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (y) [21 U.S.C. § 343(y)] of the Act. The label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 [21 U.S.C. § 379aa-1] of the Act, may receive a report of a serious adverse event with such dietary supplement.***

WOMEN'S BEST
Date Published : 12/13/2018
Eduard-Bodem-Gasse 3 , Innsbruck, Tirol AUSTRIA
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 12/13/2018

Desc: Protein Wafers Chocolate (conv food)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. ;

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 12/13/2018

Desc: Slim Body Shake All-in-One Meal Replacement Blend (conv food)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 12/13/2018

Desc: Protein Creme (conv food)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 12/13/2018

Desc: Fit Pro Whey 100% Premium Whey Protein; 3 flavors (conv food)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: BCAA Amino (2 flavors) (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: Pre Workout Booster (2 flavors) (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: True Beauty Collagen Drink for Skin;Nails & Hair (Dietary Supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: Joint Support (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: Amino & Energy Essential Amino Acid and Energy Support (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. ;


BAHAMAS


NEW LIFE NATURAL VEGETATION CELL
Date Published : 09/05/2017
Lucaya Shopping Cent 14 , Freeport City, BAHAMAS
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/05/2017

Desc: Nerve Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/05/2017

Desc: Bilberry Raspberry Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (2) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (3) Section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that it purports to be a beverage containing fruit but the label does not bear a declaration of the total percentage of juice in accordance with 21 CFR 101.30.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2017

Desc: Iron Plus Formula
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (3) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (4) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (5) Section 403(r)(1)(A) of the Act [21 U.S.C. ? 343(r)(1)(A)] because the label bears the claim ?iron plus? but does not meet the requirements in 21 CFR 101.54(e) to bear that claim.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2017

Desc: Special Healing Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(q)(5)(F) of the Act [21 U.S.C. ? 343(q)(5)(F)] in that the product fails to provide any nutrition information as required by 21 CFR 101.36 and does not appear to meet the exemption criteria provided in 21 CFR 101.36(h). (4) Section 403(i)(1) of the Act [21 U.S.C.(i)(1)] in that the ?dietary supplement? statement of identity is not in a size reasonably related to the most prominent printed matter on the principal display panel as required by 21 CFR 101.3(d). (5) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2017

Desc: Male ThunderStrike
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (2) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (3) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2017

Desc: Cat Island Restoration Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/05/2017

Desc: Sea Moss Bladderwrack Mix
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis.

56 G - - 99 Antifungal N.E.C.
Date Published: 09/05/2017

Desc: Draco Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (4) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3.

60 N - - 14 Testosterone (Androgen)
Date Published: 09/05/2017

Desc: Male ThunderStrike
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (2) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (3) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3.

62 C - - 99 Anti-Hypertensive N.E.C.
Date Published: 09/05/2017

Desc: Nerve Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis.

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 09/05/2017

Desc: Special Healing Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(q)(5)(F) of the Act [21 U.S.C. ? 343(q)(5)(F)] in that the product fails to provide any nutrition information as required by 21 CFR 101.36 and does not appear to meet the exemption criteria provided in 21 CFR 101.36(h). (4) Section 403(i)(1) of the Act [21 U.S.C.(i)(1)] in that the ?dietary supplement? statement of identity is not in a size reasonably related to the most prominent printed matter on the principal display panel as required by 21 CFR 101.3(d). (5) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis.

62 V - - 99 Anti-Viral N.E.C.
Date Published: 09/05/2017

Desc: Cat Island Restoration Tonic
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis

64 B - - 99 Diuretic N.E.C.
Date Published: 09/05/2017

Desc: Sea Moss Bladderwrack Mix
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis.

64 N - - 07 Iron Dextran (Inj) (Hematinic)
Date Published: 09/05/2017

Desc: Iron Plus Formula
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (3) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (4) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (5) Section 403(r)(1)(A) of the Act [21 U.S.C. ? 343(r)(1)(A)] because the label bears the claim ?iron plus? but does not meet the requirements in 21 CFR 101.54(e) to bear that claim.

66 S - - 40 Inositol Niacinate (Vasodilator)
Date Published: 09/05/2017

Desc: Chelation
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (4) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3.

Purity Bakery
Date Published : 11/19/2015
Market & McPherson Street , Nassau, BS-NP BAHAMAS
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 11/19/2015

Desc: Bacardi Rum Cake
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2), and 403(e)(2), of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically: "Bacardi Rum Cake," products are misbranded within meaning of section 403 (i)(2) of the Act in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. "Bacardi Rum Cake" product labels declare "vegetable oil" as an ingredient; however, you fail to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b) (14)). "Bacardi Rum Cake" product labels declare "enriched flour" which is a standardized food under 21 CFR 137.165. However, you fail to list the sub- ingredients on your finished product labels. "Bacardi Rum Cake" products are manufactured using "water;" however, you fail to list this ingredient on your finished product label. "Bacardi Rum Cake" product label declares "walnuts;" however, this is not an ingredient in your product formulation. "Bacardi Rum Cake" products are manufactured using "pudding cake base;" however, you fail to list all the sub-ingredients on your finished product labels. "Bacardi Rum Cake," products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105.

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 11/19/2015

Desc: Chocolate Rum Cake
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2), and 403(e)(2), of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically: "Chocolate Rum Cake," products are misbranded within meaning of section 403(i)(2) of the Act in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example: "Chocolate Rum Cake" product label fails to include an ingredient statement. "Chocolate Rum Cake," products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 11/19/2015

Desc: Pina Colada Rum Cake
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2), 403(e)(1), and 403(e)(2), of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically: "Pina Colada Rum Cake" products are misbranded within meaning of section 403(i)(2) of the Act in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example: "Pina Colada Rum Cake" product labels declare "vegetable oil" as an ingredient; however, you fail to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b) (14)). "Pina Colada Rum Cake" product labels declare "enriched flour" which is a standardized food under 21 CFR 137.165. However, you fail to list the sub-ingredients on your finished product labels. "Pina Colada Rum Cake" products are manufactured using "water;" however, you fail to list this ingredient on your finished product label. "Pina Colada Rum Cake" products are manufactured using "pudding cake base;" however, you fail to list all the sub-ingredients on your finished product labels. "Pina Colada Rum Cake" product are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. "Pina Colada Rum Cake" products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105.


BANGLADESH


Anraj Fish Products Industries, Ltd.
Date Published : 05/23/2018
Opposit of Amin Jute Mil , Chittagong, Biozid Thana BANGLADESH
16 A - - 99 Fish, N.E.C.
Date Published: 05/23/2018

Desc: Lotiya Mix; Bombay Duck; Anchovy; Thryssa; Pink Shrimp; Harpadon nehereus; Coilia dussumien; Thryssa mystax; Pandalus borealis;
Notes: Problem(s): Principal Display Panel Nutrition Facts Panel; Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the statement of identity on the Principal Display Panel are not accurate as required under 21 CFR 101.3. Section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information is not declared in accordance with 21 CFR 101.9.

16 A - - 99 Fish, N.E.C.
Date Published: 05/23/2018

Desc: Meshali; Bata; Banded Gourami; Swamp Barb; Gangetic Leaffish; Labeo bata; Colisa fasciatus; Puntinus chola; Nandus nandus.
Notes: Problem(s): Principal Display Panel Nutrition Facts Panel; Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the statement of identity on the Principal Display Panel are not accurate as required under 21 CFR 101.3. Section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information is not declared in accordance with 21 CFR 101.9.

BAGERHAT SEAFOOD INDUSTRIES LIMITED
Date Published : 10/02/2015
Fakirhat Town Nowapara , Bagherhat, Khulna BANGLADESH
16 J - - 05 Shrimp & Prawns
Date Published: 10/02/2015

Desc: Raw Black Tiger Shrimp
Notes: Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Raw Black Tiger Shrimp
Notes: Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07

Janata food
Date Published : 10/02/2015
Dalairbagh , Sonargaon, Narayanganj BANGLADESH
03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Date Cake
Notes: The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/02/2015

Desc: Date Cake
Notes: The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07

22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 10/02/2015

Desc: Date Cake
Notes: The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07

KN Agro Processor
Date Published : 03/05/2021
Jhawgora , Araihazar , Narayanganj, Dhaka BANGLADESH
38 C - - 99 Dried Soup, N.E.C.
Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai
Notes:                                                                                                                                                                                                                                          Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the Act because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all statements required by or under authority of the Act to appear on the label must appear in English as well as the foreign language. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute, "acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)].

38 Y - - 99 Soup, N.E.C.
Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai
Notes:                                                                                                                                                                                                                                          Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the Act because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all statements required by or under authority of the Act to appear on the label must appear in English as well as the foreign language. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute, "acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)].

Kishwan snacks limited
Date Published : 01/27/2023
Plot No.# A-6, A-7, Block# B, BSCIC 1/E, Sholosahar , Nasirabad, Chittagong BANGLADESH
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 01/27/2023

Desc: Special Toast Biscuits
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL.

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL.

03 Y - - 07 Zweiback, Toast
Date Published: 01/27/2023

Desc: Special Toast Biscuits
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9.

NESTLE BANGLADESH, LTD.
Date Published : 01/14/2021
RAJENDRAPUR CANTONMENT , SREEPUR , GAZIPUR, BANGLADESH
04 C - - 07 Noodles, Instant
Date Published: 01/14/2021

Desc: Maggi 2 Minute Noodles Masala
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredient list does not meet the requirements in 21 CFR 101.4 and 101.22. Section 403(q) of the Act [21 U.S.C. §343(q)] because the labels appear to include nutrition information; however, the labels do not appear to include a Nutrition Facts label which meets the requirements in 21 CFR 101.9. The nutrition information appears to be in another country's format, which is not permitted. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains artificial coloring and fails to bear labeling stating that fact. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages.

kishwan snacks ltd
Date Published : 06/08/2023
397, Sk. Mujib Road, Pathantooly , Agrabad , Chittagong, BD-10 BANGLADESH
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL.

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL.


BELGIUM


Sunnyland
Date Published : 08/05/2015
Everdongenlaan 12 , Turnhout, Antwerp BELGIUM
21 V - - 04 Guava, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/05/2015

Desc: Guava Juice Drink
Notes: The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine. The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. Published on 08/05/2015

21 V - - 05 Mango, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/05/2015

Desc: Mango Juice Drink
Notes: Problem(s): The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. Published on 08/05/2015

21 V - - 19 Lychee, Lichee, Litchi, Leechee, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/05/2015

Desc: Lychee Juice Drink
Notes: Problem(s): The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.. Published on 08/05/2015

W Cup Bvba
Date Published : 02/12/2016
De Weven 15 , Beringenberingen, BELGIUM
40 E - - 40 Fruit Flavored Drink
Date Published: 02/12/2016

Desc: Recovery Drink Grapefruit
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement.

40 E - - 40 Fruit Flavored Drink
Date Published: 02/12/2016

Desc: Recovery Drink Orange
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/12/2016

Desc: Recovery Drink Grapefruit
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 02/12/2016

Desc: Recovery Drink Orange
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement.


BOLIVIA


Import & Export Santa Catalina INC.
Date Published : 10/02/2015
Av. Petrolera Km. 4 1/2 # 1358 , Av. Ayacucho # 127 , Cochabamba, BO-C BOLIVIA
28 A - - 45 Spearmint, Whole (Spice)
Date Published: 10/02/2015

Desc: Spearmint Leaves
Notes: Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C, calcium, and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8)(ii) 10/31/07

31 K - - 99 Tea, N.E.C.
Date Published: 10/02/2015

Desc: Q'uillquina (Dried herbs for tea)
Notes: Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C; calcium; and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8) (ii) 10/31/07


BRAZIL


Amafil Ind. Com. Alimentos Ltda
Date Published : 07/24/2023
Estrada Para Cianorte Lote 294-A , Sao Lourenco Distrito de Cianorte , Cianorte, Parana BRAZIL
02 B - - 01 Corn, Bolted Meal or Flour
Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 B - - 02 Corn, Plain Meal
Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). Section 403(a)(1) of the Act in that the labeling is misleading because it fails to state a material fact [see section 201(n) of the Act (21 U.S.C. § 321(n))]. The principal display panel includes the term “bacon”, which appears to be the characterizing flavor, but the product does not appear to contain bacon as an ingredient and the label does not indicate that the characterizing flavor, bacon, appears to be artificial.

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Baiana’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Picanha Picante’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Carne Seca’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Suave’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR101.15(c)(2)). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term "Acidulant citric acid" and "Preservative potassium sorbate" are not declared in accordance with 21 CFR 101.4. The term “acidulant” is not part of the common or usual name of citric acid. The term “preservative” is not part of the common or usual name of potassium sorbate; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Galinha com Pequi’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient

02 E - - 13 Wheat Flour, Whole
Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Suave’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR101.15(c)(2)). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Carne Seca’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). Section 403(a)(1) of the Act in that the labeling is misleading because it fails to state a material fact [see section 201(n) of the Act (21 U.S.C. § 321(n))]. The principal display panel includes the term “bacon”, which appears to be the characterizing flavor, but the product does not appear to contain bacon as an ingredient and the label does not indicate that the characterizing flavor, bacon, appears to be artificial.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Baiana’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Galinha com Pequi’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term "Acidulant citric acid" and "Preservative potassium sorbate" are not declared in accordance with 21 CFR 101.4. The term “acidulant” is not part of the common or usual name of citric acid. The term “preservative” is not part of the common or usual name of potassium sorbate; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Polvilho de Mandioca Especial para Pao de Queijo/Cassava Starch Special Cheese Bread
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 01 Tapioca Starch Product
Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Picanha Picante’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Picanha Picante’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Galinha com Pequi’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Polvilho de Mandioca Especial para Pao de Queijo/Cassava Starch Special Cheese Bread
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Suave’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR101.15(c)(2)). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). Section 403(a)(1) of the Act in that the labeling is misleading because it fails to state a material fact [see section 201(n) of the Act (21 U.S.C. § 321(n))]. The principal display panel includes the term “bacon”, which appears to be the characterizing flavor, but the product does not appear to contain bacon as an ingredient and the label does not indicate that the characterizing flavor, bacon, appears to be artificial.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Baiana’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Carne Seca’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term "Acidulant citric acid" and "Preservative potassium sorbate" are not declared in accordance with 21 CFR 101.4. The term “acidulant” is not part of the common or usual name of citric acid. The term “preservative” is not part of the common or usual name of potassium sorbate; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

02 H - - 05 Wheat Starch
Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

03 C - - 99 Breads, Rolls, Buns, Etc N.E.C. Prepared Dry Mix Without Milk or Egg
Date Published: 07/24/2023

Desc: Polvilho de Mandioca Especial para Pao de Queijo/Cassava Starch Special Cheese Bread
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

03 S - - 01 Cake Prepared Dry Mix Without Custard or Cream Filling
Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

03 Y - - 09 Tortillas
Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Suave’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR101.15(c)(2)). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). Section 403(a)(1) of the Act in that the labeling is misleading because it fails to state a material fact [see section 201(n) of the Act (21 U.S.C. § 321(n))]. The principal display panel includes the term “bacon”, which appears to be the characterizing flavor, but the product does not appear to contain bacon as an ingredient and the label does not indicate that the characterizing flavor, bacon, appears to be artificial.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Baiana’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Picanha Picante’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Carne Seca’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Flavor designation ‘Galinha com Pequi’ does not appear to be provided in English. Not all the required information is repeated in English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term "Acidulant citric acid" and "Preservative potassium sorbate" are not declared in accordance with 21 CFR 101.4. The term “acidulant” is not part of the common or usual name of citric acid. The term “preservative” is not part of the common or usual name of potassium sorbate; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(i)(1) of the Act in that the label because it contains the same English statement of identity of “Seasoned Cassava Flour”. The use of the same English statement of identity does not appear to be appropriately descriptive term for products with different flavors or varieties. Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)). The terms “natural dye” and “natural colorant” are not part of the common or usual name for the ingredient turmeric (21 CFR 101.22(a)), and part of the common or usual name for any color ingredient.

05 B - - 01 Corn Grits, Brewers Enriched White or Yellow Corn Grits,Corn Meal Mush, Quick or Instant Cooking
Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

07 Q - - 03 Corn (Whole Kernel) Snacks, Vegetable Snacks (Other than Pulses) Baked
Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product labels do not fulfill the prominence of required statements (21 CFR 101.3 and 21 CFR 101.15). Section 403(q) of the Act. Nutrition Facts Panel is not in correct format (21 CFR 101.9). The regulation does not provide for including Nutrition Facts information in another country’s format. Section 403(i)(2) of the Act in that the term “synthetic flavoring identical to natural…” is not part of the common or usual name of flavors (21 CFR 101.4 and 101.22). Based on the term “synthetic,” this ingredient appears to be an artificial flavor. The vegetable fat ingredient does not list the fat’s vegetable source (21 CFR 101.4(b)(14). The term “flavor enhancer” is not part of the common or usual name for the ingredient monosodium glutamate (21 CFR 101.22(h)(5)). The ingredient “antioxidant butylhydroxytoluene (BHT)” is not declared in accordance with 21 CFR 101.4. The term “antioxidant” is not part of the common or usual name of “BHT”; however, it is the description of the function of this preservative (21 CFR 101.22(j)).

Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda
Date Published : 05/14/2020
Rua Alcidio Paganelli, 412 , Bebedouro, Sao Paulo BRAZIL
36 C - - 04 Honey
Date Published: 05/14/2020

Desc: Compound of Honey Propolis Extract and Ginger Spray
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

36 C - - 04 Honey
Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Mallow Spray
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

36 C - - 04 Honey
Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Pomegranate Spray
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/14/2020

Desc: Brazilian Guarana Supplement in capsules
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g). Your Brazilian Guarana Supplement in capsules product label includes a statement of identity as a "Supplement." The term "dietary supplement" may be modified by replacing the term "dietary" with the name of a dietary ingredient or ingredients or an appropriately descriptive term indicating the type of dietary ingredients that are in the product. However, the term "Supplement" is not appropriate because it does not identify or describe the dietary ingredients or combination of ingredients that the dietary supplement product supplies (see 62 FR 49826, 49827).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/14/2020

Desc: Compound of Honey Propolis Extract and Ginger Spray
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Pomegranate Spray
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/14/2020

Desc: Brazilian Guarana Supplement in powder (50g and 100g)
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.; Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Mallow Spray
Notes: Products are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a complete physical domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21CFR101.36 and 21CFR101.4. Products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21CFR101.9(b) and 21CFR101.12(b) Products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21CFR101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

Brassuco Industria de Produtos Alimenticios LTDA
Date Published : 12/05/2017
Avenida Doutor Ermelindo Maffei, 814 , Itu, Sao Paulo BRAZIL
33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate)
Date Published: 12/05/2017

Desc: Crushed Peanut Candy
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false and misleading. Specifically, the outer container label declares "Includes 0g Added Sug.;" however, the ingredient statement declares sugar. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the individual unit fails to have all mandatory information in English in accordance with 21 CFR 101.15(c)(1). The individual unit label contains information in a foreign language; it does not appear to be subject to conditions and exemptions provided by 21 CFR 1.24(a)(14) because each individual unit appears to have a bar code; and, the outer container label does not appear to have all mandatory labeling statements in the foreign language. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the net weight on the outer container label does not appear to be accurate; the lid declares 1kg in the foreign declaration, but the English declaration states 30g/1.05oz.; and, the nutrition information states that each unit is 15g and that there are 67 servings per container, which equals 1005g, which is closer to the amount provided in the foreign language.

COOCASTEL
Date Published : 12/13/2019
Rua Frederico Grassmann, 3556 , Sao Jose Dos Pinhais, Parana BRAZIL
02 G - - 99 Flours and Meals N.E.C.
Date Published: 12/13/2019

Desc: Banana flour
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)]. Nutrition Facts label is not in accordance with 21 CFR 101.9(c)(8)(ii). The label makes the claim, "containing high level of vitamin B6"; however, vitamin B6 is not listed in the Nutrition Facts. [21 CFR 101.9(c)(8)(iv]. Vitamin B6 must be sufficient for the label to qualify to bear the claim, 21 CFR 101.13(b) and 21 CFR 101.54. Vitamins A and C are not declared [21 CFR 101.9(c)(8)(ii)]. Missing 'servings per container' and fat as "fat, total," or "total fat," and combines the %DV for saturate fat and trans-fat, which is not permitted. Missing "dietary fiber," and lists nutrients in incorrect order. [21 CFR 101.9(c) and (d)]. The Nutrition Facts label fails to bear the correct footnote as listed in 21 CFR 101.9(d)(9). The statement, "*5% or less is a little, 15% or more is a lot," which is not permitted. The Nutrition Facts label not formatted correctly. 21 CFR 101.9 does not provide for another country's nutrition label on products sold in the US. Section 403(r)(1)(A). The website Jardimdegaia.com, listed on the product label, bears the claim "very rich in antioxidants." Claim does not comply with 21 CFR 101.54(g). "Antioxidant" must include the nutrient source and reference daily intake (RDI) must have been established (21 CFR 101.54(g)(1), and the nutrients must have recognized antioxidant activity (21 CFR 101.54(g)(2). Each nutrient must be sufficient to qualify for claim under 21 CFR 101.54(b), (c), or (e), (21 CFR 101.54(g)(3). "Antioxidant" must include names of the nutrients in the claim or, "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk), followed by the name ofnutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)].

General Mills - Cambara Plant
Date Published : 08/04/2017
Highway BR 369, KM 17/18 , Santa Amalia , Cambara, Parana BRAZIL
03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 08/04/2017

Desc: Corn Chips Ham Flavored (Yokitos)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Label) does not meet the requirements of 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label by the common or usual name as required by 21 CFR 101.4. The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in multiple languages, but does not repeat all the required information in all languages.

07 A - - 02 Corn Chips, Baked
Date Published: 08/04/2017

Desc: Corn Chips Ham Flavored (Yokitos)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Label) does not meet the requirements of 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label by the common or usual name as required by 21 CFR 101.4. The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in multiple languages, but does not repeat all the required information in all languages.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 08/04/2017

Desc: Corn Chips Ham Flavored (Yokitos)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Label) does not meet the requirements of 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label by the common or usual name as required by 21 CFR 101.4. The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in multiple languages, but does not repeat all the required information in all languages.

Industrial E Comercial Jandaia Ltda
Date Published : 10/02/2015
Br 53 , Pacajus, Ceara BRAZIL
21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 10/02/2015

Desc: Acerola Juice
Notes: Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09

Industrial E Comercial Jandaia Ltda
Date Published : 10/02/2015
Br 53 , Pacajus, Ceara BRAZIL
21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 10/02/2015

Desc: Acerola Juice
Notes: Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09

PIRAQUE
Date Published : 12/16/2016
Rua Leopoldino De Oliveira, 335 , Turiacu , Rio De Janeiro, Rio de Janeiro BRAZIL
03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 12/16/2016

Desc: Sesame Crackers - Piraque Agua Gerglim
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3 as follows: They appear to be misbranded per 403(f) of the Act [21 U.S.C. §343(f)]. Products fail to declare net quantity (NQ) in English (21 CFR 101.15(c)(1)). Statements of identity and NQ not declared on PDP (21 CFR 101.15(a)(1)). They appear to be misbranded per 403(q) of the Act [21 U.S.C. §343(q)]. Nutrition Facts Label fails to meet requirements in 21 CFR 101.9. • Products fail to declare Serving Size and Servings per Container (per 21 CFR 101.9(b)). • Labels fail to meet requirements in 21 CFR 101.9(c)(1)(ii). • Label formatting issues include rounding Calories for Tot. Fat, Sat.Fat, Diet. fiber, and Protein. • No "Not significant quantity" statement provided for % DV trans fat in 21 CFR 101.9(c)(2)(ii). • A N/A statement is not provided for Cholesterol, Sugars, Vitamins and Minerals in 21 CFR 101.9(c)(3); 101.9(c)(6)(ii); 101.9(c)(8). • "Total carbohydrate" and "Protein" are incorrectly declared (21 CFR 101.9(c) (7)). • The footnote "Percent daily values are based on a 2000-calorie die[t]" is provided for foods with 40 or less square inch area. Based on net wt., these products do not qualify for the exemption in 21 CFR 101.9(j)(13)(ii)(C). They appear to be misbranded per 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that they are made from two or more ingredients which are not declared by the common or usual names (21 CFR 101.4). • Light Salted Crackers declare "rich wheat flour". If ingredient is enriched wheat flour, it needs to comply with 21 CFR 137.165. • Sesame Crackers and Guava Filling Cookies declare "wheat flour enriched". The label fails to declare thiamin, riboflavin, and niacin (21 CFR 137.165). • "vegetable fat" must be declared by the specific vegetable (21 CFR 101.4(b) (14)). • Sesame Crackers declare "Bicarbonate partner". Guava Filling Cookies declare "invertide sugar" and "maize starch".

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 12/16/2016

Desc: Guava Filling Cookie - Piraque Roladinho Goiabinha
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3 as follows: They appear to be misbranded per 403(f) of the Act [21 U.S.C. §343(f)]. Products fail to declare net quantity (NQ) in English (21 CFR 101.15(c)(1)). Statements of identity and NQ not declared on PDP (21 CFR 101.15(a)(1)). They appear to be misbranded per 403(q) of the Act [21 U.S.C. §343(q)]. Nutrition Facts Label fails to meet requirements in 21 CFR 101.9. • Products fail to declare Serving Size and Servings per Container (per 21 CFR 101.9(b)). • Labels fail to meet requirements in 21 CFR 101.9(c)(1)(ii). • Label formatting issues include rounding Calories for Tot. Fat, Sat.Fat, Diet. fiber, and Protein. • No "Not significant quantity" statement provided for % DV trans fat in 21 CFR 101.9(c)(2)(ii). • A N/A statement is not provided for Cholesterol, Sugars, Vitamins and Minerals in 21 CFR 101.9(c)(3); 101.9(c)(6)(ii); 101.9(c)(8). • "Total carbohydrate" and "Protein" are incorrectly declared (21 CFR 101.9(c) (7)). • The footnote "Percent daily values are based on a 2000-calorie die[t]" is provided for foods with 40 or less square inch area. Based on net wt., these products do not qualify for the exemption in 21 CFR 101.9(j)(13)(ii)(C). They appear to be misbranded per 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that they are made from two or more ingredients which are not declared by the common or usual names (21 CFR 101.4). • Light Salted Crackers declare "rich wheat flour". If ingredient is enriched wheat flour, it needs to comply with 21 CFR 137.165. • Sesame Crackers and Guava Filling Cookies declare "wheat flour enriched". The label fails to declare thiamin, riboflavin, and niacin (21 CFR 137.165). • "vegetable fat" must be declared by the specific vegetable (21 CFR 101.4(b) (14)). • Sesame Crackers declare "Bicarbonate partner". Guava Filling Cookies declare "invertide sugar" and "maize starch".

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 12/16/2016

Desc: Light Salted Crackers - Piraque Cream Crackers Light
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3 as follows: They appear to be misbranded per 403(f) of the Act [21 U.S.C. §343(f)]. Products fail to declare net quantity (NQ) in English (21 CFR 101.15(c)(1)). Statements of identity and NQ not declared on PDP (21 CFR 101.15(a)(1)). They appear to be misbranded per 403(q) of the Act [21 U.S.C. §343(q)]. Nutrition Facts Label fails to meet requirements in 21 CFR 101.9. • Products fail to declare Serving Size and Servings per Container (per 21 CFR 101.9(b)). • Labels fail to meet requirements in 21 CFR 101.9(c)(1)(ii). • Label formatting issues include rounding Calories for Tot. Fat, Sat.Fat, Diet. fiber, and Protein. • No "Not significant quantity" statement provided for % DV trans fat in 21 CFR 101.9(c)(2)(ii). • A N/A statement is not provided for Cholesterol, Sugars, Vitamins and Minerals in 21 CFR 101.9(c)(3); 101.9(c)(6)(ii); 101.9(c)(8). • "Total carbohydrate" and "Protein" are incorrectly declared (21 CFR 101.9(c) (7)). • The footnote "Percent daily values are based on a 2000-calorie die[t]" is provided for foods with 40 or less square inch area. Based on net wt., these products do not qualify for the exemption in 21 CFR 101.9(j)(13)(ii)(C). They appear to be misbranded per 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that they are made from two or more ingredients which are not declared by the common or usual names (21 CFR 101.4). • Light Salted Crackers declare "rich wheat flour". If ingredient is enriched wheat flour, it needs to comply with 21 CFR 137.165. • Sesame Crackers and Guava Filling Cookies declare "wheat flour enriched". The label fails to declare thiamin, riboflavin, and niacin (21 CFR 137.165). • "vegetable fat" must be declared by the specific vegetable (21 CFR 101.4(b) (14)). • Sesame Crackers declare "Bicarbonate partner". Guava Filling Cookies declare "invertide sugar" and "maize starch".

Santa Helena Industria de Alimentos S.A.
Date Published : 01/10/2018
Rua Paraguai 1275 , Ribeirao Preto, Sao Paulo BRAZIL
23 B - - 07 Peanut, Shelled
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

23 B - - 07 Peanut, Shelled
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate)
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate)
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate)
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate)
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate)
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate)
Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate)
Date Published: 01/10/2018

Desc: Pacoquita Peanut Candy Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate)
Date Published: 01/10/2018

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

Sucos Do Brasil S/A
Date Published : 10/02/2015
Br Km 116 54 , Pacajus, Ceara BRAZIL
21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 10/02/2015

Desc: Acerola Juice
Notes: Product is misbranded within the meaning of Section 403(f) of the Act in that the Principal Display Panel does not bear a statement of identity in English as required by 21 CFR 101.15(c). Product is further misbranded within the meaning of Section 403(q) in that the Nutrition Facts information is not in the appropriate format as defined in 21 CFR 101.9. Product is also misbranded within the meaning of section 403(i)(2) in that the label fails to list each ingredient in the ingredient statement as required by 21 CFR 101.4(a)(1). 9/18/09

Vale D'Ouro Importacao & Exportacao S/A
Date Published : 12/13/2016
Rua Armindo Correa 77 , Planalto , Formiga, Minas Gerais BRAZIL
03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 12/13/2016

Desc: Sweet Cookies - Vale D'ouro Doce
Notes: The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(f) of the Act 21 U.S.C. 343(f). Labels contain information in foreign languages, but do not repeat all required information in all languages. All required information appears to be in the foreign language as required under 21 CFR 101.15(c)(2); however, the statement of identity is not provided in English. ; The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(1) of the Act 21 U.S.C. 343(i)(1). Product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).; The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(q) of the Act 21 U.S.C. 343(q). Nutrition information (e.g. Nutrition Facts Label) does not meet requirements under 21 CFR 101.9.; Product labels do not appear to declare calcium and iron as required under 21 CFR 101.9(c)(8)(ii) and it does not appear that the firm is using the simplified format (21 CFR 101.9(f)) or one of the formatting options permitted under 21 CFR 101.9(c)(2)(ii) and 101.9(c)(8)(iii).; Product labels appear to declare a percent Daily Value for calories on the line following "Valor Energetico 126 kcal 531 kJ." There are no provisions in 21 CFR 101.9(c) for the declaration of a percent daily value for calories. ; The nutrients declared on the product labels are not declared in the correct order as required by 21 CFR 101.9(c).; Product labels have formatting issues such as bolding, indentation, missing hairlines, the use of commas instead of decimals, and rounding. ;The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act 21 U.S.C. 343 (i)(2). They are fabricated from two or more ingredients.

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 12/13/2016

Desc: Salted Cookies - Vale D'ouro Tradicional
Notes: The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(f) of the Act 21 U.S.C. 343(f). Labels contain information in foreign languages, but do not repeat all required information in all languages. All required information appears to be in the foreign language as required under 21 CFR 101.15(c)(2); however, the statement of identity is not provided in English. ; The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(1) of the Act 21 U.S.C. 343(i)(1). Product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).; The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(q) of the Act 21 U.S.C. 343(q). Nutrition information (e.g. Nutrition Facts Label) does not meet requirements under 21 CFR 101.9.; Product labels do not appear to declare calcium and iron as required under 21 CFR 101.9(c)(8)(ii) and it does not appear that the firm is using the simplified format (21 CFR 101.9(f)) or one of the formatting options permitted under 21 CFR 101.9(c)(2)(ii) and 101.9(c)(8)(iii).; Product labels appear to declare a percent Daily Value for calories on the line following "Valor Energetico 126 kcal 531 kJ." There are no provisions in 21 CFR 101.9(c) for the declaration of a percent daily value for calories. ; The nutrients declared on the product labels are not declared in the correct order as required by 21 CFR 101.9(c).; Product labels have formatting issues such as bolding, indentation, missing hairlines, the use of commas instead of decimals, and rounding. ;The articles are subject to refusal pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act 21 U.S.C. 343 (i)(2). They are fabricated from two or more ingredients


BULGARIA


Philicon-97 S.A.
Date Published : 03/30/2020
Komatevsko Shose Blvd. 35 , Plovdiv, Plovdiv BULGARIA
20 K - - 06 Orange, Citrus Fruit Juices or Concentrates
Date Published: 03/30/2020

Desc: Orange Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Specifically, the labeling is false or misleading, due to the product labels bearing the term "fresh" on the label. This product does not qualify to bear a "fresh" claim because the product is pasteurized.

20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 03/30/2020

Desc: Apple Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Specifically, the labeling is false or misleading, due to the product labels bearing the term "fresh" on the label. This product does not qualify to bear a "fresh" claim because the product is pasteurized.

21 V - - 07 Pineapple, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 03/30/2020

Desc: Pineapple Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Specifically, the labeling is false or misleading, due to the product labels bearing the term "fresh" on the label. This product does not qualify to bear a "fresh" claim because the product is pasteurized.


BURMA (MYANMAR)


Golden Crow Shwe Kyee
Date Published : 03/15/2018
282 Magway St. Ind. Zone, Ward 23. S. , Rangoon, Rangoon BURMA (MYANMAR)
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 03/15/2018

Desc: Special Dried Butter Cake
Notes: Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(f) of the FD&C Act in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2)


CAMEROON


Brasseries du Cameroun
Date Published : 10/02/2015
BP 4036 , Douala, CM-LT CAMEROON
21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates
Date Published: 10/02/2015

Desc: Fruit Cocktail Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));

29 B - - 04 Soft Drink, Mixed Fruit Flavored, Carbonated
Date Published: 10/02/2015

Desc: Fruit Cocktail Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));

Dessco International Company Cameroon
Date Published : 10/02/2015
Carrefour Mosque, Quartier Rail , Douala , Bonaberi, CAMEROON
20 K - - 02 Grapefruit, Citrus Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: Grapefruit Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);

21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates
Date Published: 10/02/2015

Desc: Fruit Cocktail Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));

29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 10/02/2015

Desc: Grapefruit Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);

29 B - - 04 Soft Drink, Mixed Fruit Flavored, Carbonated
Date Published: 10/02/2015

Desc: Fruit Cocktail Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));

Les Brasseries du Cameroun SABC
Date Published : 10/02/2015
Balli , Douala, CAMEROON
21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates
Date Published: 10/02/2015

Desc: Fruit Cocktail Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));

29 B - - 04 Soft Drink, Mixed Fruit Flavored, Carbonated
Date Published: 10/02/2015

Desc: Fruit Cocktail Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because all required label information for the product is in a foreign language; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) because the Statement of Identity is not expressed as the common or usual name of the food in accordance with 101.3(b)(2). In addition, the Statement of Identity should be in lines generally parallel to the base on which the package rests. (21 CFR 101.3 (d));

UNION CAMEROUNAISES BRASSERIES
Date Published : 10/02/2015
Rue Bassa 56 , Douala, CAMEROON
20 K - - 02 Grapefruit, Citrus Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: Grapefruit Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);

29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 10/02/2015

Desc: Grapefruit Drink
Notes: Violation(s): The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because there is no Nutrition Facts information provided. (21 CFR 101.9(a)(l)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product contains color additives which are not declared by their common or usual names or otherwise declared according to the requirements of 21 CFR 101.22(k)(l); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product depicts a grapefruit and declares grapefruit extract in the Composition statement. A product that depicts a fruit on the labeling and contains fruit juice must declare the percentage of the fruit juice by the words "Contains _ percent (or %)__juice" or " _ percent (or %) juice" (21 CFR 101.30(b)(I)); The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) because the product lists citric acid and sodium benzoate, but does not describe the function of the additives in accordance with 21 CFR 101.220. If a food contains an added chemical preservative, the label must state both the common or usual name of the ingredients and a separate description of its function, e.g., "preservative"; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(l) because the label does not provide the name and place of business of the manufacturer, packer, or distributer as in accordance with 21 CFR 101.5(a);


CANADA


1965599 ONTARIO LTD.
Date Published : 09/20/2022
1-6360 Hawthorne Dr , Windsor, Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/20/2022

Desc: DEBLOATING - DIGESTION
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(1) in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(i)(2) in that the product label fails to declare the ingredient list immediately below the nutrition label in accordance with 21 CFR 101.4(g). Section 403(q)(1)(A) because the serving size declared on the label is incorrect. Section 403(q)(1)(B) because the label fails to list the servings per container under the serving size on the left-hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii). Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

BC HARVEST FOODS INC
Date Published : 02/22/2017
111-1551 Broadway St , Port Coquitlam, British Columbia CANADA
29 B - - 99 Carbonated Soft Drink, N.E.C.
Date Published: 02/22/2017

Desc: Yogurt Soda - Ziziphora (Kakooti)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading. For example, the Nutrition Facts label states that the product contains 455 mg of Sodium and 25% of the Daily Value for Calcium. FDA analytical results for these nutrients found sodium at 151% (original analysis) and 145% (check analysis) which is in excess of the value for that nutrient declared on the label [21 CFR 101.9(g)(5)]. The sample result also showed the Calcium at 43.2% (original analysis) and 39.2% (check analysis) which is not at least equal to 80 percent of the value for the nutrient declared on the label [21 CFR 101.9(g)(4)(ii).] ;Article is subject to refusal pursuant to section 801(a)(3) in that it appears to be misbranded within section 403(f) of the FD&C Act because it contains information in multiple languages; therefore, all required information must be in all languages (i.e., the English language as well as all foreign languages). For example, the Nutrition Facts label must be declared in both the foreign languages and English as required by 21 CFR 101.15(c)(2). ;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

BELIEVE SUPPLEMENTS
Date Published : 01/31/2024
405 Omer-Deserres St , Blainville, Quebec CANADA
21 T - - 07 Pineapple, Dried or Paste
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

21 T - - 07 Pineapple, Dried or Paste
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

Believe Supplements
Date Published : 01/31/2024
719 Boulevard Industriel , Suite 104 , Blainville, Quebec CANADA
21 T - - 07 Pineapple, Dried or Paste
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

21 T - - 07 Pineapple, Dried or Paste
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act because the unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(q) of the Act in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. Label declares dietary ingredients with amounts that are zero or can be declared as zero, or a % Daily Value less than 2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) (21 CFR 101.36(b)(2)(i)). Dietary ingredient quantitative amount by weight per serving in metric units must be in accordance with 21 CF 101.36(b)(3)(ii)(A). The % Daily Value for iron fails to be declared to the nearest whole percent (21 CFR 101.36(b)(2)(iii)(C)). The dietary ingredient sodium fails to be placed before potassium in accordance with 21 CFR 101.36(b)(2)(i)(B). Supplement Facts labels should not display a heavy bar following the declaration of protein; this bar must be replaced with a hairline. Section 403(i)(2) of the Act in that these product labels fail to declare the common and usual name of an ingredient. Bitter Gourd is not a standardized common name noted in Herbs of Commerce. A botanical must be declared by its standardized common name (SCN), or in the absence of a SCN, the Latin binomial name of the botanical (21 CFR 101.4(h) and 21 CFR 101.36(b)(3)).

Celex Laboratories Inc.
Date Published : 08/15/2022
115-21600 Westminster Hwy , Richmond, British Columbia CANADA
54 B - - 07 Iron (Mineral)
Date Published: 08/15/2022

Desc: VORST IRON
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is misleading because it fails to state a material fact and Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/15/2022

Desc: VORST IRON
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is misleading because it fails to state a material fact and Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient.

Desi Mills Inc
Date Published : 10/02/2015
Unknown , Markham, Ontario CANADA
02 F - - 02 Farina, Wheat
Date Published: 10/02/2015

Desc: Suji Fine Farina Wheat
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

02 F - - 99 Wheat, Milled Product, N.E.C.
Date Published: 10/02/2015

Desc: Pearled Soft White Winter Wheat
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 A - - 19 Adzuki beans
Date Published: 10/02/2015

Desc: Adzuki Beans
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

24 A - - 20 Chana Dal
Date Published: 10/02/2015

Desc: Chana Dal
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 A - - 51 Peas
Date Published: 10/02/2015

Desc: Yellow Split Peas
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

24 E - - 70 Lentils, Bean and Pea Sprouts
Date Published: 10/02/2015

Desc: Red Lentils
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 E - - 70 Lentils, Bean and Pea Sprouts
Date Published: 10/02/2015

Desc: Brown Lentils
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 E - - 70 Lentils, Bean and Pea Sprouts
Date Published: 10/02/2015

Desc: Mooth Whole Haleen Mix Mixed Lentils
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)
Date Published: 10/02/2015

Desc: Crushed Chili
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

Desi Mills Inc
Date Published : 10/02/2015
Unknown , Markham, Ontario CANADA
02 F - - 02 Farina, Wheat
Date Published: 10/02/2015

Desc: Sui Fine Farina Wheat
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

02 F - - 99 Wheat, Milled Product, N.E.C.
Date Published: 10/02/2015

Desc: Pearled Soft White Winter Wheat
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 A - - 19 Adzuki beans
Date Published: 10/02/2015

Desc: Adzuki Beans
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

24 A - - 20 Chana Dal
Date Published: 10/02/2015

Desc: Chana Dal
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 A - - 51 Peas
Date Published: 10/02/2015

Desc: Yellow Split Peas
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

24 E - - 70 Lentils, Bean and Pea Sprouts
Date Published: 10/02/2015

Desc: Mooth Whole Haleen Mix Mixed Lentils
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 E - - 70 Lentils, Bean and Pea Sprouts
Date Published: 10/02/2015

Desc: Red Lentils
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

24 E - - 70 Lentils, Bean and Pea Sprouts
Date Published: 10/02/2015

Desc: Brown Lentils
Notes: VIOLATION; The following product(s) Pearled Soft White Winter Wheat; Chana Dal; Mooth Whole Haleen Mix (Mixed Lentils); Red and Brown Lentils fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading.

28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)
Date Published: 10/02/2015

Desc: Crushed Chili
Notes: VIOLATION; The following product(s) Adzuki Beans; Crushed Chili; Yellow Split Peas and Suji Fine Farina Wheat fails to declare calcium and iron as per 21 CFR 101.9(g)(4)(ii) ;in that; the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore; these articles are misbranded within the meaning of section 403(a) of the ACT; in that; the labels are false or misleading. Also; these articles are further misbranded within the meaning of section 403 of the ACT; in that; the labels fails to contain an ingredient statement as required under 21 CFR 101.4

HERBALAND NATURALS INC
Date Published : 11/10/2022
13330 Maycrest Way , Richmond, British Columbia CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) because the product label bears the nutrient content claim “low sugar”, but the product does not meet the requirements to make such a claim.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) because the product label bears the nutrient content claim “low sugar”, but the product does not meet the requirements to make such a claim.

Herbaland Naturals Inc
Date Published : 11/10/2022
12340 Horseshoe Way , Richmond, British Columbia CANADA
54 A - - 99 Vitamin, N.E.C.
Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

ITN Food
Date Published : 02/02/2024
40 Commander Boulevard , Toronto, ON CANADA
28 A - - 70 Pomegranate (Spice)
Date Published: 02/02/2024

Desc: KALONJI POWDER Nigella Seeds Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act of the Act in that the product label fails to declare nutrition information in accordance with 21 CFR 101.9. Product description commonly transmitted as: “KLAUNJI” and “KLAUNJI GROUND”.

28 B - - 99 Spices, Ground, Cracked, Etc., N.E.C.
Date Published: 02/02/2024

Desc: KALONJI POWDER Nigella Seeds Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act of the Act in that the product label fails to declare nutrition information in accordance with 21 CFR 101.9. Product description commonly transmitted as: “KLAUNJI” and “KLAUNJI GROUND”.

28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C.
Date Published: 02/02/2024

Desc: TANDOORI MASALA PASTE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because the label declares the ingredient “oil” and “xanthan,” but they are not appropriate common or usual name for the ingredient per 21 CFR 101.4(a).

37 K - - 23 Curry Paste
Date Published: 02/02/2024

Desc: TANDOORI MASALA PASTE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because the label declares the ingredient “oil” and “xanthan,” but they are not appropriate common or usual name for the ingredient per 21 CFR 101.4(a).

37 K - - 99 Pastes, n.e.c.
Date Published: 02/02/2024

Desc: TANDOORI MASALA PASTE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because the label declares the ingredient “oil” and “xanthan,” but they are not appropriate common or usual name for the ingredient per 21 CFR 101.4(a).

Jamieson Laboratories
Date Published : 03/27/2015
2 St Clair Ave W 16 Th Floor , Toronto, Ontario CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/27/2015

Notes: Jamieson Calcium Magnesium Caplets NOTE: The article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(s)(2) (B)of the Act [21 U.S.C. 343 §(s)(2)(B)]in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement." Except that the word "dietary" may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product 921 CFR 101.3 (g)). The article appears to be misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343 (y)] because the label does not bear an accurate domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. The article appears to be misbranded within the meaning of section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that the package does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5;Jamieson Calcium Magnesium Caplets;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1)(B) because the labeling bears an unauthorized health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F) .The article appears to be misbranded within the meaning of section 403(i) (2) of the Act [21 U.S.C.§ 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Published on 03/31/2015

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/27/2015

Desc: Jamieson Calcium Magnesium Caplets
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(s)(2) (B)of the Act [21 U.S.C. 343 ?(s)(2)(B)]in that the label of the dietary supplement fails to identify the product by using the term ?dietary supplement.? Except that the word ?dietary? may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product 921 CFR 101.3 (g)). The article appears to be misbranded within the meaning of 403(y) of the Act [21 U.S.C. ? 343 (y)]because the label does not bear an accurate domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. The article appears to be misbranded within the meaning of section 403(e)(1) [21 U.S.C. ? 343(e)(1)] in that the package does not contain the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) (B) because the labeling bears an unauthorized health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F) in that the nutrition labeling The article appears to be misbranded within the meaning of section 403(i) (2) of the Act [21 U.S.C.§ 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Published on 03/31/2015

LES PRODUITS DE JARDIN DE GAIA
Date Published : 12/13/2019
7225 Marconi St Suite 101 , Montreal, Quebec CANADA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 12/13/2019

Desc: Banana flour
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)]. Nutrition Facts label is not in accordance with 21 CFR 101.9(c)(8)(ii). The label makes the claim, "containing high level of vitamin B6"; however, vitamin B6 is not listed in the Nutrition Facts. [21 CFR 101.9(c)(8)(iv]. Vitamin B6 must be sufficient for the label to qualify to bear the claim, 21 CFR 101.13(b) and 21 CFR 101.54. Vitamins A and C are not declared [21 CFR 101.9(c)(8)(ii)]. Missing 'servings per container' and fat as "fat, total," or "total fat," and combines the %DV for saturate fat and trans-fat, which is not permitted. Missing "dietary fiber," and lists nutrients in incorrect order. [21 CFR 101.9(c) and (d)]. The Nutrition Facts label fails to bear the correct footnote as listed in 21 CFR 101.9(d)(9). The statement, "*5% or less is a little, 15% or more is a lot," which is not permitted. The Nutrition Facts label not formatted correctly. 21 CFR 101.9 does not provide for another country's nutrition label on products sold in the US. Section 403(r)(1)(A). The website Jardimdegaia.com, listed on the product label, bears the claim "very rich in antioxidants." Claim does not comply with 21 CFR 101.54(g). "Antioxidant" must include the nutrient source and reference daily intake (RDI) must have been established (21 CFR 101.54(g)(1), and the nutrients must have recognized antioxidant activity (21 CFR 101.54(g)(2). Each nutrient must be sufficient to qualify for claim under 21 CFR 101.54(b), (c), or (e), (21 CFR 101.54(g)(3). "Antioxidant" must include names of the nutrients in the claim or, "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk), followed by the name ofnutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)].

Magnum Nutraceuticals Inc
Date Published : 03/31/2017
19278 25 Ave , Surrey, British Columbia CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/31/2017

Desc: Magnum Instincts
Notes: Section 403(q)(1)(A) of the Act in that the serving size declared on the label is incorrect. The serving size identified in the Supplement Facts label is "1 capsule." However; the recommended Dose states to "Take 1 ? 2 capsule." Section 403(q)(1)(B) of the Act in that the label fails to list the correct number of servings per container. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g.; root; leaves) from which each botanical dietary ingredient in the product is derived. Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient. The use of the registered trademark name "Carnosyn" is not the common or usual name for the ingredient beta alanine and "P.E." is not defined. Sections 403(e)(1) and (2); 403(i)(1) and (2); 403(q)(5)(F); 403(s)(2)(B) ; and 403(y) of the Act because the label of the blister pack does not meet the exemptions from required label statements.

Masi Bardi
Date Published : 04/13/2016
4677 9th Ave W , Vancouver, British Columbia CANADA
31 K - - 99 Tea, N.E.C.
Date Published: 04/13/2016

Desc: 14 Day Detox Tea
Notes: The label fails to bear nutrition information required under 21 CFR 101.9. The labeling; and website used to promote the product; steepwellness.com; bear numerous nutrient content claims which preclude the use of the exemption located in 21 CFR 101.9(j)(4). [21 CFR 101.13(n)]. The website bears antioxidant nutrient content claims but fails to comply with the requirements for using such claims. Nutrient content claims using the term "antioxidant" must comply with; among other requirements; the requirements listed in 21 CFR 101.54(g). "[N]atural source" is not a defined nutrient content claim; but even if it was synonymous with "good source"; the product would not qualify for this claim.

31 M - - 01 Tea With Fruit (peels, chunks, bits or pieces)
Date Published: 04/13/2016

Desc: 14 Day Detox Tea
Notes: The label fails to bear nutrition information required under 21 CFR 101.9. The labeling; and website used to promote the product; steepwellness.com; bear numerous nutrient content claims which preclude the use of the exemption located in 21 CFR 101.9(j)(4). [21 CFR 101.13(n)]. The website bears antioxidant nutrient content claims but fails to comply with the requirements for using such claims. Nutrient content claims using the term "antioxidant" must comply with; among other requirements; the requirements listed in 21 CFR 101.54(g). "[N]atural source" is not a defined nutrient content claim; but even if it was synonymous with "good source"; the product would not qualify for this claim. ;

31 M - - 99 Blended Teas, N.E.C.
Date Published: 04/13/2016

Desc: 14 Day Detox Tea
Notes: The label fails to bear nutrition information required under 21 CFR 101.9. The labeling; and website used to promote the product; steepwellness.com; bear numerous nutrient content claims which preclude the use of the exemption located in 21 CFR 101.9(j)(4). [21 CFR 101.13(n)]. The website bears antioxidant nutrient content claims but fails to comply with the requirements for using such claims. Nutrient content claims using the term "antioxidant" must comply with; among other requirements; the requirements listed in 21 CFR 101.54(g). "[N]atural source" is not a defined nutrient content claim; but even if it was synonymous with "good source"; the product would not qualify for this claim. ;

31 P - - 99 Tea Substitutes, N.E.C.
Date Published: 04/13/2016

Desc: 14 Day Detox Tea
Notes: The label fails to bear nutrition information required under 21 CFR 101.9. The labeling; and website used to promote the product; steepwellness.com; bear numerous nutrient content claims which preclude the use of the exemption located in 21 CFR 101.9(j)(4). [21 CFR 101.13(n)]. The website bears antioxidant nutrient content claims but fails to comply with the requirements for using such claims. Nutrient content claims using the term "antioxidant" must comply with; among other requirements; the requirements listed in 21 CFR 101.54(g). "[N]atural source" is not a defined nutrient content claim; but even if it was synonymous with "good source"; the product would not qualify for this claim. ;

Naturally Splendid Enterprises Ltd
Date Published : 10/02/2015
108-19100 Airport Way , Pitt Meadows, British Columbia CANADA
18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/02/2015

Desc: Hemp Protein Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)of the Act because the nutrition facts information does not meet the requirements specified in 21 CFR 101.9. Deficiencies were noted relating to the serving size; servings per container; declaration of saturated fat and trans fat; % daily value for protein; and statements in the nutrition label not provided for in 21 CFR 101.9. In addition; the product label lacks the name and place of business of the manufacturer; packer; or distributor as required by 21 CFR 101.5(a) and the net weight content failed to declare in avoirdupois pounds/ounces as required by 21 CFR 101.105(b)(1).

41 G - - 02 Nutrtionally Incomplete Formulations (Protein, carbohydrate or fat modulars)
Date Published: 10/02/2015

Desc: Hemp Protein Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)of the Act because the nutrition facts information does not meet the requirements specified in 21 CFR 101.9. Deficiencies were noted relating to the serving size; servings per container; declaration of saturated fat and trans fat; % daily value for protein; and statements in the nutrition label not provided for in 21 CFR 101.9. In addition; the product label lacks the name and place of business of the manufacturer; packer; or distributor as required by 21 CFR 101.5(a) and the net weight content failed to declare in avoirdupois pounds/ounces as required by 21 CFR 101.105(b)(1).

54 C - - 99 Protein N.E.C.
Date Published: 10/02/2015

Desc: Hemp Protein Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)of the Act because the nutrition facts information does not meet the requirements specified in 21 CFR 101.9. Deficiencies were noted relating to the serving size; servings per container; declaration of saturated fat and trans fat; % daily value for protein; and statements in the nutrition label not provided for in 21 CFR 101.9. In addition; the product label lacks the name and place of business of the manufacturer; packer; or distributor as required by 21 CFR 101.5(a) and the net weight content failed to declare in avoirdupois pounds/ounces as required by 21 CFR 101.105(b)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Hemp Protein Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)of the Act because the nutrition facts information does not meet the requirements specified in 21 CFR 101.9. Deficiencies were noted relating to the serving size; servings per container; declaration of saturated fat and trans fat; % daily value for protein; and statements in the nutrition label not provided for in 21 CFR 101.9. In addition; the product label lacks the name and place of business of the manufacturer; packer; or distributor as required by 21 CFR 101.5(a) and the net weight content failed to declare in avoirdupois pounds/ounces as required by 21 CFR 101.105(b)(1).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Desc: Hemp Protein Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)of the Act because the nutrition facts information does not meet the requirements specified in 21 CFR 101.9. Deficiencies were noted relating to the serving size; servings per container; declaration of saturated fat and trans fat; % daily value for protein; and statements in the nutrition label not provided for in 21 CFR 101.9. In addition; the product label lacks the name and place of business of the manufacturer; packer; or distributor as required by 21 CFR 101.5(a) and the net weight content failed to declare in avoirdupois pounds/ounces as required by 21 CFR 101.105(b)(1).

Nestle Canada, Inc. - North York Head Office
Date Published : 03/27/2015
1700-25 Sheppard Ave W , North York, Ontario CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/27/2015

Notes: Nestle Materna Pre-natal-Postpartum Vitamin & Mineral Supplement NOTE: The article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) in that the label contains added iron for use as an iron source, but the label of the product fails to bear the warning statement as required by 21CFR 101.17€: " WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison center immediately." The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F). Published on 03/31/2015

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/27/2015

Desc: Nestle Materna Pre-natal-Postpartum Vitamin & Mineral Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) in that the label contains added iron for use as an iron source; but the label of the product fails to bear the warning statement as required by 21CFR 101.17?; ? WARNING; Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose; call a doctor or poison center immediately. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F). Published on 03/31/2015

Newco Enterprise Inc.
Date Published : 10/02/2015
402-5793 10th St NE , Calgary, Alberta CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/02/2015

Desc: Brocco Gen 10 Sulforaphane Glucosinolate Capsules Dietary Supplements
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that the label or labeling appears to be misbranded; in that it fails to bear the required nutrition information [Misbranded; 403(q)(5)(F)]; it fails to bear the common or usual name of the food [Misbranded; 403(i)(1)]; and it fails to bear the common or usual name of the ingredients [Misbranded; 403(i)(2)].

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Desc: Brocco Gen 10 Sulforaphane Glucosinolate Capsules Dietary Supplements
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that the label or labeling appears to be misbranded; in that it fails to bear the required nutrition information [Misbranded; 403(q)(5)(F)]; it fails to bear the common or usual name of the food [Misbranded; 403(i)(1)]; and it fails to bear the common or usual name of the ingredients [Misbranded; 403(i)(2)].

Norcan Seeds,Inc.
Date Published : 05/02/2016
Ne5-24-1w , Fisher Branch, Manitoba CANADA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

23 R - - 20 Flax Seed (Edible Seed Paste)
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

71 L - - 99 Oilseed Byprod N.E.C.
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

71 Y - - 99 Byprod For Animal, N.E.C.
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

NuEra Nutraceutical Inc
Date Published : 08/16/2017
12031 No. 5 Rd , Richmond, British Columbia CANADA
54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals
Date Published: 08/16/2017

Desc: REDSENOL-1 CAPSULES
Notes: The product appears to be misbranded within the meaning of: (1) Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] in that the serving size is not an amount customarily consumed. (2) Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. (3) Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labeling does not include a statement of identity as a dietary supplement per 21 CFR 101.3(g). (4) Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). (5) Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label is not in accord with 21 CFR 101.36. (6) Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e, Panax ginseng, in the product is derived, as required by 21 CFR 101.4(h)(1).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/16/2017

Desc: REDSENOL-1 CAPSULES
Notes: The product appears to be misbranded within the meaning of: (1) Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] in that the serving size is not an amount customarily consumed. (2) Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. (3) Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labeling does not include a statement of identity as a dietary supplement per 21 CFR 101.3(g). (4) Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). (5) Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label is not in accord with 21 CFR 101.36. (6) Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e, Panax ginseng, in the product is derived, as required by 21 CFR 101.4(h)(1).

Nutracrea Inc.
Date Published : 06/14/2023
486 Bergeron St , Sainte-Eulalie, Quebec CANADA
54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

Omega Alpha Pharmaceuticals
Date Published : 07/06/2020
795 Pharmacy Ave , Scarborough, Ontario CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/06/2020

Desc: Aeolus Lung Cleanse
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/06/2020

Desc: Lung Flush
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/06/2020

Desc: Maculex
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/06/2020

Desc: Aeolus Lung Cleanse
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/06/2020

Desc: Maculex
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/06/2020

Desc: Lung Flush
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2020

Desc: Maculex
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2020

Desc: Lung Flush
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2020

Desc: Aeolus Lung Cleanse
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

PROVITA NUTRITION AND HEALTH INC
Date Published : 04/18/2023
1102-1225 Kingsway Ave , Port Coquitlam, British Columbia CANADA
54 E - - 91 Boswellia (Herbal & Botanical Teas)
Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)), in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. In that the article appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)], in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). In that it appears appear to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

54 F - - 50 Hawthorn (Herbal & Botanicals, not Teas)
Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

54 F - - 58 Saw Palmetto (Herbal & Botanicals, not Teas)
Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)), in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. In that the article appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)], in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). In that it appears appear to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)), in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. In that the article appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)], in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). In that it appears appear to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)), in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. In that the article appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)], in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). In that it appears appear to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)), in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. In that the article appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)], in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). In that it appears appear to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)], in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. §343(y)], in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

Pharmalab 1982 Inc. Dba. Ideal Protein
Date Published : 02/14/2023
8750 Guillaume-Couture Blvd , Levis, Quebec CANADA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 02/14/2023

Desc: Ideal Protein; Multi Vita Multi Vitamin and Mineral Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

54 B - - 99 Mineral N.E.C.
Date Published: 02/14/2023

Desc: Ideal Protein; Multi Vita Multi Vitamin and Mineral Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/14/2023

Desc: Ideal Protein; Multi Vita Multi Vitamin and Mineral Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. § 343(q)] in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Pharmaline
Date Published : 12/10/2021
2835 Argentia Rd Unit 5 , Mississauga, Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/10/2021

Desc: FULVIC CARE POWDER
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food Drug, and Cosmetic Act (FD&C Act) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. The product does not contain the declared amount of vitamin C. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (q) in that the label or labeling fails to bear the required nutrition information For example, the product label fails to declare the amount of potassium using the correct unit of measure given in 21 CFR 101.9(c)(8)(iv) as required by 21 CFR 101.36(b)(2)(ii)(B). The article appears to be misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because it fails to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii). The article appears to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to correctly declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(r)(1)(A)/(B) in that the label or labeling bears an unauthorized nutrient content/health claim Specifically, the label claims “This product is an excellent source of organic fulvic acid, humic acid, trace minerals, electrolytes, & antioxidants.” Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Polar Foods,Inc.
Date Published : 05/02/2016
Ne5-24-1w , Fisher Branch, MB CANADA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

23 R - - 20 Flax Seed (Edible Seed Paste)
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

71 L - - 99 Oilseed Byprod N.E.C.
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

71 Y - - 99 Byprod For Animal, N.E.C.
Date Published: 05/02/2016

Desc: Flax meal
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is misbranded for claiming regular meal instead screening meal. The definition of flaxseed screenings meal can be found on page 442, in Section 71: Other Oilseed Products, of the AAFCO 2016 Official Publication.

QPharm Inc
Date Published : 08/11/2017
4-1000 Bishop St N , Cambridge, Ontario CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 08/11/2017

Desc: Health Supplement Rhoziva
Notes: Sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act because the label of each multi- unit container does not meet the exemptions from required label statements. Specifically, the label of each multi-unit container does not bear: 1) the name and place of business of the manufacturer, packer, or distributor, 2) the common or usual name of each ingredient), and 3) nutrition information. The unit container is exempt from these requirements if the unit container bears the statement "This Unit Not Labeled for Retail Sale" [21 CFR 1.24(a)(14)]. Section 403(e)(2) of the Act because the multi-unit label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(s)(2)(B) of the Act because the multi-unit container fails to include a statement of identity as a dietary supplement as required by 21 CFR 101.3(g). Section 403(y) of the Act because the multi-unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement.

RHEMA HEALTH PRODUCTS Limited
Date Published : 10/11/2022
601-19055 Airport Way , Pitt Meadows, British Columbia CANADA
41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/11/2022

Desc: Meal Replacement Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the actual amounts of vitamin B3 (niacin) and vitamin B6 in the product are less than the declared value on the label. Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)], in that the labeling bears unauthorized nutrient content claims. Specifically, the statement: “Packed full of Antioxidants” is not one of the recognized terms for claims specified in 21 CFR 101.54 (b), (c), or (e) and does not identify the nutrients subject of the claim as required by 21 CFR 101.54(g). Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to the nutrient content claim for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4.

Rubicon Food Prod
Date Published : 09/27/2019
5-2220 Midland Ave , Scarborough, Ontario CANADA
21 V - - 04 Guava, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 09/27/2019

Desc: GUAVA DRINK
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in accordance with 21 CFR 101.9. The product label fails to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b), Table 2] and in a common household measure [21 CFR 101.9(b)(5)]. Saturated fat and trans fat values may not be declared with a combined %DV. The use of "Fat," "trans," and "Saturated" are not provided for under 21 CFR 101.9(c). Fiber is spelled incorrectly for the English version of the nutritional information. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in three languages, English, French, and Spanish; therefore, all required information must be in all three languages (i.e., the English language as well as the foreign languages).

21 V - - 05 Mango, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 09/30/2019

Desc: MANGO DRINK
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in accordance with 21 CFR 101.9. The product label fails to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b), Table 2] and in a common household measure [21 CFR 101.9(b)(5)]. Saturated fat and trans fat values may not be declared with a combined %DV. The use of "Fat," "trans," and "Saturated" are not provided for under 21 CFR 101.9(c). Fiber is spelled incorrectly for the English version of the nutritional information. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in three languages, English, French, and Spanish; therefore, all required information must be in all three languages (i.e., the English language as well as the foreign languages).

21 V - - 12 Passion Fruit, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 09/27/2019

Desc: PASSION DRINK
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in accordance with 21 CFR 101.9. The product label fails to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b), Table 2] and in a common household measure [21 CFR 101.9(b)(5)]. Saturated fat and trans fat values may not be declared with a combined %DV. The use of "Fat," "trans," and "Saturated" are not provided for under 21 CFR 101.9(c). Fiber is spelled incorrectly for the English version of the nutritional information. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in three languages, English, French, and Spanish; therefore, all required information must be in all three languages (i.e., the English language as well as the foreign languages).

21 V - - 19 Lychee, Lichee, Litchi, Leechee, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 09/27/2019

Desc: LYCHEE DRINK
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in accordance with 21 CFR 101.9. The product label fails to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b), Table 2] and in a common household measure [21 CFR 101.9(b)(5)]. Saturated fat and trans fat values may not be declared with a combined %DV. The use of "Fat," "trans," and "Saturated" are not provided for under 21 CFR 101.9(c). Fiber is spelled incorrectly for the English version of the nutritional information. The calories declaration for the Lychee Drink is not in accordance with 21 CFR 101.9(c)(1). Calories are to be declared in 10-calorie increments when above 50 calories. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in three languages, English, French, and Spanish; therefore, all required information must be in all three languages (i.e., the English language as well as the foreign languages).

SNAKE BRANDS INC
Date Published : 06/15/2020
25 Glenside Dr Sw , Calgary, Alberta CANADA
54 B - - 11 Potassium (Mineral)
Date Published: 06/15/2020

Desc: ELECTROLYTE POWDER - SNAKE JUICE
Notes: Food labeling violations associated with labeling/websites of the shipper in the entry, Snake Brands, not with the manufacturer in the entry. The article (outer package and individual packet) is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: • Section 403(y) [21 U.S.C. § 343(y)] of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person. • Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the common or usual name of the food is not declared in accordance with 21 CFR 101.3(d). • Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labeling is false or misleading. • Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

STAY WYLD ORGANICS LTD
Date Published : 07/27/2022
1911 Hwy 99 , Pemberton, BC CANADA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2022

Desc: Immunity Boost Capsules
Notes: Section 403(r)(1)(A) of the FD&C Act in that the label or labeling bears an unauthorized nutrient content/health claim. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. section 403(s)(2)(B) of the FD&C Act in that the label of the dietary supplement fails to identify the product by using the term “dietary supplement”. Section 403(y) of the FD&C Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(f) of the FD&C Act because the product labels contain information in two languages but do not repeat all the required information in both languages.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2022

Desc: Cordyceps Militaris Capsules/ Powder
Notes: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(e)(2) of the FD&C Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2022

Desc: Daily Immunity Mushroom Blend Capsules
Notes: Section 403(r)(1)(A) of the FD&C Act in that the label or labeling bears an unauthorized nutrient content/health claim. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. section 403(s)(2)(B) of the FD&C Act in that the label of the dietary supplement fails to identify the product by using the term “dietary supplement”. Section 403(y) of the FD&C Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(f) of the FD&C Act because the product labels contain information in two languages but do not repeat all the required information in both languages.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2022

Desc: Reishi Mushroom Capsules
Notes: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(e)(2) of the FD&C Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2022

Desc: Chaga Mushroom Capsules/Powder
Notes: Section 403(r)(1)(A) of the FD&C Act in that the label or labeling bears an unauthorized nutrient content/health claim. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(e)(2) of the FD&C Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2022

Desc: Turkey Tail Mushroom Capsules/Powder
Notes: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(e)(2) of the FD&C Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/27/2022

Desc: Lions Mane Mushroom Capsules/Powder
Notes: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(e)(2) of the FD&C Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA).

Skjodt-Barrett Foods
Date Published : 10/16/2018
5 Precidio Crt , Brampton, Ontario CANADA
21 F - - -- Mixed Fruit Purees
Date Published: 08/30/2019

Notes: Organic Slammers Banana strawberry Acai; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of; Section 403(a)(1) of the Act [21 U.S.C. ? 343(a)(1)] in that the labels are false or misleading. Specifically

40 E - - 20 Mixed Fruit (Baby)
Date Published: 08/30/2019

Notes: Organic Slammers Banana strawberry Acai; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Vitamin C content is not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)].

40 E - - 20 Mixed Fruit (Baby)
Date Published: 04/01/2019

Desc: Banana Pumpkin Organic Baby Food
Notes: This product is misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading. Specifically, the Vitamin A content is not equal to the amount declared on the label [21 CFR 101.9(g)(4)(i)].

Soylutions Inc.
Date Published : 10/02/2015
1629 Des Affaires Ave , Quebec, Quebec CANADA
14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 10/02/2015

Desc: Unsweetened Original Hemp Bliss Organic Hemp Milk
Notes: VIOLATION: The nutritional labeling does not comply with 21 CFR 101.54 requirements. The following violations were observed: Label declares that the product is rich in essential nutrients. Rich in is a synonym for high per 21 CFR 101.54(b)(1). The product does not qualify for a high nutrient claim for any nutrients. Label declared "Plus' is a relative nutrient content claim and in order to meet the requirements, the product must contain at least 10% or more of the RDI for vitamins or minerals per reference amount customarily consumed than an appropriate reference food per 21 CFR 101.54(e)(l)(i). -The identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI are not declared in immediate proximity to the most prominent such claim per 21 CFR 101.54(e)(1)(iii).

14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 10/02/2015

Desc: Hemp Dream Hemp Drink
Notes: 9/20/10; update product description 3/15/11 Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the nutrient content of the composite is not at least equal to 80 percent of the value for the nutrient declared on the label for magnesium; as required by 21 CFR 101.9(g)(4)(ii); In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that product fails to qualify for the claim; "Excellent source of... Magnesium" because the analytical findings indicate that the product contains less than 20 percent ofthe DRV per RACC; as required by 21 CFR 101.54(b); In addition; the side panel contains the nutrient content claim "Cholesterol Free" but fails to disclose that cholesterol is not usually present in the food (e.g.; "applesauce; cholesterol-free food") as required by 21 CFR 101.62 (d)(1)(i)(D) and 101.12(e)(2); Lastly; the claims "enriched with Vitamins A; B12; D; and Calcium" appear on the product label but the label does not include the additional information required under 21 CFR 101.54(e)(1) (iii) and 101. 13(j)(2) for relative claims (e.g.; information regarding the reference food);

14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 10/02/2015

Desc: Hemp Dream Hemp Drink
Notes: 9/20/10; update product description 3/15/11 Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the nutrient content of the composite is not at least equal to 80 percent of the value for the nutrient declared on the label for magnesium; as required by 21 CFR 101.9(g)(4) (ii); In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that product fails to qualify for the claim; "Excellent source of... Magnesium" because the analytical findings indicate that the product contains less than 20 percent ofthe DRV per RACC; as required by 21 CFR 101.54(b); In addition; the side panel contains the nutrient content claim "Cholesterol Free" but fails to disclose that cholesterol is not usually present in the food (e.g.; "applesauce; cholesterol-free food") as required by 21 CFR 101.62(d)(1)(i)(D) and 101.12(e)(2); Lastly; the claims "enriched with Vitamins A; B12; D; and Calcium" appear on the product label but the label does not include the additional information required under 21 CFR 101.54(e)(1)(iii) and 101. 13(j)(2) for relative claims (e.g.; information regarding the reference food);

14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 10/02/2015

Desc: Unsweetened Original Hemp Bliss Organic Hemp Milk
Notes: VIOLATION: The nutritional labeling does not comply with 21 CFR 101.54 requirements. The following violations were observed: -Label declares that the product is rich in essential nutrients. Rich in is a synonym for high per 21 CFR 101.54(b)(1). The product does not qualify for a high nutrient claim for any nutrients. - Label declared "Plus' is a relative nutrient content claim and in order to meet the requirements, the product must contain at least 10% or more of the RDI for vitamins or minerals per reference amount customarily consumed than an appropriate reference food per 21 CFR 101.54(e)(l)(i). -The identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI are not declared in immediate proximity to the most prominent such claim per 21 CFR 101.54(e)(1)(iii).

Wn Pharmaceuticals
Date Published : 10/02/2015
2000 Brigantine Dr , Coquitlam, British Columbia CANADA
54 Y - - 08 Coenzyme Q10 (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 10/02/2015

Desc: OMEGA-3 & CoQ10 WITH PLANT STEROLS
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the product is misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. ?343(q)(5)(F)] because the presentation of the nutrition information on the product labeling does not comply with 21 CFR 101.36.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate
Notes: The product appears to be misbranded within the meaning of; (1) section 403 (q)(5)(F) of the Act because it fails to present nutrition information in a Supplement Facts panel as required by 21 CFR 101.36 (e). Furthermore; it appears that glucosamine sulfate is a dietary ingredient in the product. However; the nutrition information does not clearly identify the source of the dietary ingredient as required by 21 CFR 101.36(d)(1) and 101.4(a)(1) and (g) and (2) section 403(s)(2)(B) because it fails to include a statement of identity as a dietary supplement; as required by 21 CFR 101.3(g).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: OMEGA-3 & CoQ10 WITH PLANT STEROLS
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the product is misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. ?343(q)(5)(F)] because the presentation of the nutrition information on the product labeling does not comply with 21 CFR 101.36.

55 P - - 01 Glucosamine (Pharmaceutic Necessity)
Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate
Notes: The product appears to be misbranded within the meaning of; (1) section 403(q)(5)(F) of the Act because it fails to present nutrition information in a Supplement Facts panel as required by 21 CFR 101.36 (e). Furthermore; it appears that glucosamine sulfate is a dietary ingredient in the product. However; the nutrition information does not clearly identify the source of the dietary ingredient as required by 21 CFR 101.36(d)(1) and 101.4(a)(1) and (g) and (2) section 403(s)(2)(B) because it fails to include a statement of identity as a dietary supplement; as required by 21 CFR 101.3(g).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate
Notes: The product appears to be misbranded within the meaning of; (1) section 403(q)(5)(F) of the Act because it fails to present nutrition information in a Supplement Facts panel as required by 21 CFR 101.36 (e). Furthermore; it appears that glucosamine sulfate is a dietary ingredient in the product. However; the nutrition information does not clearly identify the source of the dietary ingredient as required by 21 CFR 101.36(d)(1) and 101.4(a)(1) and (g) and (2) section 403(s)(2)(B) because it fails to include a statement of identity as a dietary supplement; as required by 21 CFR 101.3(g).


CHILE


Nestle Chile S.A.
Date Published : 07/21/2017
Ave. Las Condes No. 11.287 , Comuna de Las Condes , Santiago, Fca Graneros, CHILE
05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.
Date Published: 07/21/2017

Desc: Oatmeal Cereal Cerevita
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.


CHINA


ANHUI NEW SELECT FOOD S&T DEVELO
Date Published : 03/07/2017
No 30 Yi Feng Rd Anhui , Huaibei, Anhui CHINA
33 M - - 01 Gel Cups, Fruit Flavored
Date Published: 03/07/2017

Desc: Jelly Fruity Snack; Assorted Flavor (Konjac Jelly)
Notes: The products appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 USC 343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The product also appears to be misbranded within the meaning Section 403(f) of the Act [21 USC 343(f)] in that the product labels fail to prominently and conspicuously place necessary information; as required by 21 CFR 1. The product also appears to be misbranded within the meaning of Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

33 M - - 01 Gel Cups, Fruit Flavored
Date Published: 03/07/2017

Desc: Bursting Jelly; Picante (Konjac Jelly)
Notes: The products appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 USC 343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The product also appears to be misbranded within the meaning Section 403(f) of the Act [21 USC 343(f)] in that the product labels fail to prominently and conspicuously place necessary information; as required by 21 CFR 1. The product also appears to be misbranded within the meaning of Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

Beijing Joant Bio-Tech Co., Ltd.
Date Published : 04/06/2015
25 Yanqi Street; Economic Development Zone , Huairou, Beijing CHINA
54 A - - 17 Biotin (Vitamin H, Coenzyme R)
Date Published: 04/06/2015

Desc: Biotin
Notes: Notes(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(a)(1) in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed samples of the Calcium soft capsule to determine whether the label accurately reflects the nutrition content of the products. The Calcium soft capsule Production Plan Form states that the product provides 1000 mg/capsule. However, FDA analysis found the calcium content in the firm's Calcium soft capsule product to be 22.9% (original analysis) and 23.9% (check analysis) of the amount set in the Production Plan Form. In addition, Section 403(i)(2) as the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, the product label does not have an ingredient statement

54 E - - 48 Ginkgo biloba (Herbal & Botanical Teas)
Date Published: 04/06/2015

Desc: Gingkgo Biloba
Notes: Notes(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(a)(1) in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed samples of the Calcium soft capsule to determine whether the label accurately reflects the nutrition content of the products. The Calcium soft capsule Production Plan Form states that the product provides 1000 mg/capsule. However, FDA analysis found the calcium content in the firm's Calcium soft capsule product to be 22.9% (original analysis) and 23.9% (check analysis) of the amount set in the Production Plan Form. In addition, Section 403(i)(2) as the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, the product label does not have an ingredient statement. In addition, Section 403(e)(1) in that it fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d).

54 E - - 58 Saw Palmetto (Herbal & Botanical Teas)
Date Published: 04/06/2015

Desc: Saw Palmetto
Notes: Notes(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(a)(1) in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed samples of the Calcium soft capsule to determine whether the label accurately reflects the nutrition content of the products. The Calcium soft capsule Production Plan Form states that the product provides 1000 mg/capsule. However, FDA analysis found the calcium content in the firm's Calcium soft capsule product to be 22.9% (original analysis) and 23.9% (check analysis) of the amount set in the Production Plan Form. In addition, Section 403(i)(2) as the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, the product label does not have an ingredient statement. In addition, Section 403(e)(1) in that it fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d).

54 F - - 48 Ginkgo biloba (Herbal & Botanicals, not Teas)
Date Published: 04/06/2015

Desc: Gingkgo Biloba
Notes: Notes(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(a)(1) in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed samples of the Calcium soft capsule to determine whether the label accurately reflects the nutrition content of the products. The Calcium soft capsule Production Plan Form states that the product provides 1000 mg/capsule. However, FDA analysis found the calcium content in the firm's Calcium soft capsule product to be 22.9% (original analysis) and 23.9% (check analysis) of the amount set in the Production Plan Form. In addition, Section 403(i)(2) as the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, the product label does not have an ingredient statement. In addition, Section 403(e)(1) in that it fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d).

54 F - - 58 Saw Palmetto (Herbal & Botanicals, not Teas)
Date Published: 04/06/2015

Desc: Saw Palmetto
Notes: Notes(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(a)(1) in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed samples of the Calcium soft capsule to determine whether the label accurately reflects the nutrition content of the products. The Calcium soft capsule Production Plan Form states that the product provides 1000 mg/capsule. However, FDA analysis found the calcium content in the firm's Calcium soft capsule product to be 22.9% (original analysis) and 23.9% (check analysis) of the amount set in the Production Plan Form. In addition, Section 403(i)(2) as the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, the product label does not have an ingredient statement. In addition, Section 403(e)(1) in that it fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/06/2015

Notes: Lycopene;Notes(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(a)(1) in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed samples of the Calcium soft capsule to determine whether the label accurately reflects the nutrition content of the products. The Calcium soft capsule Production Plan Form states that the product provides 1000 mg/capsule. However, FDA analysis found the calcium content in the firm's Calcium soft capsule product to be 22.9% (original analysis) and 23.9% (check analysis) of the amount set in the Production Plan Form. In addition, Section 403(i)(2) as the product is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, the product label does not have an ingredient statement. In addition, Section 403(e)(1) in that it fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d).

CHENGHAI NATIVE PRODUCE IMP.&EXP.COMPANY OF GUANGDONG
Date Published : 10/02/2015
Zhongshan Middle Rd , Chaoyang , Shantou, Guangdong CHINA
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 10/02/2015

Notes: The product is misbranded within the meaning of section 403(e)(1) of the Act because the label fails to include the identity of the place of business as required in 21 CFR 101.5(d); The product is misbranded within the meaning of section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language; In addition; the product fails to list the statement of ingredients on the information panel as required; but instead lists them on the principal display panel; as required by 21 CFR 101.2; In addition; the

Changle Yongxin Food Co., Ltd.
Date Published : 10/02/2015
Liulin Jenfeng , Changle City, Fujian, CHINA
23 A - - 07 Peanut, In Shell
Date Published: 10/02/2015

Desc: Peanuts in Shell
Notes: Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 10/02/2015

Notes: PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07

DALIAN HUALIAN FOOD CO.LTD
Date Published : 02/28/2018
Xinglinsalian 101 , Jia Heyuan 4 ; 2 No.62; Kaifa , Dalian, Liaoning CHINA
16 W - - 27 Stuffed Pasta with mixed seafood products (n.e.c.), Mixed Fishery/Seafood Products
Date Published: 02/28/2018

Desc: Frozen Tuna Dumpling
Notes: Section 403w(1) of the FD&C Act in that the label fails to declare the presence of major food allergens present in the product; namely fish and wheat. Section 403(q) of the FD&C Act in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Section 403(i)(2) of the FD&C Act in that he product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages.

DANDONG JUNAO FOODSTUFF
Date Published : 05/23/2018
No. 96 Pingancun , Fengcheng , Dandong, Liaoning CHINA
24 A - - 13 Soybeans (See Industry 37 for 'Bean Curd')
Date Published: 05/23/2018

Desc: Edamame
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of the following sections of the FD&C Act: Section 403(e)(1) - the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(q) - the nutrition information is not in accordance to 21 CFR 101.9. Specifically, • The label appears to make claims for cholesterol and fatty acids ("cholesterol free" and "low fat"), yet it fails to declare the monounsaturated fat and polyunsaturated fat content as is required by 21 CFR 101.9(c)(2). • The label fails to declare the percent daily value for protein as required by 101.9(c)(7)(i). Section 403(r)(1)(A) - the labeling bears unauthorized nutrient content claims. For example: • "High in fiber"; The dietary fiber content does not meet the 10-19% of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per reference amount customarily consumed. • "[A] good source of Protein...and Isoflavones" is an unauthorized claim because there are no established RDI's or DRV's for this substance. • The label fails to declare a value for Omega-3 alpha-linolenic. • The product does not meet the requirements under 21 CFR 101.62(b) for a "low fat" claim. • The product claims "low sodium" and "cholesterol free", however per 21 CFR 101.13(e)(2), soybeans are naturally this way. Section 403(r)(1)(B) - the label bears an unauthorized health claim. The label has a heart symbol with a checkmark near the nutrient content claims on the product label. This is an implied health claim for cardiovascular disease. This claim does not meet the requirements to make these claims because the required language is not being used.

Dalian Hualian Food Co.,Ltd.
Date Published : 02/28/2018
Wulucun , Wuluzhen Zhuanghe , Dalian, Liaoning CHINA
16 W - - 27 Stuffed Pasta with mixed seafood products (n.e.c.), Mixed Fishery/Seafood Products
Date Published: 02/28/2018

Desc: Frozen Tuna Dumpling
Notes: Section 403w(1) of the FD&C Act in that the label fails to declare the presence of major food allergens present in the product; namely fish and wheat. Section 403(q) of the FD&C Act in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Section 403(i)(2) of the FD&C Act in that he product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages.

Dong Wan Hen Hua Cookies Co., Ltd.
Date Published : 10/02/2015
Sang Yuan Industrial Area,Building26, , Guangdong, CHINA
03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 10/02/2015

Desc: Sesame Cracker (Cookie)
Notes: Charge; 403(q) The product label fails to properly declare the serving size in a common household measured as specified in 21 CFR 101.9(b). The product label fails to declare the serving size based on the appropriate reference amount customarily consumed (RACC). The product label declares the serving size as 100g; however the established RACC for ?Snacks? is 30g as specified in 21 CFR 101.9(b)(2) and 21 CFR 101.12. The product label declares a percent daily value for trans-fat. Charge; 403(i)(2) The label declares Vegetable Oil; however; it fails to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b)(14)). The label declares sucrose; however it fails to list the common or usual name sugar as required by 21 CFR 101.4(b)(20).

FUJIAN RUIYUN FOODS CO.,LTD
Date Published : 01/06/2022
Lianjiang , Fuxi North Road; Fuzhou City , Lianjiang County, Fujian CHINA
16 C - - 56 Filefish, Cakes, Balls, Etc.
Date Published: 01/06/2022

Desc: FISH BALLS (5 LB)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

16 C - - 56 Filefish, Cakes, Balls, Etc.
Date Published: 01/06/2022

Desc: FISH BALLS (14 OZ)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 01/06/2022

Desc: FISH BALLS (5 LB)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 01/06/2022

Desc: FISH BALLS (14 OZ)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

16 W - - 29 Fish Dumplings, Mixed Fishery/Seafood Products
Date Published: 01/06/2022

Desc: FISH BALLS (5 LB)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

16 W - - 29 Fish Dumplings, Mixed Fishery/Seafood Products
Date Published: 01/06/2022

Desc: FISH BALLS (14 OZ)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

Fujian Changle Yongxin Food Co., Ltd
Date Published : 10/02/2015
No. 150 Xin Dong Yang , Jinfengzhen Changle , Fuzhou, Fujian CHINA
23 A - - 07 Peanut, In Shell
Date Published: 10/02/2015

Notes: PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 10/02/2015

Notes: PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b)(1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07

Guangdong Classic Health-Care Products Co. Ltd.
Date Published : 10/02/2015
XingJiang 3rd Road , Heyuan, Guangzhou CHINA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Vitamins (Adipovitamins)
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Food; Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36 ;

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 10/02/2015

Desc: Vitamins (Adipovitamins)
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Food; Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Vitamins (Adipovitamins)
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Food; Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36

Guangzhou Peninsula Food Co., Ltd.
Date Published : 09/25/2019
Ping Dong Industrial Zone , Huadu District , Huashan Town, CHINA
03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 09/25/2019

Desc: Chinese Moon Cake- Red Bean Paste Moon Cake with Tangerines and Nuts
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient as required by 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] because they contain a chemical preservative but fail to state a description of the function, e.g., "preservative", "to retard spoilage", "a mold inhibitor", "to help protect flavor" or "to promote color retention" [21 CFR 101.22(j)].

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 09/25/2019

Desc: Chinese Moon Cake- Red Bean Paste Moon Cake with Tangerines and Nuts
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient as required by 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] because they contain a chemical preservative but fail to state a description of the function, e.g., "preservative", "to retard spoilage", "a mold inhibitor", "to help protect flavor" or "to promote color retention" [21 CFR 101.22(j)].

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 09/25/2019

Desc: Chinese Moon Cake- Red Bean Paste Moon Cake with Tangerines and Nuts
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient as required by 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] because they contain a chemical preservative but fail to state a description of the function, e.g., "preservative", "to retard spoilage", "a mold inhibitor", "to help protect flavor" or "to promote color retention" [21 CFR 101.22(j)].

HANGZHOU XIAOSHAN HEZHUANGSHUCAI JIANGPIN CO., LTD
Date Published : 02/02/2017
43 Zhejiang Xiaoshan , River Town Village , Hangzhou, Zhejiang CHINA
25 L - - 07 Radish, Dried or Paste
Date Published: 02/02/2017

Desc: Dried Vegetable (Dried Radish)
Notes: Article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within section 403(k) of the FD&C Act. Ingredient list declares preservatives but does not declare their function, as is required under 21 CFR 101.22(j). Article is subject to refusal pursuant to section 801(a)(3) as it appears to be misbranded within section 403(q) of the FD&C Act. Nutrition information is not in the correct format as required by 21 CFR 101.9. • Total carbohydrate is declared as 0.3g. A statement of the number of grams of total carbohydrate must be expressed to the nearest gram, except that if a serving contains less than 1 gram, "Contains less than 1 gram" or "less than 1 gram" may be used, or if the serving contains less than 0.5 gram, the content may be expressed as zero [21 CFR 101.9(c)(6)]. • Calorie content is incorrectly declared. For the carbohydrates, fat, and protein amounts declared and the guidelines provided in 21 CFR 101.9(c)(i), the product cannot mathematically provide 100 Calories. • %DV for sodium declared as 108%. Based on the amount of sodium in a serving declared on the label (2180 mg) and the DRV for sodium (2400 mg), the %DV for sodium is incorrect. Article is subject to refusal pursuant to section 801(a)(3) as it appears to be misbranded within section 403(i)(1) of the FD&C Act. Label fails to bear the common or usual name as required by 21 CFR 101.3(b). Article is subject to refusal pursuant to Section 801(a)(3) as it appears to be misbranded within section 403(e)(1) of the FD&C Act. Labeling fails to list the place of business of manufacturer, packer, or distributor as required by 21 CFR 101.5(d).

Hainan Resurgence Natural Healthy F
Date Published : 10/02/2015
105 Numbersof , Guangzhou Cityguangzhou City, CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Fruta Bio Dietary Supplement
Notes: VIOLATION (IN NOTES); 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) in that the label or labeling fails to bear the required nutrition information (e.g.; Nutrition Facts panel).

Haoliyou(shanghai)Food Co
Date Published : 01/25/2022
Qingpu Industrial Park , No. 5151 Waiqingsong Road; Qingpu , Shanghai, Shanghai CHINA
07 A - - 06 Potato Chips,Baked
Date Published: 01/25/2022

Desc: POTATO CHIPS (Honey Flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label or NFL) is not in a correct format as required by 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4(a). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages.

07 B - - 06 Potato Chips,Fried
Date Published: 01/25/2022

Desc: POTATO CHIPS (Honey Flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label or NFL) is not in a correct format as required by 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4(a). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 01/25/2022

Desc: POTATO CHIPS (Honey Flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label or NFL) is not in a correct format as required by 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4(a). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages.

Hubei Minkang Pharmaceutical Co., Ltd.
Date Published : 04/24/2017
NO. 50 Xiba Road , Yichang, Hubei CHINA
54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 04/24/2017

Desc: Circulex Dietary Supplement
Notes: Section 403(y) of the FD&C Act in that the label fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 04/24/2017

Desc: Calmex Tablets
Notes: Section 403(q)(1)(A) of the FD&C Act in that the serving sizes declared on the labels are incorrect.

54 F - - 16 Licorice (Herbal & Botanicals, not Teas)
Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement tablets
Notes: Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients; and each ingredient is not declared on the label by the common or usual name. Section 403(q)(1)(A) of the FD&C Act in that the serving sizes declared on the labels are incorrect.

54 F - - 92 Codonopsis tangshen
Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)
Notes: Section 403(y) of the FD&C Act in that the label fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 92 Codonopsis tangshen
Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)
Notes: Section 403(y) of the FD&C Act in that the label fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/24/2017

Desc: Calmex Tablets
Notes: Section 403(q)(1)(A) of the FD&C Act in that the serving sizes declared on the labels are incorrect.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement tablets
Notes: Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients; and each ingredient is not declared on the label by the common or usual name. Section 403(q)(1)(A) of the FD&C Act in that the serving sizes declared on the labels are incorrect.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/24/2017

Desc: Huang Lian Su Herval Supplement tablets
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients; and each ingredient is not declared on the label by the common or usual name. Section 403(q)(1)(A) of the FD&C Act in that the serving sizes declared on the labels are incorrect.

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)
Notes: Section 403(y) of the FD&C Act in that the label fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)
Notes: Section 403(y) of the FD&C Act in that the label fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

Jiangmen Pengjiang Huiming Trading Company
Date Published : 10/02/2015
Unit A,12/F,Dongxing Ge,Donghua , Building,128 Gangkou Road,China , Jiangmen, CN-NOTA CHINA
23 A - - 07 Peanut, In Shell
Date Published: 10/02/2015

Notes: PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b) (1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07 ;

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 10/02/2015

Notes: PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b) (1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07 ;

Jiangmen Xinhui Green Day Food Co., Ltd
Date Published : 12/02/2020
No. 1 Donggua Hill, Beitou Village, Qibao , Xinhui District , Jiangmen City, Guangdong CHINA
25 S - - 10 Fungus, White, Fungi Products, N.E.C.
Date Published: 01/07/2022

Desc: INDIAN BUEAD
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4(a). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label or NFL) is not in a correct format as required by 21 CFR 101.9.

25 S - - 99 Fungi Products Not Mentioned Elsewhere, N.E.C.
Date Published: 01/07/2022

Desc: INDIAN BUEAD
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4(a). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label or NFL) is not in a correct format as required by 21 CFR 101.9.

33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 J - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 L - - 06 Flavored Candy, Soft (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

Jk Tea Co., Ltd
Date Published : 11/17/2020
No.3 Chun Hong Room 2ST , 803 Baiyundadao; Baiyun , Guangzhou, Guangdong CHINA
31 K - - 02 Tea, Green
Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). The nutrition information on the label does not comply with 21 CFR 101.36. Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

31 K - - 99 Tea, N.E.C.
Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). The nutrition information on the label does not comply with 21 CFR 101.36. Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

31 M - - 99 Blended Teas, N.E.C.
Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). The nutrition information on the label does not comply with 21 CFR 101.36. Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

54 E - - 03 Angelica (Herbals & Botanical Teas)
Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). The nutrition information on the label does not comply with 21 CFR 101.36. Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). The nutrition information on the label does not comply with 21 CFR 101.36. Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). The nutrition information on the label does not comply with 21 CFR 101.36. Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). The nutrition information on the label does not comply with 21 CFR 101.36. Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

Kaiping Qinghui Food Co., Ltd.
Date Published : 07/18/2022
Number 12 Industrial Avenue, New District, Huanggang Town , Kaiping , Jiangmen City, Guangdong Province CHINA
03 A - - 03 Biscuits
Date Published: 07/18/2022

Desc: Binji Ox Ear Biscuits
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size is declared as “1 Serving Per Container” and “100g,” but the net weight of the entire package is only 52g. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Principal Display Panel states the product is an “Ox Ear Biscuit” and the label attached to the information panel says “biscuit.” In North America, a biscuit is a small, typically round cake of bread leavened with baking powder, baking soda, or sometimes yeast. Based on the product images, this product appears to be thin, and maybe even crispy, and does not represent a biscuit product in the US. Additionally, the product does not contain any “ox” ingredient; even if “ox ear” is meant to be descriptive of the product’s shape, we question if the average US consumer would not be misled by the product name as currently declared on the PDP. Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. “Compound antioxidant” does not appear to be an appropriate and specific common or usual name for an ingredient, as required by 21 CFR 101.4(a)(1). The sub-ingredients for the red bean curd sauce include “soy sauce,” which is known to also be a multi-ingredient product; however, the sub-ingredients of the soy sauce are not listed as required by 21 CFR 101.4(b)(2)(i).

Life Rising (Tianjin) Natural Product R&D Center LTD
Date Published : 12/12/2016
# 12 Luyuan Street , Wuqing, Tianjin CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising YANT Throat Support
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising GMD Licorice Wheat & Date Formula
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising B Chest Circulation Support
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen)
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising HB Nose Regulator-H
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising EAR-CALM Ear Calm-DH
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising GH Regulate Liver
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising UT-DBS Urine Tract Cleanser
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising DHT-INT Intestine Support
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising PDL Cool Regulator
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising HWDZ Stomach Regulator
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising PROST-IF Prostate Regulator-IF
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising Qi-Yin Up Energy Support
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/12/2016

Desc: Life Rising HNSH Kidney Herb
Notes: After foreign inspection, CFSAN's review of several of the firm's product labels has determined that these products are misbranded within the meaning of sections 403(y) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, based on the review of the Life Rising DHZC-2 Blood Circulation Regulator (Lower Abdomen), Life Rising GMD Licorice Wheat & Date Formula, Life Rising PDL Cool Regulator, and Life Rising UT-DBS Urine Tract Cleanser product labels, CFSAN has determined that this product is misbranded within the meaning of sections 403(i)(2) in addition to 403(y).

MICO FOODSTUFF CO., LTD
Date Published : 07/18/2022
NO. 806 No3 West 4th Block , Longhu District , Shantou City, Guangdong CHINA
21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

S&A TRADING LIMITED
Date Published : 03/21/2016
Unit 17,5/F,Sing Win Factory BLDG,15-17 , Shing Yip ST.,Kwun Tong,Kowloon,HK , Kowloon, CN-91 CHINA
03 J - - 10 Creme Filled/Iced Cookie,Biscuit,Wafer
Date Published: 03/21/2016

Desc: Milk Biscuits (cookies)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q); 403(i)(2); and 403(f).

SHANDONG GAOTANG HAOJIAJIA FOOD CO.,LTD
Date Published : 10/26/2020
West Of Renhe Road, Gaotang County , Liaocheng, Shandong CHINA
03 A - - 03 Biscuits
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - STRAWBERRY FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(a)(1) of the Act in that the label is false and misleading because the amount of Total Sugars present is greater than 20% in excess than the value for that nutrient declared on the label (21 CFR 101.9(g)(5)). Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

03 A - - 03 Biscuits
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS- SOYMILK FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

03 A - - 03 Biscuits
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - ORIGINAL FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - STRAWBERRY FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(a)(1) of the Act in that the label is false and misleading because the amount of Total Sugars present is greater than 20% in excess than the value for that nutrient declared on the label (21 CFR 101.9(g)(5)). Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS- SOYMILK FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - ORIGINAL FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 S - - 99 Starch Snacks, n.e.c., Baked
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - STRAWBERRY FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(a)(1) of the Act in that the label is false and misleading because the amount of Total Sugars present is greater than 20% in excess than the value for that nutrient declared on the label (21 CFR 101.9(g)(5)). Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 S - - 99 Starch Snacks, n.e.c., Baked
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS- SOYMILK FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 S - - 99 Starch Snacks, n.e.c., Baked
Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - ORIGINAL FLAVOR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

SHANDONG YI QI WANG FOOD CO LTD
Date Published : 10/14/2020
1 West Of Renhe Road , Liaocheng, CHINA
21 V - - 14 Tamarind, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 10/14/2020

Desc: Yogurt Ice Pop Original
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(i)(2)] because all required information does not appear to be presented in all languages on the label (21 CFR 101.15(c)(2)). Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(g) of the Act [21 U.S.C. § 343(g)] because the product purports to be a food for which a definition and standard of identity has been prescribed by regulation, but fail to conform to such definition and standard. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9.

21 V - - 14 Tamarind, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 10/14/2020

Desc: Yogurt Ice Pop Strawberry Flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(i)(2)] because all required information does not appear to be presented in all languages on the label (21 CFR 101.15(c)(2)). Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(g) of the Act [21 U.S.C. § 343(g)] because the product purports to be a food for which a definition and standard of identity has been prescribed by regulation, but fail to conform to such definition and standard.

21 V - - 14 Tamarind, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 10/14/2020

Desc: Yogurt Ice Pop Passion Fruit
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(i)(2)] because all required information does not appear to be presented in all languages on the label (21 CFR 101.15(c)(2)). Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(g) of the Act [21 U.S.C. § 343(g)] because the product purports to be a food for which a definition and standard of identity has been prescribed by regulation, but fail to conform to such definition and standard.

SHANGHAI AB FOOD & BEVERAGES LTD.
Date Published : 10/02/2015
No.8 LANCUN RD.,MINHANG ECON,TECH& , DEV.ZONE , Shanghai, Shanghaishi CHINA
34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Ovaltine
Notes: VIOLATION (IN NOTES): 1. 403(r)(1)(A) ; 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) in that the label or labeling bears an unauthorized nutrient content claim. For example, the label declares that it contains high amounts of calcium and vitamin A. However, based on the serving size information provided, these nutrients are not present at 20 percent or more of the RDI or the DRV per reference amount customarily consumed (RACC) [21 CFR 101.54(b)];2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9. For example: The serving size is not declared in common household measure or common household unit in accordance with 21 CFR 101.9(b)(5); The declaration of Nutrition Information is not presented using the nutrient names specified and in the order and format specified in 21 CFR 101.9(c); The label is not formatted (e.g., bolding, indenting, and rounding) appropriately as specified in 21 CFR 101.9(d);3. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2): The ingredients are not declared in accordance with 21 CFR 101.4. For example, vegetable fat must be declared by its specific common or usual name of the individual vegetable fat in parenthesis [21 CFR 101.4 (b)(14)] and the term acidity regulator (E504i) is not the common or usual name of this ingredient.

SSG (CHINA)
Date Published : 08/14/2017
No. 26 Jianguomen Nei Da Jie , 5th Floor, Beijing News Plaza , Beijing, Tianjin CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/14/2017

Notes: Life Minerals Liquid; Section 403(s)(2)(B) of the Act in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement" in accordance with 21 CFR 101.3(g). Section 403(a)(1) of the Act in that the label is false and misleading in any particular. Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(r)(1)(A) of the Act because the product label bears a nutrient content claim, but fails to meet the requirements to bear the claim. Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that it is fabricated from two or more ingredients but, the product label fails to declare the source ingredient for the listed dietary ingredients as required by 21CFR 101.4(a)(1) and (g). Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages as required by 21CFR 101.15(c).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 08/14/2017

Desc: Life Minerals Liquid
Notes: Section 403(s)(2)(B) of the Act in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement" in accordance with 21 CFR 101.3(g). Section 403(a)(1) of the Act in that the label is false and misleading in any particular. Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(r)(1)(A) of the Act because the product label bears a nutrient content claim, but fails to meet the requirements to bear the claim. Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that it is fabricated from two or more ingredients but, the product label fails to declare the source ingredient for the listed dietary ingredients as required by 21CFR 101.4(a)(1) and (g). Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages as required by 21CFR 101.15(c).

SUZHOU TAISHAN FOOD INDUSTRY CO.,LTD
Date Published : 04/27/2016
Ang,Xiangcheng , No. 168 He South Street; Weitangzhen Xiangcheng , Suzhou, Jiangsu CHINA
23 K - - 04 Sunflower Seed (Edible Seed)
Date Published: 04/27/2016

Desc: Original Flavored Sunflower Seeds
Notes: The product labels fail to declare the net quantity of contents on the PDP in English in U.S. measurements (21 CFR 101.105) followed in parenthesis with the metric equivalent. [15 U.S.C. 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. The product labels display incorrect placement and prominence of the statement of identity that is not in accordance with 21 CFR 101.3. The product labels list no street address of the distributor and no address or city of the manufacturer. We would comment to the firm that the street address may be omitted only if the business is shown in a current city directory or telephone directory [21 CFR 101.5(d)]. The product labels contain a statement "Allergy Information contains sulfite; sun flower seeds (black melon seeds; pumpkin seeds); salt" which is not provided for under Food Allergen Labeling and Consumer Protection Act.

23 K - - 04 Sunflower Seed (Edible Seed)
Date Published: 04/27/2016

Desc: Spicy Flavored Sunflower Seeds
Notes: The product labels fail to declare the net quantity of contents on the PDP in English in U.S. measurements (21 CFR 101.105) followed in parenthesis with the metric equivalent. [15 U.S.C. 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. The product labels display incorrect placement and prominence of the statement of identity that is not in accordance with 21 CFR 101.3. The product labels list no street address of the distributor and no address or city of the manufacturer. We would comment to the firm that the street address may be omitted only if the business is shown in a current city directory or telephone directory [21 CFR 101.5(d)]. The product labels contain a statement "Allergy Information contains sulfite; sun flower seeds (black melon seeds; pumpkin seeds); salt" which is not provided for under Food Allergen Labeling and Consumer Protection Act.

23 K - - 05 Melon Seeds (Edible Seed)
Date Published: 04/27/2016

Desc: Licorice Flavored Melon Seeds
Notes: The product labels fail to declare the net quantity of contents on the PDP in English in U.S. measurements (21 CFR 101.105) followed in parenthesis with the metric equivalent. [15 U.S.C. 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. The product labels display incorrect placement and prominence of the statement of identity that is not in accordance with 21 CFR 101.3. The product labels list no street address of the distributor and no address or city of the manufacturer. We would comment to the firm that the street address may be omitted only if the business is shown in a current city directory or telephone directory [21 CFR 101.5(d)]. The product labels contain a statement "Allergy Information contains sulfite; sun flower seeds (black melon seeds; pumpkin seeds); salt" which is not provided for under Food Allergen Labeling and Consumer Protection Act. The Licorice Melon Seeds (Package & Container) list the incorrect common or usual names for "saccharin sodium" and "potassium acesulfame." The ingredients should be listed as "sodium saccharin" and "acesulfame potassium." (21 CFR 101.4). The amount of calcium (50% DV) declared on the nutrition label for the Licorice Melon Seeds (package and container) appears to be incorrectly declared.

Saint Honore Cake Shop (Shenzhen), Ltd.
Date Published : 12/07/2021
Hengfeng Industrial City , Hezhou, Xixiang , Baoan, Shenzhen, Guandong CHINA
03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Low Sugar Egg Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, they should also be fully labeled in English. Section 403(i)(2), of the Act [21 U.S.C. § 343(i)(2)] because product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the listing for “vegetable oil” must include the vegetable source of the oil. [21 CFR 101.4(b)(14)]

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 12/07/2021

Desc: Moon cake; Double Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m).

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Assorted nuts
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example, this product is labeled to contain “Orange Peel Jam, Rose Wine, Honey Grapefruit Jam” which would appear to themselves be comprised of multiple ingredients (sub-ingredients) which are not listed in the ingredient statement. component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include such as a statement of identity. As such, all required statements should also be present in English.

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Egg Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English.

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Assorted; mini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the listing for “vegetable oil” must include the vegetable source of the oil. [21 CFR 101.4(b)(14)]

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include such as a statement of identity. As such, all required statements should also be present in English.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Low Sugar Egg Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, they should also be fully labeled in English. Section 403(i)(2), of the Act [21 U.S.C. § 343(i)(2)] because product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the listing for “vegetable oil” must include the vegetable source of the oil. [21 CFR 101.4(b)(14)]

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Assorted nuts
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example, this product is labeled to contain “Orange Peel Jam, Rose Wine, Honey Grapefruit Jam” which would appear to themselves be comprised of multiple ingredients (sub-ingredients) which are not listed in the ingredient statement. component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Egg Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Assorted; mini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the listing for “vegetable oil” must include the vegetable source of the oil. [21 CFR 101.4(b)(14)]

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/07/2021

Desc: Moon cake; Double Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m).

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Low Sugar Egg Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, they should also be fully labeled in English. Section 403(i)(2), of the Act [21 U.S.C. § 343(i)(2)] because product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the listing for “vegetable oil” must include the vegetable source of the oil. [21 CFR 101.4(b)(14)]

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 12/07/2021

Desc: Moon cake; Double Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m).

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Assorted; mini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the listing for “vegetable oil” must include the vegetable source of the oil. [21 CFR 101.4(b)(14)]

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Egg Yolk White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; White Lotus Seed Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include such as a statement of identity. As such, all required statements should also be present in English.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 12/07/2021

Desc: Moon Cake; Assorted nuts
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. §343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example, this product is labeled to contain “Orange Peel Jam, Rose Wine, Honey Grapefruit Jam” which would appear to themselves be comprised of multiple ingredients (sub-ingredients) which are not listed in the ingredient statement. component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

Shandong Sunwell Green Food Co., Ltd.
Date Published : 10/02/2015
The Ind. Garden of Shouguang , Weifang, Shandong CHINA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/02/2015

Desc: Mixed Vegetable Chips
Notes: Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/02/2015

Desc: Mixed Vegetable Chips
Notes: Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/02/2015

Desc: Mixed Vegetable Chips
Notes: Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amounts of iron (14%) and potassium (25%) are less than 80% of the declared amounts; Product is further misbranded within the meaning of Section 403(r) (1)(A) in that the product label bears the nutrient content claim ?Excellent source-Vitamin A..? but the % DV for Vitamin A declared in the nutrition label is 6%; Product is also misbranded within the meaning of section 403(r)(1)(A) in that the product label bears the nutrient content claim ?With fewer calories than traditional potato chips..? but does not meet the requirements of 21 CFR 101.60(b)(4) and 21 CFR 101.13(j); Under Section 403(r)(1)(A) the product is misbranded as it bears the nutrient content claim ?healthy? as part of a labeling statement when the product does not meet the requirements for the term healthy under 21 CFR 101.65(d); Product is misbranded within the meaning of section 403(q) in that the serving size declaration is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12; Product is also misbranded within the meaning of 403(q) in that calcium and iron must be declared before Vitamin E as required by 21 CFR 101.9(c)(8).

Shanghai Xin Chen Da Industrial Development Co. Ltd.
Date Published : 02/02/2021
Room 1301, Building 1, No.1318, Zhouzhugong Road , Pudong New Area , Shanghai, Shanghai CHINA
16 A - - 99 Fish, N.E.C.
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

16 W - - 11 Fish fillet sandwiches, Mixed Fishery/Seafood Products
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

16 W - - 15 Fish chowder/soup/stew/bisque, Mixed Fishery/Seafood Products
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

Suzhou MyLand Pharm&Nutrition Inc.
Date Published : 02/12/2016
Hejing Fenghui Internation Suite 20 202 , Wenling Rd; Xiangcheng , Suzhou, Jiangsu CHINA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/12/2016

Desc: Blueberry extract
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice; but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. [Misbranded; Section 403(i)(2)].

Suzhou Shui Tian Tang Food Production Co., Ltd.
Date Published : 02/02/2021
No 11 Guanshan Road , High-Tech District , Suzhou, Jiangsu CHINA
16 A - - 99 Fish, N.E.C.
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

16 W - - 11 Fish fillet sandwiches, Mixed Fishery/Seafood Products
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

16 W - - 15 Fish chowder/soup/stew/bisque, Mixed Fishery/Seafood Products
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

TIANJIN FOODSTUFFS IMP. & EXP. CO., LTD.
Date Published : 05/28/2019
20 Datong Street , Heping , Tianjin, Tianjin CHINA
24 T - - 12 Chinese Cabbage, Celery Cabbage (Leaf & Stem Vegetable)
Date Published: 05/28/2019

Desc: Preserved Vegetables
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). The statement of identity on the principal display panel is "Tianjin Preserved Vegetable," which is not an appropriately descriptive common or usual name nor an appropriately descriptive term. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) does not comply with the requirements of 21 CFR 101.9. Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label's principal display panel fails to bear the net quantity of contents as required by 21 CFR 101.7. Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

24 T - - 99 Leaf & Stem Vegetables, N.E.C.
Date Published: 05/28/2019

Desc: Preserved Vegetables
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). The statement of identity on the principal display panel is "Tianjin Preserved Vegetable," which is not an appropriately descriptive common or usual name nor an appropriately descriptive term. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) does not comply with the requirements of 21 CFR 101.9. Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label's principal display panel fails to bear the net quantity of contents as required by 21 CFR 101.7. Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

Tianjin Medicines & Health Products Import & Export Corp.
Date Published : 01/13/2017
Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao , Tianjin, Tianjin CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/13/2017

Notes: All Dietary Supplements;The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343 (y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the serving size declared on the labels are incorrect.

Tianjin Medicines & Health Products Import & Export Corp.
Date Published : 01/13/2017
Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao , Tianjin, Tianjin CHINA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/13/2017

Notes: All Dietary Supplements; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343 (y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the serving size declared on the labels are incorrect.

Tianjin Zhanhe Vegetable Co.,
Date Published : 10/30/2019
Wuqing District , 8 Xixiaozhuang Village; Chagugang Town , Tianjin City, Tianjin CHINA
03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 10/30/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act 21§343(i)(2)-it is fabricated from two/more ingredients,but fails to declare each one(21CFR101.4).LBL declares "white chocolate" as an ingredient,but fails to list sub ingredients(21CFR101.4(b)(2);"vegetable oil"-if an individual ingredient,it is not declared by its common/usual name and if a blend, it is not declared by their common/usual names(21CFR101.4(b)(14);and "starch acetate" is not declared by its common/usual name. Section 403(f) of the Act (21U.S.C. §343(f)-LBL bears information in a foreign language,but fails to repeat all required information in this language(21CFR101.15(c)(2). Section 403(q) of the Act [21§343(q)-nutrition information is not presented as per 21CFR101.9."Nutrition Facts" must be set the full width of the box (21CFR 101.9(d)(2)."Servings Per Container" is not declared(21 CFR 101.9(d)(3)(ii)."Amount" must be declared as "Amount Per Serving"(21CFR101.9(d)(4).Calories must be expressed to the nearest 10-calorie increment(21CFR101.9(c)(1)."Calories from fat" is not declared (21CFR101.9(c)(1)(ii)."Fat" must be declared as "Fat,total" or "Total fat" and expressed to the nearest gram(21CFR101.9(c)(2).(21 CFR101.9(c)(2)(ii) does not provide for a "+" before "Trans" and %DV cannot be declared for saturated fat and trans-fat combined because there is no DRV established for trans-fat.21CFR101.9 does not provide for the combine %DV declaration for two nutrients."Carbohydrate" must be declared as "Carbohydrate,total" or "Total carbohydrate" and expressed to the nearest gram(21CFR101.9(c)(6)."Fiber" must be declared as "Dietary fiber" and expressed to the nearest gram(21CFR101.9(c)(6)(i).Sugars must be expressed to the nearest gram(21CFR101.9(c)(6)(ii).%DV for Vitamins A/C must be expressed to the nearest 2% increment(21CFR101.9(c)(8)(iii).Footnote is not declared(21CFR101.9(d)

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 10/30/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act 21§343(i)(2)-it is fabricated from two/more ingredients,but fails to declare each one(21CFR101.4).LBL declares "white chocolate" as an ingredient,but fails to list sub ingredients(21CFR101.4(b)(2);"vegetable oil"-if an individual ingredient,it is not declared by its common/usual name and if a blend, it is not declared by their common/usual names(21CFR101.4(b)(14);and "starch acetate" is not declared by its common/usual name. Section 403(f) of the Act (21U.S.C. §343(f)-LBL bears information in a foreign language,but fails to repeat all required information in this language(21CFR101.15(c)(2). Section 403(q) of the Act [21§343(q)-nutrition information is not presented as per 21CFR101.9."Nutrition Facts" must be set the full width of the box (21CFR 101.9(d)(2)."Servings Per Container" is not declared(21 CFR 101.9(d)(3)(ii)."Amount" must be declared as "Amount Per Serving"(21CFR101.9(d)(4).Calories must be expressed to the nearest 10-calorie increment(21CFR101.9(c)(1)."Calories from fat" is not declared (21CFR101.9(c)(1)(ii)."Fat" must be declared as "Fat,total" or "Total fat" and expressed to the nearest gram(21CFR101.9(c)(2).(21 CFR101.9(c)(2)(ii) does not provide for a "+" before "Trans" and %DV cannot be declared for saturated fat and trans-fat combined because there is no DRV established for trans-fat.21CFR101.9 does not provide for the combine %DV declaration for two nutrients."Carbohydrate" must be declared as "Carbohydrate,total" or "Total carbohydrate" and expressed to the nearest gram(21CFR101.9(c)(6)."Fiber" must be declared as "Dietary fiber" and expressed to the nearest gram(21CFR101.9(c)(6)(i).Sugars must be expressed to the nearest gram(21CFR101.9(c)(6)(ii).%DV for Vitamins A/C must be expressed to the nearest 2% increment(21CFR101.9(c)(8)(iii).Footnote is not declared(21CFR101.9(d)

03 D - - 99 Bread, Rolls, Buns, Etc N.E.C. Heat/Serve
Date Published: 10/30/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act 21§343(i)(2)-it is fabricated from two/more ingredients,but fails to declare each one(21CFR101.4).LBL declares "white chocolate" as an ingredient,but fails to list sub ingredients(21CFR101.4(b)(2);"vegetable oil"-if an individual ingredient,it is not declared by its common/usual name and if a blend, it is not declared by their common/usual names(21CFR101.4(b)(14);and "starch acetate" is not declared by its common/usual name. Section 403(f) of the Act (21U.S.C. §343(f)-LBL bears information in a foreign language,but fails to repeat all required information in this language(21CFR101.15(c)(2). Section 403(q) of the Act [21§343(q)-nutrition information is not presented as per 21CFR101.9."Nutrition Facts" must be set the full width of the box (21CFR 101.9(d)(2)."Servings Per Container" is not declared(21 CFR 101.9(d)(3)(ii)."Amount" must be declared as "Amount Per Serving"(21CFR101.9(d)(4).Calories must be expressed to the nearest 10-calorie increment(21CFR101.9(c)(1)."Calories from fat" is not declared (21CFR101.9(c)(1)(ii)."Fat" must be declared as "Fat,total" or "Total fat" and expressed to the nearest gram(21CFR101.9(c)(2).(21 CFR101.9(c)(2)(ii) does not provide for a "+" before "Trans" and %DV cannot be declared for saturated fat and trans-fat combined because there is no DRV established for trans-fat.21CFR101.9 does not provide for the combine %DV declaration for two nutrients."Carbohydrate" must be declared as "Carbohydrate,total" or "Total carbohydrate" and expressed to the nearest gram(21CFR101.9(c)(6)."Fiber" must be declared as "Dietary fiber" and expressed to the nearest gram(21CFR101.9(c)(6)(i).Sugars must be expressed to the nearest gram(21CFR101.9(c)(6)(ii).%DV for Vitamins A/C must be expressed to the nearest 2% increment(21CFR101.9(c)(8)(iii).Footnote is not declared(21CFR101.9(d)

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 10/30/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act 21§343(i)(2)-it is fabricated from two/more ingredients,but fails to declare each one(21CFR101.4).LBL declares "white chocolate" as an ingredient,but fails to list sub ingredients(21CFR101.4(b)(2);"vegetable oil"-if an individual ingredient,it is not declared by its common/usual name and if a blend, it is not declared by their common/usual names(21CFR101.4(b)(14);and "starch acetate" is not declared by its common/usual name. Section 403(f) of the Act (21U.S.C. §343(f)-LBL bears information in a foreign language,but fails to repeat all required information in this language(21CFR101.15(c)(2). Section 403(q) of the Act [21§343(q)-nutrition information is not presented as per 21CFR101.9."Nutrition Facts" must be set the full width of the box (21CFR 101.9(d)(2)."Servings Per Container" is not declared(21 CFR 101.9(d)(3)(ii)."Amount" must be declared as "Amount Per Serving"(21CFR101.9(d)(4).Calories must be expressed to the nearest 10-calorie increment(21CFR101.9(c)(1)."Calories from fat" is not declared (21CFR101.9(c)(1)(ii)."Fat" must be declared as "Fat,total" or "Total fat" and expressed to the nearest gram(21CFR101.9(c)(2).(21 CFR101.9(c)(2)(ii) does not provide for a "+" before "Trans" and %DV cannot be declared for saturated fat and trans-fat combined because there is no DRV established for trans-fat.21CFR101.9 does not provide for the combine %DV declaration for two nutrients."Carbohydrate" must be declared as "Carbohydrate,total" or "Total carbohydrate" and expressed to the nearest gram(21CFR101.9(c)(6)."Fiber" must be declared as "Dietary fiber" and expressed to the nearest gram(21CFR101.9(c)(6)(i).Sugars must be expressed to the nearest gram(21CFR101.9(c)(6)(ii).%DV for Vitamins A/C must be expressed to the nearest 2% increment(21CFR101.9(c)(8)(iii).Footnote is not declared(21CFR101.9(d)

Weihai Baihe Biology Technological Co., Ltd.
Date Published : 04/24/2023
No. 552, Chengda road, Swan Lake Economic Technical Development Zone , Rongcheng , Shandong, Shandong CHINA
36 C - - 99 Honey, N.E.C.
Date Published: 04/24/2023

Desc: Honey Complex Beverage
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. For example, the product label lists “Hedera Helix extract”, but this is not the common or usual name of the dietary ingredient. Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. Section 403(q)(1)(A) because the serving size declared on the Supplement Facts label is not declared for each intended group. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label. Section 403(e)(2) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce. The net quantity of contents statement, expressed in terms of fluid measure, must specify both metric (i.e., milliliters) and U.S. Customary System (i.e., fluid ounces). Section 403(q)(5)(F) and 403(q)(1)(A) in that the presentation of the nutrition information on the labeling of your products does not comply. Section 403(r)(6) because the required dietary supplement disclaimer which is preceded by a linking symbol, fails to be linked to the structure function claims on the product.

XINXING COUNTY HONGBAO FOOD CO., LTD
Date Published : 10/10/2018
Taiping Town , Gongcheng Dalang District , Jiangmen City, Guangdong CHINA
21 H - - 14 Plum, Dried or Paste
Date Published: 10/10/2018

Desc: Plum; 168g package
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product labels fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and 15 U.S.C. § 1453(a)(2) and 15 U.S.C. § 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1), followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of FPLA]. -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that each ingredient is not declared with an appropriate statement of identity in accordance with 21 CFR 101.3. -Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. -Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two or more languages but does not repeat all the required information in both languages. - Section 403(k) of the Act [21 U.S.C. § 343(k)]. Because the product label is not in accordance with 21 CFR 182.3640 and 182.3766 respectively, these ingredients are both chemical preservatives. Therefore, their function must be declared in accordance with 21 CFR 101.22(j), -Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

21 H - - 14 Plum, Dried or Paste
Date Published: 10/10/2018

Desc: Dried Plums; 4.9 oz jar
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product labels fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and 15 U.S.C. § 1453(a)(2) and 15 U.S.C. § 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1), followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of FPLA]. -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that each ingredient is not declared with an appropriate statement of identity in accordance with 21 CFR 101.3. -Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. -Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two or more languages but does not repeat all the required information in both languages. - Section 403(k) of the Act [21 U.S.C. § 343(k)]. Because the product label is not in accordance with 21 CFR 182.3640 and 182.3766 respectively, these ingredients are both chemical preservatives. Therefore, their function must be declared in accordance with 21 CFR 101.22(j), -Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

21 H - - 14 Plum, Dried or Paste
Date Published: 10/10/2018

Desc: Preserved Plum; 88g package
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product labels fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and 15 U.S.C. § 1453(a)(2) and 15 U.S.C. § 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1), followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of FPLA]. -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that each ingredient is not declared with an appropriate statement of identity in accordance with 21 CFR 101.3. -Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. -Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two or more languages but does not repeat all the required information in both languages. - Section 403(k) of the Act [21 U.S.C. § 343(k)]. Because the product label is not in accordance with 21 CFR 182.3640 and 182.3766 respectively, these ingredients are both chemical preservatives. Therefore, their function must be declared in accordance with 21 CFR 101.22(j), -Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

Xing Hua Food Co., Ltd
Date Published : 10/02/2015
Liu Wang Shi , Jiang Men City , Jiang Men City, Guangdong CHINA
24 T - H -- Leaf / Stem Veg, Ntrl/Artfcl Dried
Date Published: 10/02/2015

Desc: Cole; dehydrated
Notes: Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites. Product is further mislabeled in that the label does not identify sulfite as a preservative (21 CFR 101.22(j)). Note; Cole refers to a family of vegetables; which includes kale; collard greens; broccoli; cauliflower; brussel sprouts; and kohlrabi. 11/14/08

24 U - - -- Leaf/Stem Veg Dried/Paste
Date Published: 10/02/2015

Desc: Cole; dehydrated
Notes: Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites. Product is further mislabeled in that the label does not identify sulfite as a preservative (21 CFR 101.22(j)). Note; Cole refers to a family of vegetables; which includes kale; collard greens; broccoli; cauliflower; brussel sprouts; and kohlrabi. 11/14/08

ZHONGSHAN CITY HONGWANG FOOD
Date Published : 11/08/2022
Fuxing Industrial District , Lv Yun Road , Zhongshan, CN-44 CHINA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 11/08/2022

Desc: Almond Cake; 500g
Notes: - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese. - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product label lists the US firm name and address but fails to state the name of the firm qualified by a phrase that reveals the connection such person has with such food. - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1)/201(n) of the Act [21 U.S.C. § 343(a)(1)/321(n)] in that the product label fails to reveal the material fact that the identified flavor is, in part, artificially derived.

ZHONGSHAN HONGWANG FOOD CO LTD
Date Published : 11/08/2022
No. 21 Lvyun Road , Xiaolan Town , Xhongshan City, CHINA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 11/08/2022

Desc: Almond Cake; 500g
Notes: - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese. - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product label lists the US firm name and address but fails to state the name of the firm qualified by a phrase that reveals the connection such person has with such food. - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1)/201(n) of the Act [21 U.S.C. § 343(a)(1)/321(n)] in that the product label fails to reveal the material fact that the identified flavor is, in part, artificially derived.

Zhongshan Kunbo Foodstuff Import & Export Corp. Ltd.
Date Published : 10/02/2015
NO. 32 Changyi Road , Changmingshui Village, Wuguishan , Zhongshan, Guangdong CHINA
22 A - - 07 Winter Melon (Vine Fruit)
Date Published: 10/02/2015

Desc: Sweet Wintermelon
Notes: The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07

23 K - - 06 Lotus Seed (Edible Seed)
Date Published: 10/02/2015

Desc: Sweet Lotus Nuts
Notes: The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07

Zhuhai Economic Special Zone General Non-Staple Food Corp.
Date Published : 10/02/2015
1092 Jiuzhou Road , Zhuhai Guangdong, CHINA
25 J - - 14 Turnip (Root & Tuber Vegetable)
Date Published: 10/02/2015

Desc: Salted Turnip
Notes: Product is misbranded within the meaning of section 403(i)(2) of the Act because the label fails to list each ingredient in the ingredient statement (21 CFR 101.4(a)(1)). Undeclared sulfites 4/11/08

guangzhou p'product
Date Published : 04/05/2023
Chadong Industry Panyu , Shi Ji , Guangzhou, Guangdong CHINA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 04/05/2023

Desc: Herba Plantaginis (Plantain Herb)
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the Act, in that the article's labeling appears to be false or misleading. Section 403(i)(2) of the Act, in that it appears to be a food fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. Firm previously listed on deactivated Import Alert 54-08 due to the presence of Digitalis. DWPE date: 04/06/2007.

jiangmen pengjiang huiming trading company
Date Published : 10/02/2015
Flat 11 , 116 Mingxinglu; Jiangmen,Guangdong,China , Jiangmnsh, Yandong CHINA
23 A - - 07 Peanut, In Shell
Date Published: 10/02/2015

Notes: PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b) (1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 10/02/2015

Notes: PRODUCT: Peanuts in Shell - Product is misbranded under Section 403 (q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements {21 CFR 101.9(d)}; Product is further misbranded in that the net contents are not stated in ounces/pounds {21 CFR 101.105 (b) (1)}; Product is further misbranded in that the labeling uses "Edible Flavor" to list a flavor ingredient {21 CFR 101.22(i)} 6/21/07

mico foodstuff co., ltd.
Date Published : 07/18/2022
Building 19, Xinghucheng, No.179 Room 1701 , Jinsha Road; Longhu District , Shantou, Guangdong CHINA
21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 01/27/2023

Desc: CHALLENGE FRUIT SHAPE JELLIES (Fruit Shape CC Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, as required by 21 CFR 101.22(j). Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived, as required by 21 CFR 101.22(i)(2).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 01/27/2023

Desc: CHALLENGE FRUIT SHAPE JELLIES (Fruit Shape CC Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, as required by 21 CFR 101.22(j). Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived, as required by 21 CFR 101.22(i)(2).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement “WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS….” However, no actual fruit is declared as ingredient. ‘Edible’ in “Edible Artificial Color” is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. §343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] and section 201(n) of the Act [21 U.S.C. §321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.


COLOMBIA


ALIMENTIC SAS
Date Published : 11/06/2017
Calle 64a 103 18 , Bogota, Cundinamarca COLOMBIA
03 A - - 03 Biscuits
Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

07 A - - 03 Cheese Puffs, Baked
Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

07 B - - 03 Cheese Puffs, Fired
Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

GRASCO LTDA.
Date Published : 10/25/2017
Pensilvania , Carrera 35 7 - 50 , Bogota, Cundinamarca COLOMBIA
26 E - - 99 Oleomargarine, N.E.C.
Date Published: 10/25/2017

Desc: La Fina Margarina De Mesa Y Concina
Notes: The product appears to be misbranded within the meaning of: (1) Section 403(f) of the Act [21 U.S.C. §343(f)] because the labels bear representations in a foreign language; however, all of the required information does not appear to be provided in both languages. (2) Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] because the product labels bear nutrient content claims, but fail to meet the requirements to bear the claim.. (3) Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b).

26 E - - 99 Oleomargarine, N.E.C.
Date Published: 10/25/2017

Desc: La Fina Suave! Con Sal
Notes: The product appears to be misbranded within the meaning of: (1) Section 403(f) of the Act [21 U.S.C. §343(f)] because the labels bear representations in a foreign language; however, all of the required information does not appear to be provided in both languages. (2) Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] because the product labels bear nutrient content claims, but fail to meet the requirements to bear the claim.. (3) Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b).

Healthy America Colombia Sa
Date Published : 10/19/2016
Carrera 3 7 13186 , Yumbo, Valle Del Cauca COLOMBIA
54 A - - 16 Vitamin E (Tocopherol)
Date Published: 10/19/2016

Desc: XAMBO 30 Capsules
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the label fails to declare dimethylamylamine (DMAA) as an ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/19/2016

Desc: XAMBO 30 Capsules
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the label fails to declare dimethylamylamine (DMAA) as an ingredient.

LAMERICA CI SAS
Date Published : 11/01/2017
Calle 85 76 , C , Bogota, Cundinamarca COLOMBIA
09 C - - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 11/24/2017

Desc: Tubito Sweetened Condensed Milk
Notes: Section 403(q) of the Act because the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(g) of the Act in that the article appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 131.120. Section 403(f) of the Act in that the product labels contain information in two languages (English and Spanish) but do not repeat all of the required information in both languages. Section 403(i)(2) of the Act in that the each ingredient is not declared on the product label in accordance with 21 CFR 101.4.                                                                                                                                                                                                                                                                                                                                                    

34 K - - 04 Chocolate Bars
Date Published: 11/01/2017

Desc: Choco Brownie (Cookie Bagel)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section: 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. 403(k) of the Act because the product bears or contains artificial flavoring or a chemical preservative but the product labels do not comply with the applicable regulations. 403(f) of the Act because the product label contains information in two languages, but does not repeat all the required information in both languages. 403(q) of the Act because the Nutrition Facts Panel is not in a correct format as required by 21 CFR 101.9. 403(e)(2) of the Act because the net quantity of contents statement declared on the English label is incorrect because it is for one brownie, when the package contains 6 brownies.                                                                                                                                                                                                                                                                                                                                                                

Lamerica C.I. S.A.S.
Date Published : 10/27/2017
Carrera 102 # 25c-20 , Bogota, Cundinamarca COLOMBIA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/27/2017

Desc: Mani Moto Peanuts Covered with Wheat Flour (original and lemon flavors)
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. 343(k)] because the product bears or contains an artificial flavoring or a chemical preservative but does not bear a label stating that fact. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a)(2) & (e) of the Fair Packaging and Labeling Act (FPLA) because the retail bag labels fail to declare the net quantity of contents in US measure (pounds, ounces, as appropriate) on the principal display panel, as required by 21 CFR 101.7(b)(1). Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product label fails to bear the common or usual name of the food, in accordance with 21 CFR 101.3 and 21 CFR 102.5.

07 Q - - 07 Potato Snacks (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked
Date Published: 10/27/2017

Desc: De Todito Paketon BBQ Chips
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2).

07 Q - - 13 Corn Puffs (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked
Date Published: 10/27/2017

Desc: Chokis Chocolate Covered Corn Balls
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a)(2) & (e) of the Fair Packaging and Labeling Act (FPLA) because the retail bag labels fail to declare the net quantity of contents in US measure (pounds, ounces, as appropriate) on the principal display panel, as required by 21 CFR 101.7(b)(1).

07 Q - - 13 Corn Puffs (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked
Date Published: 10/27/2017

Desc: Gudiz Sweet Corn Balls
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4 Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a)(2) & (e) of the Fair Packaging and Labeling Act (FPLA) because the retail bag labels fail to declare the net quantity of contents in US measure (pounds, ounces, as appropriate) on the principal display panel, as required by 21 CFR 101.7(b)(1).

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/27/2017

Desc: Mani Moto Peanuts Covered with Wheat Flour (original and lemon flavors)
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. 343(k)] because the product bears or contains an artificial flavoring or a chemical preservative but does not bear a label stating that fact. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a)(2) & (e) of the Fair Packaging and Labeling Act (FPLA) because the retail bag labels fail to declare the net quantity of contents in US measure (pounds, ounces, as appropriate) on the principal display panel, as required by 21 CFR 101.7(b)(1). Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product label fails to bear the common or usual name of the food, in accordance with 21 CFR 101.3 and 21 CFR 102.5.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/27/2017

Desc: Chokis Chocolate Covered Corn Balls
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a)(2) & (e) of the Fair Packaging and Labeling Act (FPLA) because the retail bag labels fail to declare the net quantity of contents in US measure (pounds, ounces, as appropriate) on the principal display panel, as required by 21 CFR 101.7(b)(1).

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/27/2017

Desc: Gudiz Sweet Corn Balls
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4 Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a)(2) & (e) of the Fair Packaging and Labeling Act (FPLA) because the retail bag labels fail to declare the net quantity of contents in US measure (pounds, ounces, as appropriate) on the principal display panel, as required by 21 CFR 101.7(b)(1).

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/27/2017

Desc: De Todito Paketon BBQ Chips
Notes:                                                                                                                                                                                         Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c)(2).

09 C - - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 11/24/2017

Desc: Tubito Sweetened Condensed Milk
Notes: Section 403(q) of the Act because the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(g) of the Act in that the article appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 131.120. Section 403(f) of the Act in that the product labels contain information in two languages (English and Spanish) but do not repeat all of the required information in both languages. Section 403(i)(2) of the Act in that the each ingredient is not declared on the product label in accordance with 21 CFR 101.4.                                                                                                                                                                                                                                                                                                                                                    

34 K - - 04 Chocolate Bars
Date Published: 11/01/2017

Desc: Choco Brownie (Cookie Bagel)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section: 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. 403(k) of the Act because the product bears or contains artificial flavoring or a chemical preservative but the product labels do not comply with the applicable regulations. 403(f) of the Act because the product label contains information in two languages, but does not repeat all the required information in both languages. 403(q) of the Act because the Nutrition Facts Panel is not in a correct format as required by 21 CFR 101.9. 403(e)(2) of the Act because the net quantity of contents statement declared on the English label is incorrect because it is for one brownie, when the package contains 6 brownies.                                                                                                                                                                                                                                                                                                                                                                

PRODUCTORA NACIONAL DE ALIMENTOS PRONAL S.A.S
Date Published : 06/25/2020
Cra 16 N. 69-70 , Dosquebradas, Risaralda COLOMBIA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/25/2020

Desc: Tocineta Bacon Chips
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of Section 403(a)(1) and 201(n) of the Act [21 U.S.C. 343(a)(1)] in that the LBL is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. As required by 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the LBL shall be accompanied by the common/usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accompanied by the word(s) "artificial" or artificially flavored, in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., artificial vanilla, artificially flavored strawberry, or grape artificially flavored. Based on the ingredient list, the characterizing flavor, lemon, is derived from artificial lemon flavoring. However, the name of food is not accompanied by the word(s) "artificial" or "artificially flavored. Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). For example, the statement of identity, bacon chips, is not appropriately descriptive in accordance with 21 CFR 101.3(b). Based on the label, the food is not made from bacon or bacon flavor. Section 403(i)(2) of the Act [21 U.S.C.343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the ingredient pellet type bacon which consists of wheat flour, corn starch, salt, sodium bicarbonate, and artificial colors is not declared by its common or usual name because it does not consist of any bacon or bacon-flavoring ingredient

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/25/2020

Desc: Cheese Rings
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common/usual name in accordance with 21 CFR 101.4. Specifically, the LBL declares the multi-component ingredient "cheese" but fails to declare all sub-ingredients. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product LBL contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product LBL contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the LBL must appear in the foreign language. Specifically, the statement of identity is only present in English.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/25/2020

Desc: Wheat Puff Snacks
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common/usual name in accordance with 21 CFR 101.4. For example, "emulsifier" is not the common/usual name of an ingredient.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/25/2020

Desc: Yellow Marbles Cheese Snacks
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common/usual name in accordance with 21 CFR 101.4. Specifically, the LBL declares the multi-component ingredient "cheese" but fails to declare all sub-ingredients. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product LBL contains information in multiple languages but fails to repeat required information in all languages. As required by 21 CFR 101.15(c), if a product LBL contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the LBL must appear in the foreign language. Specifically, the statement of identity is only present in English.

07 B - - 06 Potato Chips,Fried
Date Published: 06/25/2020

Desc: Lemon Flavored Potato Chips
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) and 201(n) of the Act [21 U.S.C. §343(a)(1)] in that the LBL is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. As required by 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the LBL shall be accompanied by the common/usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accompanied by the word(s) "artificial" or "artificially flavored," in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., "artificial vanilla," "artificially flavored strawberry," or "grape artificially flavored." Based on the ingredient list, the characterizing flavor, lemon, is derived from "artificial lemon flavoring." However, the name of food is not accompanied by the word(s) "artificial" or "artificially flavored."

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 06/25/2020

Desc: Natural Snack Mix
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the LBL is false or misleading. The statement "natural snack mix" is false and misleading. FDA considers the use of the term "natural" on a food LBL to be truthful and non-misleading when "nothing artificial or synthetic" has been included in, or has been added to, a food that would not normally be expected to be in the food." [58 FR 2302, 2407, January 6, 1993]. The ingredient statement for this product declares artificial colors, artificial flavors and synthetic substances such as propylene glycol.


CROATIA


Zdenka d.d
Date Published : 02/19/2015
Trg Kralja Tomislava Square 15 , Bjelovar, Veliki Zdenci CROATIA
12 A - - 05 Cheese, Cheddar
Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 05 Cheese, Cheddar
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 A - - 05 Cheese, Cheddar
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 05 Cheese, Cheddar
Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 05 Cheese, Cheddar
Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12.. Published on 03/09/2015

12 A - - 05 Cheese, Cheddar
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 05 Cheese, Cheddar
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 A - - 05 Cheese, Cheddar
Date Published: 02/19/2015

Desc: Cheese
Notes: Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded in that the nutrition information is not provided as specified under 21 CFR 101.9. Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they contain information in two languages but does not repeat all the required label information in both languages. For example; the Nutrition Facts and statement of identity information must be declared in both; the foreign language and English as required by 21 CFR 101.15(c)(2). Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they fail to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CPR 101.105.

12 A - - 10 Cheese, Cream
Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 16 Cheese, Gouda
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 16 Cheese, Gouda
Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 16 Cheese, Gouda
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 16 Cheese, Gouda
Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 52 Cheese, Semisoft
Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 52 Cheese, Semisoft
Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 52 Cheese, Semisoft
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 B - - 05 Pasteurized Cheese Spread
Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12.; Published on 03/09/2015

12 B - - 05 Pasteurized Cheese Spread
Date Published: 02/19/2015

Desc: Cheese
Notes: Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded in that the nutrition information is not provided as specified under 21 CFR 101.9. Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they contain information in two languages but does not repeat all the required label information in both languages. For example; the Nutrition Facts and statement of identity information must be declared in both; the foreign language and English as required by 21 CFR 101.15(c)(2). Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they fail to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CPR 101.105.

12 B - - 05 Pasteurized Cheese Spread
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12 Published on 03/09/2015

12 B - - 05 Pasteurized Cheese Spread
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 B - - 05 Pasteurized Cheese Spread
Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 B - - 09 Pasteurized Process Cheese Foods
Date Published: 02/19/2015

Desc: Cheese
Notes: Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded in that the nutrition information is not provided as specified under 21 CFR 101.9. Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they contain information in two languages but does not repeat all the required label information in both languages. For example; the Nutrition Facts and statement of identity information must be declared in both; the foreign language and English as required by 21 CFR 101.15(c)(2). Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they fail to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CPR 101.105.

12 B - - 09 Pasteurized Process Cheese Foods
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 B - - 09 Pasteurized Process Cheese Foods
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12 Published on 03/09/2015

12 B - - 09 Pasteurized Process Cheese Foods
Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 B - - 09 Pasteurized Process Cheese Foods
Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 B - - 13 Cheese, Pasteurized, Process (Standardized)
Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore
Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12 Published on 03/09/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 02/19/2015

Desc: Cheese
Notes: Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded in that the nutrition information is not provided as specified under 21 CFR 101.9. Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they contain information in two languages but does not repeat all the required label information in both languages. For example; the Nutrition Facts and statement of identity information must be declared in both; the foreign language and English as required by 21 CFR 101.15(c)(2). Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they fail to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CPR 101.105.

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.


DENMARK


Funksjonell Mat AS
Date Published : 05/14/2019
Emil Neckelmanns Vej 20 , So , Odense So, Syddanmark DENMARK
20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C.
Date Published: 06/26/2019

Desc: Fruit Spread Forest Fruits
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 06/26/2019

Desc: Fruit Spread Forest Fruits
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

22 C - - 99 Vine Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 06/26/2019

Desc: Fruit Spread Forest Fruits
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

23 D - - 01 Almond, Paste
Date Published: 06/26/2019

Desc: Marzipan
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

23 M - - 99 Edible Seed Products, N.E.C.
Date Published: 06/26/2019

Desc: Sesam-mel Sesame Flour
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

23 O - - 07 Peanut, Nut Flour/Meal
Date Published: 06/26/2019

Desc: Peanottmel Peanut Flour
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

23 R - - 02 Sesame Seed (Edible Seed Paste)
Date Published: 06/26/2019

Desc: Sesam-mel Sesame Flour
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut)
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C.
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C.
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

36 A - - 99 Sugar Products, N.E.C.
Date Published: 05/14/2019

Desc: Sukrin Syrup With Artificial Sweetener
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim.

36 A - - 99 Sugar Products, N.E.C.
Date Published: 06/26/2019

Desc: Sesam-mel Sesame Flour
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 A - - 99 Sugar Products, N.E.C.
Date Published: 02/12/2020

Desc: Sukrin Plus
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 06/26/2019

Desc: Fiber Syrup Clear Liquid Sweetener
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Lower in calories than syrup'; website: 'Low calories', 'Low carb alternative'), but the product does not meet the requirements to make such a claim; 403(i)(1) because the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3 (product label implies syrup is derived from fiber, but FDA questions source of fiber based on ingredient statement); 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 05/14/2019

Desc: Sukrin Syrup With Artificial Sweetener
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim.

36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 02/12/2020

Desc: Sukrin Plus
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 05/14/2019

Desc: Sukrin Syrup With Artificial Sweetener
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim.

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 06/26/2019

Desc: Fiber Syrup Clear Liquid Sweetener
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Lower in calories than syrup'; website: 'Low calories', 'Low carb alternative'), but the product does not meet the requirements to make such a claim; 403(i)(1) because the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3 (product label implies syrup is derived from fiber, but FDA questions source of fiber based on ingredient statement); 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 02/12/2020

Desc: Sukrin Plus
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 05/14/2019

Desc: Sukrin Syrup With Artificial Sweetener
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim.

Organic Hemp Food Products
Date Published : 06/22/2015
Center Boulevard 5 , Copenhagen S, DENMARK
28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 06/22/2015

Desc: Hemp Oil
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C.343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product is misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)]because the presentation of the nutrition information on the product labeling does not comply with 21 CFR 101.36. Published on 06/23/2015

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/22/2015

Desc: Hemp Oil
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C.343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product is misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)]because the presentation of the nutrition information on the product labeling does not comply with 21 CFR 101.36. Published on 06/23/2015

54 H - - 99 Fats and Lipid Substances, N.E.C.
Date Published: 06/22/2015

Desc: Hemp Oil
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C.343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product is misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)]because the presentation of the nutrition information on the product labeling does not comply with 21 CFR 101.36. Published on 06/23/2015

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 06/22/2015

Desc: Hemp Oil
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C.343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product is misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)]because the presentation of the nutrition information on the product labeling does not comply with 21 CFR 101.36. Published on 06/23/2015


DOMINICAN REPUBLIC (THE)


Alopecil Corporation, S.R.L.
Date Published : 11/10/2016
Haina, D.N. , Autopista 30 De Mayo No. 111 , Santo Domingo Oeste, Santo Domingo DOMINICAN REPUBLIC (THE)
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016

Desc: Limpia Pecha Syrup
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i)(2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016

Desc: Balsamic Honey Syrup
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016

Desc: Punch Natural
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016

Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ; ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016

Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ; ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016

Desc: Punch Natural
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016

Desc: Balsamic Honey Syrup
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016

Desc: Limpia Pecha Syrup
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i)(2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016

Desc: Limpia Pecha Syrup
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016

Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016

Desc: Balsamic Honey Syrup
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016

Desc: Punch Natural
Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;


ECUADOR


INDUSTRIAS LACTEAS TONI S.A.
Date Published : 06/13/2019
Av. Francisco de Orellana km. 17,5, Coop. San Nicolas , Mz. 429 Solar 1 , Guayaquil, Guayas ECUADOR
09 D - - 11 Milk With Multivitamins Added,Low Fat
Date Published: 07/27/2020

Desc: VANILLA MILK DRINK
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

09 D - - 11 Milk With Multivitamins Added,Low Fat
Date Published: 04/30/2021

Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

09 H - - 06 Cultured or Acidified and Flavored Fluid Milk, Grade A
Date Published: 07/27/2020

Desc: VANILLA MILK DRINK
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

14 Y - - 99 Filled or Imitation Milk or Milk Type Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/18/2019

Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 10/18/2019

Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 10/18/2019

Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 10/18/2019

Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 07/27/2020

Desc: VANILLA MILK DRINK
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

Industrias Lacteas Toni S.A.
Date Published : 06/13/2019
Km 7 1/2 via a Daule , Guayaquil, Guayas ECUADOR
09 D - - 11 Milk With Multivitamins Added,Low Fat
Date Published: 07/27/2020

Desc: VANILLA MILK DRINK
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

09 D - - 11 Milk With Multivitamins Added,Low Fat
Date Published: 06/13/2019

Desc: Milk Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

09 H - - 06 Cultured or Acidified and Flavored Fluid Milk, Grade A
Date Published: 07/27/2020

Desc: VANILLA MILK DRINK
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

14 Y - - 99 Filled or Imitation Milk or Milk Type Products Not Elsewhere Mentioned, N.E.C.
Date Published: 06/13/2019

Desc: Milk Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 06/13/2019

Desc: Milk Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 06/13/2019

Desc: Milk Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 06/13/2019

Desc: Milk Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 07/27/2020

Desc: VANILLA MILK DRINK
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

Nelly del Carmen Alvarez Cedeno
Date Published : 10/02/2015
Cdla.Alborada Cuarta Etapa Mz F-B S.2 , Guayaquil, Guayas ECUADOR
28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 10/02/2015

Desc: Mama Tere Seasoning
Notes: The article appears to be misbranded within the meaning of section 403(q) because the nutrition label does not meet the requirements of 21 CFR 101.9: The product fails to properly declare the serving size as specified by 21 CFR 101.9 (b) and 101.12(b); therefore, the nutrition information is not correct. The nutrition label fails to declare all of the required nutrition information in accordance with 21 CFR 101.9(c). Specifically, the nutrition label has five nutrients missing (trans fat, vitamin A, vitamin C, calcium, and iron). FDA could not determine label format, in that, it appears the product could qualify for the simplified format of the nutrition label, which requires the product to contain insignificant amounts of eight or more of the nutrients listed in 21 CFR 101.9(f) and placement of an asterisk at the bottom of the label followed by the statement "Percent Daily Values are based on a 2,000 calorie diet" when the footnote is omitted [21 CFR 101.9(f)(5)]. The product label is further misbranded, in that, the quantitative amounts for total fat, saturated fat, total carbohydrate, and protein are not in accordance with 21 CFR 101.9(d)(7)(i). Specifically, the nutrient amount should be appended with a "g" for grams. The product label is further misbranded within the meaning of section 403(f) because all required words, statements and other information on the label must be included in both languages. The place of business is only in English. (21 CFR 101.15 (c)(1))


EGYPT


Al-Nour For Dairy Industries
Date Published : 07/05/2023
16,17,18 - Cairo - Egypt , 12008 Obour Industrial Zone - Block , Cairo, Cairo EGYPT
12 A - - 10 Cheese, Cream
Date Published: 01/26/2024

Desc: Processed Gruyere Cheese; Al Maraai Cream Spread; Processed Glass Jars Cheese; Cream Cheese
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the label fails to declare the net quantity of contents in the principal display panel, as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)] because the label lacks nutrition information as required by 21 CFR 101.9.

12 A - - 40 Cheese, Neufchatel
Date Published: 01/26/2024

Desc: Processed Gruyere Cheese; Al Maraai Cream Spread; Processed Glass Jars Cheese; Cream Cheese
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the label fails to declare the net quantity of contents in the principal display panel, as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)] because the label lacks nutrition information as required by 21 CFR 101.9.

12 B - - 13 Cheese, Pasteurized, Process (Standardized)
Date Published: 01/26/2024

Desc: Processed Gruyere Cheese; Al Maraai Cream Spread; Processed Glass Jars Cheese; Cream Cheese
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the label fails to declare the net quantity of contents in the principal display panel, as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)] because the label lacks nutrition information as required by 21 CFR 101.9.

12 C - - 99 Cheese Products, Non-Standardized, N.E.C.
Date Published: 01/26/2024

Desc: Processed Gruyere Cheese; Al Maraai Cream Spread; Processed Glass Jars Cheese; Cream Cheese
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the label fails to declare the net quantity of contents in the principal display panel, as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)] because the label lacks nutrition information as required by 21 CFR 101.9.

El Rashidi El Mizan Confectionery
Date Published : 08/28/2018
Industrial Zone 2, Plot No. 38-39, 18/2 , 6th Of October City, EG-NOTA EGYPT
20 C - - 09 Grape, Jam, Jelly, Preserves, Marmalade, Butter and Candied
Date Published: 08/28/2018

Desc: Grape Jelly
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(g)(1) of the Act [21 U.S. C.343(g)(1)] in that they are a food for which a definition and standard of identity has been prescribed by regulation; but they fail to conform to such definition and standard. Fruit jelly has a standard of identity under 21 CFR 150.140; and the standard does not permit the use of any color additive or added flavors to jelly.

Sham Gardens Food Industries
Date Published : 11/16/2018
2000 Jeel , Six Of October, Aljizah EGYPT
09 A - - 02 Butter Oil
Date Published: 11/16/2018

Desc: Pure Burret Ghee
Notes: Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)] in that the product labeling is false or misleading in any particular. Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label does not appear to bear a Nutrition Facts information as required by section 21 CFR 101.9. Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. §1453(a)(3)] for failing to include a net quantity of contents statement as required by section 21 CFR 101.7. Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the label bears the name of the manufacturer, "New Zealand dairy company" but fails to include the business address.


ETHIOPIA


EYERUSALEM BALTINA EXPORTER
Date Published : 05/23/2023
Misrak Sub-City Misraksub-City , Awashi, ETHIOPIA
02 A - - 02 Barley, Whole Grain
Date Published: 05/23/2023

Desc: Roasted Barley
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). In that it appears to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. In that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). In that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product label fail to bear the common or usual name of the food. In that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. In that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that product label lacks a Nutrition Facts label is not as required by 21 CFR 101.9.

02 G - - 99 Flours and Meals N.E.C.
Date Published: 05/23/2023

Desc: Roasted Barley
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3): In that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). In that it appears to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. In that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). In that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product label fail to bear the common or usual name of the food. In that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. In that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that product label lacks a Nutrition Facts label is not as required by 21 CFR 101.9.


FIJI


Frezco Beverages
Date Published : 11/04/2022
Lot 20 , Waqarda Industrial Sub-Division , Nadi, None of the above FIJI
21 V - - 43 Noni, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 11/04/2022

Desc: NONI JUICE
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to accurately declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7(b). Section 403(q) in that the presentation of the nutritional information on the labeling of the product does not comply with 21 CFR Part 101.36, and because the serving size declared on the label is incomplete. Section 403(s)(2)(B) because it does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

54 F - - 93 Noni (Herbal & Botanicals, not Teas)
Date Published: 11/04/2022

Desc: NONI JUICE
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to accurately declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7(b). Section 403(q) in that the presentation of the nutritional information on the labeling of the product does not comply with 21 CFR Part 101.36, and because the serving size declared on the label is incomplete. Section 403(s)(2)(B) because it does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

Hardip Narayan & Sons Ltd.
Date Published : 10/02/2015
Pritam Singh Road , Tumbairata, FIJI
04 C - - 07 Noodles, Instant
Date Published: 10/02/2015

Desc: Maggi 2 Minute Noodle
Notes: Product is misbranded within the meaning of Section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 [Misbranded; Section 403(q)]. 10/30/07 MANUFACTURER; Nestle Trading (Fiji) Ltd.

National Exports Limited
Date Published : 10/02/2015
22 Potts Street , BA , Lautoka, FJ-NOTA FIJI
09 C - H -- Milk/Cream, Ntrl/Artfcl Dried
Date Published: 10/02/2015

Desc: Powdered Milk
Notes: The product is misbranded in that the nutrition information that appears on the label is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403 (q)]. MANUFACTURER; Punja & Sons Ltd. 12/13/05

Nestle Trading(Fiji) Ltd
Date Published : 10/02/2015
P.O BOX 3042 , Lot 1 Wailekutu Sub - Division , Lami, Fj-C FIJI
04 C - - 07 Noodles, Instant
Date Published: 10/02/2015

Desc: Maggi 2 Minute Noodle
Notes: Product is misbranded within the meaning of Section 403 in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9 [Misbranded; Section 403(q)]. 10/30/07 SHIPPER: Hardip Narayan & Sons Ltd.

Punja & Sons (Spice) Ltd.
Date Published : 10/02/2015
1 Bouwalu St/ Santamata St. , Lautoka, Fj-W FIJI
09 C - H -- Milk/Cream, Ntrl/Artfcl Dried
Date Published: 10/02/2015

Desc: Powdered Milk
Notes: The product is misbranded in that the nutrition information that appears on the label is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403 (q)]. SHIPPER: National Exports Ltd. 12/13/05

Rewa Co-Operative Dairy Co.Ltd
Date Published : 10/02/2015
P.O. Box 3678 , Samabula, FIJI
09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/02/2015

Desc: Rewa Milk Powder
Notes: Product is misbranded within the meaning of Section 403(r)(1)(A) in that the labeling is false. Specifically, because the product bears the claim ¿... contains...energy" which is an undefined nutrient content claim. In addition, the article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q)(1) of the Act in that the nutrition information is not declared in the required format (21 CFR 101.9(d)(1). In addition, the serving size information is not declared in common household measure and is not based on the Reference Amount Customarily Consumed, in accordance with 21 CFR 101.9(b)(5). Furthermore, the nutrient panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV, in accordance with 21 CFR 101.9(d)(7)(ii) and the product also bears the claim ¿...contains.... protein..." but fails to bear the level of protein and the percent Daily Value for protein in accordance to 21 CFR 101.9(c)(7) and 21 CFR 101.9(c)(7)(ii).

Southern Cross Foods Ltd
Date Published : 10/02/2015
P.O. Box 165 , Suva, FIJI
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/02/2015

Desc: Jason's Peanut Ruffs Baked Snack
Notes: VIOLATION (IN NOTES) The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. Flavour Enhancer (621), Vegetable Oils (Antioxidant (306) (from Soy)), and Palm Olein (Antioxidant (319)) are not provided for in 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear the required nutrition information

Southern Cross Foods Ltd
Date Published : 10/02/2015
Kings Road , Yalalevu , Ba, FJ-NOTA FIJI
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/02/2015

Desc: Jason's Peanut Ruffs Baked Snack
Notes: VIOLATION (IN NOTES) The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. Flavour Enhancer (621), Vegetable Oils (Antioxidant (306) (from Soy)), and Palm Olein (Antioxidant (319)) are not provided for in 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear the required nutrition information

Vinod Maharaj Kava Exports PTE LTD
Date Published : 07/31/2023
Lot 11 , Vusiya Rd , Nausori, Central FIJI
54 F - - 52 Kava Kava (Herbal & Botanicals, not Teas)
Date Published: 07/31/2023

Desc: Fiji Vanua Kava (Piper Methysticum)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1).


GEORGIA


GFC KULA
Date Published : 04/14/2016
17 Shindis Road , Gori, None of the above GEORGIA
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Apple Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act in that the product label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act in that it fails to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CFR 101.105. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format; as required by 21 CFR 101.9.

20 S - - 04 Quince, Core Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Quince Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act in that the product label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act in that it fails to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CFR 101.105. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format; as required by 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the percentage juice declaration does not meet the requirements in 21 CFR 101.30 (b)(3) and ( e). The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(r)(1)(A)of the Act because the product label bears a nutrient content claim; but the product does not meet the requirements to make such claims.

21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 04/14/2016

Desc: Blackberry & Cherry Juice Blend
Notes: The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act in that the product label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act in that it fails to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CFR 101.105. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format; as required by 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the percentage juice declaration does not meet the requirements in 21 CFR 101.30 (b)(3) and ( e).

21 K - - 03 Cherry, Juice, Pit Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Cherry Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act in that the product label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act in that it fails to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CFR 101.105. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format; as required by 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the percentage juice declaration does not meet the requirements in 21 CFR 101.30 (b)(3) and ( e).

22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 04/14/2016

Desc: Pomegranate Juice
Notes: The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act in that the product label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act in that it fails to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CFR 101.105. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format; as required by 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the percentage juice declaration does not meet the requirements in 21 CFR 101.30 (b)(3) and ( e).


GERMANY


Aquanova AG
Date Published : 08/21/2023
Birkenweg 8-10 , Darmstadt, Hesse GERMANY
41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 08/21/2023

Desc: Nanofy
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the article is not in accordance with 21 CFR 101.36 and 101.9. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the labeling fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR 101.9(b)(7). Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the inner bottle label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

Ferrero Foods
Date Published : 10/02/2015
Neue Mainzer Str. 66-68 , Frankfurt Am Main, Hessen GERMANY
03 A - - 03 Biscuits
Date Published: 10/02/2015

Desc: Hanuta Wafer Cookie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act because it appears that the label fails to bear nutrition information as required by 21 CFR 101.9.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Hanuta Wafer Cookie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act because it appears that the label fails to bear nutrition information as required by 21 CFR 101.9.

03 J - - 05 Nut Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Hanuta Wafer Cookie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act because it appears that the label fails to bear nutrition information as required by 21 CFR 101.9.

Hipp GmbH & CO Vertrieb KG
Date Published : 02/10/2017
Georg-Hipp-Str. 7 , Pfaffenhofen a.d.Ilm, Bavaria GERMANY
40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 02/10/2017

Desc: Infant Formula HiPP Bio Combiotik stage 1
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that the label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

Krauter Mix GmbH
Date Published : 04/05/2023
Wiesentheider Str. 4 , Abtswind, Bavaria GERMANY
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/05/2023

Desc: Dried Bulk Plantain
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the Act, in that the article's labeling appears to be false or misleading. Section 403(i)(2) of the Act, in that it appears to be fabricated from two or more ingredients but fails to declare the ingredient digitalis by its common or usual name. Firm previously listed on deactivated Import Alert 54-08 due to the presence of Digitalis. DWPE date: 07/01/1997.

PLANTAFOOD MEDICAL GMBH
Date Published : 09/18/2019
Am Sportplatz 3 , Leiningen, Rhineland-Palatinate GERMANY
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Sugarit
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(i)(2) because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example, the names hydroxypropyl methyl, omega 3 powder, and cyanocobalmin on manite are not common or usual names.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Repair Food
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(s)(2)(C) in that the supplement contains an ingredient described in section 201(ff)(1)(C), but the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived, per section 21 CFR 101.36(d)(1).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Skin Food
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the serving size as declared on the label is incorrect; 403(s)(2)(C) in that the supplement contains an ingredient described in section 201(ff)(1)(C), but the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived, per section 21 CFR 101.36(d)(1).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Sleep Food
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(s)(2)(C) in that the supplement contains an ingredient described in section 201(ff)(1)(C), but the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived, per section 21 CFR 101.36(d)(1).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Cinamit
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the serving size as declared on the label is incorrect.

Paul Muggenburg Gmbh & Co
Date Published : 04/05/2023
Bahnhofstr. 2 , Alveslohe, Schleswig-Holstein GERMANY
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/05/2023

Desc: Dried Bulk Plantain
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the Act, in that the article's labeling appears to be false or misleading. Section 403(i)(2) of the Act, in that it appears to be fabricated from two or more ingredients but fails to declare the ingredient digitalis by its common or usual name. Firm previously listed on deactivated Import Alert 54-08 due to the presence of Digitalis. DWPE date: 07/01/1997.

Plantafood Medical Gmbh
Date Published : 09/18/2019
Horst-Uhlig-Str. 3 , Laudert, Rhineland-Palatinate GERMANY
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Repair Food
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(s)(2)(C) in that the supplement contains an ingredient described in section 201(ff)(1)(C), but the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived, per section 21 CFR 101.36(d)(1).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Sleep Food
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(s)(2)(C) in that the supplement contains an ingredient described in section 201(ff)(1)(C), but the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived, per section 21 CFR 101.36(d)(1).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Sugarit
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(i)(2) because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example, the names hydroxypropyl methyl, omega 3 powder, and cyanocobalmin on manite are not common or usual names.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Skin Food
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the serving size as declared on the label is incorrect; 403(s)(2)(C) in that the supplement contains an ingredient described in section 201(ff)(1)(C), but the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived, per section 21 CFR 101.36(d)(1).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/18/2019

Desc: Cinamit
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the serving size as declared on the label is incorrect.

Sedent Ltd
Date Published : 10/02/2015
Dusselberger Str 4 , Haan, Nordrhein-westfalen GERMANY
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Sanomit (Dietary Supplement)
Notes: REASON; Label is in a foreign language failing to bear the supplement facts panel.

WOMENS BEST
Date Published : 12/13/2018
Flughafenstr. 9 , Griesheim, Hesse GERMANY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 12/13/2018

Desc: Slim Body Shake All-in-One Meal Replacement Blend (conv food);
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 12/13/2018

Desc: Protein Wafers Chocolate (conv food)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 12/13/2018

Desc: Fit Pro Whey 100% Premium Whey Protein; 3 flavors (conv food)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 12/13/2018

Desc: Protein Creme (conv food)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: Joint Support (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: Amino & Energy Essential Amino Acid and Energy Support (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: BCAA Amino (2 flavors) (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: True Beauty Collagen Drink for Skin;Nails & Hair (Dietary Supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/13/2018

Desc: Pre Workout Booster (2 flavors) (dietary supplement)
Notes: Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.


GHANA


DERBY VENTURES
Date Published : 04/17/2020
Selasi Bishop Segbefia Palm Lane Street , Tema, GHANA
29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 04/17/2020

Desc: Nestle Milo Chocolate Powder
Notes: MANUFACTURER TRANSMITTED IN ACE -- The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)], in that the product does not include an appropriate statement of identity in accordance with 21 CFR 101.3. The product appears to be a mix used to prepare a drink rather than a drink. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the product does not declare the net quantity of contents in avoirdupois pound and ounce in accordance with 21 CFR 101.7(b)(1) and 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA). Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. Nutrition Facts label) appears to be provided in accordance with foreign requirement and not in accordance with 21 CFR 101.9. For example: the product fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure in accordance with 21 CFR 101.9(b)(5), and the product bears errors in formatting, including nutrient order and use of hairlines in accordance with 21 CFR 101.9(d).

HENACENT LIMITED
Date Published : 08/08/2018
125 B NUNGUA , Lashibi, GH-AA GHANA
23 B - - 07 Peanut, Shelled
Date Published: 08/08/2018

Desc: Fresh Peanut
Notes: The product appears to be misbranded within the meaning of: 1) Section 403(q)(1) of the Act because the label lacks nutritional information as required by 21 CFR 101.9. 2) Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7

Nestle (Gh) Ltd
Date Published : 04/17/2020
Unknown Street , Accra, GHANA
29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 04/17/2020

Desc: Nestle Milo Chocolate Powder
Notes: MANUFACTURER DECLARED ON PRODUCT LABEL -- The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)], in that the product does not include an appropriate statement of identity in accordance with 21 CFR 101.3. The product appears to be a mix used to prepare a drink rather than a drink. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the product does not declare the net quantity of contents in avoirdupois pound and ounce in accordance with 21 CFR 101.7(b)(1) and 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA). Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. Nutrition Facts label) appears to be provided in accordance with foreign requirement and not in accordance with 21 CFR 101.9. For example: the product fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure in accordance with 21 CFR 101.9(b)(5), and the product bears errors in formatting, including nutrient order and use of hairlines in accordance with 21 CFR 101.9(d).

Nourisher Processing Company Limited
Date Published : 04/15/2016
plot 45 Dandeban rd North Kaneshie , Accra, GH-AA GHANA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/15/2016

Desc: Osompa D.P. food Supplement
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the labels fail to bear nutrition information ("Supplements Facts" panel) as required by 21 CFR 101.36.; (2) Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because the label fails to declare each ingredient by the common or usual name required by 21 CFR 101.4(a) and 21 CFR101.4(g). Specifically; the label appears to fail to include "dietary ingredients" and "other ingredients" in full ingredient list; (3) Section 403(y) of the Act [21 U.S.C. 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement; (4) Section 403(s)(2)(B) of the Act [21 U.S.C. 343 (s)(2)(B)] because it does not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g).

Osompa Herbal Center
Date Published : 04/15/2016
P.O. Box KN 4676 , Kaneshie , Accra, GHANA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/15/2016

Desc: Osompa D.P. food Supplement
Notes: The product appears to be misbranded within the meaning of; (1) Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the labels fail to bear nutrition information ("Supplements Facts" panel) as required by 21 CFR 101.36.; (2) Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because the label fails to declare each ingredient by the common or usual name required by 21 CFR 101.4(a) and 21 CFR101.4(g). Specifically; the label appears to fail to include "dietary ingredients" and "other ingredients" in full ingredient list; (3) Section 403(y) of the Act [21 U.S.C. 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement; (4) Section 403(s)(2)(B) of the Act [21 U.S.C. 343 (s)(2)(B)] because it does not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g).


GREECE


BISCOTTI SA
Date Published : 04/14/2016
Interbalkan Area , Thessaloniki, GREECE
03 N - - 03 Pastry (Eclairs, Cream Puffs) Custard or Cream Filled
Date Published: 04/14/2016

Desc: Greek Cannoli
Notes: The product label fails to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii). There are no values provided for the vitamins and minerals on the labels as required by 21 CFR 101.9(c). The product label fails to declare calories from fat in accordance 21 CFR 101.9 (c)(1)(ii). The nutrition labels do not include the full footnote required in 21 CFR 101.9(d)(9). The serving size is not expressed in common household measure and followed by the equivalent metric quantity in parenthesis (21 CFR 101.9(b)(5) and 21 CFR 101.9(b)(7)). The heading "Nutrition Fact" must be declared as "Nutrition Facts" and must be set the full width of the nutrition label (21 CFR 101.9(d)(2)). The quantitative amount of calories and sodium must be rounded in accordance with 21 CFR 101.9(c)(1) and 21 CFR 101.9(c)(4).

Franca S.A.
Date Published : 10/02/2015
P.O. Box 46010 133 01 A. Liossia , Athens Greece, GREECE
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/02/2015

Desc: Fat Free Garlic Bagel Chips
Notes: label bears the claim "fat free" but the product fails to meet the requirements for the claim

G.S. PAPANIKOLAOU BROS O.E.
Date Published : 10/02/2015
Messinis Street 2 , Kalamata, Messinias GREECE
21 G - - 09 Olives (Pit Fruit)
Date Published: 10/02/2015

Desc: Kalamata Olives (Packed in olive Oil)
Notes: VIOLATION (IN NOTES); 1. 403(q) 2. 403(r)(1)(B) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(q) because the product does not declare trans fat in accordance with 21 CFR 101.9(c)(2)(ii). 2. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the label appears to be misbranded under section 403(r) because the product label makes unauthorized health claims. We note we have a qualified health claim where we have provided enforcement discretion for monounsaturated fatty acids from olive oil and coronary heart disease; however; we note that the statements on this product label do not meet the requirements for making such a claim.


GUATEMALA


ALIMENTOS RENE Y CIA S A
Date Published : 07/21/2017
Calzada San Juan 34-01 Zona 7 z. 7 , Guatemala, Guatemala GUATEMALA
07 B - - 02 Corn Chips, Fried
Date Published: 07/21/2017

Desc: Corn Chips Tortrix-BBQ
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Section 402(i)(2) of the FD&C Act in that they are fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(w) of the FC&C Act in that the finished product labels fail to declare the major food allergen ?milk? as required by section 402(w)(1) of the Act. Specifically; the product declares ?whey?; but does not declare ?milk? which is a component of whey.

07 B - - 02 Corn Chips, Fried
Date Published: 07/21/2017

Desc: Corn Chips Tortrix-Lemon
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in that the nutrition facts information is not an appropriate format as defined in 21 CFR 101.9. Section 402(i)(2) of the FD&C Act in that they are fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(w) of the FC&C Act in that the finished product labels fail to declare the major food allergen ?milk? as required by section 402(w)(1) of the Act. Specifically; the product declares ?whey?; but does not declare ?milk? which is a component of whey.

07 B - - 02 Corn Chips, Fried
Date Published: 07/21/2017

Desc: Corn Chips Tortrix-Hot BBQ
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

Alimentos Maravilla S.A.
Date Published : 11/02/2023
Km. 58.5 Carretera A Siquinala , Escuintla, Escuintla GUATEMALA
20 K - - 06 Orange, Citrus Fruit Juices or Concentrates
Date Published: 11/02/2023

Desc: ORANGE JUICE BEVERAGE; 33.5 oz (Bebida de Naranja; 990 ml)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) because it fails to declare the net quantity of contents in terms of avoirdupois pound and ounce, followed by the metric statement. Section 403(f) of the Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act because they are a product that purports to be a beverage containing vegetable or fruit juice but fails to contain a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food, as required by 21 CFR 101.30. Section 403(k) of the Act because the product contains artificial coloring, but fail to bear labeling stating that fact. Specifically, the products are manufactured with the certified colors FD&C Yellow No. 5 and FD&C Yellow No. 6; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

20 K - - 06 Orange, Citrus Fruit Juices or Concentrates
Date Published: 11/02/2023

Desc: ORANGE JUICE BEVERAGE; 115 oz (Bebida de Naranja; 3400 ml)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act because they are a product that purports to be a beverage containing vegetable or fruit juice but fails to contain a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food, as required by 21 CFR 101.30. Section 403(k) of the Act because the product contains artificial coloring, but fail to bear labeling stating that fact. Specifically, the products are manufactured with the certified colors FD&C Yellow No. 5 and FD&C Yellow No. 6; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

Chocolates Best de Guatemala S.A.
Date Published : 08/20/2019
4a Avenida 39-57 Z. 8 , Guatemala, Guatemala GUATEMALA
34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 08/20/2019

Desc: Chocolate Powder Drink Mix-Choco Panda (Cocoa En Polvo-Choco Panda)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)], in that the labels for the article list the ingredient folic acid. Folic acid is not an approved food additive for use in drink mixes. It is allowed in products represented as meal replacement products at specific, limited use levels. Based on the labels of this article, it does not appear to be a meal replacement product. Additionally, there is no basis to conclude that the use of folic acid in this article is GRAS. Therefore, the article appears to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. §342(a)(2)(C)(i)].

INDUSTRIAS UNIDAS, S.A.
Date Published : 10/02/2015
Km. 14.8 Carretera A Villa Canales , Boca Del Monte, Guatemala GUATEMALA
05 A - - 02 Oat Flakes, Rolled Oats,Puffs,Krispies,Loops Ready To Eat
Date Published: 10/02/2015

Desc: Oak Flakes
Notes: VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d);

05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.
Date Published: 10/02/2015

Desc: Oak Flakes
Notes: VIOLATION; The article is subject to refusal of admission pursuant to section 801 (a) (3) of the Act in that the label appears to be misbranded under section 403(r) because the product bears an unauthorized health claim but does not meet the requirements for the claims. The claim states; "You can reduce cholesterol by eating oats daily". There is an authorized health claim for soluble fiber from certain foods; such as oats; and risk of coronary heart disease in 21 CFR 101.81; however; the claim "You can reduce cholesterol by eating oats daily" is not consistent with the language provided in the regulation; The article is subject to refusal of admission pursuant to section 801(a) (3) of the Act in that the label appears to be misbranded under section 403(q) because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; There is no quantitative amount provided for total carbohydrate in accordance with 21 CFR 101.9(c)(6)(i); There is no quantitative amount provided for dietary fiber in accordance with 21 CFR 101.9(c)(6)(i)(A); There is no percent DV's provided for dietary fiber in accordance with 21 CFR 101.9(c)(7)(ii); In addition; the label does not include a declaration of Trans fat as required in 21 CFR 101.9(c)(2)(ii); The nutrition information does not meet the format requirements defined in 21 CFR 101.9(d);

Refrescos India Quiche
Date Published : 07/21/2017
1st Av y 14 street zone 4 , Sta Cruz del Quiche, Guatemala GUATEMALA
29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 07/21/2017

Desc: Lemon Lime Flavor Soda
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)]; in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example; ?Flavoring compounds? is not a common or usual name of the ingredien

29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 07/21/2017

Desc: Orange Flavor Soda
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)]; in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example; ?Flavoring compounds? is not a common or usual name of the ingredient.

29 B - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Carbonated
Date Published: 07/21/2017

Desc: Pinita Flavor Soda
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)]; in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example; ?Flavoring compounds? is not a common or usual name of the ingredient

29 B - - 99 Carbonated Soft Drink, N.E.C.
Date Published: 07/21/2017

Desc: Vanilla Flavor Soda
Notes: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages. Section 403(q) of the FD&C Act in the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)]; in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example; ?Flavoring compounds? is not a common or usual name of the ingredient.


HONG KONG SAR


CHOI YUE TRADING COMPANY
Date Published : 10/02/2015
G/f Shop 8 Belcher Court , 2 Sai Cheung Strteet, Western, Hk , HK, HK-NA HONG KONG SAR
38 C - - 99 Dried Soup, N.E.C.
Date Published: 10/02/2015

Notes: PRODUCT: Fish Abdomen with Agaricus Blazei Soup (Dried Soup Mix) - Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails toidentify each ingredient by its common or usual name. For example, the Ingredient listed as "Fish Abdomen¿ fails to identify the species of fish. Product is further misbranded in that the label does not bear nutrition information in the proper format.

Chan Yee Jai
Date Published : 10/02/2015
18/F, D Flat , Kong; 49-51 Wong Chuk Hang Road , Wong Chuk Hang, Hong Kong Island HONG KONG SAR
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Almond Cake
Notes: Charge; 403(q) The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C 343(q) in that the nutrition information is not declared as required by 21 CFR 101.9. Specifically; ?The product label does not declare a serving size or servings per container (21 CFR101.9(c)(2)(i) ?The product label does not declare the calories per serving or calories per serving from fat [21 CFR 101.9(c)(1) ?The product label does not declare the Daily Reference Value (DRV) for those substances for which a DRV has been established; such as fat; carbohydrates; and sodium [21 CFR 101.9(c)(9) ?The product label does not declare the vitamins for which an RDI has been established; or bear the statement identifying that the product is not a significant source of the nutrients [21 CFR 101.9(c)(8)

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/02/2015

Desc: Almond Cake
Notes: Charge; 403(q) The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C 343(q) in that the nutrition information is not declared as required by 21 CFR 101.9. Specifically; ?The product label does not declare a serving size or servings per container (21 CFR101.9(c)(2)(i) ?The product label does not declare the calories per serving or calories per serving from fat [21 CFR 101.9(c)(1) ?The product label does not declare the Daily Reference Value (DRV) for those substances for which a DRV has been established; such as fat; carbohydrates; and sodium [21 CFR 101.9(c)(9) ?The product label does not declare the vitamins for which an RDI has been established; or bear the statement identifying that the product is not a significant source of the nutrients [21 CFR 101.9(c)(8)

HONGKONG TIANBAO FOOD CO.,LIMITED
Date Published : 02/02/2017
Flat B07, Floor 23 , Hover Industrial Building No.; 26-38 Kai Cheong Road,N.T , Hongkong, HONG KONG SAR
25 L - - 07 Radish, Dried or Paste
Date Published: 02/02/2017

Desc: Dried Vegetable (Dried Radish)
Notes: Article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within section 403(k) of the FD&C Act. Ingredient list declares preservatives but does not declare their function, as is required under 21 CFR 101.22(j). Article is subject to refusal pursuant to section 801(a)(3) as it appears to be misbranded within section 403(q) of the FD&C Act. Nutrition information is not in the correct format as required by 21 CFR 101.9. • Total carbohydrate is declared as 0.3g. A statement of the number of grams of total carbohydrate must be expressed to the nearest gram, except that if a serving contains less than 1 gram, "Contains less than 1 gram" or "less than 1 gram" may be used, or if the serving contains less than 0.5 gram, the content may be expressed as zero [21 CFR 101.9(c)(6)]. • Calorie content is incorrectly declared. For the carbohydrates, fat, and protein amounts declared and the guidelines provided in 21 CFR 101.9(c)(i), the product cannot mathematically provide 100 Calories. • %DV for sodium declared as 108%. Based on the amount of sodium in a serving declared on the label (2180 mg) and the DRV for sodium (2400 mg), the %DV for sodium is incorrect. Article is subject to refusal pursuant to section 801(a)(3) as it appears to be misbranded within section 403(i)(1) of the FD&C Act. Label fails to bear the common or usual name as required by 21 CFR 101.3(b). Article is subject to refusal pursuant to Section 801(a)(3) as it appears to be misbranded within section 403(e)(1) of the FD&C Act. Labeling fails to list the place of business of manufacturer, packer, or distributor as required by 21 CFR 101.5(d).

MERRY GROUP HK LTD.
Date Published : 12/02/2020
15/F Hong Kong And Macau Bldg. , 156-157 Connaught Rd. , Central Hong Kong, HONG KONG SAR
33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy Candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 J - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 L - - 06 Flavored Candy, Soft (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 12/02/2020

Desc: Mix Gummy candy
Notes: (for Retail package, 8 ounces): The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Ingredient listing and nutrition facts label must be declared in both the foreign language and English, as required by 21 CFR 101.15(c)(2); Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For Individually packaged units of one gummy per package: Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food, if any there be; Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4; Section 403(e)(1) of the Act in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a);Section 403(e)(2) of the Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7;Section 403(k) of the Act in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. Products are manufactured with FD&C Yellow 5, Red 40 and Blue 1; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).

Smart Sense Group Limited
Date Published : 10/27/2021
17/F Winner Commercial Building , 401-3 Lockhart Road, Causeway Bay , Hong Kong, HONG KONG SAR
29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 10/27/2021

Desc: Liver Support Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(1), missing name and place of business of the manufacturer, packer, or distributor 21 CFR 101.5. Section 403(f), product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c). Disclaimer statement and “Other ingredient” are in a foreign language but not for the statement of identity and Supplement Facts (which may have the foreign language used for the botanical ingredients but not for their plant part). Section 403(q) in that the label or labeling fails to bear the required nutrition information. Sections 403(s)(2)(A) in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients 21 CFR 101.36. Dietary ingredients are listed after the statement of “Proprietary Blend” but the amount of the Blend per serving is not listed. Statement of “Proprietary Blend” is on the same line as the “% Daily Value which is not in accordance with 21 CFR 101.36. Section 403(s)(2)(B), missing statement of identity as a “dietary supplement” 21 CFR 101.3(g). Section 403(s)(2)(C), label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived 21 CFR 101.4(h)(1). Plant part for the Dandelion and Blessed Thistle Herb dietary ingredients is not listed. If whole plant is used, that information must be listed; “herb” and “herba” (Spanish) is not a recognized plant part. Section 403(y), label fails to bear a USA address or phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/27/2021

Desc: Liver Support Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(1), missing name and place of business of the manufacturer, packer, or distributor 21 CFR 101.5. Section 403(f), product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c). Disclaimer statement and “Other ingredient” are in a foreign language but not for the statement of identity and Supplement Facts (which may have the foreign language used for the botanical ingredients but not for their plant part). Section 403(q) in that the label or labeling fails to bear the required nutrition information. Sections 403(s)(2)(A) in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients 21 CFR 101.36. Dietary ingredients are listed after the statement of “Proprietary Blend” but the amount of the Blend per serving is not listed. Statement of “Proprietary Blend” is on the same line as the “% Daily Value which is not in accordance with 21 CFR 101.36. Section 403(s)(2)(B), missing statement of identity as a “dietary supplement” 21 CFR 101.3(g). Section 403(s)(2)(C), label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived 21 CFR 101.4(h)(1). Plant part for the Dandelion and Blessed Thistle Herb dietary ingredients is not listed. If whole plant is used, that information must be listed; “herb” and “herba” (Spanish) is not a recognized plant part. Section 403(y), label fails to bear a USA address or phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.


ICELAND


GeoSilica Iceland
Date Published : 06/05/2018
Granasbraut 506 , Reykjanesba, ICELAND
54 A - - 99 Vitamin, N.E.C.
Date Published: 06/05/2018

Desc: Geosilica Silica Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

54 A - - 99 Vitamin, N.E.C.
Date Published: 06/05/2018

Desc: Recover Muscle and Nerves Minerals
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4.

54 B - - 99 Mineral N.E.C.
Date Published: 06/05/2018

Desc: Geosilica Silica Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/05/2018

Desc: Geosilica Silica Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/05/2018

Desc: Recover Muscle and Nerves Minerals
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4.


INDIA


ADRET RETAIL PVT LTD
Date Published : 09/25/2019
1 Gupta Lane , Kolkata, West Bengal INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Kapiva Stress Guard
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(B); 403(s)(2)(C); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Kutjarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Kumari Asav Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Vasarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Punarnawarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Kumari Asav Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Vasarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Punarnawarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Kutjarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Kapiva Stress Guard
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(B); 403(s)(2)(C); 403(i)(2).

Abir International
Date Published : 03/04/2024
H No.156, Main Threekay Road , Adj. Swani Motors, Punjab , Ludhiana, Punjab INDIA
23 Y - - 99 Nuts or Edible Seeds Not Mentioned Elsewhere, N.E.C.
Date Published: 03/04/2024

Desc: White Musli Whole
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because they contain information in a foreign language; therefore, all required labeling must be presented in English and in all the foreign languages in addition to English [21 CFR 101.15(c)(1) and (2)]. There appears to be a different foreign language under “keep in cool & dry place.” Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] for failing to bear an appropriate name of a food. The name of a food must be (1) the name specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) the common or usual of the food; or, in the absence thereof, (3) an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. In this case, options 1 and 2 do not apply. The name of this product must be an appropriately descriptive term since the nature of the food is not obvious.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/04/2024

Desc: Lodh Powder
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because they contain information in a foreign language; therefore, all required labeling must be presented in English and in all the foreign languages in addition to English [21 CFR 101.15(c)(1) and (2)]. Lodh Powder appears to be foreign terms (Hindi) used in both the statements of identity and the ingredient lists. The English translation is not listed. There appears to be a different foreign language under “keep in cool & dry place.” Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] for failing to bear an appropriate name of a food. The name of a food must be (1) the name specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) the common or usual of the food; or, in the absence thereof, (3) an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. In this case, options 1 and 2 do not apply. The name of this product must be an appropriately descriptive term since the nature of the food is not obvious.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/04/2024

Desc: Inder Jon Kadve
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because they contain information in a foreign language; therefore, all required labeling must be presented in English and in all the foreign languages in addition to English [21 CFR 101.15(c)(1) and (2)]. Inder Jon Kadva appears to be foreign terms (Hindi) used in both the statements of identity and the ingredient lists. The English translation is not listed. There appears to be a different foreign language under “keep in cool & dry place.” Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] for failing to bear an appropriate name of a food. The name of a food must be (1) the name specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) the common or usual of the food; or, in the absence thereof, (3) an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. In this case, options 1 and 2 do not apply. The name of this product must be an appropriately descriptive term since the nature of the food is not obvious.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/04/2024

Desc: Nashodar
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Product label fails to declare a serving size in a common household measure. [21 CFR 101.9(b)(5) 21 CFR 101.9(b)(5)(ii) and 21 CFR 101.9(b)(7)(iv)]. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] for failing to bear an appropriate name of a food. The name of a food must be (1) the name specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) the common or usual of the food; or, in the absence thereof, (3) an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. In this case, options 1 and 2 do not apply. The name of this product must be an appropriately descriptive term since the nature of the food is not obvious. Section 403(f) of the Act [21 U.S.C. § 343(f)] because they contain information in a foreign language; therefore, all required labeling must be presented in English and in all the foreign languages in addition to English [21 CFR 101.15(c)(1) and (2)]. Nashodar appears to be foreign terms (Hindi) used in both the statements of identity and the ingredient lists. The English translation is not listed. There appears to be a different foreign language under “keep in cool & dry place.”

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/04/2024

Desc: White Musli Whole
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because they contain information in a foreign language; therefore, all required labeling must be presented in English and in all the foreign languages in addition to English [21 CFR 101.15(c)(1) and (2)]. There appears to be a different foreign language under “keep in cool & dry place.” Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] for failing to bear an appropriate name of a food. The name of a food must be (1) the name specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) the common or usual of the food; or, in the absence thereof, (3) an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. In this case, options 1 and 2 do not apply. The name of this product must be an appropriately descriptive term since the nature of the food is not obvious.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/04/2024

Desc: Ratan Jot (Ratanjot)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because they contain information in a foreign language; therefore, all required labeling must be presented in English and in all the foreign languages in addition to English [21 CFR 101.15(c)(1) and (2)]. Ratan Jot appears to be foreign terms (Hindi) used in both the statements of identity and the ingredient lists. The English translation is not listed. There appears to be a different foreign language under “keep in cool & dry place.” Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] for failing to bear an appropriate name of a food. The name of a food must be (1) the name specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) the common or usual of the food; or, in the absence thereof, (3) an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. In this case, options 1 and 2 do not apply. The name of this product must be an appropriately descriptive term since the nature of the food is not obvious.

Achaya Spices
Date Published : 12/03/2019
146 6'th East Street , Chennai, Tamil Nadu INDIA
24 B - - 09 Mung Bean, Dried or Paste
Date Published: 12/03/2019

Desc: Moong Dal Split
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the it has failed to declare the common or usual name of the food as required by 21 CFR 101.3(b). Specifically, the product name "Moong Dal Split" is not the common or usual name of mung beans; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

Adret Retail
Date Published : 09/25/2019
P-83, Benaras Road , Howrah-8 , West Bengal, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Kumari Asav Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Kutjarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Vasarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Kapiva Stress Guard
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(B); 403(s)(2)(C); 403(i)(2).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/25/2019

Desc: Punarnawarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Vasarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Punarnawarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Kapiva Stress Guard
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(B); 403(s)(2)(C); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Kutjarista Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/25/2019

Desc: Kumari Asav Syrup
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q); 403(s)(2)(A); 403(s)(2)(B); 403(s)(2)(C); 403(e)(2); 403(i)(2).

AmulFed Dairy (Previously known as Mother Dairy) - A Unit of GCMMF Ltd
Date Published : 05/10/2023
Near Indira Bridge , Gandhi Nagar, Gujarat INDIA
09 A - - 01 Butter (Plain or Whipped)
Date Published: 05/10/2023

Desc: Amul Pure Ghee
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the FD&CA in that the article's labeling appears to be false and misleading in any particular. DWPE date: 06/20/2013. Firm previously listed on deactivated Import Alert 09-01.

09 A - - 02 Butter Oil
Date Published: 05/10/2023

Desc: Amul Pure Ghee
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the FD&CA in that the article's labeling appears to be false and misleading in any particular. DWPE date: 06/20/2013. Firm previously listed on deactivated Import Alert 09-01.

09 A - - 99 Butter And Butter Products, N.E.C.
Date Published: 05/10/2023

Desc: Amul Pure Ghee
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the FD&CA in that the article's labeling appears to be false and misleading in any particular. DWPE date: 06/20/2013. Firm previously listed on deactivated Import Alert 09-01.

Ancient Greenfields
Date Published : 02/28/2018
4/159-A2, Vadavalli to Kanuvai Road , Kalappanaickenpalayam , Coimbatore, Tamil Nadu INDIA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 08/17/2022

Desc: Ashwagandha Powder
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number. Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the product label declares the dietary ingredient organic ashwagandha root powder but fails to state the quantitative amount by weight per serving, as required by 21 CFR 101.36(b)(3)(ii).

54 A - - 99 Vitamin, N.E.C.
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 08/17/2022

Desc: Ashwagandha Powder
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number. Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the product label declares the dietary ingredient organic ashwagandha root powder but fails to state the quantitative amount by weight per serving, as required by 21 CFR 101.36(b)(3)(ii).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

BRITANNIA INDUSTRIES LIMITED
Date Published : 10/02/2015
5 / 1 A Hunger Ford Street , Kolkata, West Bengal INDIA
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06 ;

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Nice Time Sugar Showered Coconut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Cashew Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04 ;

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Marie Gold Biscuits
Notes: Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: 50-50 Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

Bajrangbali Vanijya Pvt Ltd
Date Published : 12/09/2022
31/32 Milestone, Delhi Road , Pearapore, Sheoraphuly , Hooghly, West Bengal INDIA
03 J - - 04 Chocolate Chip Filled/Iced Cookies,Biscuits and Wafers
Date Published: 12/09/2022

Desc: Teddybear Choccochip Grahams Cookies (Bear Grahams Cookies; Chocolaty Chip)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labels are false and misleading because the ingredient statements are not consistent between the inner individually packaged units and the outer carton label. Additionally, the labels of the individually packaged units appear to be false because based on the evidence provided, milk is not an intentionally added ingredient.                                                                                          

Bikaji Foods International Ltd.
Date Published : 01/10/2017
F-196-197 Bichhwal Industrial Area , Rico Industrial Area, Bikaji Road , Bikaner, Rajastan INDIA
37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 01/25/2017

Desc: Badam Halwa
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

DHARA FOODS PVT .LTD
Date Published : 06/23/2023
Opp. National Research Center , Boriavi , Anand, Gujarat INDIA
02 A - - 99 Grain, Whole, N.E.C.
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 D - - 99 Rice, Processed (Packaged) N.E.C.
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 E - - 04 Wheat Flour, Durum
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 E - - 06 Wheat Flour, Gluten
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 E - - 10 Wheat Flour, Plain Self-Rising
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 E - - 13 Wheat Flour, Whole
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 E - - 15 Wheat Flour, Plain
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 E - - 99 Wheat Flour, N.E.C.
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

02 F - - 07 Wheat, Milled (Crushed, Coarse Ground or Cracked)
Date Published: 06/23/2023

Desc: Wheat Flour
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages as required by 21 CFR 101.15(c). Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

Deltas Pharma( Padmavati )
Date Published : 06/22/2017
Old Industrial Area , Haridwar, INDIA
28 C - - 04 Basil (Sweet Basil), Natural Extract or Flavor (Spice)
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares "solubiliser" along with other dietary ingredients, but this is not the common or usual name for an ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares "solubiliser" along with other dietary ingredients, but this is not the common or usual name for an ingredient.

Dhariwal Industries PVT. LTD
Date Published : 12/06/2022
N.H No. 8 At Fazalpur, Post Rayka , Vadodara, Gujarat INDIA
28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 12/06/2022

Desc: Pan Masala RMD
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because outer box and sachet contain information in a second language. All required information must be in both languages (i.e., the English language as well as the foreign language) [21 CFR 101.15(c)(2)]. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (outer box and sachet), (21 CFR 101.4). “Condiments”, “Natural Flavors” and “Herbs” are not the common or usual names for any ingredient. 21 CFR 101.4(b) does not permit the use of the collective terms “condiments” and “herbs” in the ingredient statement. Each ingredient must be listed separately in descending order of predominance by weight. “Contains Added” term is not part of the ingredient name and needs to be removed. Spices, condiments, and herbs are not considered “natural flavors” under 21 CFR 101.22. “Flavours” (sic) is not the U.S. spellings for flavors. Section 403(q) of the FD&C Act in that the nutrition facts information is not as defined in 21 CFR 101.9. The sachets do not include a Nutrition Facts label. The outer box lists nutrients that are not in the correct increments: Calories, Total Fat, Saturated Fat, Polyunsaturated Fat, Monounsaturated Fat, Total Sugars, Added Sugars, Protein, Calcium, Iron, and Potassium declarations are not expressed in the appropriate increments [21 CFR 101.9(c)].

54 K - - 11 Betel Nut (Herbal and Botanicals, not Teas II)
Date Published: 12/06/2022

Desc: Pan Masala RMD
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because outer box and sachet contain information in a second language. All required information must be in both languages (i.e., the English language as well as the foreign language) [21 CFR 101.15(c)(2)]. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (outer box and sachet), (21 CFR 101.4). “Condiments”, “Natural Flavors” and “Herbs” are not the common or usual names for any ingredient. 21 CFR 101.4(b) does not permit the use of the collective terms “condiments” and “herbs” in the ingredient statement. Each ingredient must be listed separately in descending order of predominance by weight. “Contains Added” term is not part of the ingredient name and needs to be removed. Spices, condiments, and herbs are not considered “natural flavors” under 21 CFR 101.22. “Flavours” (sic) is not the U.S. spellings for flavors. Section 403(q) of the FD&C Act in that the nutrition facts information is not as defined in 21 CFR 101.9. The sachets do not include a Nutrition Facts label. The outer box lists nutrients that are not in the correct increments: Calories, Total Fat, Saturated Fat, Polyunsaturated Fat, Monounsaturated Fat, Total Sugars, Added Sugars, Protein, Calcium, Iron, and Potassium declarations are not expressed in the appropriate increments [21 CFR 101.9(c)].

E A Currim Pvt Ltd
Date Published : 10/02/2015
19 Kazi Sayed St Ground Flr , Mumbai, INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Umber SF Supplement
Notes: Product is labeled as a dietary supplement but fails to bear nutrition labeling ("Supplement Facts" panel) as required by Section 403(q)(5)(F) and 21 CFR 101.36. Product is misbranded within the meaning of Section 403(i)(2) of the Act because the label fails to list each ingredient, specifically, the capsule ingredients, in the ingredient statement (21 CFR 101.4(a)(1)). The label fails to identify the product using the term "dietary supplement" as part of the statement of identity on the principal display panel (21 CFR 101.3(a) and (g)). The product fails to provide the appropriate "Disclaimer" in accordance with 21 CFR 101.93(a-e).

Elmac Foods
Date Published : 03/13/2023
National Highway 6 , Haora, West Bengal INDIA
20 K - - 04 Lemon, Citrus Fruit Juices or Concentrates
Date Published: 03/13/2023

Desc: KTC Lemon Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition facts information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Serving size of 100 mL. Under 21 CFR 101.9(b)(2), the serving size on label shall be determined from the Reference Amount Customarily Consumed per Eating Occasion (reference amount). Under 21 CFR 101.12(c), the correct serving size for juices used as ingredients, e.g., lemon juice is 1 teaspoon (5 mL). Because the nutrition information is based on the incorrect serving size, all nutrition information is incorrect. The nutrition information is not in correct format (21 CFR 101.9). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Ingredient “Preservative – E224 (Sulphites)” is not an appropriate common or usual name for the ingredient.

GOODCARE PHARMA PVT
Date Published : 11/08/2023
24 Parganas South , Bishnupur-1 , Bishnupur, INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Kaishore Guggulu (Goodcare Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Safed Musali (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Bhumi Amla (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Arthplus (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 11/08/2023

Desc: Moringa (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Bhumi Amla (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Kaishore Guggulu (Goodcare Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Arthplus (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Safed Musali (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

Glaxo SmithKline Ltd
Date Published : 10/02/2015
Nobha , Patiyala Road , Nabha, Punjab INDIA
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 12/14/2023

Desc: Boost Drink Powder
Notes: 1/25/2016; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that it does not bear a Nutrition Facts label as required in 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) because many of the ingredients are not declared in accordance with 21 CFR 101.4. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act because the product fails to bear the common or usual name of the food [21 CFR 101.3(a)].

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 C - - 99 Foods (including Water) with Excessive Nutritional Claims
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

Goodcare Pharma Pvt. Ltd.
Date Published : 11/08/2023
Bagi Mouza , Bishnupur-1 , 24 Parganas (South), West Bengal INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Kaishore Guggulu (Goodcare Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Bhumi Amla (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Safed Musali (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023

Desc: Arthplus (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 11/08/2023

Desc: Moringa (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Bhumi Amla (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Safed Musali (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Kaishore Guggulu (Goodcare Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023

Desc: Arthplus (Leaf Care Brand)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the label fails to display the standard of identity in lines generally parallel to the base on which the package rests as it is designed to be displayed, in accordance with 21 CFR 101.3(d). Section 403(i)(2) of the Act in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4., and in that the products are fabricated from two or more ingredients, but the labels fail to list the individual excipients as required by 21 CFR 101.4(a) and (g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Section 403(s)(2)(C) of the Act in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1); if the whole or entire plant is used, that information must be listed. Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

HINDUSTAN UNILEVER LIMITED
Date Published : 01/05/2017
Focal Point , A - 5n Phase Ii B , Patiala, Punjab INDIA
21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 01/05/2017

Desc: Mango Jam
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

21 U - - 05 Mango, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 01/05/2017

Desc: Mango Jam
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

Hindustan Coca Cola Beverages Pvt Ltd
Date Published : 10/02/2015
1105/7/8/33 Gut No , Pirangut, Dist. Pune, Maharashtra INDIA
29 B - - 50 Soft Drink, Cola, Carbonated
Date Published: 10/02/2015

Desc: ?Thumbs Up? Carbonated Soft Drink
Notes: Charge; 403(q) The Trans Fat content is not declared as required by 21 CFR 101.9(c)(2)(ii); The serving size is listed in metrics rather than common household measure [21 CFR 101.9(b)(1) as defined in 21 CFR 101.9(b)(5)]; A Percent Daily Value must not be provided for sugars (21 CFR 101.9(d)(7)(ii)). The can declares a nutrition label in another country?s format (with different nutrition label values); which is not provided for in 21 CFR 101.9. We note that the product has a nutrition label sticker that appears to be in the U.S. format; however; the sticker does not cover up the incorrect format.

INDO NISSAN FOODS LIMITED
Date Published : 10/02/2015
CENTENARY BUILDING 28 M.G. ROAD , Bangalore, Karnataka INDIA
04 C - - 07 Noodles, Instant
Date Published: 10/02/2015

Desc: Top Ramen Curry Noodles
Notes: Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09

Indo Nissin Foods Private Limited
Date Published : 08/25/2023
Kms , 91 Tehsil Bawal; Nh-8 , Rewari, Haryana INDIA
04 C - - 07 Noodles, Instant
Date Published: 08/25/2023

Desc: Top Ramen Curry Noodles
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in all languages. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is provided in another country’s nutrition label format which is not provided for in 21 CFR 101.9.

04 C - - 08 Oriental Noodles (flavored with Shrimp,Chicken,Beef,Lobster,Crab,Plain,Etc.)
Date Published: 08/25/2023

Desc: Top Ramen Curry Noodles
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in all languages. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is provided in another country’s nutrition label format which is not provided for in 21 CFR 101.9.

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 08/25/2023

Desc: Top Ramen Curry Noodles
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in all languages. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is provided in another country’s nutrition label format which is not provided for in 21 CFR 101.9.

04 Y - - 99 Macaroni/Noodle Products Not Elsewhere Mentioned, N.E.C.
Date Published: 08/25/2023

Desc: Top Ramen Curry Noodles
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in all languages. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is provided in another country’s nutrition label format which is not provided for in 21 CFR 101.9.

K & B Manufacturing
Date Published : 09/01/2022
38 Pamping Station , Ahmedabad, Gujarat INDIA
09 A - - 02 Butter Oil
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 B - - 99 Vegetable Oil Seed Stock, N.E.C.
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 C - - 06 Peanut Oil, Refined, Single Ingredient
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 C - - 15 Sunflower Oil, Single Ingredient
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 Y - - 01 Vegetable Oil with Dried Herbs
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 Y - - 02 Vegetable Oil with Fresh Herbs
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 Y - - 99 Vegetable Oils Not Mentioned Elsewhere, N.E.C.
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

27 Y - - 99 Condiments, N.E.C.
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 09/01/2022

Desc: VEGETABLE COOKING OIL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

K-Pra Foods Private Limited
Date Published : 01/10/2018
870/871 Palashi Village , Near Shirwal Town , Pune, Maharashtra INDIA
23 F - - 07 Peanut, Topping
Date Published: 01/10/2018

Desc: GROUND NUT CHATNI (CHUTNEY)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 USC 343(q)] because the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. 403(i)(2) of the Act [21 USC 343(i)(2)] because the product label fails to declare all ingredients by the common or usual name, as required by 21 CFR 101.4. 403(f) of the Act [21 USC 343(f)] because the product label contains information in two languages (English and Hindi) but does not repeat all of the required information in Hindi.

KOCHI KITCHEN EXPORTS
Date Published : 01/12/2018
23/1777 Binny Road , Kochi, Kerala INDIA
20 A - - 08 Gooseberries (Berry)
Date Published: 01/12/2018

Desc: AMLA (INDIAN GOOSEBERRY)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21U.S.C. 343(a)(1)] because the label is false and misleading. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21U.S.C. 343(r)(1)(A)] because the label bears the claim "Eastern sources the finest Alma, helping you maintain a diet rich in vitamin C, iron and zinc." The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(B) of the Act [21U.S.C. 343(r)(1)(B)] because the label bears an unauthorized health claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not using the correct serving size as defined in 21 CFR 101.9. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that product label contains information in three foreign languages in addition to English but does not repeat all the required label information in all languages.

21 S - - 34 Amla, Subtropical and Tropical Fruit
Date Published: 01/12/2018

Desc: AMLA (INDIAN GOOSEBERRY)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21U.S.C. 343(a)(1)] because the label is false and misleading. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21U.S.C. 343(r)(1)(A)] because the label bears the claim "Eastern sources the finest Alma, helping you maintain a diet rich in vitamin C, iron and zinc." The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(B) of the Act [21U.S.C. 343(r)(1)(B)] because the label bears an unauthorized health claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not using the correct serving size as defined in 21 CFR 101.9. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that product label contains information in three foreign languages in addition to English but does not repeat all the required label information in all languages.

Kamala International Exim
Date Published : 05/22/2017
7-4-112/1, Madhuban Colony Road , Kattedan , Hyderabad, IN-TG INDIA
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 05/22/2017

Desc: "King Dutch" Wafer Rolls; Hazelnut flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. The label appears to include the nutrient content claim ?0 trans-fat? on the information panel but does not declare the levels of mono- and polyunsaturated fat in the nutrition label in accordance with the requirements of 21 CFR 101.9 (c)(2)(iii) and (iv).. Based on the quality of the photo of the label we were provided; we cannot tell if there is also a claim on the Principal Display panel.

Keval Exports Pvt Ltd
Date Published : 09/14/2015
D 8/7 T T C Industrial Area , T T C Industrial Turbhe D Block Road , Navi Mumbai, Maharashtra INDIA
28 A - - 18 Fennel, Whole (Spice)
Date Published: 09/14/2015

Desc: SUGAR COATED FENNEL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the product appears to be misbranded under section 403(k) of the Act because it contains artificial coloring and fails to bear labeling stating that fact. FD&C Red No. 40; FD&C Yellow No. 5; and FD&C Blue No. 1 are not declared by their listed names or appropriate abbreviations. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the product appears to be misbranded under section 403(i)(2) of the Act because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient; as required under 21 CFR 101.4 Specifically; the product label contains no information about the ingredients contained therein

Legacy Foods Pvt. Ltd.
Date Published : 10/02/2015
17km Pinjore Nalagarh Highway , P.O. Baddi , Distt. Solan 1730205 (Hp), INDIA
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 C - - 99 Foods (including Water) with Excessive Nutritional Claims
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

M/S Hindustan Unilever Limited
Date Published : 01/31/2020
Plot No A - 8/9 , Midc Industrial Estate , Malegaon, Maharashtra INDIA
21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 01/31/2020

Desc: MIXED FRUIT JAM
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the ingredients "thickener," "acidity regulator," and "preservative" are not the common or usual name of food ingredients, but rather appear to be functional descriptions of ingredients. If these terms refer to chemical preservatives under 21 CFR 101.22(j), then they must be labeled in accordance with this regulation. Additionally, numbers, such as "440," are not common or usual names of ingredients. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act [21 U.S.C. §343(i)(1)] in that the product fails to meet the standard of identity for jam, 21 CFR 150.160. The product is made using artificial color and artificial raspberry, pineapple, and strawberry flavors, but the standard does not permit for artificial colors and artificial flavors to be added.

22 J - - 99 Other Fruit and Fruit Products, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 01/31/2020

Desc: MIXED FRUIT JAM
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the ingredients "thickener," "acidity regulator," and "preservative" are not the common or usual name of food ingredients, but rather appear to be functional descriptions of ingredients. If these terms refer to chemical preservatives under 21 CFR 101.22(j), then they must be labeled in accordance with this regulation. Additionally, numbers, such as "440," are not common or usual names of ingredients. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act [21 U.S.C. §343(i)(1)] in that the product fails to meet the standard of identity for jam, 21 CFR 150.160. The product is made using artificial color and artificial raspberry, pineapple, and strawberry flavors, but the standard does not permit for artificial colors and artificial flavors to be added.

MAPRO FRUIT BAR LLP
Date Published : 07/24/2019
117 - 121 , Mapro Fruit Bar Llp; Wai , Shendurjane, Maharashtra INDIA
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 07/24/2019

Desc: Orange Chews
Notes: 9/17/2015; NOTE; Mapro Foods Private Limited was declared as the manufacturer of products; labels show manufactured by Mapro Fruit Bar LLP.                                                                                                                                                                                                                                                                                                        Orange Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient; as required under 21 CFR 101.4. Specifically; "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally; Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 07/24/2019

Desc: Guava Chews
Notes: 9/17/2015; NOTE; Mapro Foods Private Limited was declared as the manufacturer of products; labels show manufactured by Mapro Fruit Bar LLP.                                                                                                                                                                                                                                                                                                        Orange Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient; as required under 21 CFR 101.4. Specifically; "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally; Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

MR PHARMA
Date Published : 02/20/2024
1 New Rose Colony , Rajpura Road; Gali N0 , Hira Garh, Punjab INDIA
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 02/20/2024

Desc: Lakshadi Guggul Tablets
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the product appears to be misbranded within the meaning of: Section 403 (q) of the Act in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Specifically, in that the serving size declared on the outside container and product container is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Additionally, a Supplement Facts label is not present in accordance with 21 CFR 101.36 and 21 CFR 101.9. Ingredients must be declared appropriately within the Supplement Facts label in accordance with 21 CFR 101.36 and 21 CFR 101.9 Section 403(i)(2) of the Act, in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act, in that the product label fails to specify the part of the plant for each declared botanical is derived from in accordance with 21 CFR 101.4(h)(1), e.g., guggul and aloe vera.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/20/2024

Desc: Lakshadi Guggul Tablets
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the product appears to be misbranded within the meaning of: Section 403 (q) of the Act in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Specifically, in that the serving size declared on the outside container and product container is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Additionally, a Supplement Facts label is not present in accordance with 21 CFR 101.36 and 21 CFR 101.9. Ingredients must be declared appropriately within the Supplement Facts label in accordance with 21 CFR 101.36 and 21 CFR 101.9 Section 403(i)(2) of the Act, in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act, in that the product label fails to specify the part of the plant for each declared botanical is derived from in accordance with 21 CFR 101.4(h)(1), e.g., guggul and aloe vera.

Mapro Foods Pvt Ltd
Date Published : 09/17/2015
122, Shendurjane , Dist. Satara , Wai, Maharashtra INDIA
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Orange Chews
Notes: Orange Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Mango Chews
Notes: Mango Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Strawberry Chews
Notes: Strawberry Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Allura Red AC (E-129) must be declared by the common or usual name FD&C Red 40.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 08/09/2018

Desc: Vanilla Nutritional Shake Powder
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the amount of Calcium is at 22.7%, Iron is at 19.5% and Zinc is at 6.6% of the label declaration in the Vanilla Nutritional Shake Powder.; Also, The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages. Title 21 CFR 101.15(c) states that if a product contains any representation in a foreign language, all words, statements and other information required by or under authority of the Act appear on the label must appear in the foreign language.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 08/09/2018

Desc: Strawberry Nutritional Shake Powder
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the amount of Calcium is at 25.1%, Iron is at 19.6% and Zinc is at 5.6% of the label declaration in the Strawberry Nutritional Shake Powder. Also, The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages. Title 21 CFR 101.15(c) states that if a product contains any representation in a foreign language, all words, statements and other information required by or under authority of the Act appear on the label must appear in the foreign language.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Guava Chews
Notes: Guava Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Allura Red AC (E-129) must be declared by the common or usual name FD&C Red 40.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Raw Mango Chews
Notes: Raw Mango Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

Marico Limited
Date Published : 02/28/2018
Plot No 8 Ind. Arealodhimajra, Tehsil , Solan, INDIA
26 C - - 99 Refined Vegetable Oil, Single Ingredient, N.E.C.
Date Published: 02/28/2018

Desc: Saffola Gold Vegetable Oil
Notes: Section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents in terms of fluid measure as required by 21 CFR 101.7.

26 D - - 99 Blended Vegetable Oils, Refined, N.E.C.
Date Published: 02/28/2018

Desc: Saffola Gold Vegetable Oil
Notes: Section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents in terms of fluid measure as required by 21 CFR 101.7.

26 Y - - 99 Vegetable Oils Not Mentioned Elsewhere, N.E.C.
Date Published: 02/28/2018

Desc: Saffola Gold Vegetable Oil
Notes: Section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents in terms of fluid measure as required by 21 CFR 101.7.

Mehrotra Consumer Products Private Limited
Date Published : 04/02/2019
Ecotech 1 , 26g Sector 31 , Greater Noida, Uttar Pradesh INDIA
25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 04/02/2019

Desc: Organic Tattva Triphala Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears nutrient content claims, but the product does not meet the requirements to make such claims. Claim: "Rich in Vitamin C and Antioxidants", but product does not list Vitamin C in the Nutrition Facts. Claim "rich in nutrients," but the product does not contain any nutrients that would meet the definition of "rich in" in accordance with 21 CFR 101.54(b). Claim: "antioxidant" must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). Missing name of nutrient(s) with recognized antioxidant activity, as required by 21 CFR 101.54(g)(4) Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear an appropriate statement of identity. The term "Triphala" is foreign (Indian) term meaning three fruits. Product appears to be intended to be mixed with water to be consumed as a beverage; however, the statement of identity does not indicate that it is used to make a beverage; for example, a beverage mix or a tea. Section 403(i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and the ingredients are not declared appropriately, as required under 21 CFR 101.4. The ingredient list appears to declare two terms for each ingredient. There are no provisions in 21 CFR 101.4 for declaring multiple terms for each ingredient in a food product. The terms used in the ingredient list appear to be foreign terms.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/02/2019

Desc: Organic Tattva Triphala Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears nutrient content claims, but the product does not meet the requirements to make such claims. Claim: "Rich in Vitamin C and Antioxidants", but product does not list Vitamin C in the Nutrition Facts. Claim "rich in nutrients," but the product does not contain any nutrients that would meet the definition of "rich in" in accordance with 21 CFR 101.54(b). Claim: "antioxidant" must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). Missing name of nutrient(s) with recognized antioxidant activity, as required by 21 CFR 101.54(g)(4) Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear an appropriate statement of identity. The term "Triphala" is foreign (Indian) term meaning three fruits. Product appears to be intended to be mixed with water to be consumed as a beverage; however, the statement of identity does not indicate that it is used to make a beverage; for example, a beverage mix or a tea. Section 403(i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and the ingredients are not declared appropriately, as required under 21 CFR 101.4. The ingredient list appears to declare two terms for each ingredient. There are no provisions in 21 CFR 101.4 for declaring multiple terms for each ingredient in a food product. The terms used in the ingredient list appear to be foreign terms.

Mehsana District Co-Operative Milk Producers Union LTD
Date Published : 09/22/2023
Mehsana 384 002 , Mmpo Rc No. 74/r-mmpo/93 , Mehsana, INDIA
09 A - - 02 Butter Oil
Date Published: 09/22/2023

Desc: Vegetable Cooking Oil/Cow Ghee
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

09 A - - 99 Butter And Butter Products, N.E.C.
Date Published: 09/22/2023

Desc: Vegetable Cooking Oil/Cow Ghee
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 A - - 99 Crude Vegetable Oil, N.E.C.
Date Published: 09/22/2023

Desc: Vegetable Cooking Oil/Cow Ghee
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 B - - 99 Vegetable Oil Seed Stock, N.E.C.
Date Published: 09/22/2023

Desc: Vegetable Cooking Oil/Cow Ghee
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 C - - 06 Peanut Oil, Refined, Single Ingredient
Date Published: 09/22/2023

Desc: Vegetable Cooking Oil/Cow Ghee
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 C - - 15 Sunflower Oil, Single Ingredient
Date Published: 09/22/2023

Desc: Vegetable Cooking Oil/Cow Ghee
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

26 Y - - 99 Vegetable Oils Not Mentioned Elsewhere, N.E.C.
Date Published: 09/22/2023

Desc: Vegetable Cooking Oil/Cow Ghee
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false or misleading. The product is labeled as “Amul Cow Ghee”, but the statement of identity indicates the product is “vegetable cooking oil.” The statement “vegetable cooking oil” is part of a sticker label added to the existing label. Ghee is the common or usual name of a clarified butter. Section 403(r)(1)(A)/(B) of the Act in that it appears to be misbranded. Label or labeling bears an unauthorized nutrient content/health claim. “[r]ich source of Vitamin A”. The vitamin A content in the product is not 20% or greater of the RDI per reference amount customarily consumed (21 CFR 101.54(b)).

Mondelez India Foods Limited
Date Published : 10/31/2018
Mondelez House , 210th Floor Unit No 2001; Tower - 3 , Mumbai, Maharashtra INDIA
02 J - - 99 Malt Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 Y - - 99 Cereal Preparations Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

32 A - - 99 Malt Beverages, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 J - - 99 Imitation Chocolate and Cocoa Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

NESTLE INDIA LIMITED
Date Published : 01/30/2017
Kiadb Industrial Area, Nanjangud , Mysore, Kartanaka INDIA
04 - - - -- Macaroni/Noodle Products
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

NESTLE INDIA LIMITED
Date Published : 08/31/2023
PLOT NO. SM-38, SANAND II, GIDC INDUSTRIAL ESTATE, , SIYAWADA CHOKADI, NEAR GIDC OFFICE, TAL. SANAND, , AHMEDABAD, GUJARAT INDIA
04 C - - -- Noodles/Noodle Products
Date Published: 08/31/2023

Desc: Maggi 2-Minute Noodles; 1680g (59.26oz)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act. Labels fail to declare each ingredient by their common or usual names (21 CFR 101.4). Color and food additives are not declared by their common or usual names (21 CFR 101.4(a)). Grouping is not permitted for flavor enhancers, thickeners, antioxidants, acidity regulators, etc. Percentage for “Mixed Spices;” not expressed to the nearest 1 percent (21 CFR 101.4(e)). At 2 percent or less, they may be grouped and expressed per 21 CFR 101.4(a)(2). “E” numbers are not permitted (21 CFR 101.4). “Hydrolysed” is not the English spelling for “hydrolyzed.” Section 403(q) of the Act. Nutrition Facts label (NFL) does not comply with 21 CFR 101.9. NFL of the multi-unit packages not consistent with NFL of individual units for Iron (21 CFR 101.9(c). The individual units include a no-permitted foreign NFL (21 CFR 101.9). The saturated fat and trans fat not expressed to the nearest 0.5-gram (21 CFR 101.9(c)(2)(i) and (ii)). The reference standard for calculating protein quality is casein; product does not appear to contain any casein or milk. Percent DV for protein, if declared, must be calculated per 21 CFR 101.9(c)(7)(ii). Section 403(e)(1). Labels on the multi-unit packages do not list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2). Net quantity not on PDP (21 CFR 101.7). Statement of quantity on outside of the package, number of individual units, quantity of each unit, and total quantity of contents of the multiunit package nor in accordance with 21 CFR 101.7(s), 21 CFR 101.7(a) and 101.7(b)(1)); and not in accordance with 15 U.S.C. 1453(a)(2) of the Fair Packaging and Labeling Act. “Net Wg.” is not the English spelling for “Net Wt.” (21 CFR 101.7(j)(3))

04 C - - -- Noodles/Noodle Products
Date Published: 08/31/2023

Desc: Maggi 2-Minute Noodles; 840g (29.63oz)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act. Labels fail to declare each ingredient by their common or usual names (21 CFR 101.4). Color and food additives are not declared by their common or usual names (21 CFR 101.4(a)). Grouping is not permitted for flavor enhancers, thickeners, antioxidants, acidity regulators, etc. Percentage for “Mixed Spices;” not expressed to the nearest 1 percent (21 CFR 101.4(e)). At 2 percent or less, they may be grouped and expressed per 21 CFR 101.4(a)(2). “E” numbers are not permitted (21 CFR 101.4). “Hydrolysed” is not the English spelling for “hydrolyzed.” Section 403(q) of the Act. Nutrition Facts label (NFL) does not comply with 21 CFR 101.9. NFL of the multi-unit packages not consistent with NFL of individual units for Iron (21 CFR 101.9(c). The individual units include a no-permitted foreign NFL (21 CFR 101.9). The saturated fat and trans fat not expressed to the nearest 0.5-gram (21 CFR 101.9(c)(2)(i) and (ii)). The reference standard for calculating protein quality is casein; product does not appear to contain any casein or milk. Percent DV for protein, if declared, must be calculated per 21 CFR 101.9(c)(7)(ii). Section 403(e)(1). Labels on the multi-unit packages do not list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2). Net quantity not on PDP (21 CFR 101.7). Statement of quantity on outside of the package, number of individual units, quantity of each unit, and total quantity of contents of the multiunit package nor in accordance with 21 CFR 101.7(s), 21 CFR 101.7(a) and 101.7(b)(1)); and not in accordance with 15 U.S.C. 1453(a)(2) of the Fair Packaging and Labeling Act. “Net Wg.” is not the English spelling for “Net Wt.” (21 CFR 101.7(j)(3))

Nestle India
Date Published : 02/28/2024
100/101, World Trade Centre, Barakhamba Lane , New Delhi, INDIA
04 A - - 05 Spaghetti
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 A - - 06 Vermicelli
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 01 Noodles, Chow Mein
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 05 Noodles, Wheat and Soy
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 07 Noodles, Instant
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

Nestle India Limited
Date Published : 11/04/2022
Taluka Bicholim , Bicholim, Goa INDIA
04 A - - 05 Spaghetti
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 A - - 06 Vermicelli
Date Published: 11/04/2022

Desc: Maggi Masala 2-Minute Noodles 280g and 560g
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(i)(2) of the FD&C Act in that product label fails to declare all the common or usual names of each ingredient used in accordance with the requirements in section 21 CFR 101.4. Color additives and food additives are not declared appropriately on the label (e.g., Thickeners (508 & 412), Acidity Regulators (501(i) & 500(i)) (330 & 500(ii)), humectant (451(i)); Flavour Enhancer (635), Colour (150d), mineral, and hydrolysed groundnut protein. The term “hydrolysed groundnut protein” as a sub-ingredient of the Masala *Tastemaker but not does not provide the identity of the food source from which the protein was derived in accordance with the requirements in section 21 CFR 102.22. Percentage for the ingredient "mixed spices (13.1%)" is not declared to nearest percent (21 CFR 101.4(e)). “Hydrolysed” appears to be misspelled; it should be spelled as “hydrolyzed”. Section 403(e)(2) of the FD&C Act. Label does not declare the net quantity of contents in avoirdupois pounds and ounces (21 CFR 101.7). Net quantity of contents statements on the multi-unit package do not appear to meet the requirements in section 21 CFR 101.7(s). Net quantity of contents on the bottle is not on the PDP, and not in the bottom 30 percent of the label in accordance with the requirements in section 21 CFR 101.7(f).

04 A - - 06 Vermicelli
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 01 Noodles, Chow Mein
Date Published: 11/04/2022

Desc: Maggi Masala 2-Minute Noodles 280g and 560g
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(i)(2) of the FD&C Act in that product label fails to declare all the common or usual names of each ingredient used in accordance with the requirements in section 21 CFR 101.4. Color additives and food additives are not declared appropriately on the label (e.g., Thickeners (508 & 412), Acidity Regulators (501(i) & 500(i)) (330 & 500(ii)), humectant (451(i)); Flavour Enhancer (635), Colour (150d), mineral, and hydrolysed groundnut protein. The term “hydrolysed groundnut protein” as a sub-ingredient of the Masala *Tastemaker but not does not provide the identity of the food source from which the protein was derived in accordance with the requirements in section 21 CFR 102.22. Percentage for the ingredient "mixed spices (13.1%)" is not declared to nearest percent (21 CFR 101.4(e)). “Hydrolysed” appears to be misspelled; it should be spelled as “hydrolyzed”. Section 403(e)(2) of the FD&C Act. Label does not declare the net quantity of contents in avoirdupois pounds and ounces (21 CFR 101.7). Net quantity of contents statements on the multi-unit package do not appear to meet the requirements in section 21 CFR 101.7(s). Net quantity of contents on the bottle is not on the PDP, and not in the bottom 30 percent of the label in accordance with the requirements in section 21 CFR 101.7(f).

04 C - - 01 Noodles, Chow Mein
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 05 Noodles, Wheat and Soy
Date Published: 11/04/2022

Desc: Maggi Masala 2-Minute Noodles 280g and 560g
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(i)(2) of the FD&C Act in that product label fails to declare all the common or usual names of each ingredient used in accordance with the requirements in section 21 CFR 101.4. Color additives and food additives are not declared appropriately on the label (e.g., Thickeners (508 & 412), Acidity Regulators (501(i) & 500(i)) (330 & 500(ii)), humectant (451(i)); Flavour Enhancer (635), Colour (150d), mineral, and hydrolysed groundnut protein. The term “hydrolysed groundnut protein” as a sub-ingredient of the Masala *Tastemaker but not does not provide the identity of the food source from which the protein was derived in accordance with the requirements in section 21 CFR 102.22. Percentage for the ingredient "mixed spices (13.1%)" is not declared to nearest percent (21 CFR 101.4(e)). “Hydrolysed” appears to be misspelled; it should be spelled as “hydrolyzed”. Section 403(e)(2) of the FD&C Act. Label does not declare the net quantity of contents in avoirdupois pounds and ounces (21 CFR 101.7). Net quantity of contents statements on the multi-unit package do not appear to meet the requirements in section 21 CFR 101.7(s). Net quantity of contents on the bottle is not on the PDP, and not in the bottom 30 percent of the label in accordance with the requirements in section 21 CFR 101.7(f).

04 C - - 05 Noodles, Wheat and Soy
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 07 Noodles, Instant
Date Published: 11/04/2022

Desc: Maggi Masala 2-Minute Noodles 280g and 560g
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(i)(2) of the FD&C Act in that product label fails to declare all the common or usual names of each ingredient used in accordance with the requirements in section 21 CFR 101.4. Color additives and food additives are not declared appropriately on the label (e.g., Thickeners (508 & 412), Acidity Regulators (501(i) & 500(i)) (330 & 500(ii)), humectant (451(i)); Flavour Enhancer (635), Colour (150d), mineral, and hydrolysed groundnut protein. The term “hydrolysed groundnut protein” as a sub-ingredient of the Masala *Tastemaker but not does not provide the identity of the food source from which the protein was derived in accordance with the requirements in section 21 CFR 102.22. Percentage for the ingredient "mixed spices (13.1%)" is not declared to nearest percent (21 CFR 101.4(e)). “Hydrolysed” appears to be misspelled; it should be spelled as “hydrolyzed”. Section 403(e)(2) of the FD&C Act. Label does not declare the net quantity of contents in avoirdupois pounds and ounces (21 CFR 101.7). Net quantity of contents statements on the multi-unit package do not appear to meet the requirements in section 21 CFR 101.7(s). Net quantity of contents on the bottle is not on the PDP, and not in the bottom 30 percent of the label in accordance with the requirements in section 21 CFR 101.7(f).

04 C - - 07 Noodles, Instant
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 02/28/2024

Desc: Maggi Masala 2 Minute Noodles 1.23lb (19.7oz / 560g)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the Maggi Masala 2 Minute Noodles nutrition label is false or misleading because according to FDA analyses, the value for iron is below 80% of the value declared on the nutrition label (21 CFR 101.9(g)(4)(ii)). The product label indicates that one serving (1 noodle cake + 1 spice pack, 70g) contains 2mg of iron. However, the Original Analysis showed that the actual iron content was 49.8% of the declared amount, and the Check Analysis confirmed this, finding 51.5% of the declared Iron content.

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 11/04/2022

Desc: Maggi Masala 2-Minute Noodles 280g and 560g
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(i)(2) of the FD&C Act in that product label fails to declare all the common or usual names of each ingredient used in accordance with the requirements in section 21 CFR 101.4. Color additives and food additives are not declared appropriately on the label (e.g., Thickeners (508 & 412), Acidity Regulators (501(i) & 500(i)) (330 & 500(ii)), humectant (451(i)); Flavour Enhancer (635), Colour (150d), mineral, and hydrolysed groundnut protein. The term “hydrolysed groundnut protein” as a sub-ingredient of the Masala *Tastemaker but not does not provide the identity of the food source from which the protein was derived in accordance with the requirements in section 21 CFR 102.22. Percentage for the ingredient "mixed spices (13.1%)" is not declared to nearest percent (21 CFR 101.4(e)). “Hydrolysed” appears to be misspelled; it should be spelled as “hydrolyzed”. Section 403(e)(2) of the FD&C Act. Label does not declare the net quantity of contents in avoirdupois pounds and ounces (21 CFR 101.7). Net quantity of contents statements on the multi-unit package do not appear to meet the requirements in section 21 CFR 101.7(s). Net quantity of contents on the bottle is not on the PDP, and not in the bottom 30 percent of the label in accordance with the requirements in section 21 CFR 101.7(f).

Nestle India Limited
Date Published : 01/30/2017
M Block , Jacaranda Marg, DLF City Phase II , Gurgaon, Haryana INDIA
04 - - - -- Macaroni/Noodle Products
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nestle India Limited - Moga Factory
Date Published : 10/02/2015
Ludhiana - Ferozepur Road , Box NO 11 , Atari, Punjab INDIA
04 - - - -- Macaroni/Noodle Products
Date Published: 10/02/2015

Desc: Maggi Noodles Masala with Tastemaker
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9. Section 403(i)(2) in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredients for: Hydrolysed groundnut protein, vegetable oil (21 CFR 101.4(b)(4) and mineral (170(i)), edible starch, acidifying agent (330), Flavour enhancers (627 & 631) and raising agent (500 (ii)). Section 403(e)(2) in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f) in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2).

Nestle India Limited - Moga Factory
Date Published : 01/30/2017
Ludhiana - Ferozepur Road , Box NO 11 , Atari, Punjab INDIA
04 - - - -- Macaroni/Noodle Products
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nestle India Ltd
Date Published : 10/02/2015
M-5a Connaught circus , New Delhi , New Delhi, Delhi INDIA
04 - - - -- Macaroni/Noodle Products
Date Published: 10/02/2015

Desc: Maggi Noodles Masala with Tastemaker
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9. Section 403(i)(2) in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredients for: Hydrolysed groundnut protein, vegetable oil (21 CFR 101.4(b)(4) and mineral (170(i)), edible starch, acidifying agent (330), Flavour enhancers (627 & 631) and raising agent (500 (ii)). Section 403(e)(2) in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f) in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2).

Nestle India Ltd
Date Published : 01/30/2017
Industrial Area Tahliwal , Nangal Kalan, Himachal Pradesh INDIA
04 - - - -- Macaroni/Noodle Products
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nestle India, Pantnagar
Date Published : 01/30/2017
Plot No 1,Sector No1A Integrated , Industry Estate,SIDCUL , Pantnagar, Uttaranchal INDIA
04 - - - -- Macaroni/Noodle Products
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nisarga Biotech Pvt Ltd
Date Published : 02/14/2017
J2/1 Addl. Midc , Satara, Maharashtra INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/14/2017

Desc: Ocimum Sanctum Extract
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that the labeling is false or misleading in any particular. Specifically, the product label fails to indicate the presence of ricinine.

PANCHMAHAL DIST. CO-OPERATIVE MILK PRODUCER UNION LTD.
Date Published : 06/01/2020
UNKOWN , GODHRA, INDIA
09 A - - 02 Butter Oil
Date Published: 06/01/2020

Desc: AMUL PURE GHEE
Notes: This Product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading. Specifically, the product is labeled as "Vegetable Cooking Oil" on the principal display panel but is also labeled as "Amul Pure Ghee. . .Amul Ghee is made from fresh cream. . .It also appears to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim. Specifically, the product label makes the nutrient content claim "rich source of Vitamin A" but does not meet the requirements for use of the nutrient content claim "rich source of Vitamin A" that are set forth in 21 CFR 101.54b).

PATANJALI AYURVED LIMITED
Date Published : 02/06/2024
Unit III Patanjali Food & Herbal Park , Village Mustafabad, Laksar Road , Haridwar, Uttarakhand INDIA
20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C.
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C.
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C.
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C.
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/06/2024

Desc: Amla-Aloevera Juice with Wheat Grass
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a))

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/06/2024

Desc: Giloy-Amla Juice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

PATEL RETAIL PVT.LTD.
Date Published : 12/22/2016
M - 2 Additional M.I.D.C. , Anand Nagar, Ambernant East, Tahsil Kalyan, Dist Thane , Ambernant East, Maharashtra INDIA
28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 12/22/2016

Desc: Mukhwas
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages.; As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. ; The statement of identity, nutrition information, ingredient statement, and name and place of business of the manufacturer, packer, or distributor are not declared in English on the individual retail packets.

PJ Exports
Date Published : 10/02/2015
PJ House, Z-3, Shri Arihant Compound , Reti Bunder Road, Kalher Village , Bhiwandi, Maharashtra INDIA
04 C - - 07 Noodles, Instant
Date Published: 10/02/2015

Desc: Top Ramen Curry Noodles
Notes: Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09

Padmavati Pharmaceuticals
Date Published : 06/22/2017
F/52 Industrial Area , Haridwar, INDIA
28 C - - 04 Basil (Sweet Basil), Natural Extract or Flavor (Spice)
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares "solubiliser" along with other dietary ingredients, but this is not the common or usual name for an ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares "solubiliser" along with other dietary ingredients, but this is not the common or usual name for an ingredient.

Ponmurugan Dhall Mills
Date Published : 10/02/2015
159 Kannampalayam Po , Sripathy Main Road; Sf No , Coimbatore, Tamil Nadu INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 10/02/2015

Desc: Mayil Mark - Samba Ravia; ?Deluxe Samba Wheat Brokens?
Notes: Problem(s); The product fails to properly declare the serving size in a common household measure as specified by 21 CFR 101.9(d)(3)(i). ; The serving size of 167g is not expressed as an ?amount customarily consumed? that is appropriate to the food as defined within 21 CFR 101.12(b); Table 2 and required by 21 CFR 101.9(b). Based on the following preparation instructions on the principle display panel ?Just add water & Ready to Cook;? the product appears to be a dry wheat product which is prepared and served similar to rice. The established Reference Amount Customarily Consumed (RACC) for ?Grains; e.g. rice; barley; plain? is 140g prepared; 45g dry.; The total caloric content per serving is expressed in Kcal which is not in accordance with 21 CFR 101.9(c)(l).; The Calories from Fat content per serving is expressed in gm which is not listed in accordance with 21 CFR 101.9(c)(l)(ii).; The product label fails to declare the number of servings per container as specified in 101.9(b)(8) & 101.9(d)(3)(ii).; The quantitative amount of nutrients are not rounded in accordance with the regulations for Total Fat (101.9(c)(2)); Saturated Fat (101.9(c)(2)(i)); and Sodium (101.9(c)(4)).

Ponmurugan Dhall Mills
Date Published : 10/02/2015
S F No 118 , 159 160 Main Road , Coimbatore, Tamil Nadu INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 10/02/2015

Desc: Mayil Mark - Samba Ravia; ?Deluxe Samba Wheat Brokens?
Notes: Problem(s); The product fails to properly declare the serving size in a common household measure as specified by 21 CFR 101.9(d)(3)(i). ; The serving size of 167g is not expressed as an ?amount customarily consumed? that is appropriate to the food as defined within 21 CFR 101.12(b); Table 2 and required by 21 CFR 101.9(b). Based on the following preparation instructions on the principle display panel ?Just add water & Ready to Cook;? the product appears to be a dry wheat product which is prepared and served similar to rice. The established Reference Amount Customarily Consumed (RACC) for ?Grains; e.g. rice; barley; plain? is 140g prepared; 45g dry.; The total caloric content per serving is expressed in Kcal which is not in accordance with 21 CFR 101.9(c)(l).; The Calories from Fat content per serving is expressed in gm which is not listed in accordance with 21 CFR 101.9(c)(l)(ii).; The product label fails to declare the number of servings per container as specified in 101.9(b)(8) & 101.9(d)(3)(ii).; The quantitative amount of nutrients are not rounded in accordance with the regulations for Total Fat (101.9(c)(2)); Saturated Fat (101.9(c)(2)(i)); and Sodium (101.9(c)(4)).

Quantum Naturals India Private Limited
Date Published : 01/18/2017
42 Plot No , Gurgaon, Haryana INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenAlc Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenAlc product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenAlc product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenRex Capsules -Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenRex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenRex product blister pack label does not bear a domestic address or domestic phone number

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenJoy Capsules-Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenJoy product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenJoy product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: Zen Hab Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenHab product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenFlex Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFlex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). And, the ZenFlex product label does not declare the source of the dietary ingredient Curcumin in accordance with 21 CFR 101.36(d). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: Zen Fem Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFem product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFem product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: Zen Hab Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenHab product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: Zen Fem Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFem product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFem product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenAlc Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenAlc product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenAlc product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenFlex Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFlex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). And, the ZenFlex product label does not declare the source of the dietary ingredient Curcumin in accordance with 21 CFR 101.36(d). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenJoy Capsules-Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenJoy product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenJoy product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenRex Capsules -Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenRex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenRex product blister pack label does not bear a domestic address or domestic phone number

RUCHI SOYA INDUSTRIES
Date Published : 10/02/2015
Ab Road , Talawali Chanda, Madhya Pradesh INDIA
02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Granules
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Chunks
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

37 C - - 99 Food Pack Requir Mix/Cook, n.e.c.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Chunks
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

37 C - - 99 Food Pack Requir Mix/Cook, n.e.c.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Granules
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

SAKTHI CASH AND CARRY EXPORTS
Date Published : 10/02/2015
10 A, SASTHAN KOIL STREET , VADIVEESWARAM , Nagercoil, Tamil Nadu INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 10/02/2015

Desc: ?Mayil Mark? Samba Ravia; ?Deluxe Samba Wheat Brokens?
Notes: Problem(s); The product fails to properly declare the serving size in a common household measure as specified by 21 CFR 101.9(d)(3)(i). ; The serving size of 167g is not expressed as an ?amount customarily consumed? that is appropriate to the food as defined within 21 CFR 101.12(b); Table 2 and required by 21 CFR 101.9(b). Based on the following preparation instructions on the principle display panel ?Just add water & Ready to Cook;? the product appears to be a dry wheat product which is prepared and served similar to rice. The established Reference Amount Customarily Consumed (RACC) for ?Grains; e.g. rice; barley; plain? is 140g prepared; 45g dry.; The total caloric content per serving is expressed in Kcal which is not in accordance with 21 CFR 101.9(c)(l).; The Calories from Fat content per serving is expressed in gm which is not listed in accordance with 21 CFR 101.9(c)(l)(ii).; The product label fails to declare the number of servings per container as specified in 101.9(b)(8) & 101.9(d)(3)(ii).; The quantitative amount of nutrients are not rounded in accordance with the regulations for Total Fat (101.9(c)(2)); Saturated Fat (101.9(c)(2)(i)); and Sodium (101.9(c)(4)).

SHRI SHYAM GRAH UDHYOG
Date Published : 03/04/2019
Jaipur Rajasthan , Jaipur, Rajasthan INDIA
23 K - - 99 Edible Seeds, N.E.C.
Date Published: 03/04/2019

Desc: MUKHWAAS-FENNEL SEEDS SNACK
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&CA in that it appears to be adulterated because it contains a food additive that is unsafe within the meaning of Section 409 of the Act [21 U.S.C. 348]. According to both the product label as well as an analysis of the product, it contains betel nut, an unsafe food additive. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in more than one language but does not repeat all the required information in all languages as required by 21 CFR 101.15(c). The label fails to bear all required statements in either the foreign language or in English. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&CA in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the FD&CA in that the label fails to bear the required nutrition information. Missing Nutrition Facts.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 03/04/2019

Desc: MUKHWAAS-FENNEL SEEDS SNACK
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&CA in that it appears to be adulterated because it contains a food additive that is unsafe within the meaning of Section 409 of the Act [21 U.S.C. 348]. According to both the product label as well as an analysis of the product, it contains betel nut, an unsafe food additive. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in more than one language but does not repeat all the required information in all languages as required by 21 CFR 101.15(c). The label fails to bear all required statements in either the foreign language or in English. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&CA in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the FD&CA in that the label fails to bear the required nutrition information. Missing Nutrition Facts.

STC INDIA PVT LTD.
Date Published : 11/03/2023
#201, 2nd Floor, Jyoti Industrial Estate, Shakti Nagar, Charapati Shivaji Road , Near Ashish Complex, Dahisar-East , Mumbai, INDIA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

07 G - - 09 Berry Fruit Snacks, Fruit Snack Foods, Baked
Date Published: 11/06/2023

Desc: Vita C Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

21 U - - 34 Amla, Subtropical and Tropical Fruit, Jams, Jellies, Preserves, Marmalades, Candied, Butters, Spread
Date Published: 11/06/2023

Desc: Vita C Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

27 Y - - 99 Condiments, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)
Date Published: 11/06/2023

Desc: Vita C Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Poona Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Rajwadi Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Poona Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/03/2023

Desc: Chatpat Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Rajwadi Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Poona Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Rajwadi Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/03/2023

Desc: Chatpat Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 11 Mint Candy, Soft, with Fruit, (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 11 Mint Candy, Soft, with Fruit, (without Chocolate)
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 11/03/2023

Desc: Chatpat Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

Shree Warana Sahakari Dudh Utpaadak Prakriya Sangh Ltd.
Date Published : 10/31/2018
Tatyasaheb Korenagar , Warananger, INDIA
02 J - - 99 Malt Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 Y - - 99 Cereal Preparations Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

32 A - - 99 Malt Beverages, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 J - - 99 Imitation Chocolate and Cocoa Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

Shri Mahila Griha Udyog Lijjat Papad
Date Published : 10/02/2015
Oracle Point , 3rd Floor; Opp Railway Station , Mumbai, Maharashtra INDIA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 10/02/2015

Desc: Cumin Papads
Notes: REASON; The product?s label has numerous NLEA and other violations. See CMS case #413400 for lengthy explanation of all violations

Shri Mahila Griha Udyog Lijjat Papad
Date Published : 10/02/2015
Oracle Point , 3rd Floor; Opp Railway Station , Mumbai, Maharashtra INDIA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 10/02/2015

Desc: Cumin Papads
Notes: REASON; The product?s label has numerous NLEA and other violations. See CMS case #413400 for lengthy explanation of all violations.

Stc India Pvt. Ltd.
Date Published : 11/03/2023
Reg. Office A-505, Western Edge , Mumbai, Maharashtra INDIA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

07 G - - 09 Berry Fruit Snacks, Fruit Snack Foods, Baked
Date Published: 11/06/2023

Desc: Vita C Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

21 U - - 34 Amla, Subtropical and Tropical Fruit, Jams, Jellies, Preserves, Marmalades, Candied, Butters, Spread
Date Published: 11/06/2023

Desc: Vita C Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

27 Y - - 99 Condiments, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)
Date Published: 11/06/2023

Desc: Vita C Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Rajwadi Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Poona Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/03/2023

Desc: Chatpat Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Rajwadi Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Poona Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 G - - 99 Mixed Spices and Seasonings, Liquid, Without Salt, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Rajwadi Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Poona Mukhwas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/03/2023

Desc: Chatpat Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 11/06/2023

Desc: Surati Mouth Freshener (Surti Mukhwas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 11 Mint Candy, Soft, with Fruit, (without Chocolate)
Date Published: 11/06/2023

Desc: Calcutta Mitha Pan
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 11 Mint Candy, Soft, with Fruit, (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Paan Angoori
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 11/03/2023

Desc: Chatpat Awla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 11/06/2023

Desc: Elaichi Saunf
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels contain information in multiple languages but do not repeat all the required label statements in all languages, as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product labels fail to bear an appropriately descriptive statement of identity, as required by 21 CFR 101.3. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information does not meet the requirements in 21 CFR 101.9.

Supreme Nutri Grain Pvt. Ltd.
Date Published : 06/16/2023
Rajkot - Gondal Road , 1 Survey No 37 , Bhunava, Gujarat INDIA
04 C - - 07 Noodles, Instant
Date Published: 06/16/2023

Desc: Zoopy Instant Noodles (Masala flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)). Net Wt. statement does not appear in Arabic characters. Intervening material such as, between the Nutrition Facts label and the name of the manufacturer; between the English ingredient lists themselves; and between the English ingredient lists and the English “Contains” statement (21 CFR 101.2(e) and 21 CFR 101.15(b)(3)). Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food (21 CFR 101.3(b)). The terms “Masala”, “Mirch”, and “Manchurian” flavors are not common or usual names for describing the product. Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. 21 CFR 101.4 does not provide for declaring the “E” numbers for ingredients. Each ingredient must be declared by its common or usual name, as required by 21 CFR 101.4(a). The term “Taste Blender” is not a common or usual name for “Spices” or “Flavoring”. “hydrolyzed vegetable protein” is not an appropriate common or usual name of an ingredient (21 CFR 102.22). natural and nature identical (masala) is not an appropriate common or usual name for flavor ingredients; “edible” is not part of the common or usual name of vegetable oi (21 CFR 102.22). (21 CFR 101.4 and 101.22).

04 C - - 07 Noodles, Instant
Date Published: 06/16/2023

Desc: Zoopy Instant Noodles (Mirch flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)). Net Wt. statement does not appear in Arabic characters. Intervening material such as, between the Nutrition Facts label and the name of the manufacturer; between the English ingredient lists themselves; and between the English ingredient lists and the English “Contains” statement (21 CFR 101.2(e) and 21 CFR 101.15(b)(3)). Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food (21 CFR 101.3(b)). The terms “Masala”, “Mirch”, and “Manchurian” flavors are not common or usual names for describing the product. Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. 21 CFR 101.4 does not provide for declaring the “E” numbers for ingredients. Each ingredient must be declared by its common or usual name, as required by 21 CFR 101.4(a). The term “Taste Blender” is not a common or usual name for “Spices” or “Flavoring”. “natural and nature identical (masala)” are not appropriate common or usual name of an ingredient; “edible” is not part of the common or usual name of vegetable oi (21 CFR 102.22).

04 C - - 07 Noodles, Instant
Date Published: 06/16/2023

Desc: Zoopy Instant Noodles (Shrimp flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)). Net Wt. statement does not appear in Arabic characters. Intervening material such as, between the Nutrition Facts label and the name of the manufacturer; between the English ingredient lists themselves; and between the English ingredient lists and the English “Contains” statement (21 CFR 101.2(e) and 21 CFR 101.15(b)(3)). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. 21 CFR 101.4 does not provide for declaring the “E” numbers for ingredients. Each ingredient must be declared by its common or usual name, as required by 21 CFR 101.4(a). The term “Taste Blender” is not a common or usual name for “Spices” or “Flavoring”. “hydrolyzed vegetable protein” and “natural and nature identical (shrimp)” are not appropriate common or usual name of an ingredient; “edible” is not part of the common or usual name of vegetable oil (21 CFR 102.22).

04 C - - 07 Noodles, Instant
Date Published: 06/16/2023

Desc: Zoopy Instant Noodles (Chicken flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)). Net Wt. statement does not appear in Arabic characters. Intervening material such as, between the Nutrition Facts label and the name of the manufacturer; between the English ingredient lists themselves; and between the English ingredient lists and the English “Contains” statement (21 CFR 101.2(e) and 21 CFR 101.15(b)(3)). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. 21 CFR 101.4 does not provide for declaring the “E” numbers for ingredients. Each ingredient must be declared by its common or usual name, as required by 21 CFR 101.4(a). The term “Taste Blender” is not a common or usual name for “Spices” or “Flavoring”. “natural and nature identical (chicken)” are not appropriate common or usual name of an ingredient; “edible” is not part of the common or usual name of vegetable oi (21 CFR 102.22).

04 C - - 07 Noodles, Instant
Date Published: 06/16/2023

Desc: Zoopy Instant Noodles (Manchurian flavor)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)). Net Wt. statement does not appear in Arabic characters. Intervening material such as, between the Nutrition Facts label and the name of the manufacturer; between the English ingredient lists themselves; and between the English ingredient lists and the English “Contains” statement (21 CFR 101.2(e) and 21 CFR 101.15(b)(3)). Section 403(i)(1) of the Act in that the label fails to bear the common or usual name of the food (21 CFR 101.3(b)). The terms “Masala”, “Mirch”, and “Manchurian” flavors are not common or usual names for describing the product. Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. 21 CFR 101.4 does not provide for declaring the “E” numbers for ingredients. Each ingredient must be declared by its common or usual name, as required by 21 CFR 101.4(a). The term “Taste Blender” is not a common or usual name for “Spices” or “Flavoring”. “hydrolyzed vegetable protein”, “natural and nature identical (garlic)” are not appropriate common or usual name of an ingredient; “edible” is not part of the common or usual name of vegetable oi (21 CFR 102.22).

THE GRAND SWEETS & SNACKS ADYAR
Date Published : 10/30/2020
6/2 Selvavinayagar Kovil Street , Chennai, Tamil Nadu INDIA
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/30/2020

Desc: Mini Athirasam
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/30/2020

Desc: Adhirasam
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/30/2020

Desc: Rava Laddu
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/30/2020

Desc: Adhirasam
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

Tastel
Date Published : 10/02/2015
2 Veena Vihar , Dayaldas Road , Mumbai, Maharashtra INDIA
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Cashew Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Nice Time Sugar Showered Coconut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Marie Gold Biscuits
Notes: Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: 50-50 Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

The Ravalgaon Sugar Farm
Date Published : 06/01/2020
P.O. Ravalgaon , Nasik, Maharashtra INDIA
33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 06/01/2020

Desc: PAN PASAND GOLD CANDY
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food. For example, the product label fails to declare a statement of identity of the food on the principal display panel as required by 21 CFR 101.3. The labels declare the serving size as "(4g)"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b), Table 2 [21 CFR 101.9(b)(2)]. This product is identified as being candy per the entry documents. The RACC for Hard candies, others is "15g." The serving size is not correctly determined from the RACC; therefore, all of the nutrient information may be incorrectly declared. The label fails to list the serving size in the household unit of measure (pieces or other visual unit of measure. [21 CFR 101.9(b)(1)] The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the article appears to contain artificial coloring but did not declare the common or usual name of the coloring in the ingredient statement in accordance with 21 CFR 101.4 and 101.22.

Tropicana World Trade Pvt Ltd.
Date Published : 10/02/2015
16/453 Thoppumpady Cochin , Kerala, INDIA
16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

16 Y - - 17 Sauce, seafood (n.e.c.), Fishery Products, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

16 Y - - 99 Fishery Products, N.E.C.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

37 J - - 05 Soy Sauce
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

37 J - - 23 Curry Sauce
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

37 J - - 99 Sauces, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

VAHDAM TEAS PVT LT
Date Published : 01/27/2023
C 12 3 , Noida, Uttar Pradesh INDIA
31 K - - 01 Tea, Black
Date Published: 01/27/2023

Desc: Turmeric Pepper Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

31 K - - 01 Tea, Black
Date Published: 01/27/2023

Desc: Turmeric Moringa Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

31 K - - 01 Tea, Black
Date Published: 01/27/2023

Desc: Turmeric Spiced Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

31 K - - 01 Tea, Black
Date Published: 01/27/2023

Desc: Turmeric Ginger Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

31 K - - 06 Tea, Scented
Date Published: 08/11/2023

Desc: Turmeric Pepper Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

31 K - - 06 Tea, Scented
Date Published: 08/11/2023

Desc: Turmeric Moringa Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

31 K - - 06 Tea, Scented
Date Published: 08/11/2023

Desc: Turmeric Ginger Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

31 K - - 06 Tea, Scented
Date Published: 08/11/2023

Desc: Turmeric Spiced Herbal Tea
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they fail to declare the net quantity of contents in accordance with 21 CFR 101.7.

VISNUKUMAR TRADERS PVT LTD
Date Published : 10/02/2015
28A Padur Main Road , Kuthambakkam , Chennai, Tamil Nadu INDIA
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 C - - 99 Foods (including Water) with Excessive Nutritional Claims
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

Vijay Sweets
Date Published : 11/30/2017
L4 ABHISHEK ESTATE 1, CIVIL ROAD , ASARWA , Ahmedabad, Gujarat INDIA
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/19/2017

Desc: Halwo
Notes: The Halwo article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b). The statement of identity of the Halwo product is not adequate because it is not in English. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The Halwo article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the label contains information in a foreign language but does not repeat all the required information in the foreign language.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/30/2017

Desc: HALWASAN PAK (WHEAT FLOUR PATTIES COOKED WITH SUGAR)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)], because the products do not have appropriate common or usual names as required by 21 CFR 101.3. Specifically, the names Halvasan and Halvasan Pak are not appropriate common or usual names for a food, and the name Dry Fruit Chips does not appear to accurately describe an almond and pistachio product, which do not appear to contain any fruit. -Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)], because the product labels do not bear the name and place of business of the manufacturer, packer or distributor, as required by 21 CFR 101.7. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], because the product labels do not bear a net quantity of contents statement as required by 21 CFR 101.7.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/30/2017

Desc: HALWASAN (WHEAT FLOUR PATTIES COOKED WITH SUGAR)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)], because the products do not have appropriate common or usual names as required by 21 CFR 101.3. Specifically, the names Halvasan and Halvasan Pak are not appropriate common or usual names for a food, and the name Dry Fruit Chips does not appear to accurately describe an almond and pistachio product, which do not appear to contain any fruit. -Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)], because the product labels do not bear the name and place of business of the manufacturer, packer or distributor, as required by 21 CFR 101.7. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], because the product labels do not bear a net quantity of contents statement as required by 21 CFR 101.7.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/19/2017

Desc: Sweet Khaja
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. ?343(i)(1)] in that the labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b). The Sweet Khaja label lacks any statement of identity. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7.

23 H - - 99 Mixed Nuts, Shelled, N.E.C.
Date Published: 11/30/2017

Desc: DRYFRUIT CHIPS (Sliced Pistachios and Almonds)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)], because the products do not have appropriate common or usual names as required by 21 CFR 101.3. Specifically, the names Halvasan and Halvasan Pak are not appropriate common or usual names for a food, and the name Dry Fruit Chips does not appear to accurately describe an almond and pistachio product, which do not appear to contain any fruit. -Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)], because the product labels do not bear the name and place of business of the manufacturer, packer or distributor, as required by 21 CFR 101.7. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], because the product labels do not bear a net quantity of contents statement as required by 21 CFR 101.7.


INDONESIA


P.T. Star
Date Published : 05/09/2016
Kupang Baru I/ 71 , Surabaya, Jawa Timur INDONESIA
07 G - - 08 Tropical/Subtropical Fruit Snacks, Fruit Snack Foods, Baked
Date Published: 05/09/2016

Desc: Gnetum Gnemon Chips
Notes: The articles are subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format; as required by 21 CFR 101.9. In addition; it appears to be misbranded within the meaning of Section 403 (i)(2) in that the labeling fails to bear an ingredient statement as required by 21 CFR 101.4. In addition; it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act. In addition; appears to be misbranded within the meaning of Section 403 (e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor. In addition; it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word; statement; or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words; statements; designs; or devices; in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. The label contains information in a foreign language but fails to repeat all required information; including the statement of identity; in English in accordance with 21 CFR 101.15 (c)(1).

Pt. Mikie Oleo Nabati Industri
Date Published : 01/08/2016
Bojong , 9 Jln. Berlian Raya; KM. , Bekasi, Jabotabek INDONESIA
26 F - - 99 Vegetable Shortening, N.E.C.
Date Published: 01/08/2016

Desc: Bulk Shortening
Notes: The article is subject to refusal of admission pursuant to Section 801(a)3) for the following: "It appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format in accordance with 21 CFR 101.9." "It appears to be misbranded within the meaning of section 403(i)(1) [21 U.S.C. 343(i)(l)] in that the product label does not contain a statement of identity as required by 21 CFR 101.3." "It appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example, your product label declares "antioxidant (E319)" and "Emulsifiers (E471, E322)" in the ingredient statement; however, these are not the common or usual names of these ingredients.


ISRAEL


Angel Bakeries
Date Published : 10/02/2015
Kanfei Nesharim St 1 , Jerusalem, ISRAEL
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

03 J - - 09 Fruit/Fruit Flavored Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

Angel Confectionery Ltd
Date Published : 10/02/2015
Industrial Area , Beit Shemesh, ISRAEL
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

03 J - - 09 Fruit/Fruit Flavored Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

Arza Winery LTD
Date Published : 10/02/2015
Maale Adumim, Yerushalayim , 15, Kharuvit , Ma'ale Adumim, ISRAEL
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 01/17/2024

Desc: Grape Juice
Notes: Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the article purports to be a beverage containing fruit or vegetable juice and the label fails to bear a percent juice declaration as required by 21 CFR 101.30. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the product is false and misleading in that it bears a Natural claim but fails to meet the requirements to bear such claim. FDA has not established a regulatory definition for the term natural; however, the Agency has a long-standing policy that restricts the use of the term ¿natural¿ when a product is formulated with added color, synthetic substances, and flavors as stated in 21 CFR 101.22 (see 58 FR 2407 (January 6, 1993)). Among other things, this policy states that the term natural means that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. This product appears to contain sulfur dioxide, which is listed in the ingredient statement as a preservative. Therefore, the product name can not include the term Natural. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product label does not contain a complete name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. ; 4/3/2012

B&H soft drinks ltd
Date Published : 01/23/2019
10, Hamadpisim st , Jerusalem, Jerusalem ISRAEL
29 A - - 04 Soft Drink, Mixed Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 60 Soda Water, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 B - - 11 Soda Water with Fruit Flavor, Carbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

Country Pie
Date Published : 10/02/2015
42, Uruguay , Jerusalem, ISRAEL
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cakes (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cakes (Chocolate Party Cake)
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes (Chocolate Party Cake)
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

HEKMA CENTER
Date Published : 03/13/2023
Almaskah Street , Ar'Ara, ISRAEL
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Dand (Dandelion)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: TKR (Curcumin) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Mera (Sage) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Spiru (Spirulina) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: AK (Propolis) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Ureg (Uregano)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: NOR (Olive Leaves) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Mera (Sage) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: TKR (Curcumin) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Spiru (Spirulina) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: NOR (Olive Leaves) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Ureg (Uregano)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Dand (Dandelion)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: AK (Propolis) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(s)(2)(C) of the Act in that the labels fail to identify (in English) the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. The listing of the common or usual name of a botanical in the Supplement Facts label must be followed with the declaration of the plant part; if the entire or whole plant is used, that information must be declared. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

Hekma Center
Date Published : 03/13/2023
Ara , 1, El-Masqa St. , Ar'Ara, Ha Zafon ISRAEL
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Dand (Dandelion)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: TKR (Curcumin) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: AK (Propolis) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Spiru (Spirulina) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Mera (Sage) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: NOR (Olive Leaves) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/13/2023

Desc: Ureg (Uregano)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Spiru (Spirulina) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Zinc (Zinc Picolinate) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: M. Trame (Turkey Tail Mushroom) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Dand (Dandelion)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: M. Reishi (Reishi Ganoderma Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: TKR (Curcumin) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Mera (Sage) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: AK (Propolis) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: E-Ech (Echinacea Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: S.G.1 (Siberian Ginseng) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Cam1 (Milk Thistle) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: M. Shiita (Shiitake Mushroom Extract) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Astro (Astragalus Membranaceus) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: MSM (Methyl Sulfonyl Methane) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Ureg (Uregano)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: NOR (Olive Leaves) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/13/2023

Desc: Magic.1 (Moringa Oleifera) Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of: Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. The ingredient list or other ingredient list of each component product label fails to be placed below the Supplement Facts label. Product label declares “HPMC” as an ingredient but does not list the common or usual name of that ingredient. The standardized common name (SCN) of each botanical dietary ingredient, is not listed in the Supplement Facts label. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. The label fails to declare the quantitative amount of calories per serving in the Supplement Facts label. The quantitative amount of the declared dietary ingredient fails to be expressed using metric measures in appropriate units (i.e., 1000 or more units must be declared in the next higher set of units, e.g., 1,100 mg, must be declared as 1.1 g). Label fails to declare “Supplement Facts” on the full width of the nutrition label (Supplement Facts label).

Kapulsky
Date Published : 10/02/2015
P.O Box 8172 , Netanya, ISRAEL
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cake (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cakes Chocolate Party Cake
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes Chocolate Party Cake
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

Materna Industries, Limited Partnership
Date Published : 10/02/2015
Kibbutz Maabarot , Ma'abarot, IL-NOTA ISRAEL
40 B - - -- Cereal (Baby)
Date Published: 10/02/2015

Desc: Infant Cereal
Notes: Notes;The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 MANUFACTURER; Materna Laboratorios Ltd; 11/12/09

40 B - - -- Cereal (Baby)
Date Published: 07/24/2019

Desc: Infant cereal;
Notes: The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 SHIPPER; Maabarot Products Ltd. 10/2/2015

40 N - - 01 Milk Base Infant Formula Product (0-12 months), Ready to Feed
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 O - - 01 Milk Base Infant Formula Product (0-12 months), Liquid Concentrate
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.

40 O - - 99 Other Formula Products, N.E.C., Liquid Concentrate
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 P - - 99 Other Formula Products, N.E.C., Powder Formula
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

41 G - - 01 Nutritionally Complete Formulations
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ? 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

Ramat Hagolan Dairies LTD
Date Published : 01/23/2019
Industrial Zone , Ta Do'Ar 95 , Katsrin, ISRAEL
29 A - - 04 Soft Drink, Mixed Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 60 Soda Water, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 B - - 11 Soda Water with Fruit Flavor, Carbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).


ITALY


Agugiaro & Figna Molini S.p.A.
Date Published : 12/15/2023
Strada Notari no. 25/27 , Collecchio, Parma ITALY
02 E - - 05 Wheat Flour, Enriched (All Purpose)
Date Published: 12/15/2023

Desc: Pizza Wheat Flour (FARINA DI GRANO TENERO)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in foreign languages but does not repeat all the required label information in all languages. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9.

02 E - - 15 Wheat Flour, Plain
Date Published: 12/15/2023

Desc: Pizza Wheat Flour (FARINA DI GRANO TENERO)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in foreign languages but does not repeat all the required label information in all languages. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9.

02 E - - 99 Wheat Flour, N.E.C.
Date Published: 12/15/2023

Desc: Pizza Wheat Flour (FARINA DI GRANO TENERO)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in foreign languages but does not repeat all the required label information in all languages. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9.

02 F - - 02 Farina, Wheat
Date Published: 12/15/2023

Desc: Pizza Wheat Flour (FARINA DI GRANO TENERO)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in foreign languages but does not repeat all the required label information in all languages. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9.

02 F - - 04 Semolina, Wheat
Date Published: 12/15/2023

Desc: Pizza Wheat Flour (FARINA DI GRANO TENERO)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in foreign languages but does not repeat all the required label information in all languages. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9.

Azienda Agricola Vigin
Date Published : 10/02/2015
Via Meruzzano 32a , Treiso, Cuneo ITALY
32 B - - 01 Wine, White (Still)
Date Published: 10/02/2015

Desc: Virgin Primadonna Moscato d Asti
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Act in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] because they lack nutrition information as required by 21 CFR 101.9. The products are diluted wine products with alcohol content of less than 7% and their manufacturers are not exempted under the Small Business Nutrition Labeling Exemption.

COREX
Date Published : 02/02/2017
Zona Industriale Snc , Battipaglia, Salerno ITALY
04 A - - 05 Spaghetti
Date Published: 02/02/2017

Desc: Tri Colored Fusilli Springs
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is less than the standard of identity for enriched macaroni products; 03/06/2015 ;

04 A - - 99 Macaroni and Spaghetti Products,N.E.C.
Date Published: 02/02/2017

Desc: Tri Colored Fusilli Springs
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is less than the standard of identity for enriched macaroni products; 03/06/2015

Cascina la Ghersa
Date Published : 10/02/2015
Regione Chiarina 2 , Moasca, Asti ITALY
32 B - - 01 Wine, White (Still)
Date Published: 10/02/2015

Desc: Giorgia Moscato D'asti White Wine
Notes: VIOLATIONS 403(q) AND 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the label fails to provide nutrition labeling (?Nutrition Facts? panel) which is required under 21 CFR 101.9 and the firm is not exempt from this requirement. 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the act because there is no designation of ingredients on the product label in accordance with 21 CFR 101.4.

F.lli DE CECCO di FILIPPO FARA SAN MARTINO S.P.A
Date Published : 03/30/2020
Vila F. De Cecco , Zona Industriale , Fara San Martino, Abruzzo ITALY
04 A - - 01 Macaroni Enriched
Date Published: 03/30/2020

Desc: Bucatini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(g)(1) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 139.115(a)(1). Specifically, the product was analyzed for Iron (Fe) and found to contain 10.9 mg/lb which is below the level of 13-16.5 mg/lb as required by the standard of enriched macaroni.

04 A - - 02 Macaroni
Date Published: 03/30/2020

Desc: Bucatini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(g)(1) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 139.115(a)(1). Specifically, the product was analyzed for Iron (Fe) and found to contain 10.9 mg/lb which is below the level of 13-16.5 mg/lb as required by the standard of enriched macaroni.

04 A - - 05 Spaghetti
Date Published: 03/30/2020

Desc: Bucatini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(g)(1) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 139.115(a)(1). Specifically, the product was analyzed for Iron (Fe) and found to contain 10.9 mg/lb which is below the level of 13-16.5 mg/lb as required by the standard of enriched macaroni.

IRC WILLIAM DI CARLO SRL
Date Published : 10/02/2015
Viale Del Lavoro 15-17 , Sulmona, L Aquila ITALY
34 C - - 02 Chocolate Candy Pieces, with Nuts or Nut Products (not Coconut)
Date Published: 10/02/2015

Notes: (Sugared Nuts) Product is misbranded under Section 403(q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements (21 CFR 101.9(d)); does not list the net quantity of contents (21 CFR 101.105); and all required statements; such as the statement of identity are not in both Italian and English (21 CFR 101.15(c)) NOTE; this product is also indicated for detention because its labeling fails to declare the presence of the major food allergen

Norda Spa
Date Published : 07/03/2018
Via Roncale 1 , Lecco, Lecco ITALY
29 R - - 05 Mineral Water, Noncarbonated (Nonmedicinal)
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Mossa)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

29 R - - 05 Mineral Water, Noncarbonated (Nonmedicinal)
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Ferma)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Ferma)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Mossa)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

OLEARIA F.LLI DE CECCO DI FILIPPO FARA SAN MARTINO SRL
Date Published : 03/30/2020
Zona Industriale , Fara San Martino, ITALY
04 A - - 01 Macaroni Enriched
Date Published: 03/30/2020

Desc: Bucatini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(g)(1) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 139.115(a)(1). Specifically, the product was analyzed for Iron (Fe) and found to contain 10.9 mg/lb which is below the level of 13-16.5 mg/lb as required by the standard of enriched macaroni.

04 A - - 02 Macaroni
Date Published: 03/30/2020

Desc: Bucatini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(g)(1) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 139.115(a)(1). Specifically, the product was analyzed for Iron (Fe) and found to contain 10.9 mg/lb which is below the level of 13-16.5 mg/lb as required by the standard of enriched macaroni.

04 A - - 05 Spaghetti
Date Published: 03/30/2020

Desc: Bucatini
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(g)(1) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 139.115(a)(1). Specifically, the product was analyzed for Iron (Fe) and found to contain 10.9 mg/lb which is below the level of 13-16.5 mg/lb as required by the standard of enriched macaroni.

PHARMA GREEN S.R.L.
Date Published : 01/08/2018
Strada Degli Angariari,25 , Falciano, ITALY
54 C - - 02 L-Arginine (Protein)
Date Published: 01/08/2018

Desc: MASC Supplement
Notes: 4039(i)(2) - Failure to list ingredients and common names. 403(q) - Failure to list a supplement facts panel. 403(s)(2)(b) - Failure to declare dietary supplement 403(y) - Failure to list a domestic address or phone number on label.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/20/2018

Desc: CEP Food Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(i)(2) product label fails to declare common name of each ingredient (i.e. color ingredients listed by E-number); 403(q)(5)(F) product label fails to list the required nutrition information within a supplement facts label; 403(y) product label fails to bear a domestic address or phone number through which reports of serious adverse events can be made; 403(i)(1) and 403(s)(2)(B) product label fails to identify the product using the term "dietary supplement"; 403(r)(6) product label makes structure/function claims but fails to bear dietary supplement disclaimer.

Pastificio Fabianelli S.P.A.
Date Published : 02/02/2017
Via Sant'Antonino No. 107 , Castiglion Fiorentino, Arezzo ITALY
04 A - - 01 Macaroni Enriched
Date Published: 04/12/2019

Desc: MEZZI RIGATONI TRADITIONAL CUT
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: MEZZI RIGATONI TRADITIONAL CUT
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: Spaghetti Bronze Cut
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: Cavatappi Traditional Cut
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: Fettuccine Nests Bronze Cut
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

Pastificio Gallo Natale F. LLI SRL
Date Published : 02/02/2017
Via Albert Einstein 1-3 , Mazara Del Vallo, Trapani ITALY
04 A - - 01 Macaroni Enriched
Date Published: 04/02/2018

Desc: Fusilli Coti Col Buco
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products.

Pastificio Riscossa - F.ill Mastromauro spa
Date Published : 02/26/2015
Strada Statale 98 Km 48,360 , Corato, Bari ITALY
04 A - - 01 Macaroni Enriched
Date Published: 02/02/2017

Desc: Penne Zite Rigate
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is below the standard of identity for enriched macaroni products; 12/19/2014

04 A - - 05 Spaghetti
Date Published: 02/26/2015

Desc: Enriched Linguine Product
Notes: PROBLEM- Iron less than label declared

04 C - - 01 Noodles, Chow Mein
Date Published: 02/02/2017

Desc: Italian Pasta Penne Zite
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 01/08/2016

Rebecchi Fratelli Valtrebbia S.P.A.
Date Published : 06/30/2015
Via Giuseppe Ungaretti 7 , Rivergaro, Piacenza ITALY
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/30/2015

Desc: mini macaroons
Notes: Mini Macaroons product is misbranded within the meaning of section 403(i) (2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4. For example; the ingredient armelline is not declared by its common or usual name in accordance with 21 CFR 101.4(a) (l). Additionally; the leavening agents E500 and E503 are declared as European numbers and not their common or usual ingredient names in accordance with 21 CFR 1 01. 4(b )( 16). The article is subject to refusal of admission pursuant to FDA's food labeling regulations in Section 21 CFR Part 101 (21 CFR Part 101). Based on the firm's failure to comply with 21 CFR Part 101, the labels appear to be misbranded within the meaning of Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Published on 07/14/2015

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/30/2015

Desc: mini macaroons
Notes: Mini Macaroons product is misbranded within the meaning of section 403(i)(2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4. For example; the ingredient armelline is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(l). Additionally; the leavening agents E500 and E503 are declared as European numbers and not their common or usual ingredient names in accordance with 21 CFR 1 01. 4(b )( 16).

03 U - - 01 Icing and Icing Mixes Without Chocolate or Nuts
Date Published: 10/09/2015

Desc: Mix for Custard Cream Cold-Preparation
Notes: The article is subject to refusal of admission pursuant to FDA?s food labeling regulations in Section 21 CFR Part 101 (21 CFR Part 101). Based on the firm?s failure to comply with 21 CFR Part 101; the labels appear to be misbranded within the meaning of Section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. ? 343]. Published on 07/14/2015

03 U - - 99 Icings And Icing Mixes, N.E.C.
Date Published: 06/30/2015

Desc: silver pearls
Notes: Silver Pearls are misbranded within the meaning of section 403(e)(1)-ofthe Act [21 U.S.C. 343(e)(1)] in that the product label does not contain the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5 (a). The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer; packer; or distributor. The article is subject to refusal of admission pursuant to FDA's food labeling regulations in Section 21 CFR Part 101 (21 CFR Part 101). Based on the firm's failure to comply with 21 CFR Part 101, the labels appear to be misbranded within the meaning of Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Published on 07/14/2015

03 U - - 99 Icings And Icing Mixes, N.E.C.
Date Published: 06/30/2015

Desc: mix for custard cream cold-preparation-CREMA PASTICERRA CUSTARD
Notes: Mix for Custard Cream Cold-Preparation product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.105(b)(l). For example; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "2x70g=140g"). Further; if your product is a multiunit retail package; which it appears to be; a statement of the quantity of contents shall appear on the outside of the package and shall include the number of individual units; the quantity of each individual unit; and; in parentheses; the total quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces in accordance with 21 CFR 101.1 05( s ). We also note that the net quantity of contents declaration does not appear on the principal display panel (PDP) as required by 21 CFR 101.105(a).

21 D - - 02 Citrus, Mixed, Juices or Concentrates
Date Published: 06/30/2015

Desc: orange blossom water
Notes: Orange Blossom Water product is misbranded within the meaning of section 403(i)(2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(l). Specifically; the preservative E211 is declared as a European number and not its common or usual ingredient name (i.e.; sodium benzoate). Further; the ingredient "essence of flowers" is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(l). Orange Blossom Water product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.1 05(b )(2). Specifically; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "85ml").

28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 06/30/2015

Desc: Orange Blossom Water
Notes: Orange Blossom Water product is misbranded within the meaning of section 403(i)(2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(l). Specifically; the preservative E211 is declared as a European number and not its common or usual ingredient name (i.e.; sodium benzoate). Further; the ingredient "essence of flowers" is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(l). Orange Blossom Water product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e) (2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.1 05(b )(2). Specifically; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "85ml").

35 C - - 99 Custard Pudding (Pie) Mix, N.E.C.
Date Published: 06/30/2015

Desc: mix for custard cream cold-preparation-CREMA PASTICERRA CUSTARD
Notes: Mix for Custard Cream Cold-Preparation product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.105(b)(l). For example; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "2x70g=140g"). Further; if your product is a multiunit retail package; which it appears to be; a statement of the quantity of contents shall appear on the outside of the package and shall include the number of individual units; the quantity of each individual unit; and; in parentheses; the total quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces in accordance with 21 CFR 101.1 05( s ). We also note that the net quantity of contents declaration does not appear on the principal display panel (PDP) as required by 21 CFR 101.105(a).

Spumador SpA
Date Published : 10/02/2015
Via Alla Fonte 13 , Cadorago, Como ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Cranberry Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Orange Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).

Spumador Spa
Date Published : 10/02/2015
Via Dordone 43vimodrone , Felegarafelegara, ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Cranberry Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Orange Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).


JAMAICA


Delightful Gardens Enterprise Limited
Date Published : 06/24/2020
1027 Delightful District Po , Junction, Saint Elizabeth JAMAICA
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 06/24/2020

Desc: Delightful Gardens Turmeric Root Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 06/24/2020

Desc: Delightful Gardens Turmeric Root Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

30 G - - 99 Beverage Base of Non-Fruit Origin, Liquid, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Aloenoni Plus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(y), 403(s)(2)(B), 403(s)(2)(C), 403(i)(2), 403(q), 403(e)(2), and 403(r)(1)(A).

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Aloenoni Plus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(y), 403(s)(2)(B), 403(s)(2)(C), 403(i)(2), 403(q), 403(e)(2), and 403(r)(1)(A).

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Turmeric Root Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Leaf Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2), 403(q) and 403(r)(1)(A).

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Leaf Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2), 403(q) and 403(r)(1)(A).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Aloenoni Plus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(y), 403(s)(2)(B), 403(s)(2)(C), 403(i)(2), 403(q), 403(e)(2), and 403(r)(1)(A).

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Turmeric Root Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

54 J - - 08 Aloe (Herbal and Botanical Teas II, (continued))
Date Published: 06/24/2020

Desc: Delightful Gardens Aloenoni Plus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(y), 403(s)(2)(B), 403(s)(2)(C), 403(i)(2), 403(q), 403(e)(2), and 403(r)(1)(A).

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Leaf Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2), 403(q) and 403(r)(1)(A).

54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued))
Date Published: 06/24/2020

Desc: Delightful Gardens Aloenoni Plus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(y), 403(s)(2)(B), 403(s)(2)(C), 403(i)(2), 403(q), 403(e)(2), and 403(r)(1)(A).

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Leaf Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2), 403(q) and 403(r)(1)(A).

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Turmeric Root Capsule
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Aloenoni Plus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(y), 403(s)(2)(B), 403(s)(2)(C), 403(i)(2), 403(q), 403(e)(2), and 403(r)(1)(A).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/24/2020

Desc: Delightful Gardens Moringa Plus Organic Vegetable Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Sections 403(i)(2) and 403(q).


JAPAN


BEST LINKAGE
Date Published : 03/14/2017
876-1 , Nakaishiki; Inami-Cho , Kako-Gun, Hyogo JAPAN
33 L - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 03/14/2017

Desc: Jelly Candy (Kuru Kuru Bozu Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages.

33 M - - 01 Gel Cups, Fruit Flavored
Date Published: 03/14/2017

Desc: Jelly Candy (Kuru Kuru Bozu Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 03/14/2017

Desc: Jelly Candy (Kuru Kuru Bozu Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages.

DAIDO PHARMACEUTICAL CORPORATION
Date Published : 03/02/2023
214-1 , Shi-Mura , Katsuragi, Nara JAPAN
54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 03/02/2023

Desc: Tsubaki Ageless 10000mg Marine Collagen Peptides
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading because the Vitamin C content is less than the value of the amount declared on the label [21 CFR 101.9(g)(4)(i)]. Section 403(e)(1) of the Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403(e)(2) of the Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count [21 CFR 101.7]. Section 403(i)(2) of the Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product by using the term “dietary supplement” as a part of the product’s statement of identity [21 CFR 101.3(g)]. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

DR.BAELTZ CO.,LTD
Date Published : 10/02/2015
2 Chome 3-23 , Senzui , Asaka, Saitama JAPAN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Puerafica Anti-Aging Supplement
Notes: VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling (Supplement Facts panel) in the proper format, which is required under 21 CFR 101.36. For example: The caloric content is expressed in kcal rather than Calories. The Percent Daily Value for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) are not declared. Specifically, the product does not list the percent daily values for Vitamin A, Vitamin C, Vitamin D, Vitamin E, thiamin(Vitamin B1), niacin (Vitamin B3), folate (folic acid), Vitamin B12, pantothenic acid as required by 21 CFR 101.36(b)(2)(iii). The quantitative amount by weight per serving for each dietary ingredient are not declared as required by 21 CFR 101.36(b)(2) and 101.36(b)(3). The correct nomenclature for some of the dietary ingredients is not declared, as required by 21 CFR 101.36(b)(2)(B). For example, niacin is incorrectly listed as nicotinamide. The dietary ingredients are not listed in the proper order. Specifically, Vitamin B6, Vitamin E, sodium, Vitamin C, niacin, pantothenic acid, thiamin, folic acid, Vitamin B12, Vitamin A, and Vitamin Dare not in the correct order, as required by 21 CFR 10 1.36(b )(2)(i)(B).

Japan Bio Science Laboratory Co Ltd
Date Published : 06/11/2019
1159 , Naka Hozumi Ibaraki Shi , Osaka, JAPAN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/11/2019

Desc: ORGANIC ASHITABA AOJIRU
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the nutrition information (Nutrition Facts label) on the product label is not in accordance with 21 CFR 101.9. 403(i)(2) in that the product label lists the ingredient "stevia." The term "stevia" is not a common or usual name for a food ingredient. 403 (r)(1)(A) because the product labeling bears nutrient content claims, but the product does not meet the requirements to make such claims. 403 (e)(2) for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages.

Maruto Seika Co., LTD
Date Published : 10/02/2015
Nakatsuhara 1532 , Miyuki-Cho , Fukuyama, Hiroshima JAPAN
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #62106
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is manufactured using starch according to the formulation; however; you fail to list this ingredient on your finished product label. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8) (i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Butter cake) K019
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #639735
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Butter cake #639735
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Butter cake #62106
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is manufactured using starch according to the formulation; however; you fail to list this ingredient on your finished product label. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8) (i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cake (Maruto Butter cake) K019
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 61 Cheese Cake
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 61 Cheese Cake
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 61 Cheese Cake
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Butter cake) K019
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #639735
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods.This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #62106
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is manufactured using starch according to the formulation; however; you fail to list this ingredient on your finished product label. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8) (i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

Mirei International
Date Published : 10/02/2015
92-24 , Oazaanse; Wakamatsu , Kitakyushu, Fukuoka JAPAN
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Inner 7
Notes: The product appears to be misbranded because the label fails to identify the product as a dietary supplement or some other appropriately descriptive name; (2) the label contains information in two languages but does not repeat all the required label information in both languages and (3) the label fails to declare the common or usual name of each ingredient; Specifically; Deep Ocean Salt Water is not an appropriate common or usual name for water.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Inner 7
Notes: The product appears to be misbranded because the label fails to identify the product as a dietary supplement or some other appropriately descriptive name; (2) the label contains information in two languages but does not repeat all the required label information in both languages and (3) the label fails to declare the common or usual name of each ingredient; Specifically; Deep Ocean Salt Water is not an appropriate common or usual name for water.

NAGAYAMA FOODS FACTORY CO.,LTD.
Date Published : 03/10/2015
1 Chome 15-17 , Matsushima; Higashi , Fukuoka, Fukuoka JAPAN
25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 03/10/2015

Desc: Pickled Vegetable (Fukujinduke)

25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 03/10/2015

Desc: Pickled Takana (kizami Takanaduke)

25 J - - 27 White Radish (Root & Tuber Vegetable)
Date Published: 03/10/2015

Desc: Pickled Radish (Kizami Tsuboduke)

Ohori Co. Ltd.
Date Published : 12/03/2015
4447 , Ashio-Machi , Nikko, Tochigi JAPAN
25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 12/03/2015

Desc: Edible Wild Plants
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Edible Wild Plants" product fails to declare: - the specific food source from which the protein, "Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. The "Edible Wild Plants" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Edible Wild Plants" product is misbranded within the meaning of section 403(i) (l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 J - - 14 Turnip (Root & Tuber Vegetable)
Date Published: 12/11/2015

Desc: Prepared Tsatasi
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Prepared Tsatasi" product fails to bear/declare: - the sub-ingredients for the Umami Seasoning, which is a multi- component ingredient; - the specific food source from which the protein, "Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. - the common or usual name of the specific "vegetable" to be identified in parenthesis, e.g., "vegetable oil (soybean)," as required by 21 CFR 101.4(b)(l4). The "Prepared Tsatasi" product bear: - "sweetener" as an ingredient, which is not an appropriate common or usual name as required by 21 CFR 10 1.4(b ), in that the name of the ingredient must be a specific name and not a collective (generic) name. The "Prepared Tsatasi" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Prepared Tsatasi" product is misbranded within the meaning of section 403(i) (l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 J - - 22 Burdock, Gobo (Root & Tuber Vegetable)
Date Published: 12/03/2015

Desc: Burdock Salada
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The formulation sheet for the "Burdock Salada" product lists water, "IG," citric acid, malic acid, "SK-CR," disodium glycyrrhizinate, "fureshu," and mayonnaise as ingredients; however, these ingredients are not listed in the ingredient statement. The sub-ingredients for the mayonnaise, which is incorrectly declared as "semi solid dressing" in the ingredient statement and the sub-ingredients of some of the other ingredients on the formulation sheet are not properly declared. The "Burdock Salada" product fails to declare: - the specific food source from which the protein, "Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. The "Burdock Salada" product bear: - "sweetener" as an ingredient, which is not an appropriate common or usual name as required by 21 CFR 10 1.4(b ), in that the name of the ingredient must be a specific name and not a collective (generic) name. The "Burdock Salada" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Burdock Salada" product is misbranded within the meaning of section 403(i)(l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 Q - - 99 Mushrooms and Other Fungi Products, Pieces and Stems, Sliced, N.E.C.
Date Published: 12/03/2015

Desc: Chinese Yama Kurage
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Chinese Yama Kurage" product fails to bear/declare: - the sub-ingredients for the Umami Seasoning, which is a multi- component ingredient; - the sub-ingredients for the Soy Sauce, which is a multi-component ingredient; - the specific food source from which the protein, "Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22; - the common or usual name of the specific "vegetable" to be identified in parenthesis, e.g., "vegetable oil (soybean)," as required by 21 CFR 101.4(b)(l4). The "Chinese Yama Kurage" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Chinese Yama Kurage" product is misbranded within the meaning of section 403(i)(l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 Q - - 99 Mushrooms and Other Fungi Products, Pieces and Stems, Sliced, N.E.C.
Date Published: 12/11/2015

Desc: Pickled Nozawana
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Pickled Nozawana" product fails to bear/declare: - the sub-ingredients for the Umami Seasoning, which is a multi- component ingredient; - the specific food source from which the protein, "Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. - the common or usual name of the specific "vegetable" to be identified in parenthesis, e.g., "vegetable oil (soybean)," as required by 21 CFR 101.4(b)(l4). The "Pickled Nozawana" product bear: - "sweetener" as an ingredient, which is not an appropriate common or usual name as required by 21 CFR 10 1.4(b ), in that the name of the ingredient must be a specific name and not a collective (generic) name. The "Pickled Nozawana" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The " Pickled Nozawana" product is misbranded within the meaning of section 403(i) (l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

SAKUMA CONFECTIONERY ASAMA PLANT
Date Published : 07/05/2022
553-8 , Seto , Saku, Nagano JAPAN
33 C - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 07/05/2022

Desc: SAKUMA ICHIGO MILK CANDY / Hard Candy
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains representations in a foreign language; however, all words, statements, and other information required by or under authority of the Act to appear on the label are not provided in the foreign language as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act, in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, “emulsifier,” “acidulant,” and “vegetable oil” are not common or usual names in accordance with 21 CFR 101.4(a).

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 07/05/2022

Desc: SAKUMA ICHIGO MILK CANDY / Hard Candy
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains representations in a foreign language; however, all words, statements, and other information required by or under authority of the Act to appear on the label are not provided in the foreign language as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act, in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, “emulsifier,” “acidulant,” and “vegetable oil” are not common or usual names in accordance with 21 CFR 101.4(a).

SANKOUFOODS CO.,LTD
Date Published : 12/02/2016
Ma2204 , Noma; Shodoshima-Cho , Shozu-Gun, Kagawa JAPAN
16 E - - 02 Clams
Date Published: 12/02/2016

Desc: Asari Clams Tsukudami
Notes: Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c)(2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6)(ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1)(iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas;

16 E - - 02 Clams
Date Published: 12/02/2016

Desc: Clams with Garlic Tsukudani
Notes: Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c) (2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6) (ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1) (iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas;

TAANE
Date Published : 12/10/2015
Nakano Miyagino , 5chome-7-15; Nakano; Miyagino , Sendai, Miyagi JAPAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/10/2015

Desc: Active Hydride Plasma
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3)for the following: It appears to be misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The "Suggested use" states to take 2-6 capsules daily and the Serving Size is identified as 3 capsules. It appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically, the label lists a "Proprietary blend" but fails to list all of the ingredients of the blend. It appears to be misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count on the principal display panel as required by 21 CPR 101.105. It appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. It appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages, as required by 21 CFR 101.15(c).

TOWANI CO LTD
Date Published : 02/12/2018
Shinko 723-1 , Shinkonishi , Ishikari, Hokkaido JAPAN
24 K - - 01 Egg Plant, with Sauce
Date Published: 02/12/2018

Desc: Soy Marinated Eggplant
Notes: The product appears to be misbranded within the meaning of: (1) Section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. (2) Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because each ingredient is not declared in accordance with 21 CFR 101.4. (3) Section 403(k) of the Act [21 U.S.C. §343(k)] in that the product contains a chemical preservative but does not bear labeling stating that fact as required by 21 CFR 101.22(j). Specifically, the product declares the ingredient "Sodium Nitrite" but fails to include its function.

UHA Mikakuto Co.,Ltd.
Date Published : 10/07/2015
137-5 , Imago-Cho , Yamatokoriyama, Nara JAPAN
33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 10/07/2015

Desc: Uha Puccho Stick Nama Muscat
Notes: Product is misbranded within the meaning of Section 403(k) of the FD&C Act in that the food bears or contains artificial flavoring, artificial coloring, or chemical preservatives but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act(specify flavoring, coloring, or preservative). [Misbranding, Section 403(k)]

33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 10/07/2015

Desc: Uha Puccho Stick Grape
Notes: Product is misbranded within the meaning of Section 403(k) of the FD&C Act in that the food bears or contains artificial flavoring, artificial coloring, or chemical preservatives but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act(specify flavoring, coloring, or preservative). [Misbranding, Section 403(k)]

YAMAKI SHOKUHIN CO.,LTD.
Date Published : 03/24/2015
258 , Kamiyama; Nishi , Niigata, Niigata JAPAN
25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish (Hitokuchi Shoyu Takuan)

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish (Hitokuchi Miso Daikon)

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish (Hitokuchi Ume Katsuo Takuan)

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish by Salt (Hitokuchikiri Takuan)

Yamasan Shokuhin Co. Ltd.
Date Published : 03/10/2015
2 Chome 6-15 , Yahara , Nerima, Tokyo JAPAN
25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/10/2015

Desc: Pickled Radish (Tokyo Takuan Semi Half); Pickled Radish (Tokyo Takuan Mini Half) ;
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act[21 U.S.C.§ 343(i)(2) because they fail to list the ingredients noted in the original labeling. Further, some of these ingredients, such as amino acid and antioxidant, do not appear to be declared by an appropriate or common usual name. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act[21 U.S.C.§ 343(q) in that the nutrition information is not provided as required by 21 CFR 101.9. Published on 03/10/2015

Yamayoshi Shokuhin Kogyo
Date Published : 03/13/2015
4 Chome 11-8 , Nishioizumi , Nerima, Tokyo JAPAN
25 J - - 27 White Radish (Root & Tuber Vegetable)
Date Published: 03/13/2015

Desc: Pickled Radish (Nerimanokaori Nerimatakuan)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they fail to list the ingredients noted in the original labeling. Further; the sub-ingredients for the soy sauce are not included in either the original Japanese label or on the stick-on English label. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as required by 21 CFR 101.9. Published on 03/13/2015


JORDAN


Levant Food Products Company Ltd.
Date Published : 10/06/2017
Al-Hassan Industrial Estate , Al-Mafraq St. Block#9 Sections 1,2,3 4 , Al-Hasan Industrial City P. O, Irbid JORDAN
02 F - - 07 Wheat, Milled (Crushed, Coarse Ground or Cracked)
Date Published: 10/06/2017

Desc: GREEN GROUNDED FRIKE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of; Section 403(f) of the FD&C Act in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food; if any there be. Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts; Supplement Facts; and serving size information). [Misbranded; Section 403 (q)].

The Saudi Jordanian Industrial Development co.
Date Published : 05/28/2020
Al-Qastal , Beside East Cargo Gate , Amman, The Capital JORDAN
03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 05/28/2020

Desc: Dream Cake
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act [21 U.S.C. 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 05/28/2020

Desc: Dream Cake
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act [21 U.S.C. 343(i)(2)] in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.


KENYA


FEYZO Limited
Date Published : 09/19/2023
Kenya Garden Plaza, Mombasa Road 1200519 , Mlolongo, Nairobi KENYA
09 A - - 02 Butter Oil
Date Published: 09/19/2023

Desc: GOAT GHEE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all required information in both languages. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (Nutrition Facts label or NFL) is not in accordance with the requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(R)(1)(A)] in that the labeling bears unauthorized nutrient content claims.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/19/2023

Desc: GOAT GHEE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in two languages, but does not repeat all required information in both languages. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (Nutrition Facts label or NFL) is not in accordance with the requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(R)(1)(A)] in that the labeling bears unauthorized nutrient content claims.


KOREA (THE REPUBLIC OF)


BIO PORT KOREA,INC.
Date Published : 04/06/2015
#304 Marine Biotechnology Center San1-1 , Gwaebop-Dong , Sasang-Gu, PUSAN KOREA (THE REPUBLIC OF)
54 D - - -- Unconv Diet Spec (No Vit/Min Stmt)
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor. ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor. ;

Bioport Korea, Inc.
Date Published : 04/06/2015
#207 Marine Bio-industry , development center, 27 Hoenggye-ri , Ilgwang-myeon Gijang-gun, PUSAN KOREA (THE REPUBLIC OF)
54 D - - -- Unconv Diet Spec (No Vit/Min Stmt)
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                             

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                                ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                             ;

Busan Fishcake Co. Ltd
Date Published : 08/14/2019
69-25 Junam-ro , Yangsan-si, Gyeongsangnam-do KOREA (THE REPUBLIC OF)
37 J - - 99 Sauces, n.e.c.
Date Published: 08/14/2019

Desc: Cheddar Cheese Sauce
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the products fail to declare all ingredients for mayonnaise in accordance with 21 CFR 101.4. Mayonnaise is a multi-component ingredient and product labels fail to declare all sub-ingredients. "high fructose" and "sodium di-tiadate" are not appropriate common or usual names. Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] Product bears the term "Cheese Sauce" in the name but fails to contain or be cheese, thereby rendering the labeling false and misleading.

Busan Seujin Food
Date Published : 01/03/2020
1066 Dadeo Ro , Saha Gu, Busan KOREA (THE REPUBLIC OF)
16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 01/03/2020

Desc: Fish Paste Cake "Sa Gak"
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act-it appears to be misbranded within the meaning of: Section 403(w) of the Act,21U.S.C.§343(w)-LBL fails to declare the major food allergens. Section 201(qq) of the Act,21U.S.C.§321(qq)-a major food allergen is milk, egg, fish, crustacean shellfish,tree nuts,wheat,peanuts and soybeans,as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions.A food is misbranded if it is not a raw agricultural commodity and it is,or it contains,an ingredient that bears/contains,a major food allergen,unless either:the word "Contains,"followed by the name of the food source from which the major food allergen is derived,is printed immediately after or is adjacent to the list of ingredients[section 403(w)(1)(A) of the Act,21U.S.C.§343(w)(1)(A)],or the common/usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived,except that the name of the food source is not required when either the common/usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list(unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen)[section 403(w)(1)(B) of the Act,21 U.S.C.§343(w)(1)(B)].LBL fails to declare fish by the specific species name-Section 403(w)(1) of the Act. Section 403(f) of the Act,21U.S.C.§343(f)-LBL contains information in two languages but does not repeat all the required information in both languages.21CFR101.15(a)(1)-all words,statements and other information required on the LBL shall appear in English. Section 403(i)(2) of the Act,21U.S.C.§343(i)(2)-it is fabricated from two/more ingredients and each ingredient is not declared on the LBL,as by 21CFR101.4.

16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 01/03/2020

Desc: Fish Paste Cake "Sa Gak"
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act-it appears to be misbranded within the meaning of: Section 403(w) of the Act,21U.S.C.§343(w)-LBL fails to declare the major food allergens. Section 201(qq) of the Act,21U.S.C.§321(qq)-a major food allergen is milk, egg, fish, crustacean shellfish,tree nuts,wheat,peanuts and soybeans,as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions.A food is misbranded if it is not a raw agricultural commodity and it is,or it contains,an ingredient that bears/contains,a major food allergen,unless either:the word "Contains,"followed by the name of the food source from which the major food allergen is derived,is printed immediately after or is adjacent to the list of ingredients[section 403(w)(1)(A) of the Act,21U.S.C.§343(w)(1)(A)],or the common/usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived,except that the name of the food source is not required when either the common/usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list(unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen)[section 403(w)(1)(B) of the Act,21 U.S.C.§343(w)(1)(B)].LBL fails to declare fish by the specific species name-Section 403(w)(1) of the Act. Section 403(f) of the Act,21U.S.C.§343(f)-LBL contains information in two languages but does not repeat all the required information in both languages.21CFR101.15(a)(1)-all words,statements and other information required on the LBL shall appear in English. Section 403(i)(2) of the Act,21U.S.C.§343(i)(2)-it is fabricated from two/more ingredients and each ingredient is not declared on the LBL,as by 21CFR101.4.

16 Y - - 99 Fishery Products, N.E.C.
Date Published: 01/03/2020

Desc: Fish Paste Cake "Sa Gak"
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act-it appears to be misbranded within the meaning of: Section 403(w) of the Act,21U.S.C.§343(w)-LBL fails to declare the major food allergens. Section 201(qq) of the Act,21U.S.C.§321(qq)-a major food allergen is milk, egg, fish, crustacean shellfish,tree nuts,wheat,peanuts and soybeans,as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions.A food is misbranded if it is not a raw agricultural commodity and it is,or it contains,an ingredient that bears/contains,a major food allergen,unless either:the word "Contains,"followed by the name of the food source from which the major food allergen is derived,is printed immediately after or is adjacent to the list of ingredients[section 403(w)(1)(A) of the Act,21U.S.C.§343(w)(1)(A)],or the common/usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived,except that the name of the food source is not required when either the common/usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list(unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen)[section 403(w)(1)(B) of the Act,21 U.S.C.§343(w)(1)(B)].LBL fails to declare fish by the specific species name-Section 403(w)(1) of the Act. Section 403(f) of the Act,21U.S.C.§343(f)-LBL contains information in two languages but does not repeat all the required information in both languages.21CFR101.15(a)(1)-all words,statements and other information required on the LBL shall appear in English. Section 403(i)(2) of the Act,21U.S.C.§343(i)(2)-it is fabricated from two/more ingredients and each ingredient is not declared on the LBL,as by 21CFR101.4.

CHEONGJUNGNARU FOOD
Date Published : 10/02/2015
316-1 SONGDAE-RI OCHANG-MYEON , CHEONGWON-GUN CHUNGBUK PROVINCE , Chungcheongbukdo, KR-43 KOREA (THE REPUBLIC OF)
16 E - - 02 Clams
Date Published: 10/02/2015

Desc: Salted Clams; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08

16 E - - 03 Oysters
Date Published: 10/02/2015

Desc: Salted Seasoned Oyster; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.

16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Salted Clams; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08

16 X - - 32 Oysters, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Salted Seasoned Oyster; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.

DONG LIM TRADING
Date Published : 11/10/2016
9 JIN-NAM-RO-572-BEON-GIL , PUSAN-JIN-GU , PUSAN, KR-26 KOREA (THE REPUBLIC OF)
29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 11/10/2016

Desc: Sweet Fruit Drink Apple
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) for the following: It appears to be misbranded within the meaning of Section 403(c)(f) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 343(e)(1)] in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. It appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c) (2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). Specifically, the single product unit containers do not contain all information in both English and the foreign language(s). Other labeling violations were also noted as follows; The principal display panel of a food in a package form shall bear as one of its principal features a statement of the identity of the commodity in accordance with 21 CFR 101.3(a). It appears the statement of identity on the label applied to the outer plastic shrink wrap covering of the multiunit package, Sweet Fruit Drink (Apple), and the one on the single product unit containers, Demi Soda Apple, are different.

Daedong Korea Ginseng Co., Ltd.
Date Published : 10/22/2015
Gunbuk-myun , 586 Gunbuk-ro , Geumsan-gun, Chungcheongnam-do KOREA (THE REPUBLIC OF)
25 M - - 31 Ginseng, Juice or Drink (Root & Tuber Vegetable)
Date Published: 10/22/2015

Desc: Korean Red Ginseng Extract Liquid
Notes: View case for multiple labeling violations including but not limited to; The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare a serving size in a common household measure as required by 21 CFR 101.9(b)(7). The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii).

25 M - - 31 Ginseng, Juice or Drink (Root & Tuber Vegetable)
Date Published: 10/22/2015

Desc: Korean Red Ginseng Extract Gold
Notes: View case for multiple labeling violations including but not limited to; The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare a serving size in a common household measure as required by 21 CFR 101.9(b)(7). The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii).

Farmers Guild's Corps. Cheongmaesil
Date Published : 03/23/2015
55 Jimag1-Gil , Daap-Myeon , Gwangyang, Jeonranam KOREA (THE REPUBLIC OF)
21 H - - 14 Plum, Dried or Paste
Date Published: 03/23/2015

Desc: Plum Concentration Gold product (330 g)
Notes: Plum Concentration Gold product (330 g) appears to be sold as a gift set but the label fails to provide the total quantity of contents on the PDP; as required by 21 CFR 101.105(s);HongSsangRi CheongMaeSilWon plum beverage products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they contain some form of plum pulp, puree, juice, or concentrate, but the labels do not contain declarations of the percentage of juice in the products, as required by 21 CFR 101.30(a); Published on 03/24/2015

21 H - - 14 Plum, Dried or Paste
Date Published: 03/23/2015

Desc: HongSsangRi CheongMaeSilWon (undiluted solution of plum)
Notes: HongSsangRi CheongMaeSilWon (undiluted solution of plum) 63.76 fl. oz. product is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. The product is represented for use as a conventional food; however; the label falsely identifies the product as a dietary supplement. HongSsangRi CheongMaeSilWon plum products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the labels fail to bear a statement of identity on the Principal Display Panel (PDP); in accordance with 21 CFR 101.3(a) and (d). HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)] because the products fail to completely or accurately declare the place of business; street address; city; state and zip code as required by 21 CFR 101.5. HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the outer container for your products sold to individual customers does not provide the net quantity of contents in terms of the U.S. customary system of measurement; as required under 21 CFR 101.105(a). HongSsangRi CheongMaeSilWon plum products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because your product labels contain information in two languages but do not repeat all the required label information in both languages; HongSsangRi CheongMaeSilWon (undiluted solution of plum) beverage products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; Published on 03/24/2015

21 K - - 14 Plum, Juice, Pit Fruit Juices or Concentrates
Date Published: 03/23/2015

Desc: Plum Concentration Gold product (330 g)
Notes: Plum Concentration Gold product (330 g) appears to be sold as a gift set but the label fails to provide the total quantity of contents on the PDP; as required by 21 CFR 101.105(s);Plum Concentration Gold product (330 g) Notes:HongSsangRi CheongMaeSilWon plum beverage products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they contain some form of plum pulp, puree, juice, or concentrate, but the labels do not contain declarations of the percentage of juice in the products, as required by 21 CFR 101.30(a). Published on 03/24/2015

21 K - - 14 Plum, Juice, Pit Fruit Juices or Concentrates
Date Published: 03/23/2015

Desc: HongSsangRi CheongMaeSilWon (undiluted solution of plum)
Notes: HongSsangRi CheongMaeSilWon (undiluted solution of plum) 63.76 fl. oz. product is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. The product is represented for use as a conventional food; however; the label falsely identifies the product as a dietary supplement. HongSsangRi CheongMaeSilWon plum products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the labels fail to bear a statement of identity on the Principal Display Panel (PDP); in accordance with 21 CFR 101.3(a) and (d). HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)] because the products fail to completely or accurately declare the place of business; street address; city; state and zip code as required by 21 CFR 101.5. HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the outer container for your products sold to individual customers does not provide the net quantity of contents in terms of the U.S. customary system of measurement; as required under 21 CFR 101.105(a). HongSsangRi CheongMaeSilWon plum products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because your product labels contain information in two languages but do not repeat all the required label information in both languages;HongSsangRi CheongMaeSilWon (undiluted solution of plum) beverage products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343 (q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; Published on 03/24/2015

30 B - - 05 Beverage Base, Pit Fruit, Liquid
Date Published: 03/23/2015

Desc: HongSsangRi CheongMaeSilWon (undiluted solution of plum)
Notes: HongSsangRi CheongMaeSilWon (undiluted solution of plum) 63.76 fl. oz. product is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. The product is represented for use as a conventional food; however; the label falsely identifies the product as a dietary supplement. HongSsangRi CheongMaeSilWon plum products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the labels fail to bear a statement of identity on the Principal Display Panel (PDP); in accordance with 21 CFR 101.3(a) and (d). HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)] because the products fail to completely or accurately declare the place of business; street address; city; state and zip code as required by 21 CFR 101.5. HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the outer container for your products sold to individual customers does not provide the net quantity of contents in terms of the U.S. customary system of measurement; as required under 21 CFR 101.105(a). HongSsangRi CheongMaeSilWon plum products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because your product labels contain information in two languages but do not repeat all the required label information in both languages;HongSsangRi CheongMaeSilWon (undiluted solution of plum) Notes:HongSsangRi CheongMaeSilWon (undiluted solution of plum) beverage products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 03/24/2015

30 B - - 05 Beverage Base, Pit Fruit, Liquid
Date Published: 03/23/2015

Desc: Plum Concentration Gold product (330 g)
Notes: Plum Concentration Gold product (330 g) appears to be sold as a gift set but the label fails to provide the total quantity of contents on the PDP; as required by 21 CFR 101.105(s);Plum Concentration Gold product (330 g) Notes:HongSsangRi CheongMaeSilWon plum beverage products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they contain some form of plum pulp, puree, juice, or concentrate, but the labels do not contain declarations of the percentage of juice in the products, as required by 21 CFR 101.30(a). Published on 03/24/2015

HAITAI CONFECTIONERY @FOODS CO., LTD
Date Published : 10/02/2015
15/F., SANHAK FOUNDATION BLDG., , 1337-31, SEOCHO-DONG, SEOCHO-GU, , Seoul, SEOUL KOREA (THE REPUBLIC OF)
03 F - - 02 Flavored or Party Crackers
Date Published: 10/02/2015

Desc: Almond Crackers
Notes: VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Almond Crackers
Notes: VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.

HANPOONG PHARM CO.,LTD.
Date Published : 08/14/2017
11 Guretdeul 3-Gil Deokjin-Gu , Jeonju, KOREA (THE REPUBLIC OF)
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/14/2017

Notes: DaChaiHe Tang (also known as DaChaiHu Tang); Section 403(s)(2)(B) of the Act in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement" in accordance with 21 CFR 101.3(g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 Section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21CFR 101.36. Section 403(s)(2)(C) of the Act because the label fails to identify the part of the plant from which all the botanical dietary ingredients in the product are derived as required by 21CFR 101.4(h)(1). Section 403(q) of the FD&C Act in that the required nutrition information is not in the appropriate format in accordance with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages as required by 21CFR 101.15(c). Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7.

KOLMAR BNH CO., LTD Eumseong Factory
Date Published : 06/01/2023
8 Daepungsandan1-Gil , Daeso-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF)
54 F - - 84 Milk Thistle (Herbal & Botanical other than teas)
Date Published: 10/19/2023

Desc: ATOMY RHODIOLA MILK THISTLE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in multiple languages but does not repeat all the required information in all languages. Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because it does not include a statement of identity as a “dietary supplement.” Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the blister pack labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/01/2023

Desc: Atomy Probiotics Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)(5)(F)] in that the nutrition information (e.g., Supplement Facts Label) is not in a correct format, as required by 21 CFR 101.36 and 21 CFR 101.9.

KUKJE CONFECTIONERY CO.,LTD/
Date Published : 11/15/2016
188 Gwahaksaneob3-Ro; Cheongwon , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF)
33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/15/2016

Desc: Fruit Stick Candy (Suckers)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) for the following: It appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the ingredients "blue color AC5113/gardenia blue," "shade lemon yellow/safflower color," "acidity regulator," "color preparation/cochineal color," and "shade strawberry red P(red cabbage [sic]" are not appropriate common or usual names for the subject ingredients. It appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. For example: "Calories from Fat" fails to be declared in accordance with 21 CFR 101.9(c)(1)(ii); the amount of dietary fiber fails to be declared in accordance with 21 CFR 101.9(c)(6)(i); the product does not contain a statement of the amount per serving of the vitamins and minerals, calculated as a percent of the Reference Daily Intake (RDI) and expressed as percent of Daily value, as required by 21 CFR 101.9(c)(iii).; the declaration of nutrients is not in the order as described in 21 CFR 101.9(c).; the bilingual format does not appear to meet the requirements in 21 CFR 101.9(d)(14) because the foreign language must follow English.; calorie content does not appear to be declared in accordance with 21 CFR 101.9(c)(1) because there is no provision for declaring calories as "kcal"; the label format does not appear to meet the requirements for bolding of certain nutrients and bars in 21 CFR 101.9(d).

LINK TRADING KOREA
Date Published : 08/14/2019
69-25 Junam-Ro , Yangsan-Si, Gyeongsangnam-Do KOREA (THE REPUBLIC OF)
37 J - - 99 Sauces, n.e.c.
Date Published: 08/14/2019

Desc: Cheddar Cheese Sauce
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the products fail to declare all ingredients for mayonnaise in accordance with 21 CFR 101.4. Mayonnaise is a multi-component ingredient and product labels fail to declare all sub-ingredients. "high fructose" and "sodium di-tiadate" are not appropriate common or usual names. Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] Product bears the term "Cheese Sauce" in the name but fails to contain or be cheese, thereby rendering the labeling false and misleading.

LOTTE CONFECTIONERY CO., LTD.
Date Published : 06/29/2018
1158 Yangsandae-Ro , Yangsan, Gyeongsangnam KOREA (THE REPUBLIC OF)
03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 06/29/2018

Desc: Kancho Choco Biscuit
Notes: Problem; The Kancho Choco Biscuit contains peanuts and is not on the label; Therefore it appears to be misbranded because it does include an appropriate statement of identity; in accordance with 21 CFR 101.3.

03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 06/29/2018

Desc: Margaret Cookies; Choco Pie
Notes: Problem; The nutrition information does not comply with 21 CFR 101.9. The foreign language nutrition labels do not appear to be in a format required under 21 CFR 101.9(d).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Margaret Cookies; Choco Pie
Notes: Problem; The nutrition information does not comply with 21 CFR 101.9. The foreign language nutrition labels do not appear to be in a format required under 21 CFR 101.9(d).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Choco Pie
Notes: Problem(s) The foreign language nutrition labels on do not appear to be in a format required under 21 CFR 101.9(d).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Choco Pie Cacao
Notes: Problem(s) The nutrition information does not comply with 21 CFR 101.9. The foreign language nutrition labels do not appear to be in a format required under 21 CFR 101.9(d).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Kancho Choco Biscuit
Notes: Problem; The Kancho Choco Biscuit contains peanuts and is not on the label; Therefore it appears to be misbranded because it does include an appropriate statement of identity; in accordance with 21 CFR 101.3.

Lotte Confectionery Co., Ltd.
Date Published : 04/06/2015
25 Yangpyung-Lo 21-Gil , Seoul, Youngdeungpo-Gu KOREA (THE REPUBLIC OF)
03 R - - 60 Waffles Without Custard or Cream Filling
Date Published: 04/06/2015

Desc: Lotte European Waffles
Notes: Charge: 403(i)(1) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because there is no accurate statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. We question the name of the product "Lotte Waffle" being an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food within the meaning of sections 21 CFR 101.3(b) and 21 CFR 102.5(a). The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. It appears that this product is not generally recognized by American consumers as a waffle, but may be similar to a snack cracker or cookie product. We also note that the statement of identity must be consistent wherever it appears on the label. Charge: 403(i)(2) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i) (2)] because they are fabricated from two or more ingredients but the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, Charge: 403(f) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded with the meaning of section 403(f) because the product labels contain information in two languages but do not repeat all the required label information in both languages. It appears a second language (possibly Korean) is declared on the label; therefore all words, statements, and other information required by or under authority of the act to appear on the label must also be represented in the foreign language in accordance with 21 CFR 101.15(c)(2).

03 S - - 60 Waffles Prepared Dry Mix Without Custard or Cream Filling
Date Published: 10/07/2015

Desc: The Lotte European Waffles
Notes: The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015

03 T - - 60 Waffle Dough or Batter Without Custard or Cream Filling
Date Published: 10/07/2015

Desc: The Lotte European Waffles
Notes: The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015

ORION CORP IKSAN PLANT (3)
Date Published : 07/26/2016
317 Dongseo-Ro , Iksan-Si , Jeollabuk-Do, Korea KOREA (THE REPUBLIC OF)
33 E - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, without Nuts and Fruit (without Chocolate)
Date Published: 07/26/2016

Desc: Korean Candy- Wang GGUM TUE RI
Notes: The product appears to be misbranded within the meaning of;(1)Section 403(q) of the Act; in that the nutrition information (e.g. Nutrition Facts Panel) does not meet the requirements under 21 CFR 101.9;(2)Section 403(f) of the Act because the product label contains information in two languages; but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The statement of identity; nutrition information; ingredient statement; and name and place of business of the manufacturer; packer; or distributor are not declared in English on the individual retail packets and the outer container fails to bear Korean for all words; statements; and other mandatory information as required by 21 CFR 101.15(c)(2);(3)Section 403(i)(2) of the Act; in that it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4.

Ourhome Ltd.
Date Published : 06/26/2019
(Ju)Awohom , 26-21 Je1sandan-Ro; Duma-Myeon , Gyeryong, Chungcheongnam KOREA (THE REPUBLIC OF)
37 B - - 27 Bean curd, fresh - soft or hard (Multiple Food Specialties, Side Dishes and Desserts)
Date Published: 06/26/2019

Desc: Soft Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "100 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared. [21CFR101.9(d)(3)(i) and (b)(7), respectively].The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container (21 CFR 101.9(d)(3)(ii), or the full footnote (101.9(d)(9)); and it appears that Saturated Fat and Trans Fat have been added together to show one combined % DV.Saturated Fat/Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label. Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR101.9(c)(9)and(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).Specifically, the article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

37 B - - 27 Bean curd, fresh - soft or hard (Multiple Food Specialties, Side Dishes and Desserts)
Date Published: 06/26/2019

Desc: Soybean Cooking Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "60 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared 21CFR101.9(d)(3)(i) and (b)(7), respectively.The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container(21 CFR101.9(d)(3)(ii), or the full footnote 101.9(d)(9)); and it appears that Saturated Fat/Trans Fat have been added together to show one combined % DV.Saturated Fat and Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label.Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR 101.9(c)(9)(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each language.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).The article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

37 C - - 27 Bean curd, fresh - soft or hard (Package Contains Separate Components, Require Mix/Cook)
Date Published: 06/26/2019

Desc: Soft Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "100 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared. [21CFR101.9(d)(3)(i) and (b)(7), respectively].The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container (21 CFR 101.9(d)(3)(ii), or the full footnote (101.9(d)(9)); and it appears that Saturated Fat and Trans Fat have been added together to show one combined % DV.Saturated Fat/Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label. Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR101.9(c)(9)and(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).Specifically, the article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

37 C - - 27 Bean curd, fresh - soft or hard (Package Contains Separate Components, Require Mix/Cook)
Date Published: 06/26/2019

Desc: Soybean Cooking Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "60 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared 21CFR101.9(d)(3)(i) and (b)(7), respectively.The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container(21 CFR101.9(d)(3)(ii), or the full footnote 101.9(d)(9)); and it appears that Saturated Fat/Trans Fat have been added together to show one combined % DV.Saturated Fat and Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label.Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR 101.9(c)(9)(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each language.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).The article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

PUREPLUS CO., LTD
Date Published : 03/07/2018
11 Sudongnonggong-Gil , Sudong-Myeon , Hamyang, Gyeongsangnam KOREA (THE REPUBLIC OF)
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 12/26/2019

Desc: Premium Pure Plus My Aloe Vera Drink Original
Notes: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

Pharmtech Korea
Date Published : 03/30/2020
#59 Road,Munmak Industrial Complex , Munmak-Eup , Wonju-City, KANGWON KOREA (THE REPUBLIC OF)
53 P D - 02 Collagen (Cosmetic Raw Material), Liquid, Lotion
Date Published: 03/30/2020

Desc: IMPERIAL BE COLLAGEN
Notes: • The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(a). Specifically, the principal display panel does not bear an appropriate statement of identity. The principal display panel (PDP) lists fish collagen; however, the bottom of the box label bears the product description as "mixed drinks." • The article is subject to refusal of admission pursuant to section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the ingredients are not listed in descending order of predominance as required by 21 CFR 101.4(a)(2) and because the ingredients do not appear to be appropriate common or usual names of the ingredients as required by 21 CFR 101.4(a)(1). For example: o The product label fails to deciare the specific common or usual name of the fish species o "Seven berry" does not appear to be a common or usual name of an ingredient. o "Pomegranate (flavor)" ingredient is not declared in accordance with 21 CFR 101.22(h). o "Vitamin B1" and Vitamin B2" are not declared by their common or usual name as required by 21 CFR 101.9(c)(8)(iv).

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 03/30/2020

Desc: IMPERIAL BE COLLAGEN
Notes: • The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(a). Specifically, the principal display panel does not bear an appropriate statement of identity. The principal display panel (PDP) lists fish collagen; however, the bottom of the box label bears the product description as "mixed drinks." • The article is subject to refusal of admission pursuant to section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the ingredients are not listed in descending order of predominance as required by 21 CFR 101.4(a)(2) and because the ingredients do not appear to be appropriate common or usual names of the ingredients as required by 21 CFR 101.4(a)(1). For example: o The product label fails to deciare the specific common or usual name of the fish species o "Seven berry" does not appear to be a common or usual name of an ingredient. o "Pomegranate (flavor)" ingredient is not declared in accordance with 21 CFR 101.22(h). o "Vitamin B1" and Vitamin B2" are not declared by their common or usual name as required by 21 CFR 101.9(c)(8)(iv).

Sejun Food Co., Ltd
Date Published : 10/30/2019
63 Gamaeul-Gil , Gonjiam-Eup , Gwangju, Gyeonggi KOREA (THE REPUBLIC OF)
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Ginseng Sikhye Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Sweet Pumpkin Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Original Haneulcheong Persimmon Punch
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Ginger Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Sikhye Original Haneulcheong Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Organic Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 10/30/2019

Desc: Ginger Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 10/30/2019

Desc: Sweet Pumpkin Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 10/30/2019

Desc: Sikhye Original Haneulcheong Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/30/2019

Desc: Original Haneulcheong Persimmon Punch
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act; Section 403(f) of the FD&C Act in that the product labels contain information in two languages but do not repeat all the required information in both languages, and/or they fail to declare all required information in English, and/or the required information lacks prominence and conspicuousness as required by 21 CFR 101.15; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/30/2019

Desc: Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

Seonil INT Co.,Ltd.
Date Published : 04/24/2015
Mansokdong 1 41 , Dong-Gu , Inchon, INCHON KOREA (THE REPUBLIC OF)
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 04/24/2015

Desc: Gyeran Cracker
Notes: The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] for failing to declare the common or usual name for each ingredient in accordance with 21 CFR 101.4. For example; the label in Korean declares "egg and milk" in the ingredient statement however; "egg and milk" are in declared in on the English ingredients statement. In addition; shortening on the ingredient statement of the Tayo Cracker is not a specific common or usual name as required by 21 CFR 101.4(b)(14) and Lemon Parfum on the ingredient statement of the Gyeran Cracker is not a specific common or usual food ingredient name. The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically it appears that the distributor name and address is not in the Korean language since it is provided by the exporter not the manufacturer. In addition; the nutrition information does not contain the same numerical values in the Korean declaration as the U.S. declaration.

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 04/24/2015

Desc: Tayo Cracker
Notes: The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] for failing to declare the common or usual name for each ingredient in accordance with 21 CFR 101.4. For example; the label in Korean declares "egg and milk" in the ingredient statement however; "egg and milk" are in declared in on the English ingredients statement. In addition; shortening on the ingredient statement of the Tayo Cracker is not a specific common or usual name as required by 21 CFR 101.4(b)(14) and Lemon Parfum on the ingredient statement of the Gyeran Cracker is not a specific common or usual food ingredient name. The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically it appears that the distributor name and address is not in the Korean language since it is provided by the exporter not the manufacturer. In addition; the nutrition information does not contain the same numerical values in the Korean declaration as the U.S. declaration.

SunhoFood
Date Published : 03/24/2023
Seonhosikpum , 29 Nonggongdanji2-Gil , Sokcho, Gangwon KOREA (THE REPUBLIC OF)
16 M - - 09 Octopus, Other Aquatic Species
Date Published: 03/24/2023

Desc: Seasoned Octopus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act in that the Nutrition Facts Label is not in accordance with 21 CFR 101.9. The label fails to declare a serving size based on the reference amount customarily consumed (RACC) (21 CFR 101.12(b), Table 2, and 21 CFR 101.9(b)(2). The product label declares 1 cup (55g); however, the appropriate RACC for entrees with sauce (e.g., fish with cream sauce, shrimp with lobster sauce) is 140 grams cooked, with a recommended label statement “_ cup(s) (_ g); 5 oz (140 g/visual unit of measure) if not measurable by cup.” Therefore, all nutrient information is incorrectly declared (21 CFR 101.12(b)). Section 403(i)(2) of the Act in that product is fabricated from two or more ingredients and each ingredient is not declared on the label or is not declared by its common or usual name (21 CFR 101.4). Sub-ingredients in “soft drink” and “seasoning” are not listed in the ingredient statement on product label. The terms “mixture 1” and “mixture 2” are not the common or usual names for an ingredient. If the ingredient listed as “D-Sorbitol” is actually “Sorbitol,” it must be declared as such (21 CFR 184.1835). “Glucose” is not declared by an appropriate common or usual name in accordance with 21 CFR 101.4(a) if this ingredient meets one of standards of identity in 21 CFR 168 “Sweeteners and Table Sirups. It is not clear if “plum syrup” is a multicomponent ingredient and/or whether it is an appropriate common or usual name. Section 403(f) of the Act. The product label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)(2)). The ingredient statement, “Contains” statement, and the net quantity of contents must be declared in both English and the foreign language.

16 Y - - 99 Fishery Products, N.E.C.
Date Published: 03/24/2023

Desc: Seasoned Octopus
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act in that the Nutrition Facts Label is not in accordance with 21 CFR 101.9. The label fails to declare a serving size based on the reference amount customarily consumed (RACC) (21 CFR 101.12(b), Table 2, and 21 CFR 101.9(b)(2). The product label declares 1 cup (55g); however, the appropriate RACC for entrees with sauce (e.g., fish with cream sauce, shrimp with lobster sauce) is 140 grams cooked, with a recommended label statement “_ cup(s) (_ g); 5 oz (140 g/visual unit of measure) if not measurable by cup.” Therefore, all nutrient information is incorrectly declared (21 CFR 101.12(b)). Section 403(i)(2) of the Act in that product is fabricated from two or more ingredients and each ingredient is not declared on the label or is not declared by its common or usual name (21 CFR 101.4). Sub-ingredients in “soft drink” and “seasoning” are not listed in the ingredient statement on product label. The terms “mixture 1” and “mixture 2” are not the common or usual names for an ingredient. If the ingredient listed as “D-Sorbitol” is actually “Sorbitol,” it must be declared as such (21 CFR 184.1835). “Glucose” is not declared by an appropriate common or usual name in accordance with 21 CFR 101.4(a) if this ingredient meets one of standards of identity in 21 CFR 168 “Sweeteners and Table Sirups. It is not clear if “plum syrup” is a multicomponent ingredient and/or whether it is an appropriate common or usual name. Section 403(f) of the Act. The product label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)(2)). The ingredient statement, “Contains” statement, and the net quantity of contents must be declared in both English and the foreign language.

WILLIAM XYLITOL
Date Published : 09/20/2023
8 Geoma-Ro 77beon-Gil , Ulsan, KOREA (THE REPUBLIC OF)
28 C - - 36 Peppermint, Natural Extract or Flavor (Spice)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 C - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 C - - 11 Mint Candy, Hard, with Fruit (without Chocolate)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

54 B - - 99 Mineral N.E.C.
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/20/2023

Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

WOOSHIN LABOTTACH CO.,LTD.
Date Published : 10/12/2023
# 1907 Daerung P-Toweri , Seoul, KOREA (THE REPUBLIC OF)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/12/2023

Desc: Gut Support with Probiotics
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9. Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/12/2023

Desc: Weight Control
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9. Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, (21 CFR 101.4(h)(1)). Section 403(i)(2) of the Act because each product label fails to declare all the common or usual names of each ingredient used (21 CFR 101.36 and 21 CFR 101.4(a) and (g)).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/12/2023

Desc: Nerve + Neuropathy Support
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(1) of the Act in that they fail to list the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5) Section 403(e)(2) of the Act because the labels fail to declare the net quantity of contents on the principal display panel (21 CFR 101.7} Section 403(q)(1)(B) of the Act because each product label fails to list the servings per container under the serving size on the left-hand side of the nutrition label (i.e., the Supplement Facts label) or fails to include this information as part of the net quantity of contents declaration (21 CFR 101.36(b)(1)(ii)). Section 403(q)(5)(F) of the Act because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36, 21 CFR 101.4, and 21 CFR 101.9). Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the Act because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(i)(2) of the Act because each product label fails to declare all the common or usual names of each ingredient used (21 CFR 101.36 and 21 CFR 101.4(a) and (g)).

YIRAE WORLD CORP.
Date Published : 04/05/2023
Dunchondaero Jungwon , 8 Floor Businesscenter Mtower Seongnamng 27 101beongil , Seongnam, Gyeonggido KOREA (THE REPUBLIC OF)
04 C - - 07 Noodles, Instant
Date Published: 04/05/2023

Desc: Lobster Ramen
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act. Labels declare major food allergen, egg, in the “Contains” statement, but ingredient list does not list ‘egg’. The “Contains” statement causes the product label to be false or misleading. Individual unit declares “Lobster (1.4%),” but not declared on the multi-unit container label. Section 403(q) of the Act. Nutrition Facts label (NFL) is in English, English/French, and in Chinese. The Chinese label and overall format is not as provided for in 21 CFR 101.9. Section 403(f) of the Act. Label contains information in a foreign language(s); but not all required information is in all languages (i.e., the English language as well as the foreign languages). The statement of identity, ingredient statement and net quantity must be declared in all of the foreign languages and English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act. Labels fail to bear the common or usual name of the food and statement of identity (21 CFR 101.3). Crab and shrimp ingredients appear to be in greater quantities than the “lobster powder” ingredient, based on the order of predominance. “Lobster Ramen” does not appear to be appropriately descriptive (21 CFR 101.3(b)(3)) or if the “lobster powder” is a flavor, which must be indicated in the name of the food. Section 403(i)(2) of the Act. Common or usual name of each ingredient is not on the label. Species of crab in crab extract is not declared by the acceptable market name or the common name as provided in FDA’s Seafood List. Refined salt, noodles additive, mixed preparation, kojiaji and powderd [sic] of bros yu are not common or usual ingredient names. Multicomponent ingredients are not declared with sub-ingredients. Acidity regulator is not a common or usual name of an ingredient; it is intervening material under 21 CFR 101.2(e).

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 04/05/2023

Desc: Lobster Ramen
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act. Labels declare major food allergen, egg, in the “Contains” statement, but ingredient list does not list ‘egg’. The “Contains” statement causes the product label to be false or misleading. Individual unit declares “Lobster (1.4%),” but not declared on the multi-unit container label. Section 403(q) of the Act. Nutrition Facts label (NFL) is in English, English/French, and in Chinese. The Chinese label and overall format is not as provided for in 21 CFR 101.9. Section 403(f) of the Act. Label contains information in a foreign language(s); but not all required information is in all languages (i.e., the English language as well as the foreign languages). The statement of identity, ingredient statement and net quantity must be declared in all of the foreign languages and English (21 CFR 101.15(c)(2)). Section 403(i)(1) of the Act. Labels fail to bear the common or usual name of the food and statement of identity (21 CFR 101.3). Crab and shrimp ingredients appear to be in greater quantities than the “lobster powder” ingredient, based on the order of predominance. “Lobster Ramen” does not appear to be appropriately descriptive (21 CFR 101.3(b)(3)) or if the “lobster powder” is a flavor, which must be indicated in the name of the food. Section 403(i)(2) of the Act. Common or usual name of each ingredient is not on the label. Species of crab in crab extract is not declared by the acceptable market name or the common name as provided in FDA’s Seafood List. Refined salt, noodles additive, mixed preparation, kojiaji and powderd [sic] of bros yu are not common or usual ingredient names. Multicomponent ingredients are not declared with sub-ingredients. Acidity regulator is not a common or usual name of an ingredient; it is intervening material under 21 CFR 101.2(e).


LEBANON


Nafez Albert Farah
Date Published : 06/04/2021
Kfar Saroun High Way , Majdel Koura, North LEBANON
21 U - - 03 Fig, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 06/04/2021

Desc: Fig Jam with Nuts
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The statement of identity is “Fig With Nuts” and the principal display panel has a vignette of what appears to be various types of nuts or seeds, and ingredients that appear to be walnuts and sesame seeds are apparent in the product, but are not declared in the label’s ingredient list as required by 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in a foreign language but does not repeat all the mandatory label information in the foreign language. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The Nutrition Facts, name and address of the responsible party, and the net weight are not listed in the foreign language that is present on the label.


MALAYSIA


Asian Secrets Sdn Bhd
Date Published : 03/22/2016
No. 5 Jalan 4 , C-11-4, 5&6, Wisma Goshen, Bangsar Tade Center, Plaza Pantai , Kuala Lumpur, Wp Kuala Lumpur MALAYSIA
21 A - - 20 Citrus and Other Fruits, Mixed
Date Published: 03/22/2016

Desc: TUNJUK LANGIT (FRUCTUS SWIETENIA MACROPHYLLA) SKY FRUIT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)];and, The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim, but fails to meet the requirements to bear the claim.. [Misbranded,Section 403(r)(1)(A/B)];and, The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)]because the product label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The net quantity of contents statement is not declared in the foreign language. In addition, the statement of identity, Tunjuk Langit, is not in English and appears to be in Malay language. [Misbranded, Section 403 (f)] ;

21 S - - 99 Subtropical and Tropical Fruit, N.E.C.
Date Published: 03/22/2016

Desc: TUNJUK LANGIT (FRUCTUS SWIETENIA MACROPHYLLA) SKY FRUIT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)];and, The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim, but fails to meet the requirements to bear the claim.. [Misbranded,Section 403(r)(1)(A/B)];and, The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)]because the product label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The net quantity of contents statement is not declared in the foreign language. In addition, the statement of identity, Tunjuk Langit, is not in English and appears to be in Malay language. [Misbranded, Section 403 (f)]

CAVERFLO TEXAS TRADING
Date Published : 11/28/2017
117 Lorong Bunga Raya 5 , Sungai Petani, Kedah MALAYSIA
31 A - - -- Coffee
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product's outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product's outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product's outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product's outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

Cocoaland Sdn Bhd
Date Published : 10/02/2015
Lot 100, Rawang Integrated Industrial , Rawang, Selangor MALAYSIA
33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 11/28/2017

Desc: MANGO FLAVORED CANDY
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and 15 U.S.C. § 1453(a)(2) and 15 U.S.C. § 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1), followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of FPLA]. -Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. -Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two or more languages, but does not repeat all the required information in both languages. -Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Herbal Candy Super Mint
Notes: VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded under section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the nutrition information on the labels are provided in a format not consistent with the requirements under 21 CFR 101.9. Specifically, the nutrients are not listed in order as specified under 21 CFR 101.9 (c) and that ¿Calories¿ is not declared as required under 21 CFR 101.9(c)(1). Also, the %DVs are not declared under 21 CFR 101.9(d)(7)(ii). The nutrition information does not meet the formatting requirements under 21 CFR 101.9(d)(1)(i), which states, in part, that the nutrition must be printed on a white or other neutral contrasting background whenever practical. 2. The article is subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded under sections 403 (i)(2) of the Act, in that ingredient statement does not correctly label the ¿Flavour & Flavouring¿ ingredient in accordance with 21 CFR 101.22.

DYNAMIC NUTRITION SDN BHD
Date Published : 05/20/2019
No 12c Hedgeford Innovation Park Ja , Jalan Tandang , Petaling Jaya, Selangor MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/19/2023

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient. 5/20/2019

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

Dynamic Nutrition
Date Published : 05/20/2019
18 Jalan Industri , Subang Jaya, MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

GOLD FOOD RESOURCES SDN BHD
Date Published : 03/23/2023
Lot 331 Perusahaan Buloh 3 , Ipoh, MALAYSIA
36 C - - 04 Honey
Date Published: 03/23/2023

Desc: Black Horse Vital Honey
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL).

36 C - - 99 Honey, N.E.C.
Date Published: 03/23/2023

Desc: Black Horse Vital Honey
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/23/2023

Desc: Black Horse Vital Honey
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL).

66 S - - 51 Tadalafil
Date Published: 03/23/2023

Desc: Black Horse Vital Honey
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL).

Kawan Food Manufacturing Sdn Bhd
Date Published : 03/17/2015
Lot 129351 Jalan Sungai Pinang 4/19 , Taman Perindustrian Pulau Indah; Selangor Halal Hub Fasa 2C , Pulau Indah, Selangor D.E. MALAYSIA
03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific "Raising Agent" is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 R - - 30 Pastry Shells Without Custard or Cream Filling
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific "Raising Agent" is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 T - - 25 Pastry (other than Fruit or Jelly Filled) Dough or Batter Without Custard or Cream Filling
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific "Raising Agent" is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 T - - 30 Pastry Shell Dough or Batter Without Custard or Cream Filling
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific "Raising Agent" is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 Y - - 11 Lumpia wrappers (includes pastry wrappers and sheets)
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific "Raising Agent" is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific "Raising Agent" is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

Mellips SDN BHD
Date Published : 10/02/2015
Lot 28 , Jalan Tun , Melaka, Melaka MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/02/2015

Desc: Ginseng Plus
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) in that the product label fails to bear the supplement facts in the appropriate format and fails to bear the required information of the common or usual name of the food and each ingredient in accordance with section 403(I)(2).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Desc: Ginseng Plus
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) in that the product label fails to bear the supplement facts in the appropriate format and fails to bear the required information of the common or usual name of the food and each ingredient in accordance with section 403(I)(2).

Nestle Manufacturing (MALAYSIA) SDN BHD, Shah Alam Complex
Date Published : 03/05/2021
Jalan Playar 15/1 , Shah Alam, Selangor MALAYSIA
38 C - - 99 Dried Soup, N.E.C.
Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the Act because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all statements required by or under authority of the Act to appear on the label must appear in English as well as the foreign language. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute, "acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)].

38 Y - - 99 Soup, N.E.C.
Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the Act because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all statements required by or under authority of the Act to appear on the label must appear in English as well as the foreign language. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute, "acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)].

Reishilab Sdn Bhd
Date Published : 05/20/2019
No 5 Jalan P2/4 , Semenyih, Selangor MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

Thomyam Food Industries Sdn.Bhd.
Date Published : 10/02/2015
Lot 76 No. 10 , Semambu Industrial Estate , Kuantan, Pahang MALAYSIA
35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Pandan Flavor Pudding
Notes: Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common of usual names required by 21CFR101.4. Specifically; sodium caseinate. Also; product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/5/07

35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Assorted Pudding
Notes: Product is misbranded under 403(i)(2) in that the listing of sodium caseinate as a sub-ingredient of the non-dairy creamer does not include a parenthetical term such as ?a milk derivative? as required by 21CFR101.4(d) Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07

35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Mini Pudding Tropical Fruit
Notes: Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement as required by 21CFR101.4. Specifically; sodium caseinate. Also; the product is misbranded under 403(q) in that the format for the nutrition facts label does not comply with 21CFR101.9. Product is further misbranded under 403(q) in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/4/07

35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Mango Pudding
Notes: Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common or usual name as required by 21CFR101.4. Specifically; sodium caseinate. Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07


MEXICO


API-ROYAL, S.A DE CV
Date Published : 10/02/2015
Calle 7a Altos #237 , Col. San Luis , San Luis Potosi, San Luis Potosi MEXICO
30 J - - -- Imit Flav Beverage Base
Date Published: 10/02/2015

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

30 J - - -- Imit Flav Beverage Base
Date Published: 10/02/2015

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

30 J - - -- Imit Flav Beverage Base
Date Published: 10/02/2015

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

30 Y - - -- Beverage Base N.E.C.
Date Published: 10/02/2015

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

30 Y - - -- Beverage Base N.E.C.
Date Published: 10/02/2015

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

30 Y - - -- Beverage Base N.E.C.
Date Published: 10/02/2015

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

54 I - - 99 Fiber, N.E.C.
Date Published: 10/02/2015

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

54 I - - 99 Fiber, N.E.C.
Date Published: 10/02/2015

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

54 I - - 99 Fiber, N.E.C.
Date Published: 10/02/2015

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

Agrojugos, S.A. De C.V.
Date Published : 10/02/2015
Km. 15 Carretera A Bahia Kinc , Hermosillo, Sonora, MEXICO
24 T - - 99 Leaf & Stem Vegetables, N.E.C.
Date Published: 10/02/2015

Desc: Spicy Dried Cactus (Nopalitos Deshidratados)
Notes: VIOLATION: This product is misbranded within the meaning of 403(q). The statement of the number of grams of Trans Fat is not declared as required by section 21 CFR 101.9(c)(2)(ii). The Serving Size shall be expressed in common household measure and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters) 21 CFR 101.9(b)(7)

Aide concepcion ruiz mtz
Date Published : 10/02/2015
Morlos #33-C San Jeronimo Tlacochahuaya , Oaxaca, Mexico C.P. MEXICO
03 Y - - 09 Tortillas
Date Published: 10/02/2015

Desc: Handmade Tortillas
Notes: VIOLATION (IN NOTES); 1. 403(i)(2) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded under Section 403(i)(2) of the Act because the food is fabricated from two or more ingredients; and the product label does not bear a list of ingredients

Alicia Alvarez Gutierres
Date Published : 10/02/2015
Chicalote 2620 , Mercado de Abastos , Guadalajara, Jal MEXICO
36 A - - 02 Brown Sugar (Sucrose from Cane)
Date Published: 10/02/2015

Desc: Brown Sugar
Notes: Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07

36 A - - 03 Cane Sugar (Sucrose)
Date Published: 10/02/2015

Desc: Brown Sugar
Notes: Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07

Apicola de Allende, S.A. de C.V.
Date Published : 04/24/2017
Lerdo De Tejada No. 202 Ote. , Col. Centro Seccion , Allende, Nuevo Leon MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017

Desc: Propolis Liquid Extract Drops
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017

Desc: Bee Pollen
Notes: The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of 403(r)(2)(A) of the Act [21U.S.C. § 343 (r)(2)(A)] because the label makes a claim stating the absence of a nutrient which is not in accordance with 21CFR 101.13(e)(2).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017

Desc: EspectiBron
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017

Desc: Royal Jelly
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. The product appears to be misbranded within the meaning of section 403(q)(1)(B) because the label fails to declare the servings per container in accordance with 21CFR 101.36(b)(1)(ii).

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017

Desc: Propolis Capsules
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017

Desc: Royal Jelly Capsules
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

BARCEL, S.A. DE C.V
Date Published : 08/29/2023
Carretera Mexico - Toluca Km. 54 , Lerma , Pueblo Infonavit Lerma, Mexico MEXICO
07 B G T 02 Corn Chips, Fried, Plastic, Synth, Packaged Food (Not Commercially Sterile)
Date Published: 08/29/2023

Desc: Takis Chippz Fuego (Hot Chili Pepper and Lime Potato Chips)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the sodium content exceeds the label declaration, and the potassium content does not meet the label declaration. FDA analyzed a sample of product, collected at entry, and determined that that it contained 141% and 140% (check) of the declared amount of sodium and 61.9% and 61% (check) of the declared amount of potassium per serving. This does not meet the requirements of 21 CFR 101.9(g)(4) and 101.9(g)(5) because the sample result for potassium is not at least 80% of the value declared on the label, and the sample result for sodium is greater than 20% in excess of the value declared on the label.

07 B G T 06 Potato Chips,Fried, Plastic, Synth, Packaged Food (Not Commercially Sterile)
Date Published: 08/29/2023

Desc: Takis Chippz Fuego (Hot Chili Pepper and Lime Potato Chips)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the sodium content exceeds the label declaration, and the potassium content does not meet the label declaration. FDA analyzed a sample of product, collected at entry, and determined that that it contained 141% and 140% (check) of the declared amount of sodium and 61.9% and 61% (check) of the declared amount of potassium per serving. This does not meet the requirements of 21 CFR 101.9(g)(4) and 101.9(g)(5) because the sample result for potassium is not at least 80% of the value declared on the label, and the sample result for sodium is greater than 20% in excess of the value declared on the label.

BARQUILLOS Y DULCES DELIZ
Date Published : 10/02/2015
Calle Emilio Madero 7 , Otro Zona Urbana Ejidal Santa Martha Acatitla Sur, Iztapalapa , Ciudad De Mexico, Ciudad de Mexico MEXICO
33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Marshmallows
Notes: VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).

33 L - - 09 Marshmallow Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Marshmallows
Notes: VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).

33 T - - 99 Toppings without Fruit, Nuts or Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Marshmallows
Notes: VIOLATION; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) because the Principle Display Panel (PDP) and ingredients statement appear to bear nutrient content claims. Specifically the PDP declares ?adicionado con vitamina A; fibra? which means ?added with vitamins and fiber? and ?added with vitamin A; fiber? respectively. The term ?added? when used to describe the level of a nutrient is a nutrient content claim synonymous for ?more?. The regulation that defines ?more? [21 CFR 101.54(e)] requires that the food contain at least 10 percent or more of the Recommended Daily Intake (RDI) for vitamins or minerals or of the Daily Reference Value (DRV) for protein; dietary fiber; or potassium per reference amount customarily consumed than an appropriate reference food. The product?s nutrition label fails to declare any vitamins or dietary fiber in order to determine if the product meets the claim. Therefore; the product fails to meet the conditions of the nutrient content claims and appears to be misbrand the product within the meaning of 403(r)(1)(A).

COMERCIALIZADORA PEPSICO
Date Published : 03/25/2016
Eje Vial 1 Poniente (Calzada Vallejo) No 734 , Col. Coltongo, Azcapotzalco , Ciudad De Mexico, Ciudad de Mexico MEXICO
07 A - - 02 Corn Chips, Baked
Date Published: 10/10/2018

Desc: Fritos; Limon y Sal (Fried corn chips)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

07 A - - 06 Potato Chips,Baked
Date Published: 10/10/2018

Desc: Sabritas; Fried potato chips
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

07 B - - 02 Corn Chips, Fried
Date Published: 03/25/2016

Desc: Rancheritos
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] because the required information is not in English. Specifically; 21 CFR 101.15(c)(1); requires that all words; statements; and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language. Provided; however; that in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English; the predominant language may be substituted for English.

07 B - - 02 Corn Chips, Fried
Date Published: 03/25/2016

Desc: Crujitos
Notes: The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] because the required information is not in English. Specifically; 21 CFR 101.15(c)(1); requires that all words; statements; and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language. Provided; however; that in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English; the predominant language may be substituted for English.

07 B - - 02 Corn Chips, Fried
Date Published: 03/25/2016

Desc: Cheetos Horneados; Bolitas Sabor
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] because the required information is not in English. Specifically; 21 CFR 101.15(c)(1); requires that all words; statements; and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language. Provided; however; that in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English; the predominant language may be substituted for English.

07 B - - 02 Corn Chips, Fried
Date Published: 10/10/2018

Desc: Fritos; Limon y Sal (Fried corn chips)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

07 B - - 02 Corn Chips, Fried
Date Published: 03/25/2016

Desc: Churrumais Con Limoncito
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] because the required information is not in English. Specifically; 21 CFR 101.15(c)(1); requires that all words; statements; and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language. Provided; however; that in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English; the predominant language may be substituted for English.

07 B - - 06 Potato Chips,Fried
Date Published: 03/25/2016

Desc: Adobadas
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] because the required information is not in English. Specifically; 21 CFR 101.15(c)(1); requires that all words; statements; and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language. Provided; however; that in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English; the predominant language may be substituted for English.

07 B - - 06 Potato Chips,Fried
Date Published: 10/10/2018

Desc: Sabritas; Fried potato chips
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/10/2018

Desc: Sabritas; Fried potato chips
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/10/2018

Desc: Fritos; Limon y Sal (Fried corn chips)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

07 T - - 07 Wheat Starch Snacks, Fried/Oil Cook
Date Published: 03/25/2016

Desc: Sabritones; Chile y sabor limon
Notes: The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] because the required information is not in English. Specifically; 21 CFR 101.15(c)(1); requires that all words; statements; and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language. Provided; however; that in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English; the predominant language may be substituted for English.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/10/2018

Desc: Fritos; Limon y Sal (Fried corn chips)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/10/2018

Desc: Sabritas; Fried potato chips
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the common or usual name is missing from the PDP. Section 403(i)(2) of the FD&C Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Ingredients for "corn nixtamalized", identity of vegetable oil used, common and usual name for achiote as required by 21 CFR 101.4(b)(14). Section 403(q) of the FD&C Act as follows: The nutrition labels in the foreign language do not meet the requirements in 21 CFR 101.9(d)(14) because all required information is not provided in the foreign language. The required vitamins and minerals are not declared, percent daily values are not declared for any nutrients, and the required footnote is not provided. In addition, there are formatting deviations. The serving size is not declared using an appropriate visual unit of measure (21 CFR 101.9(b)(5)). The number of servings per container on the Sabritas Originales is not declared in accordance with 21 CFR 101.9(b)(8)(i). The values for Calories and Calories from fat are not rounded in accordance with 21 CFR 101.9(c)(1) and (c)(1)(ii). The English label includes formatting errors for bolding: "Sugar" should be "Sugars," Protein should not be indented under Total Carbohydrates, and there is no provision for any additional information to be declared within the nutrition label box.

COMERCIALIZADORA PEPSICO MEXICOS DE RL DE CV
Date Published : 03/07/2023
Avenida Moctezuma 2300 , Col. Colli C.T.M., Zapopan , Zapopan, Jalisco MEXICO
07 B - - 02 Corn Chips, Fried
Date Published: 03/07/2023

Desc: Crujitos
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(k) of the Act because the products appear to contain chemical preservatives but do not bear labeling stating that fact. Section 403(q) of the Act because the products fail to declare nutrition information in accordance with 21 CFR 101.9.

07 B - - 03 Cheese Puffs, Fired
Date Published: 03/07/2023

Desc: Crujitos
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(k) of the Act because the products appear to contain chemical preservatives but do not bear labeling stating that fact. Section 403(q) of the Act because the products fail to declare nutrition information in accordance with 21 CFR 101.9.

COMERCIALIZADORA PEPSICO S DE RLDE CV
Date Published : 03/07/2023
Boulevard Las Torres 835 , Col. Parque Industrial, Cajeme , Ciudad Obregon, Sonora MEXICO
07 B - - 02 Corn Chips, Fried
Date Published: 03/07/2023

Desc: Cheetos Balls (Bolitas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(k) of the Act because the products appear to contain chemical preservatives but do not bear labeling stating that fact. Section 403(q) of the Act because the products fail to declare nutrition information in accordance with 21 CFR 101.9.

07 B - - 03 Cheese Puffs, Fired
Date Published: 03/07/2023

Desc: Cheetos Balls (Bolitas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(k) of the Act because the products appear to contain chemical preservatives but do not bear labeling stating that fact. Section 403(q) of the Act because the products fail to declare nutrition information in accordance with 21 CFR 101.9.

CONSERVAS DEL NORTE
Date Published : 08/07/2017
Carr. Estatal Los Mochis -San Blas Km 14 , El Fuerte , Mochicahui, Sinaloa MEXICO
25 E - - 02 Carrots and Peas (Sweet) (Mixed Vegetables)
Date Published: 08/07/2017

Desc: Peas and Carrots
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular.

Cafe del Pacifico
Date Published : 08/10/2017
Blvd. Enrique Mazon Lopez 626 Interior A , Col. Cuartel Xx Cafe Combate, Hermosillo , Hermosillo, Sonora MEXICO
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/18/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/21/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino and 'Original Formula Cappuccino' is not an appropriate descriptive statement of identity for a cappuccino mix that contains ganoderma and omega-3; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/10/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act: 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the serving size is not in a common household measurement and the nutrition label does not include saturated and trans fat, cholesterol, all required vitamins and minerals, etc.

31 A - - 02 Coffee, Ground
Date Published: 08/10/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act: 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the serving size is not in a common household measurement and the nutrition label does not include saturated and trans fat, cholesterol, all required vitamins and minerals, etc.

31 A - - 02 Coffee, Ground
Date Published: 08/18/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

31 A - - 02 Coffee, Ground
Date Published: 08/21/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino and 'Original Formula Cappuccino' is not an appropriate descriptive statement of identity for a cappuccino mix that contains ganoderma and omega-3; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

31 A - - 03 Coffee, Instant
Date Published: 08/18/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

31 A - - 03 Coffee, Instant
Date Published: 08/21/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino and 'Original Formula Cappuccino' is not an appropriate descriptive statement of identity for a cappuccino mix that contains ganoderma and omega-3; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

31 A - - 03 Coffee, Instant
Date Published: 08/10/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act: 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the serving size is not in a common household measurement and the nutrition label does not include saturated and trans fat, cholesterol, all required vitamins and minerals, etc.

31 A - - 99 Coffee, N.E.C.
Date Published: 08/21/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino and 'Original Formula Cappuccino' is not an appropriate descriptive statement of identity for a cappuccino mix that contains ganoderma and omega-3; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

31 A - - 99 Coffee, N.E.C.
Date Published: 08/10/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act: 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the serving size is not in a common household measurement and the nutrition label does not include saturated and trans fat, cholesterol, all required vitamins and minerals, etc.

31 A - - 99 Coffee, N.E.C.
Date Published: 08/18/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(e)(2) because the net weight is not represented in terms of avoirdupois pound and ounce and the net quantity of contents should be declared as 'net weight'; 403(i)(1) because the article appears to be cappuccino mix rather than cappuccino; 403(q) because the nutrition information is not in a correct format as required by 21CFR101.9; 403(r)(1)(A) because the nutrient content claims are not in accordance with 21CFR101.54; 403(r)(1)(B) because it bears unauthorized health claims.

Canas y piloncillos de Nayarit SPR de RL
Date Published : 10/02/2015
Cam. Uzeta-Amatlan de Canas KM 1.5 , Ejido Uzeta , Ahuacatlan, Nayarit MEXICO
36 A - - 02 Brown Sugar (Sucrose from Cane)
Date Published: 10/02/2015

Desc: Brown Sugar
Notes: The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07

36 A - - 03 Cane Sugar (Sucrose)
Date Published: 10/02/2015

Desc: Brown Sugar
Notes: The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07

36 A - - 99 Sugar Products, N.E.C.
Date Published: 10/02/2015

Desc: Brown Sugar
Notes: The product is misbranded in that the label or labeling fails to bear the required nutrition information as required by 403(q) of the FD&C Act and 21 101.9. 3/7/07

Chocolate Mayordomo de Oaxaca
Date Published : 05/03/2018
Prol Priv Chapultepec Av No 125 , Col. San Juan Chapultepec , Oaxaca, OAX MEXICO
37 K - - 18 Mole Paste
Date Published: 05/03/2018

Desc: Mole Paste Red (Mole Rojo)
Notes: Section 403(f) of the Act because the product label contains information in two languages, but does not repeat all the required information in both languages. The word "Rojo" within the product's statement of identity of "Mole Rojo" is not declared as the English translation of "Red" and the name of the food does not also appear in English as required by 21 CFR 101.15(c). Section 403(i)(2) of Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically, FDA analysis of the Mole Paste Red (Rojo) product determined the presences of sorbate, a preservative, but sorbate is not declared on the product's label. The actual sorbate ingredient would need to be declared on the label. Section (403q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. For example: o The serving size is not based on the appropriate RACC; therefore, all of the declared nutrient values are incorrect. The appropriate RACC category and reference amount for this product is "Sauces…, minor main entrée sauce, ¼ cup (___g)(60 mL)". The label declares a serving size of 100 grams; o Serving Size is not declared in household units; o Declarations for calories, sodium, and the vitamins and minerals are not in the proper increments; o Trans fat is not in the list of nutrients nor in a "not a significant source of _____" statement. Section 403(w) of the Act because the ingredient statement appears to contain at least one ingredient that is itself a multi-ingredient food, for example, "cookies," and the "cookies" sub-ingredients are not declared. If any of the sub-ingredients are major allergens, such as wheat, these ingredients should be declared.

Chuy's Crunchie Charal
Date Published : 10/02/2015
Creston De Mazatlan #209 , Hoga Del Pescador , Mazatlan, Mx-Sin MEXICO
16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 10/02/2015

Notes: Product is misbranded within the meaning of Section 403 in that the amount of sodium exceeds the declared amount [239%]; Product is further misbranded within the meaning of Section 403 in that the labeling [Nutrition Facts panel] does not comply with format requirements of 21 CFR 101.9 (d) [Required hairlines are missing; ?Calories from fat? is missing; Vitamin A; Vitamin C; iron and calcium are not declared; the format is improperly split; saturated and trans fat are not declared in proper increments; the nutrients required to be highlighted are not bolded; the nutrients are not indented as required; the required bars are missing]; Product is further misbranded in that the vegetable oil ingredient is not declared in accordance with 21 CFR 101.4(b)(14). NOTE; this product is also indicated for detention because its labeling fails to declare the presence of the major food allergen 9/24/08

Cobos Gonzalez Asociados, Sa De
Date Published : 10/02/2015
Cebolla 74 Central de Abastos , Reynosa, FN MEXICO
34 B - - 05 Chocolate Liquor, Bitter Chocolate, Bitter Chocolate Coatings, Etc. (except Choc. Candy and Choc. Be
Date Published: 10/02/2015

Desc: Cocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674

34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674

34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 MANUFACTURER; Fabrica de Chocolates La Popular; FEI #3000172674

Comercial Exportadora JASO S.A. de C.V.
Date Published : 02/28/2018
Calle Juan De Ugarte 17406 , Col. Garita De Otay, Tijuana , Tijuana, Baja California MEXICO
29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 02/28/2018

Desc: Grapefruit Soft Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] because the product label fails to present nutrition information (e.g. Nutrition Facts label) 403(f) of the Act [21 U.S.C. §343(f)] because the product label does not prominently and conspicuously place the mandatory labeling statements in the foreign language, as required by 21 CFR 101.15(a) and 101.2(c). Furthermore, the product label contains information in two languages but fails to list all mandatory information, such as the qualifying statement for the name and place of business, in English 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement.;                                                                                                                                                                                              

Comercializadora BA-CAL S.A. de C.V.
Date Published : 10/02/2015
Calle Sebastian Vizcaino No. 412 Fracc. , Garita De Otay , Tijuana, MX-BCN MEXICO
29 C - - 99 Nonalcoholic Beverages, n.e.c.
Date Published: 10/02/2015

Desc: Refrreshing Natural Beverage with Maguey Extract
Notes: Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07

30 A - - 06 Beverage Base, Subtropical or Tropical Fruit
Date Published: 10/02/2015

Desc: Refrreshing Natural Beverage with Maguey Extract
Notes: Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07

30 N - - 99 Combination True and Imitation Fruit Flavored Beverage Bases, N.E.C.
Date Published: 10/02/2015

Desc: Refrreshing Natural Beverage with Maguey Extract
Notes: Product is misbranded under 403(a)(1)in that the declared value for carbohydrates is false & misleading; Product is further misbranded under 403(q) in that the nutrition label does not comply with format requirements in 21 CFR 101.9; The statement of identity in English does not describe the food appropriately (21 CFR 101.3(b) 4/20/07

Comercializadora Cadena
Date Published : 10/02/2015
Venustiano Carranza, Col. CUCHILLA , PANTITLAN , Mexico, Distrito Federal MEXICO
31 P - - 99 Tea Substitutes, N.E.C.
Date Published: 10/02/2015

Desc: La Carabela Apple Cinnamon Tea
Notes: VIOLATION (IN NOTES); 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act in that the label or labeling fails to bear the required nutrition information in accordance with the requirements under 21 CFR 101.9.

Comercializadora Gofer S.A. de C.V.
Date Published : 10/02/2015
Calle Acatl No. 359 , Barrio Santa Lucia, Azcapotzalco , Ciudad De Mexico, Ciudad de Mexico MEXICO
03 H - - 07 Mixed Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Rancheras Cookies
Notes: VIOLATION: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) in that the label or labeling fails to bear the required nutrition information (e.g., Nutrition Facts panel); In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that Trans Fat is not declared as required [101.9(c)(2)(ii)],the increments for Calories, Calories from fat, Sodium, Vitamin C, and Iron are expressed incorrectly 101.9(c); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(a) of the Act in that the label is false and misleading because laboratory analysis demonstrates that the amount of Calcium found in the product is 1.60 and 1.56 of the amount declared on the product label respectively;The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(f) of the Act because the product label contains information in two languages, but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c) (2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the foreign language.

Compania Cabadas, S.A. de C.V.
Date Published : 10/30/2019
Calle Rafael Zendejas S/N , Col. Ejido Potrerillos, La Piedad , La Piedad De Cabadas, Michoacan de Ocampo MEXICO
03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 10/30/2019

Desc: Filled Wafer Cookies (Cajeta en Obleas)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §343(f)]. The product labels are in a foreign language and do not bear English. As required by 21 CFR 101.15(c)(1), all words, statements, and other information required to be on the label shall be in English, including the common or usual name of the food (21 CFR 101.3), the net quantity of contents (21 CFR 101.7), ingredient list (21 CFR 101.4), nutrition information (21 CFR 101.9), and name and address of the responsible party (21 CFR 101.5). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to comply with the requirements in 21 CFR 101.7. In accordance with 21 CFR 101.7(b)(1), statements of weight shall be in terms of avoirdupois pound and ounce. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9. For example: The small cookie size product labels (100g package, line 21/2) fail to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure as required by 21 CFR 101.9(b)(7) & 101.9(d)(3)(i). The labels declare a serving size of 10g. The nutrition information format of both labels does not comply with 21 CFR 101.9 in general. For example, the labels fail to include a column for % Daily Value, the identifying header should be "Nutrition Facts" and set in a single line the full width of the box, and the nutrients are not listed in the correct order.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/30/2019

Desc: Filled Wafer Cookies (Cajeta en Obleas)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §343(f)]. The product labels are in a foreign language and do not bear English. As required by 21 CFR 101.15(c)(1), all words, statements, and other information required to be on the label shall be in English, including the common or usual name of the food (21 CFR 101.3), the net quantity of contents (21 CFR 101.7), ingredient list (21 CFR 101.4), nutrition information (21 CFR 101.9), and name and address of the responsible party (21 CFR 101.5). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to comply with the requirements in 21 CFR 101.7. In accordance with 21 CFR 101.7(b)(1), statements of weight shall be in terms of avoirdupois pound and ounce. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9. For example: The small cookie size product labels (100g package, line 21/2) fail to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure as required by 21 CFR 101.9(b)(7) & 101.9(d)(3)(i). The labels declare a serving size of 10g. The nutrition information format of both labels does not comply with 21 CFR 101.9 in general. For example, the labels fail to include a column for % Daily Value, the identifying header should be "Nutrition Facts" and set in a single line the full width of the box, and the nutrients are not listed in the correct order.

Confecciones de Juarez, S.A. de C.V
Date Published : 02/20/2018
Avenida Ishikawa 9040 , Parque Industrial Parque Industrial North Gate, Juarez , Juarez, Chihuahua MEXICO
54 A - - 14 Vit D
Date Published: 02/20/2018

Desc: Vitamin D3 Gummy Bears
Notes: Section 403(a)(1) of the Act in that the label is false and misleading in any particular. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the product label of each fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4. Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that each sample package label fails to contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/20/2018

Desc: Multi-Vitamin Children's Gummy Bears
Notes: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the product label of each fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4. Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that each sample package label fails to contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/20/2018

Desc: Vitamin D3 Gummy Bears
Notes: Section 403(a)(1) of the Act in that the label is false and misleading in any particular. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the product label of each fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4. Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that each sample package label fails to contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

Corporativo Serysi, S. De R.L. De C.V.
Date Published : 12/17/2018
Avenida Paseo Royal Country No. 4596 , Col. Puerta De Hierro, Zapopan , Zapopan, Jalisco MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 12/17/2018

Desc: Soya Cappuccino Flavor Soya Milk
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium, Vitamin C, and Manganese content per serving are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. FDA scientists concluded: • the amount of Vitamin C is at 0.9% of the label declaration in the Soy Milk Powder Product. • the amount of Calcium is at 29.8% and Iron is at 13.3% of the label declaration in the Soy Milk Powder Cappuccino Product. • the amount of Manganese is at 12.9% of the label declaration in the Reishi Mushroom Powder Product. The Soya Cappuccino Flavor Soy Milk Powder and Soya Natural Soy Milk Powder products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because trans fat is not declared as required by 21 CFR 101.9(c)(2)(ii).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 06/18/2020

Desc: Honey and Herbs Syrup
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Acesulfame-K, aspartame, sucralose, rebaudioside A, stevioside and neotame are not declared on the product label. Section 403(f) of the FD&C Act because the product label contains information in two languages (English and Spanish), but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 12/17/2018

Desc: Soya Natural Soy Milk Powder
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium, Vitamin C, and Manganese content per serving are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. FDA scientists concluded: • the amount of Vitamin C is at 0.9% of the label declaration in the Soy Milk Powder Product. • the amount of Calcium is at 29.8% and Iron is at 13.3% of the label declaration in the Soy Milk Powder Cappuccino Product. • the amount of Manganese is at 12.9% of the label declaration in the Reishi Mushroom Powder Product. The Soya Cappuccino Flavor Soy Milk Powder and Soya Natural Soy Milk Powder products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because trans fat is not declared as required by 21 CFR 101.9(c)(2)(ii).

45 V - - 99 Nutritive Sweetners (Food Additives for Human Use)
Date Published: 06/18/2020

Desc: Honey and Herbs Syrup
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Acesulfame-K, aspartame, sucralose, rebaudioside A, stevioside and neotame are not declared on the product label. Section 403(f) of the FD&C Act because the product label contains information in two languages (English and Spanish), but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/17/2018

Desc: Powder and Reishi Mushroom Powder
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium, Vitamin C, and Manganese content per serving are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. FDA scientists concluded: • the amount of Vitamin C is at 0.9% of the label declaration in the Soy Milk Powder Product. • the amount of Calcium is at 29.8% and Iron is at 13.3% of the label declaration in the Soy Milk Powder Cappuccino Product. • the amount of Manganese is at 12.9% of the label declaration in the Reishi Mushroom Powder Product. The Soya Cappuccino Flavor Soy Milk Powder and Soya Natural Soy Milk Powder products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because trans fat is not declared as required by 21 CFR 101.9(c)(2)(ii).

Coyoacan Quimica, S.A. De C.V.
Date Published : 10/02/2015
Carret. Central Km. 419.1 Zona , San Luis Potosi, MEXICO
54 B - - 08 Magnesium (Mineral)
Date Published: 10/02/2015

Desc: Magnesium Carbonate
Notes: Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Magnesium Carbonate
Notes: Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)

60 S - - 13 Magnesium Carbonate (Antacid)
Date Published: 10/02/2015

Desc: Magnesium Carbonate
Notes: Notes; VIOLATION; Product label fails to bear the required nutrition information (e.g. Supplemental Facts panel)

DC FOODS MEXICO SA DE CV
Date Published : 10/11/2017
Avenida Insurgentes Sur 1605 Piso 12 , Col. San Jose Insurgentes, Benito Juarez , Ciudad De Mexico, Ciudad de Mexico MEXICO
20 A - - 04 Cranberries (Berry)
Date Published: 10/11/2017

Desc: Arandano Enchilado
Notes: Section 403(f) of the Act [21 U.S.C. §343(f)] because the labels contain information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information does not provide the required information as defined in 21 CFR 101.9.

20 Q - - 01 Apple, Dried or Paste
Date Published: 10/11/2017

Desc: Manzana Enchilada
Notes: Section 403(f) of the Act [21 U.S.C. §343(f)] because the labels contain information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information does not provide the required information as defined in 21 CFR 101.9. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4(a)(1).

22 H - - 99 Other Fruit and Fruit Products, Dried and Paste, N.E.C.
Date Published: 10/11/2017

Desc: Arandano Enchilado
Notes: Section 403(f) of the Act [21 U.S.C. §343(f)] because the labels contain information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information does not provide the required information as defined in 21 CFR 101.9.

33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/11/2017

Desc: Goma Enchilada
Notes: Section 403(f) of the Act [21 U.S.C. §343(f)] because the labels contain information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information does not provide the required information as defined in 21 CFR 101.9. Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/ § 321(n)] in that the label is false or misleading in that it fails to reveal the material fact that the identified flavor (i.e. chili) is artificially derived.

DEL RIO BRAND INTERNATIONAL TRADING SA DE CV
Date Published : 04/24/2020
Calle Paseo De Los Conejos # 3200-A , Col. Los Conejos, Tonala , Tonala, Jalisco MEXICO
33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 04/24/2020

Desc: Chamoy Flavored Candy (Burrito de Chamoy)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act [21 U.S.C. 343(i)(2)]. The food contains the preservative potassium sorbate, but it is not declared on the product label. Section 403(k) of the Act [21 U.S.C. 343(k)]. The ingredient statement lists sodium benzoate but fails to indicate that the ingredient is a preservative in accordance with 21 CFR 101.22(j). In addition, the function of potassium sorbate must be declared as well. Section 403(f) of the FD&C Act [21 U.S.C. 343(f)]. The label bears some statements in Spanish but the ingredient statement, Nutrition Facts, and the statements "Manufactured by" and "Distributed in the USA by" are in English only. It is also unclear if "Burrito de Chamoy" is the common or usual name of the product in Spanish. Section 403(q) of the FD&C Act [21 U.S.C. 343(q)]. The nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9. The serving size declared on the label is not based on the correct Reference Amount Customarily Consumed (RACC) for the product and is not declared in household measure. As a result, the number of servings per container and nutrient declarations are also incorrect.

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 04/24/2020

Desc: Chamoy Flavored Candy (Burrito de Chamoy)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act [21 U.S.C. 343(i)(2)]. The food contains the preservative potassium sorbate, but it is not declared on the product label. Section 403(k) of the Act [21 U.S.C. 343(k)]. The ingredient statement lists sodium benzoate but fails to indicate that the ingredient is a preservative in accordance with 21 CFR 101.22(j). In addition, the function of potassium sorbate must be declared as well. Section 403(f) of the FD&C Act [21 U.S.C. 343(f)]. The label bears some statements in Spanish but the ingredient statement, Nutrition Facts, and the statements "Manufactured by" and "Distributed in the USA by" are in English only. It is also unclear if "Burrito de Chamoy" is the common or usual name of the product in Spanish. Section 403(q) of the FD&C Act [21 U.S.C. 343(q)]. The nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9. The serving size declared on the label is not based on the correct Reference Amount Customarily Consumed (RACC) for the product and is not declared in household measure. As a result, the number of servings per container and nutrient declarations are also incorrect.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 04/24/2020

Desc: Chamoy Flavored Candy (Burrito de Chamoy)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act [21 U.S.C. 343(i)(2)]. The food contains the preservative potassium sorbate, but it is not declared on the product label. Section 403(k) of the Act [21 U.S.C. 343(k)]. The ingredient statement lists sodium benzoate but fails to indicate that the ingredient is a preservative in accordance with 21 CFR 101.22(j). In addition, the function of potassium sorbate must be declared as well. Section 403(f) of the FD&C Act [21 U.S.C. 343(f)]. The label bears some statements in Spanish but the ingredient statement, Nutrition Facts, and the statements "Manufactured by" and "Distributed in the USA by" are in English only. It is also unclear if "Burrito de Chamoy" is the common or usual name of the product in Spanish. Section 403(q) of the FD&C Act [21 U.S.C. 343(q)]. The nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9. The serving size declared on the label is not based on the correct Reference Amount Customarily Consumed (RACC) for the product and is not declared in household measure. As a result, the number of servings per container and nutrient declarations are also incorrect.

DISTRIBUCIONES KRIS, S.A. DE C.V.
Date Published : 08/23/2019
Calle 5 De Febrero # 2287-E , Col. Ex Ejido Coahuila, Mexicali , Mexicali, Baja California MEXICO
03 Y - - 09 Tortillas
Date Published: 08/23/2019

Desc: LA Grande Flour Tortillas Regular
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(k) of the Act [21 U.S.C. § 343(k)], because the product bears or contains a chemical preservative but does not bear labeling stating that fact, as required under 21 CFR 101.22(j). The ingredient statement fails to list Sodium Benzoate, as well as identifying Potassium Sorbate as a preservative; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4.

DULCERIA LA TAPATIA
Date Published : 10/02/2015
Priv 2a Benito Juarez 15228 , Rio Tijuana 3ra Etapa , Tijuana, BC MEXICO
33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 10/02/2015

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298

33 H - - 12 Mixed/Assorted Soft Candy with Coconut (without Chcocolate)
Date Published: 10/02/2015

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298

33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298

33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 10/02/2015

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 MANUFACTURER; El Azteca SA DE CV; FEI #3004203298

DULCES MEXICANOS MIGUEL ROBLES
Date Published : 10/02/2015
CENTRAL DE ABASTOS LOC. 19 , Iztapalapa, Edomex MEXICO
25 J - - 12 Sweet Potato (Root & Tuber Vegetable)
Date Published: 10/02/2015

Notes: Notes: VIOLATION; Ingredients used in this product are not listed in the ingredients statement. The only ingredient listed is "Yam Candy." Original analyst detected Sodium Benzoate in the sample at 0.11% by weigh by HPLC with UV detection. As per 21CFR184, the tolerance for Sodium Benzoate is 0.1%. Nutritional information incomplete and not in English.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Notes: Notes: VIOLATION; Ingredients used in this product are not listed in the ingredients statement. The only ingredient listed is "Yam Candy." Original analyst detected Sodium Benzoate in the sample at 0.11% by weigh by HPLC with UV detection. As per 21CFR184, the tolerance for Sodium Benzoate is 0.1%. Nutritional information incomplete and not in English.

DULCES REGIONALES VENSE SA DE CV
Date Published : 10/02/2015
Av. Del Mar 220, Bodega 1, Warehouse 1 , Industrial Park Viga , Guadalupe, Nuevo Leon MEXICO
33 A - - 99 Hard Candy with Nut or Nut Products, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Palanqueta Mixa (Granola nut Bars)
Notes: 1. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act because the product labels fail to include nutrition information in accordance with 21 CFR 101.9.2. The articles also are subject to refusal of admission pursuant to section 801(a)(3) the Act in that they appear to be misbranded within the meaning of section 403(f) of the Act because the product labels are not in the English language as required by 21 CFR 101.15(c).

33 A - - 99 Hard Candy with Nut or Nut Products, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Palanqueta de Cacahuate (Granola nut bars)
Notes: 1. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act because the product labels fail to include nutrition information in accordance with 21 CFR 101.9. 2. The articles also are subject to refusal of admission pursuant to section 801(a) (3) the Act in that they appear to be misbranded within the meaning of section 403 (f) of the Act because the product labels are not in the English language as required by 21 CFR 101.15(c).

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Palanqueta de Cacahuate (Granola nut bars)
Notes: 1. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act because the product labels fail to include nutrition information in accordance with 21 CFR 101.9. 2. The articles also are subject to refusal of admission pursuant to section 801(a) (3) the Act in that they appear to be misbranded within the meaning of section 403 (f) of the Act because the product labels are not in the English language as required by 21 CFR 101.15(c).

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Palanqueta Mixa (Granola nut Bars)
Notes: 1. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act because the product labels fail to include nutrition information in accordance with 21 CFR 101.9. 2. The articles also are subject to refusal of admission pursuant to section 801(a)(3) the Act in that they appear to be misbranded within the meaning of section 403(f) of the Act because the product labels are not in the English language as required by 21 CFR 101.15(c).

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Palanqueta de Cacahuate (Granola nut bars)
Notes: 1. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act because the product labels fail to include nutrition information in accordance with 21 CFR 101.9. 2. The articles also are subject to refusal of admission pursuant to section 801(a) (3) the Act in that they appear to be misbranded within the meaning of section 403 (f) of the Act because the product labels are not in the English language as required by 21 CFR 101.15(c).

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Palanqueta Mixa (Granola nut Bars)
Notes: 1. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q) of the Act because the product labels fail to include nutrition information in accordance with 21 CFR 101.9. 2. The articles also are subject to refusal of admission pursuant to section 801(a)(3) the Act in that they appear to be misbranded within the meaning of section 403(f) of the Act because the product labels are not in the English language as required by 21 CFR 101.15(c).

Dulces Mexicanos
Date Published : 10/02/2015
Revolucion No 14sta Cruz De Las Huertas , Tonala, Jalisco MEXICO
33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Coconut Candy Rolls
Notes: Total and Sat. Fat Labeled as 0% Product assayed 7.45 and 6.35gms respectively per Serving 4/4/00

Dulces Monarcates, S.A. De C.V.
Date Published : 10/02/2015
Unknown Street , Morelia, Michoacan, MEXICO
33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Ate De Mango Fruit Candy
Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act. In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c). Furthermore; the declaration of ingredients lists

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Ate De Membrillo Fruit Candy
Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Ate De Duranzo Fruit Paste Candy
Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act. In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c). Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4.

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Ate De Tejocote Fruit Candy
Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act. In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c). Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4.

33 U - - 99 Chewing Gum, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Ate De Mango Fruit Candy
Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Ate De Duranzo Fruit Paste Candy
Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ;

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Ate De Membrillo Fruit Candy
Notes: The products label fails to bear nutrition information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9 and the firm is not exempt under 403(q)(5) of the Act; In addition; the product label bears a foreign language but does not provide the ingredients and place of business in that foreign language as required by 21 CFR 101.l5(c); Furthermore; the declaration of ingredients lists "Natural Fruit Tejocote Paste." Since this appears to be a multi component ingredient; the sub- ingredients should be declared; as required by 21 CFR 101.4. ; ;

Dulces Naturales de Los Altos
Date Published : 03/13/2019
Calle General Negrete No. 10 , Col. CENTRO , San Juan de los Lagos, Jalisco MEXICO
33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 03/13/2019

Desc: Cajeta Milk caramel (14 kgs)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the label fails to declare each ingredient by its common or usual name [21 CFR 101.4]. Specifically, the products contain sodium benzoate but fail to list the common or usual name of the ingredient.

33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 03/13/2019

Desc: Dulce de leche (24 kgs)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the label fails to declare each ingredient by its common or usual name [21 CFR 101.4]. Specifically, the products contain sodium benzoate but fail to list the common or usual name of the ingredient. Further, the Dulce de Leche 24 kg product declares the ingredient "Nutrif E 01 as emulsifier" which is not a recognized common or usual name. - Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two or more languages but does not repeat all the required information in both languages.

Dulces Yely, S.A. de C.V.
Date Published : 10/02/2015
Av. de los Astros 550-7 , Monterrey, MX-NLE MEXICO
28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 10/02/2015

Desc: Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes: Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08

28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 10/02/2015

Desc: Salt-Lemon Seasoning (Checo Lim)
Notes: Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07

33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes: Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08

33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Salt-Lemon Seasoning (Checo Lim)
Notes: Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Salt-Lemon Seasoning (Checo Lim)
Notes: Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes: Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08

33 S - - 06 Lollipop (without Chocolate)
Date Published: 10/02/2015

Desc: Salt-Lemon Seasoning (Checo Lim)
Notes: Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07

33 S - - 06 Lollipop (without Chocolate)
Date Published: 10/02/2015

Desc: Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes: Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Mango and Chili Flavored Seasoning (Checo Lim Mango)
Notes: Product is misbranded under Section 403(a) in that the sodium content is greater than 20% of the value declared on the label [21 CFR 101.9(g)(5); Product is further misbranded under Section 403(q) for failure to declare trans fat [21 CFR 101.9(c)(2)(ii)]; Product is further misbranded under Section 403(q) in that the nutritional labeling does not comply with the requirements of 21 CFR 101.9 (d) [lacks proper hairlines; calories/amount per serving/daily values are not properly bolded; inadequate width of nutrition facts; Percent Daily Values declared for fats and sugars in the Facts panel) 12/16/08

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Salt-Lemon Seasoning (Checo Lim)
Notes: Product is misbranded under Section 403(a)(1)in that the sodium content is greater than 20% of the value declared on the label {21 CFR 101.9(g)(5)}; Product is further misbranded in that product fails to declare trans fat on outer and individual packages {21 CFR 101.9(c)(2)(ii)}; Product is further misbranded in that product label does not include the metric equivalent{21 CFR 101.9(b)(7)}; Product is further misbranded in that the format for the Spanish and English nutrition labels do not comply with the requirements in 21 CFR 101.9(d) 6/6/07

EL AZTECA DULCES Y GOLOSINAS DE MEXICO SA DE CV
Date Published : 07/13/2016
Calzada Independencia Norte 4447 , Col. HUENTITAN EL BAJO , Guadalajara, Jalisco MEXICO
33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 07/13/2016

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER; Dulceria La Tapatio Mayoreo; FEI #3003369184 10/02/2015 ;

33 H - - 12 Mixed/Assorted Soft Candy with Coconut (without Chcocolate)
Date Published: 07/13/2016

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER; Dulceria La Tapatio Mayoreo; FEI #3003369184 10/02/2015 ;

33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 07/13/2016

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER; Dulceria La Tapatio Mayoreo; FEI #3003369184 10/02/2015 ;

33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 07/13/2016

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER; Dulceria La Tapatio Mayoreo; FEI #3003369184 10/02/2015 ;

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 07/13/2016

Desc: Coconut Candy Rolls
Notes: The product is misbranded in that the individual retail units fail to bear a nutrition label as required by 403(q) of the FD&C Act and 21 CFR 101.9 and fails to bear a net quantity of contents statement as required by Section 403(e)(2)of the FD&C Act and 21 CFR 101.105. 8/16/05 SHIPPER; Dulceria La Tapatio Mayoreo; FEI #3003369184 10/02/2015

ENAT INTERNATIONAL S.A. de C.V.
Date Published : 10/02/2015
Carretera Federal Tramo Salamanca-Irapuato Km 320 Interior B , Salamanca, Guanajuato MEXICO
21 M - - 05 Subtropical Fruit Flavored Imitation Fruit
Date Published: 10/02/2015

Desc: Prickly Pear Puree Health Drink
Notes: Mexico

El Azteca De Mexico
Date Published : 10/02/2015
Y Colima 1-A , Blvd. Manuel Cavazos Lerma; Aldama , Aldama, Tamaulipas MEXICO
33 G - - 99 Soft Candy with Nuts or Nut Products, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Glorias Pecan Milk Candy
Notes: VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the nutrition facts panel does not meet the requirements in 21 CFR 101.9. Specifically, the Nutrition Facts Panel on the multi-unit container does not contain a listing of the percent of the Daily Recommended Value (DRV) given in a column aligned under the heading "% DV*", and the serving size is not given in common household units, the protein content is not expressed in grams. Additionally, the product is further misbranded within the meaning of Section 403(e) because the declaration of net quantity of contents on the multi-unit container does not state the quantity of each individual unit as required by 21 CFR l01.105(s).

El Azteca De Mexico
Date Published : 10/02/2015
Las Flores No. 113 , Col. Victor Hugo , Zapopan, Jalisco MEXICO
28 K - - -- Gnd/Crk Mix Spice/Season W/Salt
Date Published: 10/02/2015

Desc: Lemon Flavored Salt Powder (Limoncito)
Notes: Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08

33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Lemon Flavored Salt Powder (Limoncito)
Notes: Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08

33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Lemon Flavored Salt Powder (Limoncito)
Notes: Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Lemon Flavored Salt Powder (Limoncito)
Notes: Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Lemon Flavored Salt Powder (Limoncito)
Notes: Product is misbranded within the meaning of Section 403(q) in that labeling does not comply with nutrition labeling format requirements [incorrect hairlines; bolding; indenting]; 21 CFR 101.9; Product is further misbranded under Section 403(q)in that the nutrition facts panel in Spanish does not comply with nutrition labeling requirements; 21 CFR 101.9; Product is further misbranded under Section 403(a) in that the sodium content is greater than 20% in excess of the declared value; 21 CFR 101.9(g)(5); Product is further misbranded under Section 403(a) in that the net quantity of contents does not comply with the requirements of 21 CFR 101.105(s); if the product is sold as a multi-unit package. 10/17/08

Electropura S De R.L. De D.V.
Date Published : 02/28/2018
Carretera Federal Mexico Texcoco , La Paz, Mexico MEXICO
29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated
Date Published: 02/28/2018

Desc: Grapefruit Soft Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] because the product label fails to present nutrition information (e.g. Nutrition Facts label) 403(f) of the Act [21 U.S.C. §343(f)] because the product label does not prominently and conspicuously place the mandatory labeling statements in the foreign language, as required by 21 CFR 101.15(a) and 101.2(c). Furthermore, the product label contains information in two languages but fails to list all mandatory information, such as the qualifying statement for the name and place of business, in English 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement.

Especias Aviles S A De C Vjesus Garcia No 105 Entre
Date Published : 04/28/2017
Ninos Heroes Y Manuel Ojedavilla De , Hermosillo , Mexico, MEXICO
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 04/28/2017

Desc: Mexican Style Cocoa
Notes: The article appears to be misbranded within the meaning of Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format as required by 21 CFR 101.9. For example: • The label fails to declare dietary fiber, as required by 21 CFR 101.9(c)(6). • The label fails to declare iron, as required by 21 CFR 101.9(c)(8). • The label fails to declare the serving size in common household measures, as required by 21 CFR 101.9(b)(5). • The serving size declared on the label does not appear to be based on the appropriate Reference Amount Customarily Consumed (RACC), as required by 21 CFR 101.9(b). Since the nutrition information is based on the serving size which is not the correct RACC, all nutrition information is incorrect. • The nutrition information bears errors in layout and formatting, such as bolding, indentation, and hairlines, and fails to include the necessary footnote, as required by 21 CFR 101.9(d). The article appears to misbranded within the meaning of Section 403(a)(1) of the Act in that the label is false or misleading. Specifically, the protein content of the product is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)]. The article appears to be misbranded within the meaning of Section 403(f) of the Act because the label contains information in two languages, but does not repeat all the required information in both languages, as required by 21 CFR 101.15(c)(1).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 04/28/2017

Desc: Mexican Style Cocoa
Notes: The article appears to be misbranded within the meaning of Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format as required by 21 CFR 101.9. For example: • The label fails to declare dietary fiber, as required by 21 CFR 101.9(c)(6). • The label fails to declare iron, as required by 21 CFR 101.9(c)(8). • The label fails to declare the serving size in common household measures, as required by 21 CFR 101.9(b)(5). • The serving size declared on the label does not appear to be based on the appropriate Reference Amount Customarily Consumed (RACC), as required by 21 CFR 101.9(b). Since the nutrition information is based on the serving size which is not the correct RACC, all nutrition information is incorrect. • The nutrition information bears errors in layout and formatting, such as bolding, indentation, and hairlines, and fails to include the necessary footnote, as required by 21 CFR 101.9(d). The article appears to misbranded within the meaning of Section 403(a)(1) of the Act in that the label is false or misleading. Specifically, the protein content of the product is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)]. The article appears to be misbranded within the meaning of Section 403(f) of the Act because the label contains information in two languages, but does not repeat all the required information in both languages, as required by 21 CFR 101.15(c)(1).

FABRICA PEPSICO MEXICALI S DE RL DE CV PLANTA MEXICALI II
Date Published : 03/07/2023
Via De La Produccion # 58 , Parque Industrial PIMSA III , Mexicali, Baja California MEXICO
07 B - - 06 Potato Chips,Fried
Date Published: 03/07/2023

Desc: Adobadas Potato Chips
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(k) of the Act because the products appear to contain chemical preservatives but do not bear labeling stating that fact. Section 403(q) of the Act because the products fail to declare nutrition information in accordance with 21 CFR 101.9.

Fabrica De Chocolates La Popular
Date Published : 10/02/2015
Aramberri Ote. 112 Apdo 343 , Monterrey Nl, FN MEXICO
34 B - - 05 Chocolate Liquor, Bitter Chocolate, Bitter Chocolate Coatings, Etc. (except Choc. Candy and Choc. Be
Date Published: 10/02/2015

Desc: Chocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832

34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832 ;

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832 ;

34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Popular Para Mesa
Notes: The product appears to be misbranded within the meaning of Section 403(q) in that there are two different declarations for calories on the Nutrition Facts information. The English label declares 70 calories and the Spanish label declares 80 calories. And? The product appears to be misbranded within the meaning of Section of 404(i)(2) in that the label fails to accurately declare the common or usual name of each ingredient. Specifically; the English and Spanish ingredient statements each declare different ingredients. In English; the ingredients declared are ?Cane Sugar; Chocolate Liquor? but in Spanish the ingredients are declared as toasted ground cacao; sugar; and cinnamon. 10/11/07 SHIPPER; Cobos Gonzalez Asociados; FEI #3002697832

GRUPO AGROALIMENTARIO DON VILLA S.A. DE C.V.
Date Published : 04/28/2020
Calle 5 De Mayo Norte 3224 , Col. Miguel Hidalgo, Ahome , Los Mochis, Sinaloa MEXICO
02 G - - 01 Barley Flour
Date Published: 04/28/2020

Desc: BARLEY
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded as defined in Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because of the amount of protein present in the product is not at least equal to the value for that nutrient declared on the label (21 CFR 101.9(g)(4)(i)). The analysis found 7.8 g of protein per 100 g product in the original analysis and 7.9 g/100 g in the check analysis. However, the label declares 15 g of protein per 100 g serving. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded as defined in Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the label ingredient list does not list vitamins and minerals as required by 21 CFR 101.4(a). The product label bears the statements "Fortified with Vitamins" and "Enriched with Iron, Zinc, and Phosphorus" The ingredient list does not list these vitamins and minerals

GRUPO BOTANICO NAYEC SA DE CV
Date Published : 10/02/2015
Espana 423 , Col. San Juan Xalpa, Iztapalapa , Ciudad De Mexico, Ciudad de Mexico MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Syrup Eucalin Kid's Dietary Supplement
Notes: Note; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. ? 343(q)(5)(F)] in that the nutrition information does not comply with the requirements of 21 CFR 101.36(b)(2)(i) and 101.9.

54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 10/02/2015

Desc: Syrup Eucalin Kid's Dietary Supplement
Notes: Note; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. ? 343(q)(5)(F)] in that the nutrition information does not comply with the requirements of 21 CFR 101.36(b)(2)(i) and 101.9.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/02/2015

Desc: Syrup Eucalin Kid's Dietary Supplement
Notes: Note; The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. ? 343(q)(5)(F)] in that the nutrition information does not comply with the requirements of 21 CFR 101.36(b)(2)(i) and 101.9.

Gialive SA de CV
Date Published : 10/02/2015
Boulevard A Zacatecas Km # 8 , Col. Talamantes Ponce, Aguascalientes , Aguascalientes, Aguascalientes MEXICO
14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 10/02/2015

Desc: GIA Lactium F
Notes: Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the Calcium levels found were 46.6% and 48.2% of the label declaration.

23 C - - 07 Peanut, Butter
Date Published: 10/02/2015

Desc: GIA Lactium F
Notes: Product is misbranded within the meaning of Section 403(a) in that the labeling is false. Specifically; the Calcium levels found were 46.6% and 48.2% of the label declaration.

Gloria Lopez
Date Published : 10/02/2015
Rep. De Chile #112 Col. Las Cumbres , Matehuala, MEXICO
33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Obleas Con Cajeta De Leche de Cabra and Mini Obleas Con Cajeta
Notes: Product is misbranded within the meaning of Section 403(f) of the Act because the label fails to declare all words; statements; and other information required by the act to appear on the label in the English language as required by 21 CFR 101.l5(c)(l).

H&F TECH INTERNATIONAL S.A. DE C.V.
Date Published : 02/04/2020
Saltillo No. 200 , Av. Cazadores No 227 Parque Industrial Sierra Madre Carretera Monterrey , Sta. Catarina, Nuevo Leon MEXICO
21 D - - 03 Berries, Mixed, Juices or Concentrates
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Kiwi Strawberry Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading in that the product labels declare the ingredient "green juice concentrate" which is not juice. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 07 Subtropical/Tropical, Mixed, Juices or Concentrates
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Hibiscus (Flower of Jamaica) Passion Fruit Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 08 Vine Fruits, Mixed, Juices or Concentrates
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Hibiscus (Flower of Jamaica) Passion Fruit Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 09 Other Fruits, Mixed, Juices or Concentrates
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Kiwi Strawberry Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading in that the product labels declare the ingredient "green juice concentrate" which is not juice. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 09 Other Fruits, Mixed, Juices or Concentrates
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Hibiscus (Flower of Jamaica) Passion Fruit Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 26 Other Fruits and Subtropical/Tropical Fruit, Mixed, Juices or Concentrates
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Kiwi Strawberry Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading in that the product labels declare the ingredient "green juice concentrate" which is not juice. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 26 Other Fruits and Subtropical/Tropical Fruit, Mixed, Juices or Concentrates
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Hibiscus (Flower of Jamaica) Passion Fruit Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Hibiscus (Flower of Jamaica) Passion Fruit Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 02/04/2020

Desc: Kuii Power Drink Cactus Kiwi Strawberry Flavor
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare each ingredient by a common or usual name, as required by 21 CFR 101.4. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading in that the product labels declare the ingredient "green juice concentrate" which is not juice. The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1) of the Act [21 U.S.C. § 343(r)(1)] because the product labels bear unauthorized claims. Specifically, the product label states "Only 6 grams of sugar per serving;" however, this claim is not in accordance with the requirements for sugar content claims in 21 CFR 101.60(c) nor the general requirements for nutrient content claims in 21 CFR 101.13(i). The products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the characterizing flavors named in the statements of identity are not declared in accordance with the requirements in 21 CFR 101.22(i)(1)(i). Specifically, the characterizing flavors are from natural flavors, not actual fruit ingredients, and, therefore, the name of the characterizing flavor must be followed by the word "flavored."

Healthy People Labs S de RL de CV
Date Published : 08/14/2015
Avenida Alvaro Obregon 145 , Col. Irapuato Centro, Irapuato , Irapuato, Guanajuato MEXICO
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/07/2015

Desc: Nectar Ancestral
Notes: Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               Published on 08/17/2015

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/07/2015

Desc: Healthy Flex
Notes: Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               Published on 08/17/2015

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/07/2015

Desc: Belle Femme
Notes: Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               ; Published on 08/17/2015

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/07/2015

Desc: Rena Extreme
Notes: Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               Published on 08/17/2015

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 10/07/2015

Desc: Oxikids
Notes: Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               ; Published on 08/17/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2015

Desc: Rena Extreme
Notes: "Healthy Flex;" "Oxikids;" "Nectar Ancestral;" "Rena Extreme;" and "Belle Femme Bf" the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of sections 403(y) and 403(s)(2)(C) of the Act [21 U.S.C. 343(y) and 343(s)(2) (C)];Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               ; Published on 08/17/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2015

Desc: Healthy Flex
Notes: "Healthy Flex;" "Oxikids;" "Nectar Ancestral;" "Rena Extreme;" and "Belle Femme Bf" the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of sections 403(y) and 403(s)(2)(C) of the Act [21 U.S.C. ? 343(y) and 343(s) (2)(C)];Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               Published on 08/17/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2015

Desc: Belle Femme
Notes: "Healthy Flex;" "Oxikids;" "Nectar Ancestral;" "Rena Extreme;" and "Belle Femme Bf" the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of sections 403(y) and 403(s)(2)(C) of the Act [21 U.S.C. 343 (y) and 343(s)(2)(C)];Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               ; Published on 08/17/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2015

Desc: Nectar Ancestral
Notes: "Healthy Flex;" "Oxikids;" "Nectar Ancestral;" "Rena Extreme;" and "Belle Femme Bf" the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of sections 403(y) and 403 (s)(2) (C) of the Act [21 U.S.C. 343(y) and 343(s)(2)(C)];Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               Published on 08/17/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/14/2015

Desc: Oxikids
Notes: "Healthy Flex;" "Oxikids;" "Nectar Ancestral;" "Rena Extreme;" and "Belle Femme Bf" the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of sections 403(y) and 403(s)(2)(C) of the Act [21 U.S.C. 343(y) and 343(s)(2) (C)];Based on the review of the "Healthy Flex" "Oxikids"; "Nectar Ancestral"; "Rena Extreme"; and "Belle Femme Bf" products labeling; we have determined that these products are misbranded within the meaning of section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9.                                                               ; Published on 08/17/2015

Herbal Solution's Health S.A. de C.V.
Date Published : 08/21/2023
Calzada Insurgentes Poniente No. 322 , Barrio Barrio De Santa Anita, Irapuato , Irapuato, Guanajuato MEXICO
31 K - - 99 Tea, N.E.C.
Date Published: 08/21/2023

Desc: Insulin Plant
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because the product label fails to declare the common or usual name of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Chamaecostus cuspidatus is not a botanical listed in Herbs of Commerce and does not have a standardized common name; if a botanical is not listed in Herbs of Commerce, then only the Latin binomial name of the botanical is the common or usual name of the dietary ingredient. “Insulin Plant” is not a standardized common name.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/21/2023

Desc: Insulin Plant
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because the product label fails to declare the common or usual name of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Chamaecostus cuspidatus is not a botanical listed in Herbs of Commerce and does not have a standardized common name; if a botanical is not listed in Herbs of Commerce, then only the Latin binomial name of the botanical is the common or usual name of the dietary ingredient. “Insulin Plant” is not a standardized common name.

Herbolaris Internacional
Date Published : 10/02/2015
Calle Los Robles 122 , Col. Parques De Zapopan, Zapopan , Zapopan, Jalisco MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Nutty Light Cappuccino Flavor Shake
Notes: Problem(s): Charge: 403(q) • The dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as defined in 101.36(b)(2), for example, Vitamin B1, Vitamin B2, and Vitamin B3, must be listed according to the nomenclature specified in § 101.9(c)(8)(iv) and follow the listing order according to 21 CFR 101.36(b)(2)(i)(B). • The percent of Daily Value (% DV) for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as defined in 101.36(b)(2), for example, Vitamin A, riboflavin, Vitamin B6, and Calcium, must be calculated by dividing the quantitative amount by weight of each ingredient by the RDI as established in §101.9(c)(8)(iv) or the DRV as established in §101.9(c)(9) for the specified dietary ingredient and multiplying by 100, as required by 21 CFR 101.36(b)(2)(iii)(B).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Mi Desayuno Diario (My Daily Breakfast)
Notes: Problem(s): Charge: 403(q) • The dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as defined in 101.36(b)(2), for example, Vitamin B1, Vitamin B2, and Vitamin B3, must be listed according to the nomenclature specified in § 101.9(c)(8)(iv) and follow the listing order according to 21 CFR 101.36(b)(2)(i)(B). • The percent of Daily Value (% DV) for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as defined in 101.36(b)(2), for example, Vitamin A, riboflavin, Vitamin B6, and Calcium, must be calculated by dividing the quantitative amount by weight of each ingredient by the RDI as established in §101.9(c)(8)(iv) or the DRV as established in §101.9(c)(9) for the specified dietary ingredient and multiplying by 100, as required by 21 CFR 101.36(b)(2)(iii)(B).

Importadora y Comercializadora de Uncaria Tormentosa SA DE C
Date Published : 10/02/2015
Avenida De La Patria 1357 , Col. Mirador Del Sol, Zapopan , Zapopan, Jalisco MEXICO
34 B - - 06 Chocolate Syrup (except Chocolate Candy and Chocolate Beverage Base)
Date Published: 10/02/2015

Desc: Chocolate Fiber for Kids
Notes: Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07

34 B - - 99 Chocolate and Cocoa, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Fiber for Kids
Notes: Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Chocolate Fiber for Kids
Notes: Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Cocolate Fiber for Kids
Notes: Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07

34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Fiber for Kids
Notes: Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Fiber for Kids
Notes: Product appears to be misbranded with-in the meaning of Section 403(r)(1)(B) of the Act (21 USC 343(r)(1)(B) in that the label or labeling is unqualified to bear fiber-related health claims specified under 21 CFR 101.76 and 101.77. Del SolThe label declares the following claims; ?Fiber...help move food through the digestive ystem...protecting...against...cancers and constipation.? and ?Fiber May also lower...cholesterol and ...beneficial...diabetes...heart disease.? Neither statement meets the requirements of their referenced health claims because This product is neither a grain product; fruit; nor vegetable. 5/17/07

JC SNACKS Mexico DE RL
Date Published : 04/06/2017
Calle Maquiladoras # 1416 Int C , Parque Industrial Ciudad Industrial, Tijuana , Tijuana, Baja California MEXICO
21 S - - 05 Mango (Subtropical and Tropical Fruit)
Date Published: 04/06/2017

Desc: Dried Mango with Chile
Notes: The product appears to be misbranded within the meaning of the following sections of the Federal Food, Drug, and Cosmetic Act: (1) Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) does not meet the requirements under 21 CFR 101.9; (2) Section 403(e)(2) in that individual containers fail to declare a net quantity of contents statement as required by 21 CFR 101.7; (3) Section 403(i)(1) in that the individual containers lack a statement of identity; (4) Section 403(i)(2) in that the product declares "chili mix" as an ingredient, which appears to be a multi-component ingredient, but the label fails to declare the sub-ingredients in accordance with 21 CFR 101.4; (5) section 403(k) in that the ingredient list declares the preservative sodium benzoate, but does not declare the function as required by 21 CFR 101.22(j).

Jugomex (Planta Xalostoc)
Date Published : 10/02/2015
Km. 12. 5 , Col. Rustica Xalostoc, Ecatepec De Morelos , Ecatepec De Morelos, Mexico MEXICO
21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 10/02/2015

Desc: Pau Pau Cherry Juice Drink
Notes: Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05

21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 10/02/2015

Desc: Jumex Blends Exotic Medley Juice Drink
Notes: Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07

21 K - - 03 Cherry, Juice, Pit Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: Pau Pau Cherry Juice Drink
Notes: Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05

22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 10/02/2015

Desc: Pau Pau Cherry Juice Drink
Notes: Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05

22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 10/02/2015

Desc: Jumex Blends Exotic Medley Juice Drink
Notes: Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07

40 E - - 40 Fruit Flavored Drink
Date Published: 10/02/2015

Desc: Pau Pau Cherry Juice Drink
Notes: Analysis determined that the product does not contain 10% of the RDI for Vitamin C as declared on the label. Therefore the product is misbranded under Section 403(r)(1) of the FFD&C Act because it bears the nutrient content claim ?enriched with Vitamins A; C; B1; B2;? however the label declaration for vitamins A (4%); B1(6%); and B2(6%) are less than 10% of the RDI for Vitamins A; B1; and B2. 12/20/05

40 E - - 40 Fruit Flavored Drink
Date Published: 10/02/2015

Desc: Jumex Blends Exotic Medley Juice Drink
Notes: Analysis determined that the product does not contain 10% of the RDI for Vitamin A & C as declared on the label. Therefore the product is misbranded under Section [403(r)(1)(A)] of the FFD&C Act. In addition the product appears to contain only a small percentage of the label-declared amount of iron [Misbranding;403(a)(1)] 6/26/07

Jugos y Bebidas del Valle de Mexico
Date Published : 07/17/2019
Mario Pani # 750 Piso 3 , Col. Santa Fe , Cuajimalpa, MEXICO
21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 07/17/2019

Desc: REFRES COCO Carbonated Coconut Water
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act; 403(i)(2) because the label fails to declare the common or usual name of each ingredient; as required under section 21 CFR 101.4(a) - For example; the product label fails to declare the ingredient "potassium sorbate" which was detected through FDA analysis; 403(f) because the label appears to contain information in two or more languages but does not repeat all the required label information in English and the respective foreign language - Specifically; the product label contains information in a foreign language ("Refres Coco") on the principal display panel but does not appear to represent all the required label information in both English and the foreign language.

29 C - - 99 Nonalcoholic Beverages, n.e.c.
Date Published: 07/17/2019

Desc: REFRES COCO Carbonated Coconut Water
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act; 403(i)(2) because the label fails to declare the common or usual name of each ingredient; as required under section 21 CFR 101.4(a) - For example; the product label fails to declare the ingredient "potassium sorbate" which was detected through FDA analysis; 403(f) because the label appears to contain information in two or more languages but does not repeat all the required label information in English and the respective foreign language - Specifically; the product label contains information in a foreign language ("Refres Coco") on the principal display panel but does not appear to represent all the required label information in both English and the foreign language.

29 S - - 06 Mineral Water with Fruit Flavor, Carbonated Water (Nonmedicinal)
Date Published: 07/17/2019

Desc: REFRES COCO Carbonated Coconut Water
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act; 403(i)(2) because the label fails to declare the common or usual name of each ingredient; as required under section 21 CFR 101.4(a) - For example; the product label fails to declare the ingredient "potassium sorbate" which was detected through FDA analysis; 403(f) because the label appears to contain information in two or more languages but does not repeat all the required label information in English and the respective foreign language - Specifically; the product label contains information in a foreign language ("Refres Coco") on the principal display panel but does not appear to represent all the required label information in both English and the foreign language.

Jugos y Bebidas del Valle de Mexico
Date Published : 07/17/2019
San Francisco No. 18 , Lerma , Lerma De Villada, Mexico MEXICO
21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 07/17/2019

Desc: REFRES COCO Carbonated Coconut Water
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act; 403(i)(2) because the label fails to declare the common or usual name of each ingredient; as required under section 21 CFR 101.4(a) - For example; the product label fails to declare the ingredient "potassium sorbate" which was detected through FDA analysis; 403(f) because the label appears to contain information in two or more languages but does not repeat all the required label information in English and the respective foreign language - Specifically; the product label contains information in a foreign language ("Refres Coco") on the principal display panel but does not appear to represent all the required label information in both English and the foreign language.

29 C - - 99 Nonalcoholic Beverages, n.e.c.
Date Published: 07/17/2019

Desc: REFRES COCO Carbonated Coconut Water
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act; 403(i)(2) because the label fails to declare the common or usual name of each ingredient; as required under section 21 CFR 101.4(a) - For example; the product label fails to declare the ingredient "potassium sorbate" which was detected through FDA analysis; 403(f) because the label appears to contain information in two or more languages but does not repeat all the required label information in English and the respective foreign language - Specifically; the product label contains information in a foreign language ("Refres Coco") on the principal display panel but does not appear to represent all the required label information in both English and the foreign language.

29 S - - 06 Mineral Water with Fruit Flavor, Carbonated Water (Nonmedicinal)
Date Published: 07/17/2019

Desc: REFRES COCO Carbonated Coconut Water
Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act; 403(i)(2) because the label fails to declare the common or usual name of each ingredient; as required under section 21 CFR 101.4(a) - For example; the product label fails to declare the ingredient "potassium sorbate" which was detected through FDA analysis; 403(f) because the label appears to contain information in two or more languages but does not repeat all the required label information in English and the respective foreign language - Specifically; the product label contains information in a foreign language ("Refres Coco") on the principal display panel but does not appear to represent all the required label information in both English and the foreign language.

LABORATORIOS PISA, S.A. DE C.V.
Date Published : 07/06/2022
Carretera San Isidro Mazatepec # 7000 , Santa Cruz de Las Flores , Tlajomulco de Zuniga, MEXICO
20 - - - -- Fruit/Fruit Products
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

21 M - - -- Imit Fruit
Date Published: 07/06/2022

Desc: Strawberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

21 M - - -- Imit Fruit
Date Published: 07/06/2022

Desc: Jamaica Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

21 M - - -- Imit Fruit
Date Published: 07/06/2022

Desc: Blueberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

21 - - - -- Fruit/Fruit Products
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

24 - - - -- Vegetables/Vegetable Products
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

28 - - - -- Spices, Flavors And Salts
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

29 R - - -- Noncarbonated Water (Nonmedicinal)
Date Published: 07/06/2022

Desc: Blueberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

29 R - - -- Noncarbonated Water (Nonmedicinal)
Date Published: 07/06/2022

Desc: Strawberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

29 R - - -- Noncarbonated Water (Nonmedicinal)
Date Published: 07/06/2022

Desc: Jamaica Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

29 - - - -- Soft Drinks/Water
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

30 K - - -- Imit Flav Beverage Base Liq
Date Published: 07/06/2022

Desc: Blueberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

30 K - - -- Imit Flav Beverage Base Liq
Date Published: 07/06/2022

Desc: Jamaica Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

30 K - - -- Imit Flav Beverage Base Liq
Date Published: 07/06/2022

Desc: Strawberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

41 G - - 03 Oral Rehydration Products
Date Published: 07/06/2022

Desc: Jamaica Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

41 G - - 03 Oral Rehydration Products
Date Published: 07/06/2022

Desc: Strawberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

41 G - - 03 Oral Rehydration Products
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

41 G - - 03 Oral Rehydration Products
Date Published: 07/06/2022

Desc: Blueberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 07/06/2022

Desc: Blueberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/14/2022

Desc: Electrolit (all flavors)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 07/06/2022

Desc: Strawberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 07/06/2022

Desc: Jamaica Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/06/2022

Desc: Jamaica Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/06/2022

Desc: Blueberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/06/2022

Desc: Strawberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2022

Desc: Jamaica Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2022

Desc: Strawberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/06/2022

Desc: Blueberry Rehydrating Beverage
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

La Italiana, S.A. de C.V.
Date Published : 02/02/2017
28 Poniente Street #1308 , Santa Anita , Puebla, Puebla MEXICO
04 A - - 02 Macaroni
Date Published: 02/02/2017

Desc: Melon Seed Enriched Pasta
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 10/14/2015

Laboratorio Mas Natural S. de R.L. de C.V.
Date Published : 06/17/2015
Camino a Serrano No. 846 , Col. ZONA CENTRO , Irapuato, Guanajuato MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/07/2015

Desc: Goji-Loe
Notes: Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/07/2015

Desc: Colageno Hidrolizado Shake Alteada
Notes: Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36 Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/17/2015

Desc: Oxicell
Notes: OxiCell product label is misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. OxiCell product is misbranded within the meaning of Section 403(k) of the Act [21 U.S.C. § 343(k)] in that the product bears or contains chemical preservatives, but fails to provide a separate description of the function of these ingredients as required. In accordance with 21 CFR 10 1.22(j), the label of a food to which a chemical preservative has been added shall bear a declaration of both the common or usual name of the ingredient and a separate description of its function, e.g., "preservative." The ingredient statement for your OxiCell product declares the presence of Sodium Benzoate and Sodium Propinate, but fails to provide a separate description of the function of these ingredients as required. Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/17/2015

Desc: Nectar Supreme
Notes: Nectar Supreme product is misbranded within the meaning of section 403(a) (l) of the Act [21 U.S.C. § 343(a)(l)] in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed the sample of your Nectar Supreme to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states that one serving (1 113 tablespoons) contains 400 IU of Vitamin D and 100 mg of Vitamin C. However, FDA analysis found the Vitamin D content was 86.8% (original analysis) and 80.3% (check analysis) of declared value. Analysis revealed the Vitamin C content was 32.5% (original analysis) and 34% mg (check analysis) of declared value. Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

Luis Alain Aviles A
Date Published : 04/28/2017
Residential , Calle San Gelacio # 38 , Hermosillo, Sonora MEXICO
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 04/28/2017

Desc: Mexican Style Cocoa
Notes: The article appears to be misbranded within the meaning of Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format as required by 21 CFR 101.9. For example: • The label fails to declare dietary fiber, as required by 21 CFR 101.9(c)(6). • The label fails to declare iron, as required by 21 CFR 101.9(c)(8). • The label fails to declare the serving size in common household measures, as required by 21 CFR 101.9(b)(5). • The serving size declared on the label does not appear to be based on the appropriate Reference Amount Customarily Consumed (RACC), as required by 21 CFR 101.9(b). Since the nutrition information is based on the serving size which is not the correct RACC, all nutrition information is incorrect. • The nutrition information bears errors in layout and formatting, such as bolding, indentation, and hairlines, and fails to include the necessary footnote, as required by 21 CFR 101.9(d). The article appears to misbranded within the meaning of Section 403(a)(1) of the Act in that the label is false or misleading. Specifically, the protein content of the product is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)]. The article appears to be misbranded within the meaning of Section 403(f) of the Act because the label contains information in two languages, but does not repeat all the required information in both languages, as required by 21 CFR 101.15(c)(1).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 04/28/2017

Desc: Mexican Style Cocoa
Notes: The article appears to be misbranded within the meaning of Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format as required by 21 CFR 101.9. For example: • The label fails to declare dietary fiber, as required by 21 CFR 101.9(c)(6). • The label fails to declare iron, as required by 21 CFR 101.9(c)(8). • The label fails to declare the serving size in common household measures, as required by 21 CFR 101.9(b)(5). • The serving size declared on the label does not appear to be based on the appropriate Reference Amount Customarily Consumed (RACC), as required by 21 CFR 101.9(b). Since the nutrition information is based on the serving size which is not the correct RACC, all nutrition information is incorrect. • The nutrition information bears errors in layout and formatting, such as bolding, indentation, and hairlines, and fails to include the necessary footnote, as required by 21 CFR 101.9(d). The article appears to misbranded within the meaning of Section 403(a)(1) of the Act in that the label is false or misleading. Specifically, the protein content of the product is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)]. The article appears to be misbranded within the meaning of Section 403(f) of the Act because the label contains information in two languages, but does not repeat all the required information in both languages, as required by 21 CFR 101.15(c)(1).

MARCO ANTONIO MORENO PRESIADO
Date Published : 07/09/2018
Juarez # 13 , Ures , Pueblo Guadalupe, Sonora MEXICO
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 07/09/2018

Desc: Milk Candy Canister w/ 48 PCS
Notes: The product is misbranded: -within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it has failed to declare each ingredient as required by 21 CFR 101.4. -within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because it has failed to declare nutrition information in accordance with 21 CFR 101.9. -within the meaning of section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the product name (Jamoncillos) does not appear to be an appropriate common or usual name of the food, as required by 21 CFR 101.3. -within the meaning of section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] because the individually wrapped units have failed to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Furthermore, the individual units do not bear the required statement to meet the exemption criteria in 21 CFR 1.24(a)(14). -within the meaning of section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because it has failed to declare the net quantity of contents in accordance with 21 CFR 101.7. Specifically, the individually wrapped units declare the net weight to be "1 Pza." but do not declare the net weight in terms of avoirdupois pound and ounce [21 CFR 101.7(b)(1)].

Manuel Gonzalez Blanco
Date Published : 10/02/2015
Ahuehuete No. 53 ( Juncos Y Sauces ) , Fraccionamiento Floresta , Veracruz, Veracruz MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes: Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/02/2015

Desc: Su-K rofitina syrup
Notes: The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Su-K rofitina syrup
Notes: The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes: Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 MANUFACTURER: Plantas Medicinales Anahuac SA de CV; FEI #1000599639

Marco Aurelio Gamino Franco
Date Published : 10/02/2015
Calle Milan No. 2595 , Fracc. PROVIDENCIA 2A. SECCION , Guadalajara, Jalisco MEXICO
33 H - - -- Soft Candy W/Coconut
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1-lb package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 H - - -- Soft Candy W/Coconut
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1.76 oz package)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table).

33 H - - -- Soft Candy W/Coconut
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy(7.05 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 H - - -- Soft Candy W/Coconut
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (5.29 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4)

33 L - - -- Soft Candy W/O Nut/Fruit
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (5.29 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4)

33 L - - -- Soft Candy W/O Nut/Fruit
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1-lb package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 L - - -- Soft Candy W/O Nut/Fruit
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1.76 oz package)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table).

33 L - - -- Soft Candy W/O Nut/Fruit
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy(7.05 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 S - - -- Candy Specialties
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy(7.05 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 S - - -- Candy Specialties
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1-lb package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 S - - -- Candy Specialties
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (5.29 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4)

33 S - - -- Candy Specialties
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1.76 oz package)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table).

33 Y - - -- Candy Wo/Choc N.E.C.
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1-lb package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 Y - - -- Candy Wo/Choc N.E.C.
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy(7.05 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5)

33 Y - - -- Candy Wo/Choc N.E.C.
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (5.29 oz package)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4)

33 Y - - -- Candy Wo/Choc N.E.C.
Date Published: 08/21/2018

Desc: Rollo De Coco Soft Candy (1.76 oz package)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table).

Mas Natural Salud Y Bienestar
Date Published : 06/17/2015
Calle Escuadron 201 24la Moderna , Col. Moderna, Irapuato , Irapuato, Guanajuato MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/17/2015

Desc: Oxicell
Notes: OxiCell product label is misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. OxiCell product is misbranded within the meaning of Section 403(k) of the Act [21 U.S.C. § 343(k)] in that the product bears or contains chemical preservatives, but fails to provide a separate description of the function of these ingredients as required. In accordance with 21 CFR 10 1.22(j), the label of a food to which a chemical preservative has been added shall bear a declaration of both the common or usual name of the ingredient and a separate description of its function, e.g., "preservative." The ingredient statement for your OxiCell product declares the presence of Sodium Benzoate and Sodium Propinate, but fails to provide a separate description of the function of these ingredients as required. Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/07/2015

Desc: Colageno Hidrolizado Shake Alteada
Notes: Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36 Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/07/2015

Desc: Goji-Loe
Notes: Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/17/2015

Desc: Nectar Supreme
Notes: Nectar Supreme product is misbranded within the meaning of section 403(a) (l) of the Act [21 U.S.C. § 343(a)(l)] in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed the sample of your Nectar Supreme to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states that one serving (1 113 tablespoons) contains 400 IU of Vitamin D and 100 mg of Vitamin C. However, FDA analysis found the Vitamin D content was 86.8% (original analysis) and 80.3% (check analysis) of declared value. Analysis revealed the Vitamin C content was 32.5% (original analysis) and 34% mg (check analysis) of declared value. Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

Mas Natural Salud y Bienestar, S. de R.L. de C.V.
Date Published : 06/17/2015
Calle Emilio Carranza No. 1055 , Col. RODRIGUEZ , Irapuato, Guanajuato MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/17/2015

Desc: Oxicell
Notes: OxiCell product label is misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. OxiCell product is misbranded within the meaning of Section 403(k) of the Act [21 U.S.C. § 343(k)] in that the product bears or contains chemical preservatives, but fails to provide a separate description of the function of these ingredients as required. In accordance with 21 CFR 10 1.22(j), the label of a food to which a chemical preservative has been added shall bear a declaration of both the common or usual name of the ingredient and a separate description of its function, e.g., "preservative." The ingredient statement for your OxiCell product declares the presence of Sodium Benzoate and Sodium Propinate, but fails to provide a separate description of the function of these ingredients as required. Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Desc:Oxicell Notes:Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/17/2015

Desc: Nectar Supreme
Notes: Nectar Supreme product is misbranded within the meaning of section 403(a) (l) of the Act [21 U.S.C. § 343(a)(l)] in that the labels are false or misleading because the amount of nutrient present is less than the amount declared on the label. Specifically, FDA analyzed the sample of your Nectar Supreme to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states that one serving (1 113 tablespoons) contains 400 IU of Vitamin D and 100 mg of Vitamin C. However, FDA analysis found the Vitamin D content was 86.8% (original analysis) and 80.3% (check analysis) of declared value. Analysis revealed the Vitamin C content was 32.5% (original analysis) and 34% mg (check analysis) of declared value. Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/07/2015

Desc: Colageno Hidrolizado Shake Alteada
Notes: Colageno Hidrolizado Shake, Goji-Loe, Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36 Published on 06/11/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/07/2015

Desc: Goji-Loe
Notes: Colageno Hidrolizado Shake; Goji-Loe; Nectar Supreme and OxiCell products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36 Published on 06/11/2015

Mead Johnson & Company
Date Published : 12/04/2018
E.P.F. Piso 11 , Lago Zurich No. 245 , Delegacion Miguel Hidalgo, Cuidad de Mexico MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/04/2018

Desc: CHOCO MILK 6-1750 GR
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] because the label is false and misleading.; - Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two or more languages but does not repeat all the required information in both languages. - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears nutrient content claims, but the product does not meet the requirements to make such claims.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     

Molinos del Fenix, S.A. de C.V.
Date Published : 02/02/2017
Emilio Carranza y Ramos Arizpe s/n , Zona Centro , Saltillo, Coah MEXICO
04 A - - 06 Vermicelli
Date Published: 02/02/2017

Desc: Vermicelli
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 09/29/2003

04 A - - -- Macaroni/Spaghetti
Date Published: 02/02/2017

Desc: Star Pasta
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 10/17/2003

Natural de Alimentos
Date Published : 10/02/2015
Loma Linda Camino Al Rosario Km 2. 5 , Rancho o Rancheria Loma Linda , San Juan Del Rio, Queretaro MEXICO
26 E - - 01 Oleomargarine
Date Published: 10/02/2015

Desc: Saborex Margarine
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the nutrition facts information does not meet the format requirements as required by 21 CFR 101.9. Specifically, the Nutrition Facts panel is not in the proper format, and the serving size does not appear to be based on the Reference Amount Customarily Consumed (RACC) for margarine specified in Table 2 of 21 CFR 101.12 (b). In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act in that the nutrition label is not in English as required by 21 CFR 101.15(c)(1). Lastly, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act because it appears to purport to be margarine; however, based on the nutrition information and ingredient list the product does not appear to meet the standard for margarine as required by 21 CFR 166.110. Specifically, in accordance with 21 CFR 166.110(a), margarine must contain not less than 80 percent fat; however, the nutrition label declares fat as 72 g per 100 g (72%). In addition, in accordance with 21 CFR 166.110(a)(3), margarine must contain at least 15,000 international units per pound of vitamin A. The nutrition label does not declare vitamin A and the ingredient list does not appear to contain any ingredient that is a source of vitamin A.

26 E - - 99 Oleomargarine, N.E.C.
Date Published: 10/02/2015

Desc: Saborex Margarine
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) because the nutrition facts information does not meet the format requirements as required by 21 CFR 101.9. Specifically, the Nutrition Facts panel is not in the proper format, and the serving size does not appear to be based on the Reference Amount Customarily Consumed (RACC) for margarine specified in Table 2 of 21 CFR 101.12 (b). In addition, article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act in that the nutrition label is not in English as required by 21 CFR 101.15(c)(1). Lastly, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(g) of the Act because it appears to purport to be margarine; however, based on the nutrition information and ingredient list the product does not appear to meet the standard for margarine as required by 21 CFR 166.110. Specifically, in accordance with 21 CFR 166.110(a), margarine must contain not less than 80 percent fat; however, the nutrition label declares fat as 72 g per 100 g (72%). In addition, in accordance with 21 CFR 166.110(a)(3), margarine must contain at least 15,000 international units per pound of vitamin A. The nutrition label does not declare vitamin A and the ingredient list does not appear to contain any ingredient that is a source of vitamin A.

Nostalxico S De Rl De Cv
Date Published : 01/10/2018
Calle Vialidad de La Barranca 13 , Fracc. VALLE DE LAS PALMAS , Huixquilucan, Mexico MEXICO
33 U - - 02 Chewing Gum (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Fresa (Strawberry Flavored Liquid Centre Chewing Gum Fresa)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement. 403(k) of the Act [21 U.S.C. §343(k)] in that the food bears or contains artificial coloring, but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act.                                                                                                                               

33 U - - 02 Chewing Gum (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Menta (Mint Flavored Liquid Centre Chewing Gum Menta)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement. 403(k) of the Act [21 U.S.C. §343(k)] in that the food bears or contains artificial coloring, but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act.                                                                                                                               

33 U - - 02 Chewing Gum (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Banana (Banana Flavored Liquid Centre Chewing Gum Platano)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement.                                                                                                                               

33 U - - 02 Chewing Gum (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Tutti Frutti (Tutti Frutti Flavored Liquid Centre Chewing Gum)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement.                                                                                                                               

33 U - - 99 Chewing Gum, N.E.C. (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Fresa (Strawberry Flavored Liquid Centre Chewing Gum Fresa)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement. 403(k) of the Act [21 U.S.C. §343(k)] in that the food bears or contains artificial coloring, but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act.                                                                                                                               

33 U - - 99 Chewing Gum, N.E.C. (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Tutti Frutti (Tutti Frutti Flavored Liquid Centre Chewing Gum)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement.                                                                                                                               

33 U - - 99 Chewing Gum, N.E.C. (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Menta (Mint Flavored Liquid Centre Chewing Gum Menta)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement. 403(k) of the Act [21 U.S.C. §343(k)] in that the food bears or contains artificial coloring, but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act.                                                                                                                               

33 U - - 99 Chewing Gum, N.E.C. (without Chocolate)
Date Published: 01/10/2018

Desc: Bubble Gum Bubbaloo Banana (Banana Flavored Liquid Centre Chewing Gum Platano)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (e.g. Nutrition Facts Label) is not in an appropriate format. 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients on the English label does not appear to match the foreign language ingredient statement.                                                                                                                               

Olnatura, S. A. de C. V.
Date Published : 11/16/2015
Sur, Mnz. 40 Pb 8 , Civac , Jiutepec, Morelos MEXICO
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 11/16/2015

Desc: Biofiberex
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word; statement; or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words; statements; designs; or devices; in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example; label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2); or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1); except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). [Misbranded; Section 403 (f)]"

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 11/16/2015

Desc: Dietgenix Shake (Chocolate)
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word; statement; or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words; statements; designs; or devices; in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example; label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2); or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1); except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). [Misbranded; Section 403 (f)]"

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 11/16/2015

Desc: Biogaxtric
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word; statement; or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words; statements; designs; or devices; in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example; label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2); or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1); except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). [Misbranded; Section 403 (f)]"

54 I - - -- Fiber
Date Published: 11/16/2015

Desc: Dietgenix Shake (Chocolate)
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word; statement; or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words; statements; designs; or devices; in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example; label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c) (2); or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1); except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). [Misbranded; Section 403 (f)]"

54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C.
Date Published: 11/16/2015

Desc: Dietgenix Shake (Chocolate)
Notes: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded; Section 403 (a)(1)]" "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word; statement; or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words; statements; designs; or devices; in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example; label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c) (2); or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1); except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). [Misbranded; Section 403 (f)]"

PLANTAS MEDICINALES DE MEXICO
Date Published : 08/19/2019
MELCHOR OCAMPO 55 LOCAL D , DELEGACION XOCHIMILCO C.P, MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Artritis
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Mujer
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Rinon
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Higado Vesicula
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/27/2019

Desc: Ajo King Brand Glucosamina
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English-21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name-21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL-21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients-21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived-21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LBB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer-21CFR101.93(b) and that a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Jengibre
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/10/2020

Desc: Ajo King Brand Colesterol
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients,and they are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36.Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived,as per 21CFR101.4(h)(1).Section 403(y) of the Act[21U.S.C.§343(y)] in that the BLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Presion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Nervios
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Gastritis
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Diabetes
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/29/2020

Desc: Ajo King Brand Mujer
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Circulacion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Curcuma
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/19/2019

Desc: Ajo King Brand Vision
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which ingredient in the product is derived,as per 21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/25/2021

Desc: Ajo King Mejora Tu Vision
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

60 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: Ajo King Brand Mujer
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Rinon
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Circulacion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Artritis
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Presion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Mujer
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Mejora Tu Vision
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Gastritis
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Diabetes
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Nervios
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Jengibre
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Curcuma
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

65 C - - 99 Nutrient/Tonic N.E.C.
Date Published: 01/25/2021

Desc: Ajo King Higado Vesicula
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

65 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: Ajo King Brand Mujer
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Mujer
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Circulacion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Diabetes
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Nervios
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Curcuma
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Mejora Tu Vision
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Gastritis
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Higado Vesicula
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Jengibre
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Rinon
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Presion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/25/2021

Desc: Ajo King Artritis
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages.

66 - - - -- Human and Animal Drugs
Date Published: 01/29/2020

Desc: Ajo King Brand Mujer
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

66 - - - -- Human and Animal Drugs
Date Published: 08/19/2019

Desc: Ajo King Brand Vision
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which ingredient in the product is derived,as per 21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer.

66 - - - -- Human and Animal Drugs
Date Published: 01/10/2020

Desc: Ajo King Brand Colesterol
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients,and they are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36.Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived,as per 21CFR101.4(h)(1).Section 403(y) of the Act[21U.S.C.§343(y)] in that the BLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer

66 - - - -- Human and Animal Drugs
Date Published: 08/27/2019

Desc: Ajo King Brand Glucosamina
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English-21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name-21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL-21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients-21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived-21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LBB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer-21CFR101.93(b) and that a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer.

PROCESAMIENTO ESP EXPORTER
Date Published : 10/12/2023
Avenida Insurgentes Sur 730 Piso 17 , Col. Juarez, Cuauhtemoc , Ciudad De Mexico, Ciudad de Mexico MEXICO
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 10/12/2023

Desc: Duchess Light Tuna in Water (Canned)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)], in that the product label is false and misleading. Specifically, the label states the product contains 30% textured soy protein while the formulation sheet indicates the product contains 20.42 % soy protein and 0.99 % soy fiber. Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)], in that the product label does not provide a statement of identity that is descriptive enough to convey the significant soy protein content alongside the tuna and is not in accordance with 21 CFR 101.3. In addition, the term “contains” should be reserved only for allergen declaration as required under section 403(w).                                                                                                                                                                                                                                                                                                      

PROCESAMIENTO ESPECILIZADO DE ALIM SAPI
Date Published : 02/16/2023
Avenida Insurgentes Sur 601 Piso 15 Oficina 113 , Otro Napoles, Benito Juarez , Ciudad De Mexico, Ciudad de Mexico MEXICO
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 02/16/2023

Desc: CHUNK LIGHT TUNA IN WATER (CANNED)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(g)(1) of the Act because the product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 161.190. Specifically, the ingredient statement declares “Texturized Soy Protein.” The addition of texturized soy protein to the canned tuna product means that the product would not meet the specifications for the canned tuna standard listed in 21 CFR 161.190. Since the product does not meet the requirements of the canned tuna standard, the product name would need to be differentiated from the standardized canned tuna products. The food needs to be identified with an appropriately descriptive term, should not be misleading, and be consistent with 21 CFR 101.3.

PROCESAMIENTO ESPECILIZADO DE ALIM SAPI de CV
Date Published : 10/12/2023
Ave Central Sur, Entresur Y Uno Norte , Manzana C Industrial Francsco I., Madero , Tapachula, CHP MEXICO
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 11/13/2023

Desc: SCOUT SEAFOOD SNACKS - WILD YELLOWFIN TUNA IN OLIVE OIL W/ CHILI CRISP TOPPER
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the sodium and iron content exceeds the label declarations. FDA analysis determined that the sodium content is 140% and 145% (check analysis) of declared amount, and the iron content is 200% and 231% (check analysis) of the declared amount per serving.

16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 10/12/2023

Desc: Duchess Light Tuna in Water (Canned)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)], in that the product label is false and misleading. Specifically, the label states the product contains 30% textured soy protein while the formulation sheet indicates the product contains 20.42 % soy protein and 0.99 % soy fiber. Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)], in that the product label does not provide a statement of identity that is descriptive enough to convey the significant soy protein content alongside the tuna and is not in accordance with 21 CFR 101.3. In addition, the term “contains” should be reserved only for allergen declaration as required under section 403(w).                                                                                                                                                                                                                                                                                                      

PRODUCTOS DEL VALLE
Date Published : 10/02/2015
Calle Del Rayo No 67 , Fracc. Fracc Jardines De San Marcos, Mexicali , Mexicali, Baja California MEXICO
07 A - - 02 Corn Chips, Baked
Date Published: 10/02/2015

Desc: Corn Snacks (Churritos De Maiz Super 30)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/02/2015

Desc: Corn Snacks (Churritos De Maiz Super 30)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.

07 B - - 02 Corn Chips, Fried
Date Published: 10/02/2015

Desc: Corn Snacks (Churritos De Maiz Super 30)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/02/2015

Desc: Corn Snacks (Churritos De Maiz Super 30)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/02/2015

Desc: Corn Snacks (Churritos De Maiz Super 30)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) in that the outer multi-pack label is fabricated from two or more ingredients, and the common or usual name of each such ingredient is not declared in accordance with 21 CFR 101.4. In addition, the article appears to be misbranded within the meaning of section 403 (q) in that the outer multi-pack label fails to bear nutrition information in accordance with 21 CFR 101.9. In addition, the article appears to be misbranded within the meaning of section 403 (i)(2) in that the inner individual bag label fails to declared corn and wheat flour collectively as required by 21 CFR 101.4(a) and the specific type of vegetable oil is not declared as required by 21 CFR 101.4(b)(14). Lastly, the article appears to be misbranded within the meaning of section 403(q) in that inner individual bag label fails to present the nutritional information as prescribed by 21 CFR 101.9(d). For example, the foreign language should follow English, and improper bolding, indentation, rounding, placement of headings and use of hairlines/bars. In addition, there is no percent daily value for trans fat.

Pablo Ignacio Michel Ontiveros
Date Published : 10/02/2015
Quintana Roo 1611 , Col. Guadalupana , Guadalajara, Jalisco MEXICO
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Botu 2 Lollipop with Chili Powder (Assort Fruit Flavors)
Notes: VIOLATION (IN NOTES): 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded product within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example: The Caloric content is not declared in accordance with 21 CFR 101.9(c)(l). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "k" or "kcal." The "Energy Content" may be expressed in kilojoules units, added in parentheses immediately following the statement of caloric content. The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii). The Calcium and Iron content is not declared as required by 21 CFR 101.9(c)(8) (ii)..

Pablo Ignacio Michel Ontiveros Group Industrial Michel
Date Published : 10/02/2015
Carretera Escuela Agricultura 7620 , La Venta Del Astillero, Jalisco MEXICO
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Botu 2 Lollipop with Chili Powder (Assort Fruit Flavors)
Notes: VIOLATION (IN NOTES): 1. 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded product within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example: The Caloric content is not declared in accordance with 21 CFR 101.9(c)(l). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "k" or "kcal." The "Energy Content" may be expressed in kilojoules units, added in parentheses immediately following the statement of caloric content. The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii). The Calcium and Iron content is not declared as required by 21 CFR 101.9(c)(8) (ii)..

Pagasa SA de CV
Date Published : 10/02/2015
Calle Jose Gallego Lugo # 13240 , Col. Fracc Del Prado Este, Tijuana , Tijuana, Baja California MEXICO
04 A - - 01 Macaroni Enriched
Date Published: 10/02/2015

Desc: Pagasa Brand Macaroni Products;
Notes: Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; the label does not list trans fat as required in 21 CFR 101.9(c)(2)(ii) [Misbranded; Section 403 (q)] 12/20/07 NOTE: these products are also indicated for detention because their labeling fails to declare the presence of the major food allergen ¿wheat¿ as required by section 403(w)(1) of the Act. The products list semolina in the ingredient statement (semolina is wheat and wheat is a major food allergen). [Misbranded, section 403(w); use OASIS charge code ALLERGEN]

04 A - - 01 Macaroni Enriched
Date Published: 02/02/2017

Desc: Macaroni Seeds
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; Insufficient Riboflavin; 08/04/2006

Pastas Alimenticias Laziali Sa Cv
Date Published : 10/02/2015
Calle 4 Norte No. 301 Lote 17 , Toluca Edo De Mexico, MEXICO
04 C - - 02 Noodles, Enriched
Date Published: 10/02/2015

Desc: Stars Pasta (Faraon Brand)
Notes: Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] NOTE; this product is also indicated for detention in that it does not meet the 21 CFR 139.115(a)(1) requirement for enriched macaroni products; laboratory analysis revealed the product contained less than 1.7mg/lb of riboflavin; 21 CFR 139.115(a)(1) requires between 1.7mg/lb and 2.2mg/lb of riboflavin for enriched macaroni products [Misbranded; section 403(g); use OASIS charge code STD IDENT] 7/20/05

04 C - - 02 Noodles, Enriched
Date Published: 10/02/2015

Desc: Alphabet Pasta (Faraon Brand)
Notes: Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] 7/20/05

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 10/02/2015

Desc: Alphabet Pasta (Faraon Brand)
Notes: Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] 7/20/05

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 10/02/2015

Desc: Stars Pasta (Faraon Brand)
Notes: Product?s label fails to bear required nutrition information in the format required by 21CFR 101.9; specifically; label print too small; incorrect bolding; no indentation. Serving size visual unit of measure not listed first; calories not expressed in 10 cal increment. [Misbranded; Section 403 (q)] NOTE; this product is also indicated for detention in that it does not meet the 21 CFR 139.115(a)(1) requirement for enriched macaroni products; laboratory analysis revealed the product contained less than 1.7mg/lb of riboflavin; 21 CFR 139.115(a)(1) requires between 1.7mg/lb and 2.2mg/lb of riboflavin for enriched macaroni products [Misbranded; section 403(g); use OASIS charge code STD IDENT] 7/20/05

Pastas Molisaba, S.A. de C.V.
Date Published : 02/02/2017
Boulevard Licenciado Gustavo Diaz Ordaz Km 333 , Col. Estacion La Leona, San Pedro Garza Garcia , San Pedro Garza Garcia, Nuevo Leon MEXICO
04 A - - 01 Macaroni Enriched
Date Published: 02/02/2017

Desc: Shell Pastas (Conchitas)
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 01/12/2017

04 A - - 02 Macaroni
Date Published: 02/02/2017

Desc: Shell Pastas (Conchitas)
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 01/12/2017

Plantas Medicinales Anahuac, S.A. De C.V.
Date Published : 10/02/2015
Del. Iztacalco , Calle Oriente 255 # 57 , Mexico, Distrito Federal MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes: Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/02/2015

Desc: Su-K rofitina syrup
Notes: The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Corn Silk Blend Capsules (Cabellos de Elote Enebro)
Notes: Product is misbranded under 403(q)(5)(F) in that the nutrition label does not include adequate information; Product is further misbranded under 403(a)(1)in that the declared value for Vitamin E is false & misleading; Product is further misbranded under 403(i)(2) in that the label does not declare the capsule ingredient; and under 403(s)(2)(C)in that the label does not declare the plant parts used {21CFR 101.36; 101.3(g); and 101.4(h)} 8/13/07 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Su-K rofitina syrup
Notes: The nutritional information is not in the format specified by 21 CFR 101.9 [Misbranded; Section 403(q)] 6/30/06 SHIPPER: Manuel Goknzalez Blanco, FEI #3004679342

Procesadora de Guayaba de Calvillo, S.A. de C.V.
Date Published : 02/28/2018
Boulevard Rodolfo Landeros Gallegos 407-A , Col. Arroyo De Los Caballos , Calvillo, Aguascalientes MEXICO
21 J - - 04 Maraschino Cherry, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 02/28/2018

Desc: Guava Fruit Candy With Chamoy (Miniatura De Guayaba Con Chamoy)
Notes: Section 403(a)(1) of the FD&C Act, in that the label is false or misleading. Section 403(i)(2) of the FD&C Act, because sodium benzoate is not declared in the ingredient statement as required by 21 CFR 101.4 and 101.22(j). Section 403(k) of the FD&C Act, because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the FD&C Act, in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

21 T - - 04 Guava, Dried or Paste
Date Published: 02/28/2018

Desc: Guava Fruit Candy With Chamoy (Miniatura De Guayaba Con Chamoy)
Notes: Section 403(a)(1) of the FD&C Act, in that the label is false or misleading. Section 403(i)(2) of the FD&C Act, because sodium benzoate is not declared in the ingredient statement as required by 21 CFR 101.4 and 101.22(j). Section 403(k) of the FD&C Act, because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the FD&C Act, in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 02/28/2018

Desc: Guava Fruit Candy With Chamoy (Miniatura De Guayaba Con Chamoy)
Notes: Section 403(a)(1) of the FD&C Act, in that the label is false or misleading. Section 403(i)(2) of the FD&C Act, because sodium benzoate is not declared in the ingredient statement as required by 21 CFR 101.4 and 101.22(j). Section 403(k) of the FD&C Act, because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the FD&C Act, in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

33 J - - 99 Soft Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 02/28/2018

Desc: Guava Fruit Candy With Chamoy (Miniatura De Guayaba Con Chamoy)
Notes: Section 403(a)(1) of the FD&C Act, in that the label is false or misleading. Section 403(i)(2) of the FD&C Act, because sodium benzoate is not declared in the ingredient statement as required by 21 CFR 101.4 and 101.22(j). Section 403(k) of the FD&C Act, because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the FD&C Act, in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 02/28/2018

Desc: Guava Fruit Candy With Chamoy (Miniatura De Guayaba Con Chamoy)
Notes: Section 403(a)(1) of the FD&C Act, in that the label is false or misleading. Section 403(i)(2) of the FD&C Act, because sodium benzoate is not declared in the ingredient statement as required by 21 CFR 101.4 and 101.22(j). Section 403(k) of the FD&C Act, because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Section 403(q) of the FD&C Act, in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

Productos Alimenticios La Moderna, S.A. de C.V.
Date Published : 02/02/2017
Francisco I. Madero No. 1675 Norte , Col. ZONA CENTRO , Gomez Palacio, Durango MEXICO
04 A - - 01 Macaroni Enriched
Date Published: 02/02/2017

Desc: Small Elbow Enriched Macaroni
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 11/3/2014

04 A - - 05 Spaghetti
Date Published: 02/02/2017

Desc: Enriched Spaghetti Pasta
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 8/11/2015

Productos Avila Sa De Cv
Date Published : 10/02/2015
Calle Puerto Melaque 1379 , Col. Santa Maria, Guadalajara , Guadalajara, Jalisco MEXICO
33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 10/02/2015

Notes: Liquid (Liquid Chili Snack/Barril con Chili)

33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Notes: Liquid (Liquid Chili Snack/Barril con Chili)

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Notes: Liquid (Liquid Chili Snack/Barril con Chili)

Productos Bryanda
Date Published : 10/02/2015
Avenida Constituyentes No 268 , Col. LEY 57 , Hermosillo, Sonora MEXICO
03 J - - 10 Creme Filled/Iced Cookie,Biscuit,Wafer
Date Published: 10/02/2015

Desc: Filled Pastries (Coyotas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) in that the labeling is false or misleading in any particular. FDA's sample analysis found that the total fat and saturated fat contents were greater than 20 percent in excess of the value declared on the label. Section 403(i)(1) in that the label fails to bear the common or usual name of the food. English translation of the statement of identity does not appear to be an appropriately descriptive term for this product in accordance with 21 CFR 101.3(b). Section 403(i)(2) in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredients. English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b)(14). Spanish language label does not declare the "molasses" and "water" ingredients that are declared on the English version. Section 403(f) in that the label contains information in two or more languages but fails to principal display panel does not bear a statement of identity in English in accordance with 21 CFR 10 1.15(c)(1), and to display all required information in both languages in accordance with 21 CFR 101.15(c)(2). Section 403(q) in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9.

33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Filled Pastries (Coyotas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) in that the labeling is false or misleading in any particular. FDA's sample analysis found that the total fat and saturated fat contents were greater than 20 percent in excess of the value declared on the label. Section 403(i)(1) in that the label fails to bear the common or usual name of the food. English translation of the statement of identity does not appear to be an appropriately descriptive term for this product in accordance with 21 CFR 101.3(b). Section 403(i)(2) in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredients. English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b)(14). Spanish language label does not declare the "molasses" and "water" ingredients that are declared on the English version. Section 403(f) in that the label contains information in two or more languages but fails to principal display panel does not bear a statement of identity in English in accordance with 21 CFR 10 1.15(c)(1), and to display all required information in both languages in accordance with 21 CFR 101.15(c)(2). Section 403(q) in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Filled Pastries (Coyotas)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) in that the labeling is false or misleading in any particular. FDA's sample analysis found that the total fat and saturated fat contents were greater than 20 percent in excess of the value declared on the label. Section 403(i)(1) in that the label fails to bear the common or usual name of the food. English translation of the statement of identity does not appear to be an appropriately descriptive term for this product in accordance with 21 CFR 101.3(b). Section 403(i)(2) in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredients. English translation of the ingredient statement declares "milk candy", but the Spanish version declares "leche condensada" which translates as "condensed (concentrated) milk". Spanish ingredient statement lists "aceite vegetal" (vegetable fat) and the English ingredient statement lists "vegetal fat", which both fail to include the source of the fat in accordance with 21 CFR 101.4(b)(14). Spanish language label does not declare the "molasses" and "water" ingredients that are declared on the English version. Section 403(f) in that the label contains information in two or more languages but fails to principal display panel does not bear a statement of identity in English in accordance with 21 CFR 10 1.15(c)(1), and to display all required information in both languages in accordance with 21 CFR 101.15(c)(2). Section 403(q) in that the nutrition information is incomplete and does not meet the formatting requirements specified under 21 CFR 101.9.

Productos Cihuapilli
Date Published : 10/02/2015
Luis Cabrera No. 562 , Colinas de la Normal , Guadalajara, Jalisco MEXICO
33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 10/02/2015

Notes: Coconut Candy Rolls

33 H - - 12 Mixed/Assorted Soft Candy with Coconut (without Chcocolate)
Date Published: 10/02/2015

Notes: Coconut Candy Rolls

33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Notes: Coconut Candy Rolls

33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 10/02/2015

Notes: Coconut Candy Rolls

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Notes: Coconut Candy Rolls

Productos De Harina
Date Published : 12/01/2015
Calle 32 No. 231 X 21 Y 28 A , Col. Garcia Gineres , Merida, Yucatan MEXICO
04 A - - 05 Spaghetti
Date Published: 12/01/2015

Desc: Noodles Pasta Alimentes Fideos
Notes: VIOLATION: The following product Pasta Alimentes Fideos Noodles fails to declare iron as per 21 CFR 101.9(g)(4)(ii) ,in that, the nutrient content of the composite tested was not equal to 80% of the value for the nutrient declared on the label. Therefore, these articles are misbranded within the meaning of section 403(a) of the ACT, in that; the labels are false or misleading. The vitamins and minerals are not ordered in accordance with 21 CFR 101.9(c)(8)(iii). The Nutrition Facts Panel headings are not bolded nor are nutrients indented as required and hairlines are not used appropriately. [21 CFR 101.9(d)] Further more, the product is misbranded within the meaning of Section 403(q) of the Act in that the nutritional facts information is not declared in accordance with the requirements under 21 CFR 101.9. For example: The serving declaration, 25g is not in expressed in common household measure. The Total Calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)] The Saturated Fat content should be expressed as zero when a serving contains less that 0.5- grams of saturated fat [ 21 CFR 101.9(c)(2)(i)] The Cholesterol content should be expressed to the nearest milligram [21 CFR 101.9(c)(3)] The Sodium content should be expressed in milligrams. In addition, when a serving contains less that 5-milligrams of sodium, it should be expressed as zero. [21 CFR 101.9(c)(4)] The Total carbohydrate content in a serving should be declared as Carbohydrate, total or Total carbohydrate and should be expressed in grams. [21 CFR 101.9(c)(6)] The Sugar content should be declared as Sugars. [21 CFR 101.9(c)(6)(ii)] The Protein should be expressed to the nearest gram. [21 CFR 101.9(c)(7)] Vitamins and minerals shall be expressed to the nearest 2% increment up to and including 10- percent level and the nearest 5% increment above 10% and including 50% level. [21 CFR 101.9(c)(8)(iii)]; 10/02/2015

Productos Safari
Date Published : 04/04/2016
Bahia De Ohulra 136 Sur, Cp 81200 , Ahome, Sinaloa MEXICO
33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 04/04/2016

Desc: Coconut Candy Flag (Bandera de Coco)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

33 H - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Coconut (without Chocolate)
Date Published: 04/04/2016

Desc: Coconut Candy Flag (Bandera de Coco)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

33 H - - 99 Soft Candy with Coconut, N.E.C. (without Chocolate)
Date Published: 04/04/2016

Desc: Coconut Candy Flag (Bandera de Coco)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 04/04/2016

Desc: Coconut Candy Flag (Bandera de Coco)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 04/04/2016

Desc: Coconut Candy Flag (Bandera de Coco)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

Productos de Trigo S.A. de C.V.
Date Published : 10/02/2015
Calle Quetzal 1132 , Col. Morelos, Guadalajara , Guadalajara, Jalisco MEXICO
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Rancheritas Cookies
Notes: 5/1/06

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 10/02/2015

Notes: Rancheritas Cookies; 5/1/06

04 A - - -- Macaroni/Spaghetti
Date Published: 02/02/2017

Desc: All Pasta Products
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 11/3/2003

SABRITAS, S.de R.L. de C.V.
Date Published : 10/02/2015
Calle Norte 45 # 740 , Col. Industrial Vallejo, Azcapotzalco , Ciudad De Mexico, Ciudad de Mexico MEXICO
07 B - - 02 Corn Chips, Fried
Date Published: 09/20/2019

Desc: Tostitos Salsa Verde Corn Chips
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1), product declares "Total Fat" as "8g"; however, the "Calories from Fat" appear to be incorrectly declared as "0". Section 403(i)(2), missing declaration of the common or usual name for each ingredient: 'mixed cheeses', 'corn flakes' and 'chili mix (21 CFR 101.4); 'flavoring' (21 CFR 101.22) and 'vegetable oil' (21 CFR 101.4(b)(14)). Section 403(r)(1)(A), product declares 'Low in Saturated Fat' and '25% less saturated fat', but fails to meet the requirements of 21 CFR 101.62(c)(2) and 21 CFR 101.130. Section 403(q), serving sizes does not appear to be represented in an amount customarily consumed and are not expressed in a common household measure that is appropriate to the food, in accordance with 21 CFR 101.9(b). Product declares serving size as "25g" without declaring the common household unit, such as 'pieces'. The reference amount for these snack products would be 30g; therefore, it appears that the nutrient values for these products were all based on an improper amount. Products incorrectly declare "trans fat" after "polyunsaturated fat", rather than after the "saturated fat" (21 CFR 101.9(c)); and the dietary fiber fails to declare a %DV (21 CFR 101.9(d)).

07 B - - 03 Cheese Puffs, Fired
Date Published: 09/20/2019

Desc: Cheetos Horneados Bolitas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1), product declares "Total Fat" as "6g"; however, the "Calories from Fat" appear to be incorrectly declared as "0". Section 403(i)(2), product declares "hydrolyzed protein meat", which is not the common or usual name of the ingredient in accordance with 21 CFR 101.A and "vegetable oil" is not declared in accordance with 21 CFR 101.4(b)(l4). Section 403(r)(1)(A), product declares "0g trans fat" on the PDP, but fails to declare the disclosure statement required under 21 CFR 101.13(h); this statement is required because it contains 5g of saturated fat per 50g (based on the label declaration). Section 403(q), serving sizes does not appear to be represented in an amount customarily consumed and are not expressed in a common household measure that is appropriate to the food, in accordance with 21 CFR 101.9(b). Product declares their serving size as "25g" without declaring the common household unit, such as 'pieces'. The reference amount for these snack products would be 30g; therefore, it appears that the nutrient values for these products were all based on an improper amount. And products incorrectly declare "trans fat" after "polyunsaturated fat", rather than after the "saturated fat" (21 CFR 101.9(c)); and the dietary fiber fails to declare a %DV (21 CFR 101.9(d)).

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 09/20/2019

Desc: Cheetos Horneados Bolitas
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1), product declares "Total Fat" as "8g"; however, the "Calories from Fat" appear to be incorrectly declared as "0". Section 403(i)(2), missing declaration of the common or usual name for each ingredient: 'mixed cheeses', 'corn flakes' and 'chili mix (21 CFR 101.4); 'flavoring' (21 CFR 101.22) and 'vegetable oil' (21 CFR 101.4(b)(14)). Section 403(r)(1)(A), product declares 'Low in Saturated Fat' and '25% less saturated fat', but fails to meet the requirements of 21 CFR 101.62(c)(2) and 21 CFR 101.130. Section 403(q), serving sizes does not appear to be represented in an amount customarily consumed and are not expressed in a common household measure that is appropriate to the food, in accordance with 21 CFR 101.9(b). Product declares serving size as "25g" without declaring the common household unit, such as 'pieces'. The reference amount for these snack products would be 30g; therefore, it appears that the nutrient values for these products were all based on an improper amount. Products incorrectly declare "trans fat" after "polyunsaturated fat", rather than after the "saturated fat" (21 CFR 101.9(c)); and the dietary fiber fails to declare a %DV (21 CFR 101.9(d)).

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 09/20/2019

Desc: Tostitos Salsa Verde Corn Chips
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1), product declares "Total Fat" as "6g"; however, the "Calories from Fat" appear to be incorrectly declared as "0". Section 403(i)(2), product declares "hydrolyzed protein meat", which is not the common or usual name of the ingredient in accordance with 21 CFR 101.A and "vegetable oil" is not declared in accordance with 21 CFR 101.4(b)(l4). Section 403(r)(1)(A), product declares "0g trans fat" on the PDP, but fails to declare the disclosure statement required under 21 CFR 101.13(h); this statement is required because it contains 5g of saturated fat per 50g (based on the label declaration). Section 403(q), serving sizes does not appear to be represented in an amount customarily consumed and are not expressed in a common household measure that is appropriate to the food, in accordance with 21 CFR 101.9(b). Product declares their serving size as "25g" without declaring the common household unit, such as 'pieces'. The reference amount for these snack products would be 30g; therefore, it appears that the nutrient values for these products were all based on an improper amount. And products incorrectly declare "trans fat" after "polyunsaturated fat", rather than after the "saturated fat" (21 CFR 101.9(c)); and the dietary fiber fails to declare a %DV (21 CFR 101.9(d)).

Salud Natural Mexicana SA de CV
Date Published : 10/02/2015
Avenida Inglaterra 3109 , Col. Jardines De Los Arcos, Guadalajara , Guadalajara, Jalisco MEXICO
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Notes: ActiKrol Brand Glutamic Acid Syrup for Children

54 B - - 01 Calcium (Mineral)
Date Published: 10/02/2015

Notes: Caltron 600 D calcium supplent

54 C - - 07 L-Glutamic Acid (Protein)
Date Published: 10/02/2015

Notes: ActiKrol Brand Glutamic Acid Syrup for Children

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Notes: Dinamax Jr. a liquid vitamin supplement

Silvana Natalia Galvan Ponce De Leon
Date Published : 07/31/2019
Roque Estrade #26 Planta , Deleg.Tlaplpan Mexico D, MEXICO
30 N - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors
Date Published: 08/01/2019

Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling.

30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid
Date Published: 07/31/2019

Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX CUBANA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. The ingredient statement fails to declare "sorbate" and "benzoate"; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages. The statement of identity, ingredients, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid
Date Published: 08/01/2019

Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling.

TOMA PRODUCTS, S DE R.L. DE C.V.
Date Published : 10/02/2015
Calle Los Pinos Km. 1,5 , Col. Sin Nombre De Colonia 6 , Ramos Arizpe, Coahuila de Zaragoza MEXICO
22 D - - 01 Cantaloupe, Juice, Vine Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: Agua Fruta Melon(Cantaloupe) Fruit Drink

Tonic Life S de RL
Date Published : 06/03/2020
Calle Acambaro 1008 , Col. Fracc Plan De Guanajuato, Irapuato , Irapuato, Guanajuato MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Lexi Life
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Aby Life capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient - Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Tnic Clean Liquid
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Vita Boys
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Mango Life
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient - Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Tnic Life capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Collagen Tropical Fruit
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Tnic Clean Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient - Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling of the product with added iron fails to bear the required warning statement. [21 CFR § 101.17(e)]

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: TBC
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient - Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the label fails to declare each ingredient by its common or usual name [21 CFR 101.4].

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Collagen Blueberry
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient.

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/03/2020

Desc: Xuca Gold Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient - Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4

Trigos Industrializados de Mexico SA de CV
Date Published : 02/02/2017
Calle Pilares S/n Frente A Ffcc , Colonia San Luis , Hermosillo, MX-SON MEXICO
04 A - - 01 Macaroni Enriched
Date Published: 02/02/2017

Desc: Macaroni
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 10/20/2003

Unilever Manufacturera S. de R.L. de C.V.
Date Published : 10/02/2015
km 52.8, A lot , Mexico-Toluca road , Lerma, Mexico MEXICO
26 E - - 01 Oleomargarine
Date Published: 10/02/2015

Desc: Flex Margarine Blue
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].

26 E - - 01 Oleomargarine
Date Published: 10/02/2015

Desc: Flex Margarine Red
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].

26 E - - 99 Oleomargarine, N.E.C.
Date Published: 10/02/2015

Desc: Flex Margarine Blue
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)].

26 E - - 99 Oleomargarine, N.E.C.
Date Published: 10/02/2015

Desc: Flex Margarine Red
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example: The Sugar content is not declared as required by [21 CFR 101.9(c)(6)(ii)]. The Vitamin and Mineral content is not declared as required by [21 CFR 101.9(c) (8)]. The product label fails to include a footnote that states, Percent Daily Values are based on a 2,000 calorie diet. You daily values may be higher or lower depending on your calorie needs as required by 21 CFR 101.9(d)(9). The Nutrition Fact Panel is not formatted in accordance with 21 CFR 101.9(d). The serving size declaration for this product, "5g" is not expressed in common household measure in accordance with 21 CFR101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is "1 tbsp (_ g)"; or "1 tbsp (15mL). The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content units should be in calories, not KJ KCAL. The Energy Content may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content. The Calories from Fat content is not declared as required by [21 CFR 101.9(c)(1) (ii)]. The Total Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2). The Polyunsaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iii). The Monosaturated Fat content is not rounded to the nearest 0.5g increment as required by 21 CFR 101.9(c)(2)(iv). The Dietary Fiber content is not declared as required by [21 CFR 101.9(c)(6)(i)]. ;

Vicce Enterprise
Date Published : 01/21/2015
Calle Benito Juarez Y/O Segunda No. 237 , Col. Zona Centro, Tijuana , Tijuana, Baja California MEXICO
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 01/21/2015

Desc: Herbal supplement with L.Carnitine and Magnesium/IMA Capsules
Notes: Problem; Magnesium less than declared amount

54 B - - 08 Magnesium (Mineral)
Date Published: 01/21/2015

Desc: Herbal supplement with L.Carnitine and Magnesium/IMA Capsules
Notes: Problem; Magnesium less than declared amount

Vida Herbal, S.A de C.V
Date Published : 10/26/2017
Mariano Matamoros No. 243 , Col. Analco , Guadalajara, Jalisco MEXICO
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/26/2017

Desc: Activated Carbon Dietary Supplement (Carbon Activado)
Notes: Section 403(a)(1) of the FD&C Act in that the product contains the ingredient activated carbon.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/26/2017

Desc: Passion Flower Dietary Supplement (Pasiflora)
Notes: Section 403(a)(1) of the FD&C Act in that the label contains the official logo of the FDA. Section 403(q)(5)(F) of the FD&C Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(i)(2) of the FD&C Act in that the label fails to declare each ingredient as required by 21 CFR 101.4(a) and 21 CFR 101.4(g). Section 403(e)(1) of the FD&C Act in that in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(y) of the Act [21 U.S.C. §343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

54 F - - 87 Passionflower (Herbal & Botanicals, not Teas)
Date Published: 10/26/2017

Desc: Passion Flower Dietary Supplement (Pasiflora)
Notes: Section 403(a)(1) of the FD&C Act in that the label contains the official logo of the FDA. Section 403(q)(5)(F) of the FD&C Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(i)(2) of the FD&C Act in that the label fails to declare each ingredient as required by 21 CFR 101.4(a) and 21 CFR 101.4(g). Section 403(e)(1) of the FD&C Act in that in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(y) of the Act [21 U.S.C. §343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

61 R - - 11 Activated Charcoal (Antidote)
Date Published: 10/26/2017

Desc: Activated Carbon Dietary Supplement (Carbon Activado)
Notes: Section 403(a)(1) of the FD&C Act in that the product contains the ingredient activated carbon.


MOROCCO


Somafaco, SA
Date Published : 10/12/2023
Km 10.5 Route Del Jadida , Lissasfa , Casablanca, Casablanca MOROCCO
03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 10/12/2023

Desc: Powder Preparation for Flan - Chocolate Hazelnut Aroma
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because it contains information in a foreign language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign languages). Required label information is not consistently repeated in all these languages on the label as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (NFL) is not as defined in 21 CFR 101.9.                                                                                                                 

13 B - - 01 Custard, Regular, Vanilla or Vanillin Flavored
Date Published: 10/12/2023

Desc: Powder Preparation for Flan - Chocolate Hazelnut Aroma
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because it contains information in a foreign language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign languages). Required label information is not consistently repeated in all these languages on the label as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (NFL) is not as defined in 21 CFR 101.9.                                                                                                                 

35 C - - 99 Custard Pudding (Pie) Mix, N.E.C.
Date Published: 10/12/2023

Desc: Powder Preparation for Flan - Chocolate Hazelnut Aroma
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because it contains information in a foreign language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign languages). Required label information is not consistently repeated in all these languages on the label as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (NFL) is not as defined in 21 CFR 101.9.                                                                                                                 


NEPAL


Aasharibad Trading
Date Published : 08/14/2017
Tokha Municipality Ward no: 10, , Gongabu , Kathmandu, Kathmandu NEPAL
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 08/14/2017

Desc: Furundana (Nepali Snacks Chanachur)
Notes: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Peanuts; beans; gram flour; spices; potato; salt; and chilies are ingredients in the product; but are not declared on the product label. Section 403(f) of the Act because the product label contains information in two languages; but does not repeat all the required information in both languages. Section 403(q) of the Act in that all of the declared nutrient values are incorrect; the serving size is not declared in common household measures; the number of servings per container is not declared; an amount is not declared for Trans-fat; the quantitative value for sodium is not rounded; the percent daily values for vitamins A and C; and iron are not declared; and the amount of Calories from Fat is not rounded.


NETHERLANDS


Erdic International
Date Published : 10/02/2015
Lucas Gasselstraat 2 A , Eindhoven, Noord-brabant NETHERLANDS
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/02/2015

Notes: Erdic Breast Beautifying Program Tablets The Plant Based Food Supplement for Beautiful Breasts; VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) in that the label fails to bear the required nutrition labeling in the form of a Supplement Facts label in accordance with 21 CFR 101.36.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Notes: Erdic Breast Beautifying Program Tablets The Plant Based Food Supplement for Beautiful Breasts; VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) in that the label fails to bear the required nutrition labeling in the form of a Supplement Facts label in accordance with 21 CFR 101.36.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Notes: Erdic Breast Beautifying Program Tablets The Plant Based Food Supplement for Beautiful Breasts;VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) in that the label fails to bear the required nutrition labeling in the form of a Supplement Facts label in accordance with 21 CFR 101.36.

H&A HOLLAND
Date Published : 12/20/2021
Stephensonstraat 10 R , Zoetermeer, Zuid-Holland NETHERLANDS
23 R - - 02 Sesame Seed (Edible Seed Paste)
Date Published: 12/20/2021

Desc: MAZI TAHIN (SESAME PASTE)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (i.e., Nutrition Facts label, or NFL) fails to comply with the requirements of 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in multiple languages but does not repeat all the required information in all languages. Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label’s net quantity of contents statement fails to comply with 21 CFR 101.7.

37 K - - 21 Sesame Paste
Date Published: 12/20/2021

Desc: MAZI TAHIN (SESAME PASTE)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (i.e., Nutrition Facts label, or NFL) fails to comply with the requirements of 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in multiple languages but does not repeat all the required information in all languages. Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the label’s net quantity of contents statement fails to comply with 21 CFR 101.7.

Infra Foodbrands b.v.
Date Published : 08/05/2015
Hogehilweg 5W , ZUIDOOST , Amsterdam, Noord-Holland NETHERLANDS
21 V - - 04 Guava, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/05/2015

Desc: Guava Juice Drink
Notes: Problem(s): The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine;                                                                                                                                                                                                     

21 V - - 05 Mango, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/05/2015

Desc: Mango Juice Drink
Notes: Problem(s): The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine;                                                                                                                                                                                                       ;

21 V - - 19 Lychee, Lichee, Litchi, Leechee, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 08/05/2015

Desc: Lychee Juice Drink
Notes: Problem(s): The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine;                                                                                                                                                                                                       ;

The Magic Touch of The Dutch MTD BV
Date Published : 11/28/2018
Flevolaan 14 , Weesp, Noord-Holland NETHERLANDS
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/28/2018

Desc: Syrup Waffles in Tin; Sunflowers
Notes: Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in accordance with 21 CFR 101.9. Specifically, the outer tins do not contain any nutrition information and the inner label does not provide required nutrition information consistent with 21 CFR 101.9, including egregious formatting violations. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two or more languages but does not repeat all the required label information in all languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] because the outer packaging of the product fails to completely or accurately declare the place of business, street address, city, state and zip code. Section 801(a)(3) in that that the articles appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product fails to declare a statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.7. Specifically, the outer packaging fails to declare the net quantity of contents.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/28/2018

Desc: Syrup Waffles in Tin; Almond Blossom
Notes: Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in accordance with 21 CFR 101.9. Specifically, the outer tins do not contain any nutrition information and the inner label does not provide required nutrition information consistent with 21 CFR 101.9, including egregious formatting violations. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two or more languages but does not repeat all the required label information in all languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] because the outer packaging of the product fails to completely or accurately declare the place of business, street address, city, state and zip code. Section 801(a)(3) in that that the articles appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product fails to declare a statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.7. Specifically, the outer packaging fails to declare the net quantity of contents.

36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 11/28/2018

Desc: Syrup Waffles in Tin; Sunflowers
Notes: Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in accordance with 21 CFR 101.9. Specifically, the outer tins do not contain any nutrition information and the inner label does not provide required nutrition information consistent with 21 CFR 101.9, including egregious formatting violations. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two or more languages but does not repeat all the required label information in all languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] because the outer packaging of the product fails to completely or accurately declare the place of business, street address, city, state and zip code. Section 801(a)(3) in that that the articles appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product fails to declare a statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.7. Specifically, the outer packaging fails to declare the net quantity of contents.

36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 11/28/2018

Desc: Syrup Waffles in Tin; Almond Blossom
Notes: Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in accordance with 21 CFR 101.9. Specifically, the outer tins do not contain any nutrition information and the inner label does not provide required nutrition information consistent with 21 CFR 101.9, including egregious formatting violations. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two or more languages but does not repeat all the required label information in all languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 801(a)(3) in that the articles appear to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] because the outer packaging of the product fails to completely or accurately declare the place of business, street address, city, state and zip code. Section 801(a)(3) in that that the articles appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product fails to declare a statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.7. Specifically, the outer packaging fails to declare the net quantity of contents.

Visser Kaashandel B.V.
Date Published : 10/02/2015
Nijverheidsweg 20 , Huizen, Noord-Holland NETHERLANDS
12 A - - 12 Cheese, Edam
Date Published: 10/02/2015

Desc: Edam Cheese
Notes: Product is misbranded within the meaning of section 403(i)(2) in that the label does not declare the product ingredients by the common or usual name as required by 21 CFR 101.4; Also; the product label does not declare the name and place of business of the manufacturer; packer or distributor in accordance with 21 CFR 101.5; Also; the product label does not declare the major food allergen properly using the word ¿contains¿; followed by the name of the food source from which the major food allergen is derived; Also; the product label does not declare the color additive(s) as required by 21 CFR 101.22.


NEW ZEALAND


NRG Group Limited
Date Published : 05/16/2019
Avondale , 438b Rosebank Road , Auckland, Auckland NEW ZEALAND
28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 05/16/2019

Desc: SeaCare Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 05/16/2019

Desc: SeaCare Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 05/16/2019

Desc: SeaCare Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/16/2019

Desc: SeaCare Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 05/16/2019

Desc: SeaCare Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/16/2019

Desc: SeaCare Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

Nrg Group Ltd
Date Published : 12/13/2016
76 Bluegrey Avenue , Auckland, NEW ZEALAND
28 C - - 99 Natural Extract or Flavor, N.E.C.
Date Published: 05/10/2019

Desc: Sea Care Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 05/10/2019

Desc: Sea Care Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 12/13/2016

Desc: Sea Care Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/10/2019

Desc: Sea Care Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 05/10/2019

Desc: Sea Care Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/10/2019

Desc: Sea Care Dietary Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive): 403(q)(5)(F) because the label fails to bear nutrition information as required by 21CFR101.36 - for example: (a) protein is declared above total carbohydrate; (b) protein is declared as '.7g'; (c) The product fails to express the nutrition information for the serving size of ½ tub for children (4 or more years of age) as noted under "Suggested Use". Nutrition information must be declared per serving size of the product for the intended group in accordance with 21 CFR 101.36(b)(1) and 101.36(b)(2)(iii)(E). Furthermore, the product fails to declare the number of servings for children in accordance with 21 CFR 101.36(b)(1)(ii).


NORWAY


Nutraq as
Date Published : 05/05/2015
Enebakkveien 117 , Oslo, NO-03 NORWAY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 05/05/2015

Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 05/05/2015

Desc: nbg 24 7 Dietary Supplement W/ Vit. C
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015

46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 05/05/2015

Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015

46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 05/05/2015

Desc: nbg 24 7 Dietary Supplement W/ Vit. C
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/05/2015

Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/05/2015

Desc: nbg 24 7 Dietary Supplement W/ Vit. C
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/05/2015

Desc: nbg 24 7 Dietary Supplement W/ Vit. C
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/05/2015

Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015


PAKISTAN


English Biscuit Manufacturers (Pvt.) Ltd.
Date Published : 10/02/2015
Plot 1-4, Sector 23, Korangi Industrial Area , Karachi, Sindh PAKISTAN
03 A - - 03 Biscuits
Date Published: 10/02/2015

Desc: Whole Wheat Slices - Pure Fibre
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) because the product label contains information in two languages, but does not repeat all the required information in both languages (e.g. Nutritonal Facts, name and address of responsible party, and net quantity of contents); Section 403(i)(1) because the statement of identity, "Whole Wheat Slices - Pure Fibre," is not the common or usual name for this product; Section 403(q) in that the nutrition information (e.g. Nutrition Facts Label) does not comply with the requirements in 21 CFR 101.9 (e.g. the serving size is incorrect as it is not based on the appropriate RACC and therefore the servings per container and all nutrient amounts are also incorrect, and the website which is listed on the product label includes the incorrect nutrition information); Section 403(r)(1)(B) because the product label bears health claims that have not been authorized by regulation or the Act (e.g. website label bears an unauthorized health claim: 'Whole Wheat Slices can regulate the digestive system, thus helping you to reduce cholesterol.').

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Whole Wheat Slices - Pure Fibre
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) because the product label contains information in two languages, but does not repeat all the required information in both languages (e.g. Nutritonal Facts, name and address of responsible party, and net quantity of contents); Section 403(i)(1) because the statement of identity, "Whole Wheat Slices - Pure Fibre," is not the common or usual name for this product; Section 403(q) in that the nutrition information (e.g. Nutrition Facts Label) does not comply with the requirements in 21 CFR 101.9 (e.g. the serving size is incorrect as it is not based on the appropriate RACC and therefore the servings per container and all nutrient amounts are also incorrect, and the website which is listed on the product label includes the incorrect nutrition information); Section 403(r)(1)(B) because the product label bears health claims that have not been authorized by regulation or the Act (e.g. website label bears an unauthorized health claim: 'Whole Wheat Slices can regulate the digestive system, thus helping you to reduce cholesterol.').

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Whole Wheat Slices - Pure Fibre
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) because the product label contains information in two languages, but does not repeat all the required information in both languages (e.g. Nutritonal Facts, name and address of responsible party, and net quantity of contents); Section 403(i)(1) because the statement of identity, "Whole Wheat Slices - Pure Fibre," is not the common or usual name for this product; Section 403(q) in that the nutrition information (e.g. Nutrition Facts Label) does not comply with the requirements in 21 CFR 101.9 (e.g. the serving size is incorrect as it is not based on the appropriate RACC and therefore the servings per container and all nutrient amounts are also incorrect, and the website which is listed on the product label includes the incorrect nutrition information); Section 403(r)(1)(B) because the product label bears health claims that have not been authorized by regulation or the Act (e.g. website label bears an unauthorized health claim: 'Whole Wheat Slices can regulate the digestive system, thus helping you to reduce cholesterol.').

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 10/02/2015

Desc: Whole Wheat Slices - Pure Fibre
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) because the product label contains information in two languages, but does not repeat all the required information in both languages (e.g. Nutritonal Facts, name and address of responsible party, and net quantity of contents); Section 403(i)(1) because the statement of identity, "Whole Wheat Slices - Pure Fibre," is not the common or usual name for this product; Section 403(q) in that the nutrition information (e.g. Nutrition Facts Label) does not comply with the requirements in 21 CFR 101.9 (e.g. the serving size is incorrect as it is not based on the appropriate RACC and therefore the servings per container and all nutrient amounts are also incorrect, and the website which is listed on the product label includes the incorrect nutrition information); Section 403(r)(1)(B) because the product label bears health claims that have not been authorized by regulation or the Act (e.g. website label bears an unauthorized health claim: 'Whole Wheat Slices can regulate the digestive system, thus helping you to reduce cholesterol.').

Golden Harvest Foods Pvt Ltd DBA Dawn Bread
Date Published : 08/25/2017
24-Plot 33 Sector , Karachi, Sindh PAKISTAN
03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 08/25/2017

Desc: Anarakali Whole Wheat Paratha
Notes: Section 403(e)(1) of the FD&C Act in that the product label fails to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. Section 403(f) of the FD&C Act in that the the product label contains information in a foreign language; but does not repeat all the required information in the foreign language as required by 21 CFR 101.15(c)(2). Additionally; the information required by 21 CFR 101.5(c) where the food is not manufactured by the person whose name appears on the label is qualified by a phrase that reveals the connection the person has with the food is not declared in the foreign language. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4.

National Foods
Date Published : 06/28/2019
F/160-C, S.I.T.E. , Karachi, SIND PAKISTAN
20 R - - 01 Apple, Jam, Jelly, Preserves, Marmalade, Butter and Candied
Date Published: 06/28/2019

Desc: Apple Jam
Notes: Article appears to be misbranded under:Section 403(g)-fails to conform to definition/standard.Product labeled as "Apple Jam" and ingredient statement includes artificial apple flavor. Standard for fruit preserves/jams does not provide for the use of apple as the sole fruit ingredient.Product contains ingredients not permitted 21CFR150.160.Sections 403(a)(1)/201(n)-LBL is false/misleading and fails to reveal the identified flavor is artificially derived.When a food contains any artificial flavor that simulates/resembles/reinforces the characterizing flavor,name of the food on LBL panels shall be accompanied by the common/usual name of characterizing flavor in letters not less than one-half the height of the letters used in the name of food/characterizing flavor shall be accompanied by the words "artificial"/"artificially flavored" in letters not less than one-half the height of the letters in the name of the characterizing flavor.Name of food is not accompanied by the words "artificial"/"artificially flavored" 21CFR101.22(i)2).Section 403(q)-nutrition facts LBL is not in accordance with 21CFR101.9:"Calories"/"Calories from Fat" does not appear on the same line 21CFR101.9(d)(5);"% Daily Value" precedes the "Calories"/"Calories from Fat" instead of following this information and the bar is missing after the information on "Calories"/"Calories from Fat." 21CFR101.9(d)(6);quantitative amounts for Total Fat,Saturated Fat,Cholesterol,Total Carbohydrate,Dietary Fiber,Sugars and Protein are not rounded correctly because they are declared to the first decimal place, and must be rounded in accordance with 21CFR101.9(c)(2)-101.9(c)(7);saturated fat/trans fat declarations cannot be combined/appear on the same line 21CFR101.9(d)(7);name of the nutrient is trans fat,not "trans."21CFR101.9(c)(2)(ii);bullets are not permitted to precede vitamin/mineral declarations 21CFR101.9(d)(8) and metric equivalent must be declared parenthetically instead of the common measure 21CFR101.9(b)(7).

21 C - - 20 Citrus and Other Fruits, Mixed, Flavored Jams, Jellies, Preserves, Marmalades, Butters and Candied
Date Published: 06/28/2019

Desc: Apple Jam
Notes: Article appears to be misbranded under:Section 403(g)-fails to conform to definition/standard.Product labeled as "Apple Jam" and ingredient statement includes artificial apple flavor. Standard for fruit preserves/jams does not provide for the use of apple as the sole fruit ingredient.Product contains ingredients not permitted 21CFR150.160.Sections 403(a)(1)/201(n)-LBL is false/misleading and fails to reveal the identified flavor is artificially derived.When a food contains any artificial flavor that simulates/resembles/reinforces the characterizing flavor,name of the food on LBL panels shall be accompanied by the common/usual name of characterizing flavor in letters not less than one-half the height of the letters used in the name of food/characterizing flavor shall be accompanied by the words "artificial"/"artificially flavored" in letters not less than one-half the height of the letters in the name of the characterizing flavor.Name of food is not accompanied by the words "artificial"/"artificially flavored" 21CFR101.22(i)2).Section 403(q)-nutrition facts LBL is not in accordance with 21CFR101.9:"Calories"/"Calories from Fat" does not appear on the same line 21CFR101.9(d)(5);"% Daily Value" precedes the "Calories"/"Calories from Fat" instead of following this information and the bar is missing after the information on "Calories"/"Calories from Fat." 21CFR101.9(d)(6);quantitative amounts for Total Fat,Saturated Fat,Cholesterol,Total Carbohydrate,Dietary Fiber,Sugars and Protein are not rounded correctly because they are declared to the first decimal place, and must be rounded in accordance with 21CFR101.9(c)(2)-101.9(c)(7);saturated fat/trans fat declarations cannot be combined/appear on the same line 21CFR101.9(d)(7);name of the nutrient is trans fat,not "trans."21CFR101.9(c)(2)(ii);bullets are not permitted to precede vitamin/mineral declarations 21CFR101.9(d)(8) and metric equivalent must be declared parenthetically instead of the common measure 21CFR101.9(b)(7).

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 06/28/2019

Desc: Apple Jam
Notes: Article appears to be misbranded under:Section 403(g)-fails to conform to definition/standard.Product labeled as "Apple Jam" and ingredient statement includes artificial apple flavor. Standard for fruit preserves/jams does not provide for the use of apple as the sole fruit ingredient.Product contains ingredients not permitted 21CFR150.160.Sections 403(a)(1)/201(n)-LBL is false/misleading and fails to reveal the identified flavor is artificially derived.When a food contains any artificial flavor that simulates/resembles/reinforces the characterizing flavor,name of the food on LBL panels shall be accompanied by the common/usual name of characterizing flavor in letters not less than one-half the height of the letters used in the name of food/characterizing flavor shall be accompanied by the words "artificial"/"artificially flavored" in letters not less than one-half the height of the letters in the name of the characterizing flavor.Name of food is not accompanied by the words "artificial"/"artificially flavored" 21CFR101.22(i)2).Section 403(q)-nutrition facts LBL is not in accordance with 21CFR101.9:"Calories"/"Calories from Fat" does not appear on the same line 21CFR101.9(d)(5);"% Daily Value" precedes the "Calories"/"Calories from Fat" instead of following this information and the bar is missing after the information on "Calories"/"Calories from Fat." 21CFR101.9(d)(6);quantitative amounts for Total Fat,Saturated Fat,Cholesterol,Total Carbohydrate,Dietary Fiber,Sugars and Protein are not rounded correctly because they are declared to the first decimal place, and must be rounded in accordance with 21CFR101.9(c)(2)-101.9(c)(7);saturated fat/trans fat declarations cannot be combined/appear on the same line 21CFR101.9(d)(7);name of the nutrient is trans fat,not "trans."21CFR101.9(c)(2)(ii);bullets are not permitted to precede vitamin/mineral declarations 21CFR101.9(d)(8) and metric equivalent must be declared parenthetically instead of the common measure 21CFR101.9(b)(7).

27 Y - - 03 Chutney
Date Published: 06/28/2019

Desc: Apple Jam
Notes: Article appears to be misbranded under:Section 403(g)-fails to conform to definition/standard.Product labeled as "Apple Jam" and ingredient statement includes artificial apple flavor. Standard for fruit preserves/jams does not provide for the use of apple as the sole fruit ingredient.Product contains ingredients not permitted 21CFR150.160.Sections 403(a)(1)/201(n)-LBL is false/misleading and fails to reveal the identified flavor is artificially derived.When a food contains any artificial flavor that simulates/resembles/reinforces the characterizing flavor,name of the food on LBL panels shall be accompanied by the common/usual name of characterizing flavor in letters not less than one-half the height of the letters used in the name of food/characterizing flavor shall be accompanied by the words "artificial"/"artificially flavored" in letters not less than one-half the height of the letters in the name of the characterizing flavor.Name of food is not accompanied by the words "artificial"/"artificially flavored" 21CFR101.22(i)2).Section 403(q)-nutrition facts LBL is not in accordance with 21CFR101.9:"Calories"/"Calories from Fat" does not appear on the same line 21CFR101.9(d)(5);"% Daily Value" precedes the "Calories"/"Calories from Fat" instead of following this information and the bar is missing after the information on "Calories"/"Calories from Fat." 21CFR101.9(d)(6);quantitative amounts for Total Fat,Saturated Fat,Cholesterol,Total Carbohydrate,Dietary Fiber,Sugars and Protein are not rounded correctly because they are declared to the first decimal place, and must be rounded in accordance with 21CFR101.9(c)(2)-101.9(c)(7);saturated fat/trans fat declarations cannot be combined/appear on the same line 21CFR101.9(d)(7);name of the nutrient is trans fat,not "trans."21CFR101.9(c)(2)(ii);bullets are not permitted to precede vitamin/mineral declarations 21CFR101.9(d)(8) and metric equivalent must be declared parenthetically instead of the common measure 21CFR101.9(b)(7).

Qarshi Industries (Pvt) Ltd
Date Published : 10/02/2015
Plot No. 56/1-4, Industrial Estate , Hattar, Distt: Haripur, Khyber Pakhtunkhwa , Haripur, Khyber Pakhtunkhwa PAKISTAN
22 J - - 99 Other Fruit and Fruit Products, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 10/02/2015

Desc: Qarshi Amla Preserve
Notes: Charge; 403(q) Crude Fat is not an allowed term for Total Fat [21 CFR 101.9(c)(2)]. The amount of Sodium is not declared [21 CFR 101.9(c)(4)]. Crude Fibre is not an allowed term for Dietary Fiber [21 CFR 101.9(c)(6)(i)]. Crude Protein is not an allowed term for Protein [21 CFR 101.9(c)(7)]. The footnote calculations are not being declared correctly in accordance with 21 CFR 101.9(d)(9)(i).

22 J - - 99 Other Fruit and Fruit Products, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 10/02/2015

Desc: Qarshi Carrot Preserve
Notes: Charge; 403(q) Crude Fat is not an allowed term for Total Fat [21 CFR 101.9(c)(2)]. The amount of Sodium is not declared [21 CFR 101.9(c)(4)]. Crude Fibre is not an allowed term for Dietary Fiber [21 CFR 101.9(c)(6)(i)]. Crude Protein is not an allowed term for Protein [21 CFR 101.9(c)(7)]. The footnote calculations are not being declared correctly in accordance with 21 CFR 101.9(d)(9)(i).

22 J - - 99 Other Fruit and Fruit Products, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 10/02/2015

Desc: Qarshi Apple Preserve
Notes: Charge; 403(q) Crude Fat is not an allowed term for Total Fat [21 CFR 101.9(c)(2)]. The amount of Sodium is not declared [21 CFR 101.9(c)(4)]. Crude Fibre is not an allowed term for Dietary Fiber [21 CFR 101.9(c)(6)(i)]. Crude Protein is not an allowed term for Protein [21 CFR 101.9(c)(7)]. The footnote calculations are not being declared correctly in accordance with 21 CFR 101.9(d)(9)(i).

22 J - - 99 Other Fruit and Fruit Products, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 10/02/2015

Desc: Qarshi Harar Preserve
Notes: Charge; 403(q) Crude Fat is not an allowed term for Total Fat [21 CFR 101.9(c)(2)]. The amount of Sodium is not declared [21 CFR 101.9(c)(4)]. Crude Fibre is not an allowed term for Dietary Fiber [21 CFR 101.9(c)(6)(i)]. Crude Protein is not an allowed term for Protein [21 CFR 101.9(c)(7)]. The footnote calculations are not being declared correctly in accordance with 21 CFR 101.9(d)(9)(i).

Rehmat-e-Shereen
Date Published : 10/02/2015
Shams Centre, Main Tariq Road , Karachi, Sindh PAKISTAN
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/02/2015

Desc: Akhrot Halwa (Walnut Fudge)
Notes: • The serving size and servings per container are not declared; 2) Amount Per Serving is not declared; 3)nutrient terms are not stated correctly: Calories from Fat, Total Fat, Saturated Fat, Trans Fat, Total Carbohydrates, and Dietary Fiber; 4) statement "Not significant values" declared for Vitamin A and Vitamin C within the Nutrition Facts panel is not allowed; 5) there is no Daily Value for sugar so a percent daily value should not be declared; 6) Calcium and Iron are listed in mg amounts which is not permitted; 7)saturated fat and trans-fat values are inappropriately added together with a single daily value. These values must be declared separately. Additionally, there is no established daily value for trans fat. • While not deviations covered by IA 99-20, other label violations of note include: The net wt. statement does not appear on the PDP as required and information appears in more than one language but, all required information does not appear in all languages as required. For example, the ingredient statement does not appear in all languages.

33 G - - 99 Soft Candy with Nuts or Nut Products, N.E.C. (without Chocolate)
Date Published: 10/02/2015

Desc: Akhrot Halwa (Walnut Fudge)
Notes: • The serving size and servings per container are not declared; 2) Amount Per Serving is not declared; 3)nutrient terms are not stated correctly: Calories from Fat, Total Fat, Saturated Fat, Trans Fat, Total Carbohydrates, and Dietary Fiber; 4) statement "Not significant values" declared for Vitamin A and Vitamin C within the Nutrition Facts panel is not allowed; 5) there is no Daily Value for sugar so a percent daily value should not be declared; 6) Calcium and Iron are listed in mg amounts which is not permitted; 7)saturated fat and trans-fat values are inappropriately added together with a single daily value. These values must be declared separately. Additionally, there is no established daily value for trans fat. • While not deviations covered by IA 99-20, other label violations of note include: The net wt. statement does not appear on the PDP as required and information appears in more than one language but, all required information does not appear in all languages as required. For example, the ingredient statement does not appear in all languages.

37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 10/02/2015

Desc: Akhrot Halwa (Walnut Fudge)
Notes: • The serving size and servings per container are not declared; 2) Amount Per Serving is not declared; 3)nutrient terms are not stated correctly: Calories from Fat, Total Fat, Saturated Fat, Trans Fat, Total Carbohydrates, and Dietary Fiber; 4) statement "Not significant values" declared for Vitamin A and Vitamin C within the Nutrition Facts panel is not allowed; 5) there is no Daily Value for sugar so a percent daily value should not be declared; 6) Calcium and Iron are listed in mg amounts which is not permitted; 7)saturated fat and trans-fat values are inappropriately added together with a single daily value. These values must be declared separately. Additionally, there is no established daily value for trans fat. • While not deviations covered by IA 99-20, other label violations of note include: The net wt. statement does not appear on the PDP as required and information appears in more than one language but, all required information does not appear in all languages as required. For example, the ingredient statement does not appear in all languages.

Shangrila Foods Private Limited
Date Published : 09/13/2017
Plot No. F-33, Site Phase Ii , Scheme 33, Super Highway , Karachi, Sindh PAKISTAN
21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates
Date Published: 09/13/2017

Desc: Fruit Punch Drink
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(f) of the FD&C Act in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2).

21 D - - 09 Other Fruits, Mixed, Juices or Concentrates
Date Published: 09/13/2017

Desc: Fruit Punch Drink
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(f) of the FD&C Act in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2).

21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 09/13/2017

Desc: Fruit Punch Drink
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(f) of the FD&C Act in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2).


PHILIPPINES


Amherst Laboratories
Date Published : 05/11/2023
Greenfield Industrial , Binan Laguna, PHILIPPINES
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 05/11/2023

Desc: Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within of section: 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and section 1453(a)(3)(A)(i) of the FPLA [15 U.S.C. §1453(a)(3)(A)(i)] because the labels fail to declare a complete and accurate statement of the net quantity of contents on the principal display panel as required by 21 CFR 101.7. 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual names of each dietary ingredient and dietary ingredient source as required by 21 CFR 101.36 and 21 CFR 101.4. 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

54 A - - 99 Vitamin, N.E.C.
Date Published: 05/11/2023

Desc: Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within of section: 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and section 1453(a)(3)(A)(i) of the FPLA [15 U.S.C. §1453(a)(3)(A)(i)] because the labels fail to declare a complete and accurate statement of the net quantity of contents on the principal display panel as required by 21 CFR 101.7. 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual names of each dietary ingredient and dietary ingredient source as required by 21 CFR 101.36 and 21 CFR 101.4. 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

CROLEY FOODS MANUFACTURING CORPORATION
Date Published : 11/16/2022
London Drive, Bgy Gulod, Novaliches , Quezon City, National Capital Region (Manil PHILIPPINES
03 A - - 03 Biscuits
Date Published: 11/16/2022

Desc: Sunflower Crackers Cream Sandwich Mango Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)], in that each ingredient is not declared by its common or usual name [21 CFR 101.4]. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 A - - 03 Biscuits
Date Published: 11/16/2022

Desc: Butter Cream Crackers
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)], because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 A - - 03 Biscuits
Date Published: 11/16/2022

Desc: Sunflower Crackers Original
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9].

03 A - - 03 Biscuits
Date Published: 11/16/2022

Desc: Sunflower Crackers Cream Sandwich Strawberry Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)], in that each ingredient is not declared by its common or usual name [21 CFR 101.4]. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 F - - 02 Flavored or Party Crackers
Date Published: 11/16/2022

Desc: Butter Cream Crackers
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)], because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 F - - 02 Flavored or Party Crackers
Date Published: 11/16/2022

Desc: Sunflower Crackers Original
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9].

03 F - - 02 Flavored or Party Crackers
Date Published: 11/16/2022

Desc: Sunflower Crackers Cream Sandwich Strawberry Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)], in that each ingredient is not declared by its common or usual name [21 CFR 101.4]. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 F - - 02 Flavored or Party Crackers
Date Published: 11/16/2022

Desc: Sunflower Crackers Cream Sandwich Mango Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)], in that each ingredient is not declared by its common or usual name [21 CFR 101.4]. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 11/16/2022

Desc: Sunflower Crackers Original
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9].

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 11/16/2022

Desc: Butter Cream Crackers
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)], because the product label contains information in two languages, but does not repeat all the required information in both languages. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 G - - 99 Filled Crackers N.E.C.
Date Published: 11/16/2022

Desc: Sunflower Crackers Cream Sandwich Mango Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)], in that each ingredient is not declared by its common or usual name [21 CFR 101.4]. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

03 G - - 99 Filled Crackers N.E.C.
Date Published: 11/16/2022

Desc: Sunflower Crackers Cream Sandwich Strawberry Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)], in that each ingredient is not declared by its common or usual name [21 CFR 101.4]. Section 403(k) of the Act [21 U.S.C. 343(k)], in that the products contain artificial coloring but fail to bear labeling stating that fact. Section 403(q) of the Act [21 U.S.C. 343(q)], in that the nutrition information is not in a correct format [21 CFR 101.9]. Section 403(k) of the Act [21 U.S.C. 343(k)] in that the products contain artificial coloring but fail to bear labeling stating that fact.

Coca-Cola Beverages Philippines
Date Published : 09/12/2016
28f Net Lima Building, 5th Avenue Corner 26th Street , Bonifacio Global City , Taguig City, PH-00 PHILIPPINES
29 B - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Carbonated
Date Published: 09/12/2016

Desc: Royal Tru Orange Carbonated Drink (1.5 L bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403 (e)(2) of the FD&C Act.

29 B - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Carbonated
Date Published: 09/12/2016

Desc: Royal Tru Orange Carbonated Drink (500 mL bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

29 B - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Carbonated
Date Published: 09/12/2016

Desc: Royal Tru Orange Carbonated Drink (330 mL can)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) in that the label or labeling bears an unauthorized nutrient content/health claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403 (e)(2) of the FD&C Act.

EXTREME XCIENCE, INC.
Date Published : 10/02/2015
Antel Global Corporate Center , Unit 1010 , Metro Manila, National Capital Region PHILIPPINES
25 G - - 99 Mixed Vegetables, Juice or Drink, N.E.C.
Date Published: 10/02/2015

Desc: Greenlife Veggie Plus Health Drink
Notes: NOTE; SRL analyzed the protein content of these products (sample #728571; #728624). Their findings indicate that these products were violative for protein content; as percent label declared amount. The lab?s review of the labels also found that the products do not comply with NLEA or DSHEA labeling requirements.

50 L - - 32 Vegetable Juice
Date Published: 10/02/2015

Desc: Greenlife Veggie Plus Health Drink
Notes: NOTE; SRL analyzed the protein content of these products (sample #728571; #728624). Their findings indicate that these products were violative for protein content; as percent label declared amount. The lab?s review of the labels also found that the products do not comply with NLEA or DSHEA labeling requirements.

Edlou Enterprises
Date Published : 10/02/2015
341 Cristobal Street, Samapaloc, Manila , Manila, PH-ILS PHILIPPINES
16 J - H 05 Shrimp & Prawns, Ntrl/Artfcl Dried
Date Published: 10/02/2015

Notes: Dried Shrimp Fry

16 X - H 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Ntrl/Artfcl Dried
Date Published: 10/02/2015

Notes: Dried Shrimp Fry

Goldilocks Bakeshop
Date Published : 05/05/2023
498 Shaw Boulevard , Metro Manila, National Capital Region PHILIPPINES
03 A - - 03 Biscuits
Date Published: 05/05/2023

Desc: Goldilocks Sweet Delights Ube Polvoron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)], in that the label is false or misleading because it fails to reveal the material fact that the identified flavor “ube” is artificially derived, as required by 21 CFR 101.22(i)(2). Section 403(f) of the Act [21 U.S.C. §343(f)], in that the labels (inner and outer) bear foreign terms such as “ube” and “Polvoron”, but fail to declare any other information required in the foreign language, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the label declares Artificial Colors (Lake Violet and Lake Allura Red), and the article was found to contain FD&C Blue No. 1 and FD&C Red No. 3, and were not declared, as required by 21 CFR 101.22(k)(1); in that the ingredient “Fortified Wheat Flour (Wheat Flour, Iron and Vitamin A)” is not declared by its common or usual name, as required by 21 CFR 101.4(a)(1); and that the ingredient “refined sugar” is not declared by its common or usual name, as required by CFR 101.4(b)(20). Section 403(q) of the Act [21 U.S.C. 343(q)], in that its inner unit containers do not bear nutrition information on the labeling, and is not an exemption under 21 CFR 101.9(j)(15).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 05/05/2023

Desc: Goldilocks Sweet Delights Ube Polvoron
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)], in that the label is false or misleading because it fails to reveal the material fact that the identified flavor “ube” is artificially derived, as required by 21 CFR 101.22(i)(2). Section 403(f) of the Act [21 U.S.C. §343(f)], in that the labels (inner and outer) bear foreign terms such as “ube” and “Polvoron”, but fail to declare any other information required in the foreign language, as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the label declares Artificial Colors (Lake Violet and Lake Allura Red), and the article was found to contain FD&C Blue No. 1 and FD&C Red No. 3, and were not declared, as required by 21 CFR 101.22(k)(1); in that the ingredient “Fortified Wheat Flour (Wheat Flour, Iron and Vitamin A)” is not declared by its common or usual name, as required by 21 CFR 101.4(a)(1); and that the ingredient “refined sugar” is not declared by its common or usual name, as required by CFR 101.4(b)(20). Section 403(q) of the Act [21 U.S.C. 343(q)], in that its inner unit containers do not bear nutrition information on the labeling, and is not an exemption under 21 CFR 101.9(j)(15).

IMXPO INCORPORATED
Date Published : 09/12/2016
186 Brgy. 2/F Mt. Apo Building Victoria , Wave Special Economic Zone , Metro Manila, National Capital Region PHILIPPINES
29 B - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Carbonated
Date Published: 09/12/2016

Desc: Royal Tru Orange Carbonated Drink (330 mL can)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) in that the label or labeling bears an unauthorized nutrient content/health claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403 (e)(2) of the FD&C Act.

29 B - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Carbonated
Date Published: 09/12/2016

Desc: Royal Tru Orange Carbonated Drink (500 mL bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

29 B - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Carbonated
Date Published: 09/12/2016

Desc: Royal Tru Orange Carbonated Drink (1.5 L bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403 (e)(2) of the FD&C Act.

JOY TABLE SAUCE
Date Published : 10/02/2015
13 4th Street , Butuan City, Caraga PHILIPPINES
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/02/2015

Notes: Desc; Hydrosol; Joy Tanglad Distilled Lemongrass (Hydrosol-Yellow Colored Label);Note; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title ?Supplement Facts?; in accordance with 21 CFR 101.36. In addition; the article is misbranded within the meaning of sections 403(s)(2)(B) of the Act in that the label fails to identify the products using the term ?dietary supplement? in accordance with 21 CFR 101.3(g) as part of the product's statement of identity; except that the word

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/02/2015

Desc: Hydrosol Arapal Livelihood Distilled Lemongrass*
Notes: Desc; Hydrosol; Arapal Livelihood Distilled Lemongrass (Hydrosol-Lime Green/Yellow Gradient Label);Note: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear supplement facts information in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403(e) (1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 10/02/2015

Desc: Hydrosol Joy Tanglad Distilled Lemongrass
Notes: Desc: Hydrosol; Joy Tanglad DNote: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts, in accordance with 21 CFR 101.36;In addition, the article is misbranded within the meaning of section 403(s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product; In addition, the article is misbranded within the meaning of section 403(e)(1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5 istilled Lemongrass (Orange Colored Label);

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Desc: Hydrosol Joy Tanglad Distilled Lemongrass*
Notes: Desc: Hydrosol; Joy Tanglad Distilled Lemongrass (Hydrosol-Yellow Colored Label) Note: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts, in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403 (y) of the Act in that the label fails to include a domestic address or phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Desc: Hydrosol Joy Tanglad Distilled Lemongrass
Notes: Desc: Hydrosol; Joy Tanglad DNote: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition information enclosed in a box using hairlines with the title Supplement Facts, in accordance with 21 CFR 101.36;In addition, the article is misbranded within the meaning of section 403(s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product; In addition, the article is misbranded within the meaning of section 403(e)(1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5 istilled Lemongrass (Orange Colored Label); ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Desc: Hydrosol Arapal Livelihood Distilled Lemongrass*
Notes: Desc; Hydrosol; Arapal Livelihood Distilled Lemongrass (Hydrosol-Lime Green/Yellow Gradient Label)Note: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear supplement facts information in accordance with 21 CFR 101.36. In addition, the article is misbranded within the meaning of sections 403 (s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g) as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product. In addition, the article is misbranded within the meaning of section 403(e) (1) of the Act in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

Kraft Foods Philipppines Inc.
Date Published : 02/03/2015
8378 Dr A Santos Avenue , Paranaque City , Metro Manila, PHILIPPINES
12 A - - 05 Cheese, Cheddar
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives; and food starches are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

12 B - - 05 Pasteurized Cheese Spread
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives; and food starches are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

12 B - - 09 Pasteurized Process Cheese Foods
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives; and food starches are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives and food starched are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

LEJAL LAB INC.
Date Published : 03/12/2020
MacArthur Highway , Meycauayan, Bulacan PHILIPPINES
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022

60 - - - -- Human and Animal Drugs
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

61 - - - -- Human and Animal Drugs
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

62 - - - -- Human and Animal Drugs
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

63 - - - -- Human and Animal Drugs
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

64 - - - -- Human and Animal Drugs
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

65 - - - -- Human and Animal Drugs
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

66 - - - -- Human and Animal Drugs
Date Published: 03/12/2020

Desc: LiverGuard Silymarin Lecithin Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

Mondelez Global
Date Published : 02/03/2015
8378 Dr. A. Santos Avenue , Paranaque, National Capital Region PHILIPPINES
12 A - - 05 Cheese, Cheddar
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives; and food starches are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

12 B - - 05 Pasteurized Cheese Spread
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives; and food starches are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). ; The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

12 B - - 09 Pasteurized Process Cheese Foods
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: ;Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives; and food starches are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). ; The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Pasteurized Process Cheese Foods Desc:Eden Cheese Notes:The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 02/03/2015

Desc: Eden Cheese
Notes: ;Problem(s); The net weight statement does not appear on the Principal Display Panel In terms of avoirdupois pound and ounce. The ingredient Natural Cheese appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed. Further; the terms emulsifiers; preservatives; and food starches are not specific common or usual names. The label bears information in a foreign language but it does not bear all the required information in both English and the foreign language in accordance with 21 CFR 101.15(c)(2). ; The nutrition facts information is not in an appropriate format; the serving size is not listed in household measure. The product is labeled with the statement "High in iron; iodine; vit A & B2" but the listed percent RDI for iron and vitamin B2 is 10% which does not meet the requirement for a high claim. Published on 02/02/2015

Nutri-Asia, Incorporated dba UFC Philippines
Date Published : 03/18/2016
Diezmo Road, Sitio IIaya , Barangy Diezmo , Laguna, Calabarzon PHILIPPINES
27 Y - - 99 Condiments, N.E.C.
Date Published: 02/15/2024

Desc: Hot & Spicy Jufran Banana Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Product labels contain information in multiple languages but does not repeat the required information in all languages (21 CFR 101.15(c) and 21 CFR 101.15(c)(2)). Section 403(a)(1) of the Act in that the labels are false or misleading. The labels fail to declare the artificial flavor as part of the statement of identity, in accordance with 21 CFR 101.22(i)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the Nutrition Facts label does not meet the requirements under 21 CFR 101.9. The serving size for the product does not appear to be based on the correct reference amount customarily consumed (RACC) ( 21 CFR 101.12(b) and 21 CFR 101.9(b)(2) Table 2. RACC for these products would fall under “Major condiments, e.g., catsup, steak sauce, soy sauce, vinegar, teriyaki sauce, marinades” which is 1 tbsp. Consequently, all the nutrient information is incorrectly declared.

37 J - - 03 Chili Sauce
Date Published: 03/18/2016

Desc: Sweet Chili Sauce
Notes: The following are not declared as required; Calories from Fat content; Total fat content; Saturated Fat content; Trans fat content; Sodium content; Dietary fiber content; Sugars content; Protein content; and Vitamins and Minerals. The heading and values for the %Daily Value of the required nutrients; vitamins and minerals is not declared as required. The nutrient information in the footnote or the abbreviated footnote with an asterisk with the statement "Percent daily values are based on a 2;000 calorie diet"is not declared as required. The product fails to declare the net quantity of contents statement in avoirdupois pound and ounce on the PDP as required. The product label lists the following ingredient;"acidulant." All ingredients must be listed by their appropriate common and usual names.

37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 02/15/2024

Desc: Hot & Spicy Jufran Banana Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Product labels contain information in multiple languages but does not repeat the required information in all languages (21 CFR 101.15(c) and 21 CFR 101.15(c)(2)). Section 403(a)(1) of the Act in that the labels are false or misleading. The labels fail to declare the artificial flavor as part of the statement of identity, in accordance with 21 CFR 101.22(i)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the Nutrition Facts label does not meet the requirements under 21 CFR 101.9. The serving size for the product does not appear to be based on the correct reference amount customarily consumed (RACC) ( 21 CFR 101.12(b) and 21 CFR 101.9(b)(2) Table 2. RACC for these products would fall under “Major condiments, e.g., catsup, steak sauce, soy sauce, vinegar, teriyaki sauce, marinades” which is 1 tbsp. Consequently, all the nutrient information is incorrectly declared.

37 J - - 13 Banana Sauce
Date Published: 02/15/2024

Desc: Hot & Spicy Jufran Banana Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Product labels contain information in multiple languages but does not repeat the required information in all languages (21 CFR 101.15(c) and 21 CFR 101.15(c)(2)). Section 403(a)(1) of the Act in that the labels are false or misleading. The labels fail to declare the artificial flavor as part of the statement of identity, in accordance with 21 CFR 101.22(i)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the Nutrition Facts label does not meet the requirements under 21 CFR 101.9. The serving size for the product does not appear to be based on the correct reference amount customarily consumed (RACC) ( 21 CFR 101.12(b) and 21 CFR 101.9(b)(2) Table 2. RACC for these products would fall under “Major condiments, e.g., catsup, steak sauce, soy sauce, vinegar, teriyaki sauce, marinades” which is 1 tbsp. Consequently, all the nutrient information is incorrectly declared.

37 J - - 99 Sauces, n.e.c.
Date Published: 02/15/2024

Desc: Hot & Spicy Jufran Banana Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act. Product labels contain information in multiple languages but does not repeat the required information in all languages (21 CFR 101.15(c) and 21 CFR 101.15(c)(2)). Section 403(a)(1) of the Act in that the labels are false or misleading. The labels fail to declare the artificial flavor as part of the statement of identity, in accordance with 21 CFR 101.22(i)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the Nutrition Facts label does not meet the requirements under 21 CFR 101.9. The serving size for the product does not appear to be based on the correct reference amount customarily consumed (RACC) ( 21 CFR 101.12(b) and 21 CFR 101.9(b)(2) Table 2. RACC for these products would fall under “Major condiments, e.g., catsup, steak sauce, soy sauce, vinegar, teriyaki sauce, marinades” which is 1 tbsp. Consequently, all the nutrient information is incorrectly declared.

RFM Corporation
Date Published : 06/26/2019
Pioneer Business Park , Fairlane Street, Pineda , Metro Manila, National Capital Region PHILIPPINES
37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 06/26/2019

Desc: Sweet spaghetti sauce with Parmesan cheese
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 USC §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9, whereby the product label fails to declare a serving size based on the reference amount customarily consumed (RACC); nutrition information lists a daily value for Calories, which is not permitted, and fails to list the daily values for fats, cholesterol, sodium, Total Carbohydrates, and dietary fiber; the footnote is not declared in accordance with 21 CFR 101.9(d)(9). The Nutrition Facts heading is not set with the full width of the Nutrition Facts label. [21 CFR 101.9(d)(2)]. Section 403(i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and the ingredients are not declared appropriately, as required under 21 CFR 101.4. Vegetable protein does not list source; "Seasoning" is not the common or usual name of a food ingredient; the sub-ingredients of the parmesan cheese are not listed on the label. Note that parmesan cheese is a standardized food, 21 CFR 133.165, European "E" numbers for additives are not part of the common or usual name of these ingredients and are not permitted to be in the ingredient statement and are intervening material in this location (21 CFR 101.2(e)). Section 403(f) of the Act [21 USC §343(f)] because the product label contains information in multiple languages but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c)(2), The label bears statements in French and Filipino, in addition to English. Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure in US measure (avoirdupois pound(s) and ounce(s)) as required by 21 CFR 101.7.

Total Nature's Great Value, Inc.
Date Published : 10/02/2015
Balite I , Silang, Cavite PHILIPPINES
21 D - - 13 Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates
Date Published: 10/02/2015

Notes: Bio Enzyme Plus Natural Fruit Juice

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 10/02/2015

Notes: Bio Enzyme Plus Natural Fruit Juice

W.L. Food Products
Date Published : 12/13/2019
No. 8 Furong Street , Metro Manila, National Capital Region PHILIPPINES
07 B - - 02 Corn Chips, Fried
Date Published: 12/13/2019

Desc: Super Bawang Corn Snack Natural Garlic Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two/more ingredients and the common/usual name of each ingredient is not declared on the LBL, as required under 21 CFR 101.4.For example: the product is labeled to contain "soy sauce powder."This ingredient is itself comprised of multiple ingredients which are not declared on the LBL. [21 CFR 101.4(b)(2)].The product is labeled to contain "hydrolyzed vegetable protein;" however, the vegetable source is not identified as required by 21 CFR 101.4(b)(14). According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or "sub- ingredients") may be met by either parenthetically listing the component ingredients after the common/usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9.Specifically, the serving size does not appear to be based upon the correct RACC as required by 21 CFR 101.12(b), Table 2.The RACC for snack foods is 30 grams, not 100 grams. As such, all of the nutrient values and the servings per container statement are incorrect. Product shipments of this violative product were transmitted under various PC's to FDA. Therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 12/13/2019

Desc: Super Bawang Corn Snack Natural Garlic Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two/more ingredients and the common/usual name of each ingredient is not declared on the LBL, as required under 21 CFR 101.4.For example: the product is labeled to contain "soy sauce powder."This ingredient is itself comprised of multiple ingredients which are not declared on the LBL. [21 CFR 101.4(b)(2)].The product is labeled to contain "hydrolyzed vegetable protein;" however, the vegetable source is not identified as required by 21 CFR 101.4(b)(14). According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or "sub- ingredients") may be met by either parenthetically listing the component ingredients after the common/usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9.Specifically, the serving size does not appear to be based upon the correct RACC as required by 21 CFR 101.12(b), Table 2.The RACC for snack foods is 30 grams, not 100 grams. As such, all of the nutrient values and the servings per container statement are incorrect. Product shipments of this violative product were transmitted under various PC's to FDA. Therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

07 Q - - 03 Corn (Whole Kernel) Snacks, Vegetable Snacks (Other than Pulses) Baked
Date Published: 12/13/2019

Desc: Super Bawang Corn Snack Natural Garlic Flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two/more ingredients and the common/usual name of each ingredient is not declared on the LBL, as required under 21 CFR 101.4.For example: the product is labeled to contain "soy sauce powder."This ingredient is itself comprised of multiple ingredients which are not declared on the LBL. [21 CFR 101.4(b)(2)].The product is labeled to contain "hydrolyzed vegetable protein;" however, the vegetable source is not identified as required by 21 CFR 101.4(b)(14). According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or "sub- ingredients") may be met by either parenthetically listing the component ingredients after the common/usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9.Specifically, the serving size does not appear to be based upon the correct RACC as required by 21 CFR 101.12(b), Table 2.The RACC for snack foods is 30 grams, not 100 grams. As such, all of the nutrient values and the servings per container statement are incorrect. Product shipments of this violative product were transmitted under various PC's to FDA. Therefore, please verify the true identity of product shipments from this firm offered for entry into the US.


POLAND


Cinna-Produkty Zdrowia Sp.z o.o.
Date Published : 10/02/2015
Ul. Poznanska 88 , Pobiedziska, Wielkopolskie POLAND
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 02/20/2019

Desc: LycoLife Lycopene Drink; Apple Peach Flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Grape flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

20 D - - 13 Raspberry, Red, Berry Juice or Concentrates
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Peach flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Apple Mango Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Grape flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Pomegranate flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a) (3), 403(r)(1)(A), 403(q) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9 (b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans fat- however there is no DV for trans fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

21 K - - 13 Peach, Juice, Pit Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Peach flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a) (3), 403(r)(1)(A), 403(q) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9 (b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans fat- however there is no DV for trans fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

21 K - - 13 Peach, Juice, Pit Fruit Juices or Concentrates
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Pomegranate flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a) (3), 403(r)(1)(A), 403(q) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9 (b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans fat- however there is no DV for trans fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

24 J - - 50 Tomatoes, Juice
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Apple Mango Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

24 J - - 50 Tomatoes, Juice
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Pomegranate flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a) (3), 403(r)(1)(A), 403(q) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9 (b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans fat- however there is no DV for trans fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

24 J - - 50 Tomatoes, Juice
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

24 J - - 50 Tomatoes, Juice
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Peach flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

24 J - - 50 Tomatoes, Juice
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Grape flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 04/28/2016

Desc: LycoLife Lycopene Drink; Apple Grape flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 04/28/2016

Desc: LycoLife Lycopene Drink; Apple Pomegranate flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a) (3), 403(r)(1)(A), 403(q) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9 (b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans fat- however there is no DV for trans fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Apple Mango Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 04/28/2016

Desc: LycoLife Lycopene Drink; Apple Peach flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

30 A - - 04 Beverage Base, Mixed Fruit
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

30 A - - 04 Beverage Base, Mixed Fruit
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Apple Mango Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

30 A - - 04 Beverage Base, Mixed Fruit
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Grape flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

30 A - - 04 Beverage Base, Mixed Fruit
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Peach flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

30 A - - 04 Beverage Base, Mixed Fruit
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Pomegranate flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a) (3), 403(r)(1)(A), 403(q) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9 (b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans fat- however there is no DV for trans fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

30 B - - 01 Beverage Base, Berry, Liquid
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

30 B - - 03 Beverage Base, Core Fruit, Liquid
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Pomegranate flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a) (3), 403(r)(1)(A), 403(q) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9 (b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans fat- however there is no DV for trans fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

30 B - - 03 Beverage Base, Core Fruit, Liquid
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Peach flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

30 B - - 03 Beverage Base, Core Fruit, Liquid
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

30 B - - 03 Beverage Base, Core Fruit, Liquid
Date Published: 10/02/2015

Desc: LycoLife Lycopene Drink; Apple Grape flavored
Notes: The drinks appear to be misbranded within the meaning of Sections 801(a)(3), 403(r)(1)(A), 403(q), 403(i)(1) and 403(i)(2) of the Act. For 403(r)(1)(A), in that the labeling bears unauthorized nutrient content claims not complying with: 21 CFR 101.60(c)(2)(v)(no sugar added claim); 21 CFR 101.60(a)(natural sugar claims); and 21 CFR 101.54 (lycopene claims). For 403(q) in that the nutrition information does not comply with the following regulations: serving size is not based on 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b); Vitamin A, iron, and calcium are not declared per 21 CFR 101.9(c)(8); Lycopene is not permitted to be declared in the nutrition facts panel under 21 CFR 101.9; and the label provides a percent daily value for trans-fat- however there is no DV for trans-fat; for the apple grape and apple peach products, there is no statement of the number of grams of protein [21 CFR 101.9(c)(7)] and there is no percent daily value declared for dietary fiber [21 CFR 101.9(d)(7)]. For 403(i)(1) in that the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted." For 403(i)(2) in that the labels do not bear a statement of the total percentage of fruit juice contained in the food as required by 21 CFR 101.30.

30 B - - 03 Beverage Base, Core Fruit, Liquid
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Apple Mango Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

30 B - - 04 Beverage Base, Mixed Fruit, Liquid
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Multi-Fruit Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

30 B - - 04 Beverage Base, Mixed Fruit, Liquid
Date Published: 02/19/2019

Desc: LycoLife Lycopene Drink; Apple Mango Flavored
Notes: The products are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the names of the products do not meet the requirements in 21 CFR 102.33(g)(1). According to the ingredient lists, the products are made with multiple juices from concentrate; however, the names of the products do not include a term that indicates that the beverages are "from concentrate" or "reconstituted."

Kdc Sp. Zoo
Date Published : 06/24/2016
Ul Wysogotowska 15 , Przezmierowo, POLAND
20 C - - 05 Currants, Black, Jam, Jelly, Preserves, Marmalade, Butter and Candied
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C.
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

33 L - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

Pomorzanka, Ul
Date Published : 06/24/2016
Zielona 24, 83-200, starogard , Gdanski, POLAND
20 C - - 05 Currants, Black, Jam, Jelly, Preserves, Marmalade, Butter and Candied
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C.
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

33 L - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

33 M - - 06 Jelly Fruit Poppers Candy
Date Published: 06/24/2016

Desc: Makarena Fruit Jelly
Notes: The product appears to be misbranded within the meaning of:(1)Section 403 (f) of the FD&C Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language); (2)Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format, as required by 21 CFR 101.9; (3) Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard;(4) Section 403(i)(2) of the Act for failing to declare the ingredients (i.e., "acidity regulator: citric acid," "thickener: agar," "flavors," and "color") by their common or usual name in accordance with 21 CFR 101.4(a).

SPOLDZIELNIA MLECZARSKA
Date Published : 07/23/2020
Ul. Elewatorska 13 , Grajewo, Podlaskie POLAND
09 C - - 09 Milk, Plain
Date Published: 07/23/2020

Desc: Milk UHT With Strawberry
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] . Carotenes" is not a specific name of an ingredient. If "carotenes" refers to a color additive, the ingredient must be named in accordance with 21 CFR 101.22(k). If this is a color additive, the product appears to be misbranded with the meaning of section 403(k) of the Act. It does not appear to be used as a nutrient supplement because there is no vitamin A declaration in the nutrition label as required under 21 CFR 101.9(c)(8)(ii) if a nutrient is added as a nutrient supplement. Articles based upon the fat content of the products, the milk ingredients should be declared as "reduced fat milk" or "low fat milk" in the ingredient statement depending on which nutrient content claim the food qualifies for under 21 CFR 101.62.

09 C - - 09 Milk, Plain
Date Published: 07/23/2020

Desc: MILK UHT
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] . "Carotenes" is not a specific name of an ingredient. If "carotenes" refers to a color additive, the ingredient must be named in accordance with 21 CFR 101.22(k). If this is a color additive, the products appear to be misbranded with the meaning of section 403(k) of the Act. It does not appear to be used as a nutrient supplement because there is no vitamin A declaration in the nutrition label as required under 21 CFR 101.9(c)(8)(ii) if a nutrient is added as a nutrient supplement. Articles based upon the fat content of the products, the milk ingredients should be declared as "reduced fat milk" or "low fat milk" in the ingredient statement depending on which nutrient content claim the food qualifies for under 21 CFR 101.62.

09 C - - 09 Milk, Plain
Date Published: 07/23/2020

Desc: MILK UHT With Banana Flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)]. Carotenes" is not a specific name of an ingredient. We also note that if "carotenes" refers to a color additive, the ingredient must be named in accordance with 21 CFR 101.22(k). Furthermore, if this is a color additive, the products appear to be misbranded with the meaning of section 403(k) of the Act. It does not appear to be used as a nutrient supplement because there is no vitamin A declaration in the nutrition label as required under 21 CFR 101.9(c)(8)(ii) if a nutrient is added as a nutrient supplement. Articles based upon the fat content of the products, the milk ingredients should be declared as "reduced fat milk" or "low fat milk" in the ingredient statement depending on which nutrient content claim the food qualifies for under 21 CFR 101.62.

09 C - - 09 Milk, Plain
Date Published: 07/23/2020

Desc: Milk UHT With Vanilla Flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)]. Carotenes" is not a specific name of an ingredient. We also note that if "carotenes" refers to a color additive, the ingredient must be named in accordance with 21 CFR 101.22(k). Furthermore, if this is a color additive, the products appear to be misbranded with the meaning of section 403(k) of the Act. It does not appear to be used as a nutrient supplement because there is no vitamin A declaration in the nutrition label as required under 21 CFR 101.9(c)(8)(ii) if a nutrient is added as a nutrient supplement. Articles based upon the fat content of the products, the milk ingredients should be declared as "reduced fat milk" or "low fat milk" in the ingredient statement depending on which nutrient content claim the food qualifies for under 21 CFR 101.62.

09 C - - 09 Milk, Plain
Date Published: 07/23/2020

Desc: MILK UHT With Chocolate
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)]. Articles based upon the fat content of the products, the milk ingredients should be declared as "reduced fat milk" or "low fat milk" in the ingredient statement depending on which nutrient content claim the food qualifies for under 21 CFR 101.62.

Wroclawskie Zaklady Zielarskie Herbapol S.A.
Date Published : 07/10/2015
Ul. Swietego Mikolaja 65/68 , Wroclaw, Dolnoslaskie POLAND
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/10/2015

Desc: Radirex (Rhubarb root extract)
Notes: The product is misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the label or labeling of the dietary supplement fails to identify the product by using the term "dietary supplement"; or an appropriately descriptive term indicating the type of dietary ingredients that are in the product on the principal display panel as required by 21 CFR 101.3 (g). The product is misbranded within the meaning of section 403(y) [21 U.S.C. 343 (y)] of the Act because the label fails to bear a domestic address or domestic phone number through which the responsible person; as described in section 761 [21 U.S.C. 379aa-1] of the Act; may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1) (A) of the Act [21 U.S.C. §343(q)(1)(A)]. Published on 07/14/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/10/2015

Desc: Radirex (Rhubarb root extract)
Notes: The product is misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the label or labeling of the dietary supplement fails to identify the product by using the term "dietary supplement"; or an appropriately descriptive term indicating the type of dietary ingredients that are in the product on the principal display panel as required by 21 CFR 101.3 (g). The product is misbranded within the meaning of section 403(y) [21 U.S.C. 343 (y)] of the Act because the label fails to bear a domestic address or domestic phone number through which the responsible person; as described in section 761 [21 U.S.C. 379aa-1] of the Act; may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1) (A) of the Act [21 U.S.C. §343(q)(1)(A)]. Published on 07/14/2015

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 07/10/2015

Desc: Radirex (Rhubarb root extract)
Notes: The product is misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] because the label or labeling of the dietary supplement fails to identify the product by using the term "dietary supplement"; or an appropriately descriptive term indicating the type of dietary ingredients that are in the product on the principal display panel as required by 21 CFR 101.3 (g). The product is misbranded within the meaning of section 403(y) [21 U.S.C. 343 (y)] of the Act because the label fails to bear a domestic address or domestic phone number through which the responsible person; as described in section 761 [21 U.S.C. 379aa-1] of the Act; may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1) (A) of the Act [21 U.S.C. §343(q)(1)(A)].


PORTUGAL


Almerinda & Filhos Lda.
Date Published : 01/10/2017
Casal Pedro , Rua Da Nazare N. 3; Casal do Pardo , Alfeizerao, Leiria PORTUGAL
16 C - - 12 Cod, Cakes, Balls, Etc.
Date Published: 01/10/2017

Desc: Frozen Cod Fish Cakes (25 count and 50 count packages)
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)]. Labels fail to bear ingredients with the common or usual names, as required by 21 CFR 101.4. Frozen Cod Fish Cakes (25ct and 50ct): o sub-ingredients "E471", "E450", "E304", "E330", "E223" and "gluten" are not common or usual names, in accordance with 21 CFR 101.4. o labels fail to declare common or usual name of sub-ingredients for "mashed potatoes," in accordance with 21 CFR 101.4(b)(2). Frozen Shrimp Cakes: o sub-ingredients "E223" "E330" "E331" "E223" "E621" "E102" "E124" and "soja" are not common or usual names, in accordance with 21 CFR 101.4. o labels fail to declare common or usual name of sub-ingredients for "bread crumbs," in accordance with 21 CFR 101.4(b)(2). o "Oil" is not declared according to 21 CFR 101.4(b)(14);The articles are subject to refusal pursuant to 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)]. Labels contain information in two languages but do not repeat all required information in both languages as is required in 21 CFR 101.15(c).; The articles are subject to refusal of admission pursuant to 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)]. Labels fail to bear nutrition information in the correct format as required by 21 CFR 101.9. Nutrient amounts are based on incorrect serving sizes. Cod Fish Cakes labels state "Serving Size 1 Cake (33g-1.164oz),". Shrimp Cakes labels state "Serving Size 1 cake (45g-1.587 oz).The Reference Amount Customarily Consumed (RACC) for "fish and shellfish cake" is "85g cooked; 110g uncooked," according to 21 CFR 101.12, Table 2.

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 01/10/2017

Desc: Frozen Shrimp Cakes
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)]. Labels fail to bear ingredients with the common or usual names, as required by 21 CFR 101.4. Frozen Cod Fish Cakes (25ct and 50ct): o sub- ingredients "E471", "E450", "E304", "E330", "E223" and "gluten" are not common or usual names, in accordance with 21 CFR 101.4. o labels fail to declare common or usual name of sub-ingredients for "mashed potatoes," in accordance with 21 CFR 101.4(b)(2). Frozen Shrimp Cakes: o sub- ingredients "E223" "E330" "E331" "E223" "E621" "E102" "E124" and "soja" are not common or usual names, in accordance with 21 CFR 101.4. o labels fail to declare common or usual name of sub-ingredients for "bread crumbs," in accordance with 21 CFR 101.4(b)(2). o "Oil" is not declared according to 21 CFR 101.4(b)(14);The articles are subject to refusal pursuant to 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (f) of the Act [21 U.S.C. 343(f)]. Labels contain information in two languages but do not repeat all required information in both languages as is required in 21 CFR 101.15(c).; The articles are subject to refusal of admission pursuant to 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)]. Labels fail to bear nutrition information in the correct format as required by 21 CFR 101.9. Nutrient amounts are based on incorrect serving sizes. Cod Fish Cakes labels state "Serving Size 1 Cake (33g-1.164oz),". Shrimp Cakes labels state "Serving Size 1 cake (45g-1.587 oz).The Reference Amount Customarily Consumed (RACC) for "fish and shellfish cake" is "85g cooked; 110g uncooked," according to 21 CFR 101.12, Table 2. ;

HERO PORTUGAL
Date Published : 06/06/2019
Avenida Das Laranjeiras N. 6 , Amadora, Lisbon PORTUGAL
20 C - - 01 Blackberry, Jam, Jelly, Preserves, Marmalades, Butters and Candied
Date Published: 06/06/2019

Desc: Jam (Blackberry)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

20 C - - 02 Blueberry, Jam, Jelly, Preserves, Marmalade, Butter and Candied
Date Published: 06/06/2019

Desc: Jam (Blueberry)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

20 C - - 14 Strawberry, Jam, Jelly, Preserves, Marmalade, Butter and Candied
Date Published: 06/06/2019

Desc: Jam (Strawberry)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9.

20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C.
Date Published: 06/06/2019

Desc: Jam (Blueberry)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C.
Date Published: 06/06/2019

Desc: Jam (Tomato)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

21 C - - 25 Vine Fruit and Other Fruits, Mixed, Flavored Jams, Jellies, Preserves, Marmalades, Butters and Candi
Date Published: 06/06/2019

Desc: Jam (Tomato)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

21 J - - 13 Peach, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 06/06/2019

Desc: Jam (Peach)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).


ROMANIA


SC PlantExtrakt
Date Published : 03/23/2017
Zalaului f.n. , Radaia, Cluj ROMANIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: UTI Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Common Fig
Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Earache Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Flu Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Silver Birch
Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Anxiety Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Digestive Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Allergy Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 03/23/2017

Desc: Black Currant
Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Silver Birch
Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Allergy Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Earache Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Anxiety Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Flu Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Black Currant
Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: UTI Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Digestive Relief
Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/23/2017

Desc: Common Fig
Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number.


RUSSIA


"Market Plus" Co.Ltd
Date Published : 10/02/2015
11/1 Hlopina Str. Lit B , Sankt-Petersburg, RU-SPE RUSSIA
16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Herring Salted
Notes: These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading "Servings Per Container"; "Amount Per Serving"; "Calories from Fat"; and "% Daily Value*" [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as "gr." And "mgr." respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]

16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Tsar's Cuisine Herring in Oil w/Smoke flavor
Notes: These Product(s) are misbranded within the meaning of 403(f). The words; statements; and other required information does not appear to be in English on the label [21 CFR 101.15(c)(1)]

16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Herring w/olives
Notes: This Product is misbranded within the meaning of 403(i)(2) The label declares the Ingredients "E211" and "E202" instead of using the common or usual names sodium benzoate and potassium sorbate and a seperate description of their functions [21CFR 101.22(j)]

16 - - - -- Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Kilka of Baltic Salted Small Fish
Notes: These Product(s) are misbranded within the meaning of 403(q). The nutrtional panel does not Declare trans fat; vitamin A; vitamin C; calcium or iron as required by [21CFR 101.9(c)(8)(ii) The nutritional panel is not set in a box by the use of hairlines [21CFR 101.9(d)(1)(i) The nutritional panel is missing the heading "Servings Per Container"; "Amount Per Serving"; "Calories from Fat"; and "% Daily Value*" [21CFR 101.9(d)(3)-(6)] Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as ¿gr.¿ And ¿mgr.¿ respectively [21CFR 101.9(d)(7)(i)] The nutritional panel does not provide a listing of the percent of the DRV for each nutrient declared that has an established DRV [21CFR 101.9)(d)(7)(ii)] The serving size declaration Is not expressed in common household measures [21CFR 101.9(b)(5) and 21 CFR 101.12(b)] The nutritional panel does not contain a footnote beneath the list of vitamins and minerals as required by [21CFR 101.9(d)(9) Caloric content is not expressed in kilojoules or calories [21CFR 101.9(c) (1)(i)] Cholesterol and sodium content are not rounded according to [21CFR 101.9(c)(3)-(4)]

Aleshin
Date Published : 06/08/2022
Ul. Vyatkina 33, A 1 , Abakan, Khakasiya Resp RUSSIA
03 A - - 03 Biscuits
Date Published: 06/08/2022

Desc: Assorted "Flowers Like Mushrooms" With White And Chocolate Glaze
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

03 F - - 02 Flavored or Party Crackers
Date Published: 06/08/2022

Desc: Bakery Product "Stars On The Wave"
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 02 Corn Chips, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 02 Corn Chips, Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 02 Corn Chips, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 03 Cheese Puffs, Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 03 Cheese Puffs, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 03 Cheese Puffs, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 07 Pretzels,Baked
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 A - - 07 Pretzels,Baked
Date Published: 06/08/2022

Desc: Bakery Product "Stars On The Wave"
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 07 Pretzels,Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 07 Pretzels,Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 07 Pretzels,Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 C - - 01 Bread Sticks (Flavored or Unflavored), Bread Snacks Baked
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 C - - 99 Bread Snacks, n.e.c.
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

Aleshin E.O
Date Published : 06/08/2022
ul. Kravchenko 11-3 , Abakan, Khakasiya Resp RUSSIA
03 A - - 03 Biscuits
Date Published: 06/08/2022

Desc: Assorted "Flowers Like Mushrooms" With White And Chocolate Glaze
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

03 F - - 02 Flavored or Party Crackers
Date Published: 06/08/2022

Desc: Bakery Product "Stars On The Wave"
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 01 Bread Sticks (Flavored or Unflavored), Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 02 Corn Chips, Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 02 Corn Chips, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 02 Corn Chips, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 03 Cheese Puffs, Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 03 Cheese Puffs, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 03 Cheese Puffs, Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 07 Pretzels,Baked
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 07 Pretzels,Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 07 Pretzels,Baked
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 A - - 07 Pretzels,Baked
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 07 Pretzels,Baked
Date Published: 06/08/2022

Desc: Bakery Product "Stars On The Wave"
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/27/2022

Desc: Bread Sticks Vanilla For Mom
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name. Carotenes does not appear to be the common or usual name of the ingredient, and “food additive” and “antioxidants” are not common or usual names in accordance with 21 CFR 101.4(a) Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men W / Chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/08/2022

Desc: Biscuits Dessert Assorted Forest Men
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information (21 CFR 101.9). Serving size for each product is listed as 3.5 oz (100g); appropriate RACC for the product is 30 g (21 CFR 101.12(b) – Table 2 – Cookies). Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(i)(1) of the Act in that the product labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b).

07 C - - 01 Bread Sticks (Flavored or Unflavored), Bread Snacks Baked
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

07 C - - 99 Bread Snacks, n.e.c.
Date Published: 09/13/2022

Desc: Bread Sticks; Sweet 'For Daughter'
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act in that the nutrition information is not in compliance with 21 CFR 101.9. Section 403(f) of the Act in that product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2). Section 403(k) of the Act in that the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. Label declares the ingredient “sodium metabisulphite,” which appears to be a chemical preservative in accordance with 21 CFR 182.3766, and the descriptor of the function of the ingredient is missing. “metabisulphite” is not the correct U.S. spelling.

Baltic Shore Organization
Date Published : 10/02/2015
Paper Street , Division 17 Room 256 , Saint Petersburg, RUSSIA
16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Herring w/olives
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)].

16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Tsar's Cuisine Herring in Oil w/Smoke flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)]. Section 403(i)(2); the labels declare ingredients as "E211" and/or "E202" instead of using the common or usual name sodium benzoate and/or potassium sorbate and a separate description of their functions [21CFR101.22(j)]. Section 403(q); The nutrition panel: Does not declare trans fat, vitamin A, vitamin C, calcium or iron as required by 21CFR101.9(c)(2)(ii) and 21CFR101.9(c)(8)(ii). Is not set off in a box by the use of hairlines [21 CFR101.9( d)(l )(i)]. Does not provide a listing of the percent of the ORV for each nutrient declared that has an established ORV [21 CFR 101.9(d)(7)(ii)]. Does not contain a footnote beneath the list of vitamins and minerals as required by 21 CFR 101. 9( d)(9). Missing the headings "Servings Per Container", "Amount Per Serving", and "% Daily Value" [21 CFR 101.9(d)(3)(6)]. Missing the heading "Calories from fat" as required by 21 CFR 101.9(c )(I )(ii). Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as "gr." and "mgr." [21 CFR 101.9( d)(7)(i)]. The serving size declaration is not expressed in common household measures [21CFR 101.9(b)(5) and 21CFR101.12(b)]. Caloric content is not expressed in kilojoules or calories [21 CFR 101.9(c)(l)(i)]. Cholesterol and sodium content is not rounded according to 21 CFR 101.9(c)(3)(4).

16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Herring Salted
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)]. Section 403(i)(2); the labels declare ingredients as "E211" and/or "E202" instead of using the common or usual name sodium benzoate and/or potassium sorbate and a separate description of their functions [21CFR101.22(j)]. Section 403(q); The ingredients "Salted Water" are not declared in accordance with 21 CFR 101.4. And the nutrition panel: Does not declare trans fat, vitamin A, vitamin C, calcium or iron as required by 21CFR101.9(c)(2)(ii) and 21CFR101.9(c)(8)(ii). Is not set off in a box by the use of hairlines [21 CFR101.9( d)(l )(i)]. Does not provide a listing of the percent of the ORV for each nutrient declared that has an established ORV [21 CFR 101.9(d)(7)(ii)]. Does not contain a footnote beneath the list of vitamins and minerals as required by 21 CFR 101. 9( d)(9). Missing the headings "Servings Per Container", "Amount Per Serving", and "% Daily Value" [21 CFR 101.9(d)(3)(6)]. Missing the heading "Calories from fat" as required by 21 CFR 101.9(c )(I )(ii). Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as "gr." and "mgr." [21 CFR 101.9( d)(7)(i)]. The serving size declaration is not expressed in common household measures [21CFR 101.9(b)(5) and 21CFR101.12(b)]. Caloric content is not expressed in kilojoules or calories [21 CFR 101.9(c)(l)(i)]. Cholesterol and sodium content is not rounded according to 21 CFR 101.9(c)(3)(4).

16 - - - -- Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Kilka of Baltic Salted Small Fish
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)]. Section 403(i)(2); the labels declare ingredients as "E211" and/or "E202" instead of using the common or usual name sodium benzoate and/or potassium sorbate and a separate description of their functions [21CFR101.22(j)]. Section 403(q); The ingredients "4Kilka" and "Salted Water" on the label are not declared in accordance with 21 CFR 101.4. And the nutrition panel: Does not declare trans fat, vitamin A, vitamin C, calcium or iron as required by 21CFR101.9(c)(2)(ii) and 21CFR101.9(c)(8)(ii). Is not set off in a box by the use of hairlines [21 CFR101.9( d)(l )(i)]. Does not provide a listing of the percent of the ORV for each nutrient declared that has an established ORV [21 CFR 101.9(d)(7)(ii)]. Does not contain a footnote beneath the list of vitamins and minerals as required by 21 CFR 101. 9( d)(9). Missing the headings "Servings Per Container", "Amount Per Serving", and "% Daily Value" [21 CFR 101.9(d)(3)(6)]. Missing the heading "Calories from fat" as required by 21 CFR 101.9(c )(I )(ii). Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as "gr." and "mgr." [21 CFR 101.9( d)(7)(i)]. The serving size declaration is not expressed in common household measures [21CFR 101.9(b)(5) and 21CFR101.12(b)]. Caloric content is not expressed in kilojoules or calories [21 CFR 101.9(c)(l)(i)]. Cholesterol and sodium content is not rounded according to 21 CFR 101.9(c)(3)(4).

Donskoy Konditer
Date Published : 06/10/2019
Ul. Belorusskaya 2a , Rostov-Na-Donu, Rostovskaya obl RUSSIA
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/10/2019

Desc: Sugar Cookies Honey
Notes: The article (outer packaging) appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages - for example, all required information in accordance with 21 CFR 101.9 is not in English. The article (individual unit packaging) appears to be misbranded within the meaning of the following sections of the FD&C Act: 403(i)(2) in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4; 403(f) because the product labels contain information in two languages but does not repeat all the required information in both languages; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not meet the requirements of 21 CFR 101.9.

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/10/2019

Desc: Sugar Cookies Condensed Milk
Notes: The article (outer packaging) appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages - for example, all required information in accordance with 21 CFR 101.9 is not in English. The article (individual unit packaging) appears to be misbranded within the meaning of the following sections of the FD&C Act: 403(i)(2) in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4; 403(f) because the product labels contain information in two languages but does not repeat all the required information in both languages; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not meet the requirements of 21 CFR 101.9.

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/10/2019

Desc: Sugar Cookies Jewelery
Notes: The article (outer packaging) appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages - for example, all required information in accordance with 21 CFR 101.9 is not in English. The article (individual unit packaging) appears to be misbranded within the meaning of the following sections of the FD&C Act: 403(i)(2) in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4; 403(f) because the product labels contain information in two languages but does not repeat all the required information in both languages; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not meet the requirements of 21 CFR 101.9.

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/10/2019

Desc: Sugar Cookies Creamy
Notes: The article (outer packaging) appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages - for example, all required information in accordance with 21 CFR 101.9 is not in English. The article (individual unit packaging) appears to be misbranded within the meaning of the following sections of the FD&C Act: 403(i)(2) in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4; 403(f) because the product labels contain information in two languages but does not repeat all the required information in both languages; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not meet the requirements of 21 CFR 101.9.

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/10/2019

Desc: Sugar Cookies Rostovskoe
Notes: The article (outer packaging) appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages - for example, all required information in accordance with 21 CFR 101.9 is not in English. The article (individual unit packaging) appears to be misbranded within the meaning of the following sections of the FD&C Act: 403(i)(2) in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4; 403(f) because the product labels contain information in two languages but does not repeat all the required information in both languages; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not meet the requirements of 21 CFR 101.9.

03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/10/2019

Desc: Sugar Cookies Wild Strawberry
Notes: The article (outer packaging) appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages - for example, all required information in accordance with 21 CFR 101.9 is not in English. The article (individual unit packaging) appears to be misbranded within the meaning of the following sections of the FD&C Act: 403(i)(2) in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4; 403(f) because the product labels contain information in two languages but does not repeat all the required information in both languages; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not meet the requirements of 21 CFR 101.9.

Galan Oao
Date Published : 10/02/2015
158 Kommunisticheskaya St , Kurganinsk, RUSSIA
34 F - - 07 Mixed or Assorted Chocolate Candies (Bars, Boxes, Loose Form), without Nuts and Fruit
Date Published: 10/02/2015

Notes: Chocolate Egg Toy inside

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 10/02/2015

Notes: Chocolate Egg Toy inside

Iriada International Limited
Date Published : 10/02/2015
Building 529 , ul. Novo-Rybinskaya 19-21 , Sankt-Peterburg, Sankt-Peterburg g RUSSIA
33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Soft Candy (Marmalade)
Notes: VIOLATION (IN NOTES): 1. 403(q) and 2. 403(i)(2) 1. The product fails to properly declare the serving size as specified by 21 CFR 101.9(b) and 101.12(b). Specifically, the product declares the serving size as 3.50z (l00 gr); however the established Reference Amount Customarily Consumed (RACC) for All other candies [21 CFR 101.12(b), Table 2, under Sugars and Sweets] is 40 g. Therefore, the nutrition information is not correct because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and the "Servings Per Container" is not consistent with the requirements under 21 CFR 101.9(b)(8); The product fails to meet the requirements of 21 CFR 101.9(c) for the declaration of the required nutrients, the level of those nutrients, and the specified order of those nutrients. Specifically, the nutrition label fails to declare: calories from fat, saturated fat, trans fat, cholesterol, sodium, dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron. "Organic acid" is not permitted to be declared in the nutrition label. Also, protein must be declared after carbohydrate on the nutrition label. "Carbohydrate" must be declared as "Carbohydrate, total" or "Total carbohydrate"; The quantitative amounts of the declared nutrients are not rounded in accordance with 21 CFR 101.9(c) and the amounts are declared using commas instead of decimal points;¿ The nutrition information is not provided in the format specified by 21 CFR 101.9. For example, the full footnote is not provided in accordance with 21 CFR 101.9(d)(9)(i). Also, the nutrition label declares "gr" rather than the appropriate abbreviation, "g", for grams [21 CFR 101.9(d)(7)(i)]. In addition, the nutrition label fails to list the numerical percent of the DRV in a column aligned under the heading "% DV" as required per 21 CFR 101.9(d)(7)(ii).

LLC PHARMACOR PRODUCTION
Date Published : 02/23/2024
K. 5 Ofis 247 , Ul. Repischeva D. 14 , Sankt-Peterburg, Sankt-Peterburg g RUSSIA
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 02/23/2024

Desc: DIETARY SUPPLEMENT VLADONIX
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the label fails to declare each ingredient by its common or usual name [21 CFR 101.4]. - Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. - Section 403(r)(6) because the inner booklet insert makes structure/function claims but fails to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 02/23/2024

Desc: DIETARY SUPPLEMENT VLADONIX
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the label fails to declare each ingredient by its common or usual name [21 CFR 101.4]. - Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. - Section 403(r)(6) because the inner booklet insert makes structure/function claims but fails to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).

MARKET PLUS
Date Published : 10/02/2015
Lit B , ul. Uchitelskaya 16 , Sankt-Peterburg, Sankt-Peterburg g RUSSIA
16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Herring Salted
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)]. Section 403(i)(2); the labels declare ingredients as "E211" and/or "E202" instead of using the common or usual name sodium benzoate and/or potassium sorbate and a separate description of their functions [21CFR101.22(j)]. Section 403(q); The ingredients "Salted Water" are not declared in accordance with 21 CFR 101.4. And the nutrition panel: Does not declare trans fat, vitamin A, vitamin C, calcium or iron as required by 21CFR101.9(c)(2)(ii) and 21CFR101.9(c)(8)(ii). Is not set off in a box by the use of hairlines [21 CFR101.9( d)(l )(i)]. Does not provide a listing of the percent of the ORV for each nutrient declared that has an established ORV [21 CFR 101.9(d)(7)(ii)]. Does not contain a footnote beneath the list of vitamins and minerals as required by 21 CFR 101. 9( d)(9). Missing the headings "Servings Per Container", "Amount Per Serving", and "% Daily Value" [21 CFR 101.9(d)(3)(6)]. Missing the heading "Calories from fat" as required by 21 CFR 101.9(c )(I )(ii). Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as "gr." and "mgr." [21 CFR 101.9( d)(7)(i)]. The serving size declaration is not expressed in common household measures [21CFR 101.9(b)(5) and 21CFR101.12(b)]. Caloric content is not expressed in kilojoules or calories [21 CFR 101.9(c)(l)(i)]. Cholesterol and sodium content is not rounded according to 21 CFR 101.9(c)(3)(4).

16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Herring w/olives
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)].

16 A - - 21 Herring
Date Published: 10/02/2015

Desc: Tsar's Cuisine Herring in Oil w/smoke flavor
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)]. Section 403(i)(2); the labels declare ingredients as "E211" and/or "E202" instead of using the common or usual name sodium benzoate and/or potassium sorbate and a separate description of their functions [21CFR101.22(j)]. Section 403(q); The nutrition panel: Does not declare trans fat, vitamin A, vitamin C, calcium or iron as required by 21CFR101.9(c)(2)(ii) and 21CFR101.9(c)(8)(ii). Is not set off in a box by the use of hairlines [21 CFR101.9( d)(l )(i)]. Does not provide a listing of the percent of the ORV for each nutrient declared that has an established ORV [21 CFR 101.9(d)(7)(ii)]. Does not contain a footnote beneath the list of vitamins and minerals as required by 21 CFR 101. 9( d)(9). Missing the headings "Servings Per Container", "Amount Per Serving", and "% Daily Value" [21 CFR 101.9(d)(3)(6)]. Missing the heading "Calories from fat" as required by 21 CFR 101.9(c )(I )(ii). Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as "gr." and "mgr." [21 CFR 101.9( d)(7)(i)]. The serving size declaration is not expressed in common household measures [21CFR 101.9(b)(5) and 21CFR101.12(b)]. Caloric content is not expressed in kilojoules or calories [21 CFR 101.9(c)(l)(i)]. Cholesterol and sodium content is not rounded according to 21 CFR 101.9(c)(3)(4).

16 - - - -- Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Kilka of Baltic Salted Small Fish
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f); All words, statements, and other required information on the label does not appear in English [21 CFR 101.15( c )(I)]. Section 403(i)(2); the labels declare ingredients as "E211" and/or "E202" instead of using the common or usual name sodium benzoate and/or potassium sorbate and a separate description of their functions [21CFR101.22(j)]. Section 403(q); The ingredients "4Kilka" and "Salted Water" on the label are not declared in accordance with 21 CFR 101.4. And the nutrition panel: Does not declare trans fat, vitamin A, vitamin C, calcium or iron as required by 21CFR101.9(c)(2)(ii) and 21CFR101.9(c)(8)(ii). Is not set off in a box by the use of hairlines [21 CFR101.9( d)(l )(i)]. Does not provide a listing of the percent of the ORV for each nutrient declared that has an established ORV [21 CFR 101.9(d)(7)(ii)]. Does not contain a footnote beneath the list of vitamins and minerals as required by 21 CFR 101. 9( d)(9). Missing the headings "Servings Per Container", "Amount Per Serving", and "% Daily Value" [21 CFR 101.9(d)(3)(6)]. Missing the heading "Calories from fat" as required by 21 CFR 101.9(c )(I )(ii). Quantitative amounts by weight for mandatory nutrients that are given in grams or milligrams are incorrectly abbreviated as "gr." and "mgr." [21 CFR 101.9( d)(7)(i)]. The serving size declaration is not expressed in common household measures [21CFR 101.9(b)(5) and 21CFR101.12(b)]. Caloric content is not expressed in kilojoules or calories [21 CFR 101.9(c)(l)(i)]. Cholesterol and sodium content is not rounded according to 21 CFR 101.9(c)(3)(4).

NAR LTD
Date Published : 10/02/2015
Tchaikovsky Street 7a , Slantsy, Leningradskaya obl RUSSIA
22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 10/02/2015

Desc: Pomegranate Juice
Notes: VIOLATION (IN NOTES); 1. 403(q); 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9 (e.g.; rounding of calories; indenting; holding; footnote not complete; and Nutrition Facts information is not set of in a box by the use of hairlines). 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that the label or labeling fails to bear a percent juice declaration as required by 21 CFR 101.30.


SAINT LUCIA


Scylla Premium Seamoss
Date Published : 06/04/2021
La - Pointe, Mon-Repos , Micoud, Vieux Fort SAINT LUCIA
24 T - - 29 Seaweed (Leaf & Stem Vegetable)
Date Published: 06/04/2021

Desc: Dried Sea Moss
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)] in that the labeling bears nutrient content claims but the product does not meet the requirements to bear the claims. The labeling states “mineral-rich” and “Rich in Iron, Zinc, B Vitamins, Magnesium.” Based on the Nutrition Facts label, none of these nutrients are present at the level of 20% or above of the RDI (21 CFR 101.54(b)).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2021

Desc: Dried Sea Moss
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)] in that the labeling bears nutrient content claims but the product does not meet the requirements to bear the claims. The labeling states “mineral-rich” and “Rich in Iron, Zinc, B Vitamins, Magnesium.” Based on the Nutrition Facts label, none of these nutrients are present at the level of 20% or above of the RDI (21 CFR 101.54(b)).

THE GREAT PHYSICIAN INTERNATIONAL
Date Published : 08/09/2019
Jeremie Street , Castries, SAINT LUCIA
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 08/09/2019

Desc: The Answer
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that it does not include a statement of identity as a "dietary supplement" as required by 21CFR101.3(g). Sections 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 U.S.C. §343(s)(2)(A) and 343(q)(5)(F)] in that the LBL fails to list the name of each dietary ingredient of the supplement described in sections 201(ff) and the quantity of each ingredient. Section 403(q)(1)(B) of the Act [21 U.S.C. §343(q)(1)(B)] in that the LBL fails to list the servings per container in accordance with 21 CFR 101.36(b)(1)(ii). Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that it fails to list the name and place of business of the manufacturer, packer or distributor in accordance with 21CFR101.5. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that it is fabricated from two or more ingredients, and each ingredient is not declared on the LBL by the common/usual name, in accordance with 21CFR101.4 and 21CFR101.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21CFR101.4(h)(1). Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the serving size on the LBL is incomplete. Specifically, the LBL fails to declare the equivalent metric quantity in parenthesis following the "capful". Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the FDA disclaimer statement is incomplete and not linked to the structure function claim made on the LBL, per 21 CFR 101.93(c)-(d)


SIERRA LEONE


Sierra Fisheries
Date Published : 08/08/2018
Kissy Dock Yard , Freetown, SIERRA LEONE
26 C - - 05 Palm Kernel Oil, Refined, Single Ingredient
Date Published: 08/08/2018

Desc: Palm Oil
Notes: Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)]in that the nutrition facts information is not as defined in 21 CFR 101.9. ; Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears nutrient content claims, but the product does not meet the requirements to make such claims.; Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food.; Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). ; Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a foreign language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language) as required by 21 CFR 101.15(c).; Section 801(a)(3) in that it appears to be misbranded within the meaning of section 1453(a)(2) and (a)(3) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2) and (a)(3)] because it fails to bear an accurate statement of the net quantity of contents in terms of U.S. customary units [21 CFR 101.7(b)].


SOUTH AFRICA


Hersol Manufacturing Laboratories cc
Date Published : 10/02/2015
36 Madison Street , Johannesburg, Gauteng SOUTH AFRICA
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Nuerovance (Dietary Supplement)
Notes: VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Antagolin (Dietary Supplement)
Notes: VIOLATION (IN NOTES): 403(q)(5)(F) Specifically, the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts panel) [Misbranded, Section 403 (q)(5)(F)]".

Indian Ocean Export Company
Date Published : 01/25/2016
197 Goble Road , Durban, Kwazulu-Natal SOUTH AFRICA
33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 01/25/2016

Desc: Super C Orange Flavored Sweets
Notes: The article is subject to refusal of admission pursuant to Section 801(a)3) for the following: "It appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format in accordance with 21 CFR 101.9." "It appears to be misbranded within the meaning of section 403(i)(1) [21 U.S.C. 343(i)(l)] in that the product label does not contain a statement of identity as required by 21 CFR 101.3." "It appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example, your product label declares "antioxidant (E319)" and "Emulsifiers (E471, E322)" in the ingredient statement; however, these are not the common or usual names of these ingredients.

Tiger Food Brands Limited
Date Published : 10/02/2015
Maitland , 3 Bayete Road , Cape Town, Western Cape SOUTH AFRICA
40 B - - 06 Wheat Cereal (Baby)
Date Published: 10/02/2015

Notes: Baby Cereal; wheat with bananas

40 B - - 20 Mixed Cereal, with Fruit (Baby)
Date Published: 10/02/2015

Notes: Baby Cereal; mix with strawberries

Tiger Food Brands Ltd - Culinary
Date Published : 10/02/2015
54 Oxford Street , Durbanville, Western Cape SOUTH AFRICA
40 B - - 06 Wheat Cereal (Baby)
Date Published: 10/02/2015

Notes: Baby Cereal; wheat with bananas

40 B - - 20 Mixed Cereal, with Fruit (Baby)
Date Published: 10/02/2015

Notes: Baby Cereal; mix with strawberries


SPAIN


Almendrera del Sur, S.Coop. And.
Date Published : 03/24/2016
Calle De Almeria S/N 29580 , Cartama, Malaga SPAIN
23 B - - 01 Almond, Shelled
Date Published: 03/24/2016

Desc: Peeled Fried Almonds
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403 (f) of the Act in that the product label contains information in a foreign language but does not appear to represent all the required label information in both English and the foreign language [21 CFR 101.15(c)(1)].

B.E.S. (BARCELONA EUROPE SUPPLY)
Date Published : 07/24/2015
Enric Prat De La Riba, 12 Pol. Ind. Sala , Sant Boi De Llobregat , Barcelona, Cataluna SPAIN
21 G - - 09 Olives (Pit Fruit)
Date Published: 07/24/2015

Desc: Olives
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that all words; statements; and other information required by or under authority of the Act; on the label or labeling must appear there on in the English language as required by 21 CFR 101.15(c)(1).

FERNANDEZ Y CANIVELL SA
Date Published : 03/29/2016
Calle Severo Ochoa 13 , Malaga, Malaga SPAIN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/10/2017

Desc: CEREGUMIL ROYAL JELLY CAPS
Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/10/2017

Desc: CEREGUMIL ORIGINAL 200ML
Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/10/2017

Desc: CEREGUMIL KIDS 250ML
Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/10/2017

Desc: CEREGUMIL LIQUID IRON 250ML
Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/10/2017

Desc: CEREGUMIL VITAMIX PLUS CAPS
Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/29/2016

Desc: Cereguimil
Notes: The article is subject to refusal of admission pursuant to section 801(a) (3) in that the product is misbranded within the meaning of section 403 (i)(2) [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label; as required by 21 CFR 101.4(b)(2). We object to the way "syrup" is used in the ingredient statement. Syrup should not be listed in the ingredient statement unless it is actually used as an ingredient. If syrup is used as an ingredient; the manufacturer may declare syrup on the ingredient statement by either listing the component ingredients (sub-ingredients) used to make the syrup (e.g. water; honey; sugar) (21 CFR 101.4(b)(2) (ii)) or by listing syrup followed by a parenthetical declaration of each sub-ingredient (e.g. syrup (water; honey; sugar)) (21 CFR 101.4(b)(2) (i)). Under the first alternative; the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative; the component ingredients must be listed in descending order of predominance in the finished food. (21 CFR 101.4(a)) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded with the meaning of section 403(f) [21 U.S.C. 343(f)] because the product label contains information in two languages but does not repeat all the required label information in both languages. For example; the supplement facts label and ingredients list are presented in English only. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language Published on 06/25/2015

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/10/2017

Desc: CEREGUMIL VITAMIX 250ML/500ML
Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a).

Nestle Espana
Date Published : 10/02/2015
Avenida Paisos Catalans 25 51 , Esplugues de Llobregat, Barcelona SPAIN
34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Chocolate Beverage Base Nescafe Nesquick Dolce Gusto
Notes: VIOLATIONS; The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it is misbranded within the meaning of 403(q) in that it fails to bear a Nutrition Facts label in the appropriate format defined in 21 CFR 101.9.


SRI LANKA


ARUNALU PRODUCTS
Date Published : 06/13/2016
Kandawala , 30/7 Torington Estate , Katana, Gampaha SRI LANKA
16 A - - 01 Anchovy
Date Published: 06/13/2016

Desc: Arunalu Dry Fish Headless Sprats
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) for the following: It appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined by 21 CFR 101.9. • The label fails to declare the nutrient information on the correct serving size based on the appropriate reference amount customarily consumed (RACC) in accordance with 21 CFR 10 1.9(b) and 21 CFR 101.12. • The Nutrition Facts label fails to list all the required n nutrients as provided under 21 CFR 101.9(c). It appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15( c )(2), if the label contains any representation in a foreign language, all words, statements, and other information required by or under the authority of the act must appear in the foreign language. It appears to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)]because the statement of identity on the Principal Display Panel does not accurately describe the product, as required under 21 CFR 101.3. It it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4.

Nestle Lanka PLC
Date Published : 08/31/2023
Makandura , Kurunegala Factory , Gonawila, Kurunegala SRI LANKA
21 V - H 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars, Ntrl/Artfcl Dried
Date Published: 08/31/2023

Desc: Maggi Real Coconut Milk Powder; 300 gram box
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The label declares “Servings per container 20”. The number of servings should be declared following the servings per container statement, i.e. “____ servings per container,” in accordance with 21 CFR 101.9(d)(3)(i). In accordance with 21 CFR 101.9(b)(11), two columns of nutrition information must be provided.

23 O - - 05 Coconut, Nut Flour/Meal
Date Published: 08/31/2023

Desc: Maggi Real Coconut Milk Powder; 300 gram box
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The label declares “Servings per container 20”. The number of servings should be declared following the servings per container statement, i.e. “____ servings per container,” in accordance with 21 CFR 101.9(d)(3)(i). In accordance with 21 CFR 101.9(b)(11), two columns of nutrition information must be provided.


SWEDEN


Lantmannen
Date Published : 08/18/2017
Granngarden Ab , Bassangkajen 14se , Malmo, Skane Lan SWEDEN
41 G - - 99 Medical Foods, N.E.C.
Date Published: 08/18/2017

Desc: SPC-FLAKES
Notes: The product appears to be misbranded within the meaning of: (1) Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading. (2) Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information provided is not consistent with the requirements under 21 CFR 101.9. (3) Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). In addition, the net quantity of contents statement is not placed as a distinct item in the bottom 30 percent of the principal display panel as required by 21 CFR 101.7. (4) Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product does not bear an appropriate statement of identity.

Mattias Edins Styrkeshop
Date Published : 12/22/2015
Loftets Grand 16 , Umea, Vasterbottens Lan SWEDEN
54 C - - 99 Protein N.E.C.
Date Published: 12/22/2015

Desc: Altius Nutrition Whey Protein Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3 for the following: "It appears to be misbranded within the meaning of Section 403(q)(5)(f) in that the label or labeling fails to bear the required nutrition information (e.g. Supplement Facts Panel) in accordance with 21 CFR 101.36." "It appears to be misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because it does not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g)." "It appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5." "It appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act." "It is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. [Misbranding, Section 403(y)]"

MedicaNatumin AB
Date Published : 10/02/2015
Snickaregatan 10s , Habo, Jonkopings Lan SWEDEN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 08/23/2016

Desc: Shark Liver Oil (Brand name; Military Formula)
Notes: The product is; (1) misbranded within the meaning of section 403(q)(1)(A) of the FD&CA because the serving size declared on the label is incorrect; and (2) misbranded within the meaning of Section 403(q)(5)(F) of the FD&CA in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36.

54 H - - 04 Fish Oil (Fats and Lipid Substances)
Date Published: 08/23/2016

Desc: Shark Liver Oil (Brand name; Military Formula)
Notes: The product is; (1) misbranded within the meaning of section 403(q)(1)(A) of the FD&CA because the serving size declared on the label is incorrect; and (2) misbranded within the meaning of Section 403(q)(5)(F) of the FD&CA in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/23/2016

Desc: Shark Liver Oil (Brand name; Military Formula)
Notes: The product is; (1) misbranded within the meaning of section 403(q)(1)(A) of the FD&CA because the serving size declared on the label is incorrect; and (2) misbranded within the meaning of Section 403(q)(5)(F) of the FD&CA in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36.


SWITZERLAND


Chocolat Stella S.A.
Date Published : 05/14/2019
via alle Gerre 28 , Giubiasco, Ticino SWITZERLAND
34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut)
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C.
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C.
Date Published: 05/14/2019

Desc: Sugarfree chocolate
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2).

Confiserie Sprungli AG
Date Published : 09/13/2019
Bernstrasse 89 , Dietikon, Zurich SWITZERLAND
34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut)
Date Published: 09/13/2019

Desc: Pralines
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product fails to bear labeling with the common or usual name of the food as required by 21 CFR 101.3. Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because it fails to bear labeling with the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In accordance with 21 CFR 101.5(d), the statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.

34 Y - - 99 Chocolate and Cocoa Products, N.E.C.
Date Published: 09/13/2019

Desc: Pralines
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product fails to bear labeling with the common or usual name of the food as required by 21 CFR 101.3. Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because it fails to bear labeling with the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In accordance with 21 CFR 101.5(d), the statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.

HOLLE FOOD
Date Published : 02/13/2017
Baselstrasse 11 , Riehen, Basel Stadt SWITZERLAND
40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 02/13/2017

Desc: Holle Organic Infant Formula Bio-Folgemilch 2
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that the label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

HOLLE FOOD
Date Published : 10/31/2016
Lorracherstrasse 50 , Riehen, Basel Stadt SWITZERLAND
40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(e)(1) of the Act in that the business association to the product is not declared as required in 21 CFR 101.5(c). Specifically, the business addresses provided lack the name of the country. Section 403(e)(2) of the Act in that the label appears to lack the net quantity of contents statement in avoirdupois pound and ounces on the principal display panel in accordance with 21 CFR 101.105. The ingredient list appears to include the intervening material, "Germany" (21 CFR 101.2(e)). Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4. For example, it appears that the foreign spelling of the words "zinc sulphate," "copper sulphate," "manganese sulphate," and "demineralised." is used. Additionally, the label appears to refer to this infant formula product as "milk" in several places. This infant formula product should not be referred to as "milk."

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 10/31/2016

Desc: Anfangs-milch 1 (infant formula)
Notes: The article is subject to refusal of admission pursuant to section 801(a) (3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that the label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Also; the labels appear to not comply with the requirements of 21 CFR 101.5; in part; because it appears that the business address lacks the name of the country. We further note that a statement of the country of manufacturer has little bearing on the requirements of 21 CFR 101.5. The labels appear to not comply with the requirements of 21 CFR 101.105. The net quantity of contents is not on the PDP or in the U.S. customary units. In addition; the firm should be advised that for products represented for use as an infant formula; Section 412 of the Federal Food; Drug; and Cosmetic Act requires persons responsible for the manufacture or distribution of infant formula to register and submit certain information to FDA. Failure to comply with these provisions is a prohibited act under section 301(s) of the FD&C Act. Products represented for use as an infant formula must comply with the labeling provisions of 21 CFR Part 107. Failure to comply with these regulations causes the products to be misbranded under section 403(a)/201(z) of the FD&C Act. Section 412 (a) of the Act stipulates that an infant formula is deemed adulterated if the processing of such infant formula is not in compliance with the good manufacturing practices and quality control procedures found in Title 21 of the Code of Federal Regulations Part 106.

NAHRIN AG
Date Published : 07/07/2023
Industriestrasse 27 , Sarnen, Obwalden SWITZERLAND
54 A - - 02 Vitamin B1 (Thiamine)
Date Published: 07/07/2023

Desc: AGE-DEFY Immunity and Regeneressence Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 A - - 02 Vitamin B1 (Thiamine)
Date Published: 07/07/2023

Desc: ENERGY Focus & Performance Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 A - - 06 Niacin (Nicotinic Acid) (Vitamin)
Date Published: 07/07/2023

Desc: ENERGY Focus & Performance Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 A - - 06 Niacin (Nicotinic Acid) (Vitamin)
Date Published: 07/07/2023

Desc: AGE-DEFY Immunity and Regeneressence Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas)
Date Published: 07/07/2023

Desc: AGE-DEFY Immunity and Regeneressence Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas)
Date Published: 07/07/2023

Desc: ENERGY Focus & Performance Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 07/07/2023

Desc: ENERGY Focus & Performance Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 07/07/2023

Desc: AGE-DEFY Immunity and Regeneressence Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/07/2023

Desc: ENERGY Focus & Performance Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/07/2023

Desc: AGE-DEFY Immunity and Regeneressence Food Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement.


SYRIAN ARAB REPUBLIC


Adabesqee
Date Published : 04/14/2023
Jezmatieh Street Plot, No 11007 , Maydan, Rif Damascus SYRIAN ARAB REPUBLIC
21 G - - 09 Olives (Pit Fruit)
Date Published: 04/14/2023

Desc: Roasted Green Olives
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(1) of the Act in that the place of business is not provided as required by 21 CFR 101.5. Section 403 (e)(2) of the Act in that the net quantity of contents is declared only in metric terms (gram amount) and on the cap of the container, not on the principal display panel within the bottom 30 percent of the area of the label panel in lines generally parallel to the base as required by 21 CFR 101.7(b)(1), 21 CFR 101.7(e), and 21 CFR 101.7(f). Section 403(f) of the Act because the product label contains information in multiple language besides English but does not repeat all required information in each of the languages. Section 403(q) of the Act in that the nutrition information is not provided as required under 21 CFR 101.9.

21 G - - 11 Olives, Green, (Pit Fruit)
Date Published: 04/14/2023

Desc: Roasted Green Olives
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(1) of the Act in that the place of business is not provided as required by 21 CFR 101.5. Section 403 (e)(2) of the Act in that the net quantity of contents is declared only in metric terms (gram amount) and on the cap of the container, not on the principal display panel within the bottom 30 percent of the area of the label panel in lines generally parallel to the base as required by 21 CFR 101.7(b)(1), 21 CFR 101.7(e), and 21 CFR 101.7(f). Section 403(f) of the Act because the product label contains information in multiple language besides English but does not repeat all required information in each of the languages. Section 403(q) of the Act in that the nutrition information is not provided as required under 21 CFR 101.9.


TAIWAN


Biotanico, Inc.
Date Published : 10/12/2023
No. 1 Nanke 1st Rd. , Xinshi Dist. , Tainan City, TAIWAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/12/2023

Desc: CLEAR SKIN FORMULA (tablets)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e) of the Act because the product fails to completely or accurately declare the place of business, of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the article is not in accordance with 21 CFR 101.36. Section 403(s)(2)(C) of the Act because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

Da Cheng Vegetarian International Co., Ltd.
Date Published : 03/21/2023
No. 268, Wuhe St., , Qionglin Township,, Hsinchu County TAIWAN
18 A - - 05 Meat-Textured Vegetable Protein Product with Appearance of Red Meat Portion
Date Published: 06/08/2023

Desc: Vegan Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

18 B - - 01 Chicken-Flavored Crumbs or Chips (Vegetable Protein)
Date Published: 08/21/2023

Desc: VEGAN CHICKEN CUBE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12).

18 B - - 02 Chicken-Flavored Loaf (Vegetable Protein)
Date Published: 08/21/2023

Desc: VEGAN CHICKEN CUBE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12).

18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions
Date Published: 06/08/2023

Desc: Vegan Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions
Date Published: 08/21/2023

Desc: VEGAN CHICKEN CUBE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12).

18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions
Date Published: 06/08/2023

Desc: Vegan Chicken Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions
Date Published: 03/21/2023

Desc: Vegan Golden Nugget
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions
Date Published: 03/21/2023

Desc: Vegan Drum Stick
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C.
Date Published: 03/21/2023

Desc: Vegan Golden Nugget
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C.
Date Published: 06/08/2023

Desc: Vegan Chicken Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C.
Date Published: 08/21/2023

Desc: VEGAN CHICKEN CUBE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12).

18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C.
Date Published: 03/21/2023

Desc: Vegan Drum Stick
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 C - - 02 Poultry-Like Combinations (Vegetable Proteins)
Date Published: 03/21/2023

Desc: Vegan Golden Nugget
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 C - - 02 Poultry-Like Combinations (Vegetable Proteins)
Date Published: 03/21/2023

Desc: Vegan Drum Stick
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C.
Date Published: 03/21/2023

Desc: Vegan Drum Stick
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C.
Date Published: 03/21/2023

Desc: Vegan Golden Nugget
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 D - - 01 Fish-Textured Vegetable Protein (Products having Appearance of Fish Portions, Fillets, Etc.)
Date Published: 06/08/2023

Desc: VEGAN CODFISH STEAK
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9.

18 E - - 03 Soybean Protein Powder (Meat Extender)
Date Published: 06/08/2023

Desc: VEGAN CODFISH STEAK
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9.

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 06/08/2023

Desc: VEGAN CODFISH STEAK
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9.

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 03/21/2023

Desc: Vegan Golden Nugget
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 06/08/2023

Desc: Vegan Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 06/08/2023

Desc: Vegan Chicken Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.
Date Published: 03/21/2023

Desc: Vegan Drum Stick
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9.

25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 06/08/2023

Desc: Vegan Chicken Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts)
Date Published: 06/08/2023

Desc: Vegan Chicken Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

37 K - - 17 Bean, Ground Paste
Date Published: 06/08/2023

Desc: Vegan Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

37 K - - 17 Bean, Ground Paste
Date Published: 06/08/2023

Desc: Vegan Chicken Ham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

Fengjia Biotechnology Ltd
Date Published : 01/18/2024
No 160 Lunnei , Tuku Township , Yunlin County, Yunlin TAIWAN
41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 01/18/2024

Desc: Collagen Glow Berries
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n).

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/18/2024

Desc: Sicilian Orange Slimming Elixir
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n).

54 A - - 99 Vitamin, N.E.C.
Date Published: 01/18/2024

Desc: Collagen Glow Berries
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n).

54 E - - 12 Ginseng (Herbal & Botanical Teas)
Date Published: 01/18/2024

Desc: Ginseng Turmeric Superjuice
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/18/2024

Desc: Sicilian Orange Slimming Elixir
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C §343(s)(2)(B)] because the product label fails to bear a statement of identity as a “dietary supplement” on the principal display panel. Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] because the product label fails to include a serving size with the common measure followed by the equivalent metric quantity as required by 21 CFR101.9(b)(7). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because the product label fails to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.105. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bear nutrient content claims and it does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b), (c), (e), (g), and (n).

Fu Chi Foods Co., Ltd. (FCE 09789)
Date Published : 10/04/2017
No. 5 Guiyang St. , New Taipei City, TAIWAN
25 J - - 07 Radish (Root & Tuber Vegetable)
Date Published: 10/04/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(f) of the FD&C Act because product label contains information in two languages but does not repeat all the required label information in both languages. Section 403(q) of the FD&C Act in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

25 N - - 14 Turnip, with Sauce
Date Published: 10/04/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(f) of the FD&C Act because product label contains information in two languages but does not repeat all the required label information in both languages. Section 403(q) of the FD&C Act in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

37 J - - 03 Chili Sauce
Date Published: 10/04/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(f) of the FD&C Act because product label contains information in two languages but does not repeat all the required label information in both languages. Section 403(q) of the FD&C Act in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

37 J - - 99 Sauces, n.e.c.
Date Published: 10/04/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(f) of the FD&C Act because product label contains information in two languages but does not repeat all the required label information in both languages. Section 403(q) of the FD&C Act in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9.

Horng Chia Foods Co., Ltd
Date Published : 01/09/2020
No.5, Lane 1, Chia Hsin E Rd , Kaohsiung City, Gang-Shan District TAIWAN
16 C - - 28 Pollack, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Labels fails to declare ingredients in accordance with 21 CFR 101.4. Fish Ball Roe products declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

16 C - - 28 Pollack, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the products fail to declare the ingredients in accordance with 21 CFR 101.4. Ingredient list declares the multi-component ingredient "cheese" but fails to list the sub-ingredients. The Cheese Fish Ball product declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

16 C - - 84 Threadfin, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Labels fails to declare ingredients in accordance with 21 CFR 101.4. Fish Ball Roe products declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

16 C - - 84 Threadfin, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the products fail to declare the ingredients in accordance with 21 CFR 101.4. Ingredient list declares the multi-component ingredient "cheese" but fails to list the sub-ingredients. The Cheese Fish Ball product declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Labels fails to declare ingredients in accordance with 21 CFR 101.4. Fish Ball Roe products declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the products fail to declare the ingredients in accordance with 21 CFR 101.4. Ingredient list declares the multi-component ingredient "cheese" but fails to list the sub-ingredients. The Cheese Fish Ball product declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

16 P - - 99 Other Aquatic Animals, Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Labels fails to declare ingredients in accordance with 21 CFR 101.4. Fish Ball Roe products declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

16 P - - 99 Other Aquatic Animals, Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the products fail to declare the ingredients in accordance with 21 CFR 101.4. Ingredient list declares the multi-component ingredient "cheese" but fails to list the sub-ingredients. The Cheese Fish Ball product declare the ingredient "roe;" which is not the common or usual name of the ingredient as it is a general category of fish eggs, not a specific type of fish species name [21 CFR 101.4(a)(1) and 102.5(a)].

Hsiang Ho Food
Date Published : 09/27/2017
NO. 706-14, 14 F. , Zhongzheng Rd.; Xinzhuang Dist. , New Taipei City, TAIWAN
14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 09/27/2017

Desc: Non-Dairy Creamer
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act because the label bears representations in a foreign language; however; all of the required information does not appear to be provided in the foreign language in accordance with 21 CFR 101.15(c)(2). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information does not meet the requirements of 21 CFR 101.9.

30 A - - 06 Beverage Base, Subtropical or Tropical Fruit
Date Published: 09/27/2017

Desc: Passion Fruit Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act because the label bears representations in a foreign language; however; all of the required information does not appear to be provided in the foreign language in accordance with 21 CFR 101.15(c)(2). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information does not meet the requirements of 21 CFR 101.9.

30 F - - 99 Beverage Base of Non-Fruit Origin, N.E.C.
Date Published: 09/27/2017

Desc: Shake Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act because the label bears representations in a foreign language; however; all of the required information does not appear to be provided in the foreign language in accordance with 21 CFR 101.15(c)(2). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information does not meet the requirements of 21 CFR 101.9.

30 F - - 99 Beverage Base of Non-Fruit Origin, N.E.C.
Date Published: 09/27/2017

Desc: Coffee Smoothie Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act because the label bears representations in a foreign language; however; all of the required information does not appear to be provided in the foreign language in accordance with 21 CFR 101.15(c)(2). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that the nutrition information does not meet the requirements of 21 CFR 101.9.

Kugi Foods Co., Ltd.
Date Published : 03/22/2019
No. 508-35 Wenxian Rd., Sec.1 , Rende Dist. , Tainan City, Tainan TAIWAN
14 B - - 06 Imitation Milk, Dried Milk Type Product
Date Published: 03/22/2019

Desc: HOKKAIDE FLAVOR POWDER
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. The product was analyzed to contain milk, but the label does not appear to declare milk or milk-containing ingredient. Further, the ingredient "glucose" is not a recognized common or usual name of an ingredient in the U.S. in accordance with 21 CFR 101.4(a)(1). If the ingredient is one of the standardized foods, Glucose Sirup (21 CFR 168.120) or Dried Glucose Sirup, it must be declared in accordance with the applicable standard. - Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a). -Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). For example, the statement of identity, ingredients, nutrition facts label, and net quantity of content must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

Ming Teh Food Industry, Co., LTD
Date Published : 08/09/2017
1F.,N0.128,SEC.2,HETI RD. , KAOHSIUNG CITY, GANGSHAN DIST. TAIWAN
37 J - - 03 Chili Sauce
Date Published: 08/09/2017

Desc: Grandpa's Chili Oil (301/1)
Notes: Section 403(i)(2) of the FD &C Act in that each ingredient is not declared by its common or usual name Section 403(f) of the FD&C Act in that the product label contains information in two languages but does not repeat all the required information in both languages

MingTeh Food Industry Co., Ltd.(Alian Factory)
Date Published : 08/09/2017
NO. 172 Fu an , Alian Dist. , Kaohsiung City, TW-KHQ TAIWAN
37 J - - 03 Chili Sauce
Date Published: 08/09/2017

Desc: Grandpa's Chili Oil (301/1)
Notes: Section 403(i)(2) of the FD &C Act in that each ingredient is not declared by its common or usual name Section 403(f) of the FD&C Act in that the product label contains information in two languages but does not repeat all the required information in both languages

NORTHWEST FOOD IND. CO., LTD
Date Published : 06/22/2020
Linkou Dist, New Taipei City, Taiwan , No. 102 Fenliao Rd., Sec. 1; Linkou Dist. , New Taipei City, TAIWAN
16 C - - 84 Threadfin, Cakes, Balls, Etc.
Date Published: 06/22/2020

Desc: FISH DUMPLING
Notes: The Fish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language The Fish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 06/22/2020

Desc: SHRIMP DUMPLING
Notes: The Shrimp Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language. The Shrimp Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

16 P - - 07 Cuttlefish, Cakes, Balls, Etc., Other Aquatic Species
Date Published: 06/22/2020

Desc: CUTTLEFISH DUMPLING
Notes: The Cuttlefish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language. The Cuttlefish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 06/22/2020

Desc: FISH DUMPLING
Notes: The Fish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language The Fish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 06/22/2020

Desc: CUTTLEFISH DUMPLING
Notes: The Cuttlefish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language. The Cuttlefish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 06/22/2020

Desc: SHRIMP DUMPLING
Notes: The Shrimp Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language. The Shrimp Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 06/22/2020

Desc: SHRIMP DUMPLING
Notes: The Shrimp Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language. The Shrimp Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 06/22/2020

Desc: CUTTLEFISH DUMPLING
Notes: The Cuttlefish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language. The Cuttlefish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 06/22/2020

Desc: FISH DUMPLING
Notes: The Fish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the products label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, these products fail to declare the nutrition information in the foreign language The Fish Dumpling products are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information does not comply with 21 CFR 101.9. Specifically, the serving sizes do not appear to be based on the appropriate reference amount customarily consumed (RACC) [21 CFR 101.9(b)(2) and 101.12(b)(Table 2)]. The products appear to fall under the "Entrees without sauce, e.g. plain..." category which has a RACC of 85g cooked; 110g uncooked. The serving sizes for these products are declared as 56g; consequently, all the nutrient information on these products appears to be incorrect.

RADIANT FROZEN FOODS CO., LTD.
Date Published : 11/08/2019
Wuxun St. , No. 8 Anle Dist. , Keelung, Keelung TAIWAN
16 A - - 99 Fish, N.E.C.
Date Published: 11/08/2019

Desc: Frozen Simulated Lobster Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] because it fails to declare nutrition information in accordance with 21 CFR 101.9. Specifically: The serving size is declared as 100 g. The appropriate RACC is 85 g cooked or 110 g uncooked (21 CFR 101.12-Table 2-Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake); therefore, all nutrition information is incorrect. Furthermore, the serving size is not expressed in a common household measure as a number of discrete pieces. The Percent Daily Value for Vitamin A, Vitamin C, Calcium, and Iron have been left blank. If these nutrients are absent or present at levels to be declared as 0%, the nutrition information should reflect such information. The product bears errors in formatting and rounding. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)] because the product fails to declare each ingredient, in accordance with 21 CFR 101.4. Specifically, the product label fails to declare ingredients in descending order of prominence. The product label appears to collectively group the additives (through the use of intervening material in the form of the word "Additives").

16 C - - 28 Pollack, Cakes, Balls, Etc.
Date Published: 11/08/2019

Desc: Frozen Simulated Lobster Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] because it fails to declare nutrition information in accordance with 21 CFR 101.9. Specifically: The serving size is declared as 100 g. The appropriate RACC is 85 g cooked or 110 g uncooked (21 CFR 101.12-Table 2-Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake); therefore, all nutrition information is incorrect. Furthermore, the serving size is not expressed in a common household measure as a number of discrete pieces. The Percent Daily Value for Vitamin A, Vitamin C, Calcium, and Iron have been left blank. If these nutrients are absent or present at levels to be declared as 0%, the nutrition information should reflect such information. The product bears errors in formatting and rounding. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)] because the product fails to declare each ingredient, in accordance with 21 CFR 101.4. Specifically, the product label fails to declare ingredients in descending order of prominence. The product label appears to collectively group the additives (through the use of intervening material in the form of the word "Additives").

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 11/08/2019

Desc: Frozen Simulated Lobster Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] because it fails to declare nutrition information in accordance with 21 CFR 101.9. Specifically: The serving size is declared as 100 g. The appropriate RACC is 85 g cooked or 110 g uncooked (21 CFR 101.12-Table 2-Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake); therefore, all nutrition information is incorrect. Furthermore, the serving size is not expressed in a common household measure as a number of discrete pieces. The Percent Daily Value for Vitamin A, Vitamin C, Calcium, and Iron have been left blank. If these nutrients are absent or present at levels to be declared as 0%, the nutrition information should reflect such information. The product bears errors in formatting and rounding. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)] because the product fails to declare each ingredient, in accordance with 21 CFR 101.4. Specifically, the product label fails to declare ingredients in descending order of prominence. The product label appears to collectively group the additives (through the use of intervening material in the form of the word "Additives").

16 J - - 04 Lobster
Date Published: 11/08/2019

Desc: Frozen Simulated Lobster Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] because it fails to declare nutrition information in accordance with 21 CFR 101.9. Specifically: The serving size is declared as 100 g. The appropriate RACC is 85 g cooked or 110 g uncooked (21 CFR 101.12-Table 2-Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake); therefore, all nutrition information is incorrect. Furthermore, the serving size is not expressed in a common household measure as a number of discrete pieces. The Percent Daily Value for Vitamin A, Vitamin C, Calcium, and Iron have been left blank. If these nutrients are absent or present at levels to be declared as 0%, the nutrition information should reflect such information. The product bears errors in formatting and rounding. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)] because the product fails to declare each ingredient, in accordance with 21 CFR 101.4. Specifically, the product label fails to declare ingredients in descending order of prominence. The product label appears to collectively group the additives (through the use of intervening material in the form of the word "Additives").

16 R - - 02 Crab, Imitation
Date Published: 11/08/2019

Desc: Frozen Simulated Lobster Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] because it fails to declare nutrition information in accordance with 21 CFR 101.9. Specifically: The serving size is declared as 100 g. The appropriate RACC is 85 g cooked or 110 g uncooked (21 CFR 101.12-Table 2-Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake); therefore, all nutrition information is incorrect. Furthermore, the serving size is not expressed in a common household measure as a number of discrete pieces. The Percent Daily Value for Vitamin A, Vitamin C, Calcium, and Iron have been left blank. If these nutrients are absent or present at levels to be declared as 0%, the nutrition information should reflect such information. The product bears errors in formatting and rounding. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)] because the product fails to declare each ingredient, in accordance with 21 CFR 101.4. Specifically, the product label fails to declare ingredients in descending order of prominence. The product label appears to collectively group the additives (through the use of intervening material in the form of the word "Additives").

16 R - - 04 Lobster, Imitation
Date Published: 11/08/2019

Desc: Frozen Simulated Lobster Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] because it fails to declare nutrition information in accordance with 21 CFR 101.9. Specifically: The serving size is declared as 100 g. The appropriate RACC is 85 g cooked or 110 g uncooked (21 CFR 101.12-Table 2-Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake); therefore, all nutrition information is incorrect. Furthermore, the serving size is not expressed in a common household measure as a number of discrete pieces. The Percent Daily Value for Vitamin A, Vitamin C, Calcium, and Iron have been left blank. If these nutrients are absent or present at levels to be declared as 0%, the nutrition information should reflect such information. The product bears errors in formatting and rounding. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)] because the product fails to declare each ingredient, in accordance with 21 CFR 101.4. Specifically, the product label fails to declare ingredients in descending order of prominence. The product label appears to collectively group the additives (through the use of intervening material in the form of the word "Additives").

Sauceco Food Co., Ltd.
Date Published : 07/21/2017
No. 701, Shi Shih Road , Feng Yuan District , Taichung, Taichung TAIWAN
25 L - - 19 Lily (Flower, Bulb, Stem), Dried or Paste
Date Published: 07/21/2017

Desc: Hand Roasted Natural Day Lily
Notes: Section 403(f) of the Act because it does not contain all required statements in English; as required by 21 CFR 101.15(c)(1). Section 403(e)(2) of the Act and 15 USC 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce [21 CFR 101.7(b)(1)].

TCI Co., Ltd
Date Published : 10/06/2022
8F, No. 187 Kang Chien Rd., , Taipei, R. O. C. , Taipei, TW-TPE TAIWAN
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/06/2022

Desc: HAIR REVIVAL TABLET
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) because the label fails to declare the number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/06/2022

Desc: HAIR REVIVAL TABLET
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) because the label fails to declare the number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii).

TS BEEHONEY CO., LTD.
Date Published : 04/04/2018
No. 67 Sanmin Dist. , Chongqing St. , Kaohsiung City, Kaohsiung - District TAIWAN
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 04/04/2018

Desc: Royal Jelly Honey Syrup
Notes: Section 403(a)(1) of the FD&C Act in that the label is false and misleading. • The product is declared as Royal Jelly, but this product is not fabricated from royal jelly per the ingredients. • The nutrition information appears to be false. For example, the product label fails to declare total fat as required by 21 CFR 101.9(c)(2). • The "Calories from fat" value does not appear to be appropriate based on total fat declared. Section 403(i)(1) of the FD&C Act in that the labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b). • It is unclear whether the product is intended to be "honey" or "honey syrup" based on the product label. "Honey" is declared as part of the statement of identity located on the principal display panel for both products. The information panel located on the back of the packages appear to declare the products as a "honey syrup." • The information panel on the back of the packages state that the product is "honey syrup." The use of the term "honey syrup" falls under the standard of identity for "table syrup" in 21 CFR 168.180. • Under 168.180(d)(2) if the food has a statement or vignettes or pictures representing that the characterizing flavor is honey, the total quantity of honey must be greater than 10% by weight of the finished food. Unable to determine based on the percent of honey in the product. • Regarding this product, this is not an appropriate statement of identity because based on the ingredient statement, the product does not contain any royal jelly ingredient. Section 403(f) of the FD&C Act in that the product labels contain information in two languages, but does not repeat all the required information in both languages as required by 21 CFR 101.15(c.

36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 04/04/2018

Desc: Longan Honey Syrup
Notes: Section 403(i)(1) of the FD&C Act in that the labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b). • It is unclear whether the product is intended to be "honey" or "honey syrup" based on the product label. "Honey" is declared as part of the statement of identity located on the principal display panel for both products. The information panel located on the back of the packages appear to declare the products as a "honey syrup." • The information panel on the back of the packages state that the product is "honey syrup." The use of the term "honey syrup" falls under the standard of identity for "table syrup" in 21 CFR 168.180. • Under 168.180(d)(2) if the food has a statement or vignettes or pictures representing that the characterizing flavor is honey, the total quantity of honey must be greater than 10% by weight of the finished food. Unable to determine based on the percent of honey in the product. • Honey is a single-ingredient food and this product contains multiple ingredients; therefore, "Longan honey" is not an appropriate name for this product. Section 403(f) of the FD&C Act in that the product labels contain information in two languages, but does not repeat all the required information in both languages as required by 21 CFR 101.15(c. For example, it appears the list of ingredients and qualifying information for the name and place of business are not provided in the foreign language.

Taiwan Wachine Co., Ltd
Date Published : 10/02/2015
Zhongzheng Dist., Taipei City, Taiwan , NO. 83, 2 F.; Ningbo W. St. , Taipei City, TW-TPQ TAIWAN
24 T - - 03 Bamboo Shoots (Leaf & Stem Vegetable)
Date Published: 10/02/2015

Notes: Bamboo shoots; cooked This bamboo product is also indicated for detention in that a chemical preservative (sulfite) is an ingredient in the product and is not identified as a preservative [FFD&CA Section 403(k); 21 CFR 101.22(j)].

Taiwan You good Food Co., Ltd.
Date Published : 03/10/2015
No.5, Caofong Rd., Lane 501 , Hsien Hsi Hsiang , Changhua Hsien, TW-CHA TAIWAN
03 R - - 25 Pastry (Other than Fruit or Jelly Filled) Without Custard or Cream Filling
Date Published: 03/16/2020

Desc: Butter Raisin Pie
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(e)] because the ingredient "Vegetable Margarine" appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed, as required under 21 CFR 101.4(b)(2). B-carotene listed on the label was identified by the FDA to be a product called "Vegex NC 2c Ws" which is also comprised of multiple ingredients. The product name is not the common or usual name nor are its ingredients listed. Section 403(i)(1) of the Act [21 U.S.C. 343(e)] "Glucose" is not the common or usual name for sugar, as required under 21 CFR 101.4(a)(l).; 3/10/2015

03 R - - 25 Pastry (Other than Fruit or Jelly Filled) Without Custard or Cream Filling
Date Published: 03/16/2020

Desc: Butterfly Pie
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(e)] because the ingredient "Vegetable Margarine" appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed, as required under 21 CFR 101.4(b)(2). B-carotene listed on the label was identified by the FDA to be a product called "Vegex NC 2c Ws" which is also comprised of multiple ingredients. The product name is not the common or usual name nor are its ingredients listed. Section 403(i)(1) of the Act [21 U.S.C. 343(e)] "Glucose" is not the common or usual name for sugar, as required under 21 CFR 101.4(a)(l).; 3/10/015

03 R - - 35 Pastry, Fruit or Jelly Filled, Without Custard or Cream Filling
Date Published: 03/16/2020

Desc: Butter Raisin Pie
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(e)] because the ingredient "Vegetable Margarine" appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed, as required under 21 CFR 101.4(b)(2). B-carotene listed on the label was identified by the FDA to be a product called "Vegex NC 2c Ws" which is also comprised of multiple ingredients. The product name is not the common or usual name nor are its ingredients listed. Section 403(i)(1) of the Act [21 U.S.C. 343(e)] "Glucose" is not the common or usual name for sugar, as required under 21 CFR 101.4(a)(l).; 3/10/2015

03 R - - 35 Pastry, Fruit or Jelly Filled, Without Custard or Cream Filling
Date Published: 03/16/2020

Desc: Butterfly Pie
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(e)] because the ingredient "Vegetable Margarine" appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed, as required under 21 CFR 101.4(b)(2). B-carotene listed on the label was identified by the FDA to be a product called "Vegex NC 2c Ws" which is also comprised of multiple ingredients. The product name is not the common or usual name nor are its ingredients listed. Section 403(i)(1) of the Act [21 U.S.C. 343(e)] "Glucose" is not the common or usual name for sugar, as required under 21 CFR 101.4(a)(l).; 3/10/015

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 03/16/2020

Desc: Butter Raisin Pie
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(e)] because the ingredient "Vegetable Margarine" appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed, as required under 21 CFR 101.4(b)(2). B-carotene listed on the label was identified by the FDA to be a product called "Vegex NC 2c Ws" which is also comprised of multiple ingredients. The product name is not the common or usual name nor are its ingredients listed. Section 403(i)(1) of the Act [21 U.S.C. 343(e)] "Glucose" is not the common or usual name for sugar, as required under 21 CFR 101.4(a)(l).; 3/10/2015

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 03/16/2020

Desc: Butterfly Pie
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. 343(e)] because the ingredient "Vegetable Margarine" appears to be an ingredient which itself is comprised of multiple ingredients and those ingredients are not listed, as required under 21 CFR 101.4(b)(2). B-carotene listed on the label was identified by the FDA to be a product called "Vegex NC 2c Ws" which is also comprised of multiple ingredients. The product name is not the common or usual name nor are its ingredients listed. Section 403(i)(1) of the Act [21 U.S.C. 343(e)] "Glucose" is not the common or usual name for sugar, as required under 21 CFR 101.4(a)(l).; 3/10/015

Wei Jung Food Industry Co.,Ltd
Date Published : 07/21/2017
701 Xishi Rd, San Chun Li , Fengyuan , Fengyuan, Taichung - District TAIWAN
25 L - - 19 Lily (Flower, Bulb, Stem), Dried or Paste
Date Published: 07/21/2017

Desc: Hand Roasted Natural Day Lily
Notes: Section 403(f) of the Act because it does not contain all required statements in English; as required by 21 CFR 101.15(c)(1). Section 403(e)(2) of the Act and 15 USC 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce [21 CFR 101.7(b)(1)].


THAILAND


European Food Public Company Limited
Date Published : 10/02/2015
140 Moo 4 Raboapai Road , Srimahapho, Prachinburi THAILAND
33 G - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts or Nut Products (without Chocolate)
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 G - - 07 Jellied Candies, Soft (Jelly Beans, Gum Drops, Etc.), with Nuts or Nut Products (without Chocolate)
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 J - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 K - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 K - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 M - - 01 Gel Cups, Fruit Flavored
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 M - - 03 Gel Cups, Fruit Flavored w/Fruit Candy
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 M - - 05 Gel Cups Candy
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

33 M - - 07 Gel Candy on a Stick Candy
Date Published: 10/02/2015

Desc: Assorted Jelly Candy (Pipo Brand)
Notes: VIOLATION: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug and Cosmetic Act because the Variety Flavored Jelly Dessert product fails to accurately declare the characterizing flavor of this product. The term "Nature Identical Flavor" is not a recognized common or usual name of an ingredient, as required by 21 CFR 101.22(h)(1). In addition, The article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(l) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product contains no prominent statement of identity on the Principal Display Panel, as required by 21 CFR 101.3. Furthermore, the at1icle is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Federal Food, Drug and Cosmetic Act (the Act) because your Variety Flavoured Jelly Dessert product does not contain the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5.

Go Truerich de Saraphi Co.,Ltd.
Date Published : 06/01/2020
333 Moo.4 Banthatonkuaw , T. Chompoo , A. Saraphi, TH-50 THAILAND
31 K - - 20 Tea, Liquid
Date Published: 06/01/2020

Desc: THAI TEA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because it fails to bear nutrition information, as required by 21 CFR 101.9. Although unsweetened teas are generally exempt from declaring nutrition information under 21 CFR 101.9(j)(4) for containing insignificant amounts of all of the nutrients, this product contains honey as an ingredient and, therefore, this exemption does not appear to apply. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it fails to declare all ingredients in accordance with 21 CFR 101.4. Specifically, the product fails to declare each ingredient by its common or usual name. Furthermore, the product label declares "And Others" at the end of the ingredient list which indicates that the product contains ingredients which have not been declared.

31 K - - 99 Tea, N.E.C.
Date Published: 06/01/2020

Desc: THAI TEA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because it fails to bear nutrition information, as required by 21 CFR 101.9. Although unsweetened teas are generally exempt from declaring nutrition information under 21 CFR 101.9(j)(4) for containing insignificant amounts of all of the nutrients, this product contains honey as an ingredient and, therefore, this exemption does not appear to apply. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it fails to declare all ingredients in accordance with 21 CFR 101.4. Specifically, the product fails to declare each ingredient by its common or usual name. Furthermore, the product label declares "And Others" at the end of the ingredient list which indicates that the product contains ingredients which have not been declared.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 06/01/2020

Desc: THAI TEA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because it fails to bear nutrition information, as required by 21 CFR 101.9. Although unsweetened teas are generally exempt from declaring nutrition information under 21 CFR 101.9(j)(4) for containing insignificant amounts of all of the nutrients, this product contains honey as an ingredient and, therefore, this exemption does not appear to apply. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it fails to declare all ingredients in accordance with 21 CFR 101.4. Specifically, the product fails to declare each ingredient by its common or usual name. Furthermore, the product label declares "And Others" at the end of the ingredient list which indicates that the product contains ingredients which have not been declared.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/01/2020

Desc: THAI TEA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because it fails to bear nutrition information, as required by 21 CFR 101.9. Although unsweetened teas are generally exempt from declaring nutrition information under 21 CFR 101.9(j)(4) for containing insignificant amounts of all of the nutrients, this product contains honey as an ingredient and, therefore, this exemption does not appear to apply. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it fails to declare all ingredients in accordance with 21 CFR 101.4. Specifically, the product fails to declare each ingredient by its common or usual name. Furthermore, the product label declares "And Others" at the end of the ingredient list which indicates that the product contains ingredients which have not been declared.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/01/2020

Desc: THAI TEA
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because it fails to bear nutrition information, as required by 21 CFR 101.9. Although unsweetened teas are generally exempt from declaring nutrition information under 21 CFR 101.9(j)(4) for containing insignificant amounts of all of the nutrients, this product contains honey as an ingredient and, therefore, this exemption does not appear to apply. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it fails to declare all ingredients in accordance with 21 CFR 101.4. Specifically, the product fails to declare each ingredient by its common or usual name. Furthermore, the product label declares "And Others" at the end of the ingredient list which indicates that the product contains ingredients which have not been declared.

Green Giant Co., Ltd.
Date Published : 07/25/2022
19/7 Moo 15 Tapa , Leab Klong Cholpratan Rd , Banpong, Ratchaburi THAILAND
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 07/25/2022

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 07/25/2022

Desc: Sponsor Sports Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 07/25/2022

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (can)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

29 B - - 06 Soft Drink, Imitation Fruit Flavored, Carbonated
Date Published: 07/25/2022

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

29 B - - 06 Soft Drink, Imitation Fruit Flavored, Carbonated
Date Published: 12/14/2023

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (can)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). 07/25/2022

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 07/25/2022

Desc: Sponsor Sports Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 07/25/2022

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (can)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 07/25/2022

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 07/25/2022

Desc: Sponsor Sports Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 07/25/2022

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (can)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 07/25/2022

Desc: Carbonated Soft Drink Cream Soda Flavored - Fanta Brand (bottle)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language).

Huychun (Thailand)
Date Published : 05/23/2019
16/3 Moo 2 Nongpaklong A. Muang , Nakornpatom, TH-73 THAILAND
29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Strawberry Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Rose Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Banana Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Mango Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Rose Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Mango Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Banana Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Strawberry Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived.

Jack Hua Co., Ltd
Date Published : 09/27/2023
51, 53, 55 Sudprasert Road , Bangklo, Bangkorlaem , Bangkok, TH-NOTA THAILAND
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 01 Anchovy
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 59 Scad
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 76 Saury
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 80 Bream
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 99 Fish, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 C - - -- Fish,Cakes,Balls,etc
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 Y - - 99 Fishery Products, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

Korn Thai Co Ltd
Date Published : 02/22/2022
64 , Muang; 99 Thanon Rungrueang Soi 3 , Mueang Ratchaburi, Ratchaburi THAILAND
21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 02/22/2022

Desc: COCONUT CREAM POWDER
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a several foreign languages; therefore, all required information must be in all of the represented languages (i.e., the English language as well as the foreign languages).

Korn Thai Co., Ltd.
Date Published : 02/22/2022
419 Soi Khema,pattanakarn Road , Suan Luang, Bangkok THAILAND
21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 02/22/2022

Desc: COCONUT CREAM POWDER
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a several foreign languages; therefore, all required information must be in all of the represented languages (i.e., the English language as well as the foreign languages).

Phetdamfoods Co.,Ltd.
Date Published : 10/22/2019
Amphoe Maung , 193 Villeage No.5 Tambol Hui Pho , Kalasin, Kalasin THAILAND
16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 10/22/2019

Desc: Plala Fish Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the FDCA in that it appears to be misbranded within the meaning of: Section 403(f) of the FDCA [21 U.S.C. 343(f)]-the LBL appears to contain information in two or more languages but does not repeat all the required LBL information in English and the respective foreign language. In accordance with section 21CFR101.15(c)(2),if a LBL contains any representation in a foreign language, all words,statements,and other information required by or under authority of the Act to appear on the LBL must appear in the foreign language. Specifically,the product fails to list the nutrition information and ingredient statement in the foreign language. We also note that the product fails to declare the statement of identity (SOI) in the English language as required by section 21CFR 101.15(c)(1). Section 403(i)(2) of the FDCA [21 U.S.C. 343(i)(2)]-the LBL fails to declare the sub-ingredients for an ingredient which contains two or more ingredients,as required under section 21CFR101.4(b). For example,the ingredient statement lists "Fish sauce" and "Garlic juice"; however,it appears the sub-ingredients are not declared. The requirement to list these component ingredients (or "sub- ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient,or by listing the component ingredients without listing the ingredient itself. Under the first alternative,the component ingredients must be listed in descending order of predominance within the multi-component ingredient;and under the second alternative,the component ingredients must be listed in descending order of predominance in the finished food.

Rungroj Fish Sauce Development Co.,Ltd
Date Published : 03/18/2016
Thambon Bangpreng , 261; 56 Moo 2 Panvithee road , Bang Bo, Samut Prakan THAILAND
37 J - - 03 Chili Sauce
Date Published: 03/18/2016

Desc: Buffalo Brand Spring Rolls Sauce
Notes: The product appears to be misbranded within the meaning of; (1)section 403(k) of the Act in that the product bears or contains a chemical preservative; sodium benzoate; but does not bear labeling stating that fact; (2)section 403(f) of the Act in that it contains information (e.g. statement of identity; net quantity of contents; ingredient statement; and Nutritional Facts Panel) in languages (e.g. Vietnamese; Thai; and/or Chinese)other than English and therefore all required information must be in each language (e.g. the English language as well as the foreign language); (3)section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format (e.g. the product label states a serving size of ?2 tbsps (38g)? and a servings per container of ?about 3?- for three servings of 38 grams; the net quantity of content for the product would be approximately 114 grams; however; the product is labeled to contain 900 grams and therefore the servings per container should be approximately 24).

37 J - - 99 Sauces, n.e.c.
Date Published: 03/18/2016

Desc: Buffalo Brand Spring Rolls Sauce
Notes: The product appears to be misbranded within the meaning of; (1) section 403(k) of the Act in that the product bears or contains a chemical preservative; sodium benzoate; but does not bear labeling stating that fact; (2)section 403(f) of the Act in that it contains information (e.g. statement of identity; net quantity of contents; ingredient statement; and Nutritional Facts Panel) in languages (e.g. Vietnamese; Thai; and/or Chinese)other than English and therefore all required information must be in each language (e.g. the English language as well as the foreign language); (3)section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format (e.g. the product label states a serving size of ?2 tbsps (38g)? and a servings per container of ?about 3?- for three servings of 38 grams; the net quantity of content for the product would be approximately 114 grams; however; the product is labeled to contain 900 grams and therefore the servings per container should be approximately 24).

Sun Yang Food Co., Ltd.
Date Published : 09/27/2023
13/8 Moo 4, Takham , Sampran, Nakonpathom THAILAND
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 01 Anchovy
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 59 Scad
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 76 Saury
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 80 Bream
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 A - - 99 Fish, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 C - - -- Fish,Cakes,Balls,etc
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

16 Y - - 99 Fishery Products, N.E.C.
Date Published: 09/27/2023

Desc: Prepared Fish (BBQ Flavor) (Saurida undosquamis)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act because it is fabricated from two or more ingredients and each ingredient is not declared on the label (21 CFR 101.4(b)(2)). The Thai version of the ingredient statement does not include the following ingredients found in the English version: Sugar, Chili Pepper, Tapioca Flour. Artificial colors INS 102, INS 110 and Preservatives INS 202 are not the common or usual names for colors or preservative. Soy Sauce is a multi-ingredient item and the sub ingredients are not listed. Section 403(f) of the Act. Product label contains information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)). Soy Sauce, Disodium 5-ribonucleotide, Artificial Colors etc., are not declared in the English label’s ingredient statement. Sugar, Chili Pepper, and Tapioca Flour appear in English but not on the Thai version. Section 403(q) of the Act. Nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. The regulations do not provide for the use of two different Nutrition Facts labels with one being in another countries’ format. Section 403(k) of the Act. Product appears to contain artificial coloring or chemical preservative but is not declared in the ingredient list. Thai language label declares “preservative INS 202” and “artificial colors INS 102, INS 110” but fails to list them in the English ingredient statement. Spices, flavorings, colors, and chemical preservatives must be declared (21 CFR 101.22).

Thanya Farm Co Ltd
Date Published : 02/27/2024
Moo 3 , 62 3 Bangyai , Bang Yai, Nonthaburi THAILAND
21 T - - 14 Tamarind, Dried or Paste
Date Published: 02/27/2024

Desc: Tamarind Paste
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in a foreign language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign languages). For example, the Nutrition Facts label and net quantity of content statement must be declared in both the foreign languages and English as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4.

The Union Frozen Products Co., Ltd.
Date Published : 10/02/2015
Ampur Muang , 1259 1094/10 Wichianchodok Road , Muang Samut Sakhon, Samut Sakhon THAILAND
16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 10/02/2015

Desc: Frozen Seafood Mix
Notes: This product is misbranded within the meaning of section 403(i)(2)because the label or labeling fails to bear the required information. Specifically, The ingredients in the product are not identified according to 21 CFR101.4(b) The principal display panel and the ingredients statement declare: ¿Cooked Clams or Mussels." Also, the product bears a ¿contains¿ statement that Reads ¿Allergen Warning: Contains shrimp and Shellfish ingredients.¿ ¿Shellfish ingredients¿ is not a major food allergen; therefore, according to 403(w) of the Act, it should not be in the ¿contains¿ statement. The UPC code and the Statement ¿Allergen Warning¿ is intervening material according to 21 CFR 101.2(e)

UNIVERSITY OF MAE FAH LUANG
Date Published : 08/19/2019
Herbal Plant 333 Moo 1t Tha Suea , Chiang Rai, THAILAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Formulated for multiple diseases and regulates body balance
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Formulated for blood pressure and blood sugar balance
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Relieve Hemorrhoids
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Intestinal Cleanser
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Formulated for nerve pain
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Toxin Neutralizer
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Gout Support
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Healthy Heart Support
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2019

Desc: Natural Miracle Herbs brand Improves energy and overall wellness; For Gentlemen
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

V-SERVE LOGISTICS LTD.
Date Published : 03/15/2018
1119 Sukhumvit 105 (Soi Lasale) , Sukhumvit Rd., Bangna , Bangkok, TH-10 THAILAND
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 03/15/2018

Desc: Special Dried Butter Cake
Notes: Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient; Section 403(f) of the FD&C Act in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2)

eastern Food Co., Ltd.
Date Published : 02/23/2016
209 Lardpro 53rd. , Lardpro Road, Vangthonglarn , Bangkok, TH-NOTA THAILAND
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 02/23/2016

Desc: PINEAPPLE BISCUIT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product declares that it contains "No Preservatives" when the product appears to contain sulfites as an ingredient. The article is subject to refusal of admission pursuant to Section 801(a)(3) n that it appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15( c )(2), if the label contains any representation in a foreign language, all words, statements, and other information required by or under the authority of the act must appear in the foreign language. We note that all mandatory information, including the nutrition label, is not provided in the foreign language. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined by 21 CFR 101.9.


TURKEY


Alhatoglu Gida Ltd. Sti.
Date Published : 04/26/2023
Inonu Mah. , Nuri Giyik Sanayi Sitesi.4 Blok Sok. 3 Tobb Akhisar Tic. Bor. Onder Yamanel , Akhisar, Manisa TURKEY
20 K - - 04 Lemon, Citrus Fruit Juices or Concentrates
Date Published: 04/26/2023

Desc: Lemon Juice
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the FD&CA in that the article's labeling appears to be false and misleading in any particular. Section 403(g)(1) of the FD&CA in that the article appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR §146.114. Section 403(i)(2) of the FD&CA in that it is a food which purports to be a beverage containing fruit or vegetable juice, but the label fails to bear a statement on the information panel of the total percentage of such fruit or vegetable juice contained in the food [21 CFR 101.30(a)]. DWPE date: 04/15/2014. Firm previously listed on deactivated Import Alert 22-04.

Bumin Gida Sanayi Ve Ticaret Ltd
Date Published : 10/02/2015
Organize Sanayi Bolgasi , Turgutlu / Manisa, TURKEY
27 V - - 01 Cider Vinegar (Apple)
Date Published: 10/02/2015

Desc: Apple Cider Vinegar
Notes: VIOLATION (IN NOTES); 403(i)(2) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(2) because the labels fails to declare E223 by the common or usual name; sodium metabisulphite; in accordance with 21 CFR 101.4.

27 V - - 03 Wine Vinegar
Date Published: 10/02/2015

Desc: Grape Wine Vinegar
Notes: VIOLATION (IN NOTES); 403(i)(2) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(i)(2) because the labels fails to declare E223 by the common or usual name; sodium metabisulphite; in accordance with 21 CFR 101.4.

Kent Boringer Dis Tic Ltd Sti
Date Published : 10/02/2015
Akcaburgaz Mah. , 3 Sokak No. 1 Kap. , Esenyurt, Istanbul TURKEY
30 J - - 05 Beverage Base, Imitation Pit Fruit
Date Published: 10/02/2015

Desc: Instant Powder Drink Orange Flavoured
Notes: VIOLATION (IN NOTES): 1. 403(q) 1. The articles are subject to refusal of admission pursuant to section 801 (a)(3) in that they appear to be misbranded within the meaning of 403(q) because: • The serving size declaration is not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). In addition, the declared serving size is incorrect; it should be the amount to make 240 ml (8fl oz) and the nutrition value must be based on this serving size. Therefore, the "Serving per container" may also need to be corrected. • The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "kcal." The "Energy Content" may be expressed in kilojoule units, parenthetically following the statement of caloric content. • There is no established Daily Valve (DV) for trans fat; therefore, a %DV for trans fat cannot be declared in the Nutrition Facts" panel [21 CFR 101.9(d)(7)(ii)]. • The mandatory nutrients, vitamin A, calcium and iron are not declared as required by 21 CFR 101.9(c)(8). • The Total Carbohydrate content is not expressed to the nearest gram [21 CFR 101.9(c)(6)] • The Sugar content is not expressed to the nearest gram [21 CFR 101.9(c)(6)(ii)]. • The nutrition label does not meet the formatting requirements of21 CFR 101.9(d).

Simsek Biskuvi ve gida sanayii A.s.
Date Published : 10/02/2015
Organize Sanayii Bolgesi , Karaman, Tr-70 TURKEY
34 C - - 07 Mixed or Assorted Chocolate Candies (Bars, Boxes, Loose Form), with Nuts or Nut Products (not Coconu
Date Published: 10/02/2015

Notes: Simsek Milky Kid Milk Chocolate Covered Suprprised Egg Candy. The product fails to properly declare the Organize serving size and fails to provide

Soyyigit Gida Sanayi ve Ticaret
Date Published : 10/02/2015
Akcaburgaz Mah. , 110 Sokak No 3 , Esenyurt, Istanbul TURKEY
30 J - - 05 Beverage Base, Imitation Pit Fruit
Date Published: 10/02/2015

Desc: Instant Powder Drink Orange Flavoured
Notes: VIOLATION (IN NOTES): 1. 403(q) 1. The articles are subject to refusal of admission pursuant to section 801 (a)(3) in that they appear to be misbranded within the meaning of 403(q) because: • The serving size declaration is not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). In addition, the declared serving size is incorrect; it should be the amount to make 240 ml (8fl oz) and the nutrition value must be based on this serving size. Therefore, the "Serving per container" may also need to be corrected. • The Caloric content is not declared in accordance with 21 CFR 101.9(c)(1). Specifically, the caloric content should be declared as "Calories" and the units should be in calories, not "kcal." The "Energy Content" may be expressed in kilojoule units, parenthetically following the statement of caloric content. • There is no established Daily Valve (DV) for trans fat; therefore, a %DV for trans fat cannot be declared in the Nutrition Facts" panel [21 CFR 101.9(d)(7)(ii)]. • The mandatory nutrients, vitamin A, calcium and iron are not declared as required by 21 CFR 101.9(c)(8). • The Total Carbohydrate content is not expressed to the nearest gram [21 CFR 101.9(c)(6)] • The Sugar content is not expressed to the nearest gram [21 CFR 101.9(c)(6)(ii)]. • The nutrition label does not meet the formatting requirements of21 CFR 101.9(d).

Tibet Ithalat Ihracat Ve Kozmetik Sanayi A.S.
Date Published : 09/11/2019
No. 344 Seyhli Mahallesi , Ankara Caddesi , Pendik, Istanbul TURKEY
02 G - - 99 Flours and Meals N.E.C.
Date Published: 09/11/2019

Desc: Blue Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

02 G - - 99 Flours and Meals N.E.C.
Date Published: 09/11/2019

Desc: Red Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 09/11/2019

Desc: Sugar Paste; Yellow
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 09/11/2019

Desc: Sugar Paste; Blue
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 09/11/2019

Desc: Sugar Paste; Green
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 09/11/2019

Desc: Sugar Paste; Pink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 09/11/2019

Desc: Sugar Paste; Red
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 N - - 03 Pastry (Eclairs, Cream Puffs) Custard or Cream Filled
Date Published: 09/11/2019

Desc: Red Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

03 N - - 04 Pies or Puddings, Custard or Cream Filled
Date Published: 09/11/2019

Desc: Blue Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

03 S - - 01 Cake Prepared Dry Mix Without Custard or Cream Filling
Date Published: 09/11/2019

Desc: Red Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

03 S - - 01 Cake Prepared Dry Mix Without Custard or Cream Filling
Date Published: 09/11/2019

Desc: Blue Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

03 S - - 01 Cake Prepared Dry Mix Without Custard or Cream Filling
Date Published: 09/11/2019

Desc: Jello Powder Mix; Kiwi
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to declare if "Kiwi Flavoured Jelly" product is artificial. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages. Name of the product is not on the principal display panel in any of the foreign languages.

03 T - - 25 Pastry (other than Fruit or Jelly Filled) Dough or Batter Without Custard or Cream Filling
Date Published: 09/11/2019

Desc: Blue Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

03 T - - 25 Pastry (other than Fruit or Jelly Filled) Dough or Batter Without Custard or Cream Filling
Date Published: 09/11/2019

Desc: Red Velvet Cake Mix
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the US measure in pounds followed by the remainder in ounces or common or decimal fractions of the pound. Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the labels are false or misleading because the principal display panels bear the statement, "Cream in Pack." However, according to the ingredient statements, the products do not contain cream. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to bear their ingredient statements on the information panels and fail to list the type of vegetable oil in the product. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages.

03 U - - 04 Demiglace Icings and Icing Mixes
Date Published: 09/11/2019

Desc: Sugar Paste; Yellow
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 U - - 04 Demiglace Icings and Icing Mixes
Date Published: 09/11/2019

Desc: Sugar Paste; Blue
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 U - - 04 Demiglace Icings and Icing Mixes
Date Published: 09/11/2019

Desc: Sugar Paste; Green
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 U - - 04 Demiglace Icings and Icing Mixes
Date Published: 09/11/2019

Desc: Sugar Paste; Red
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

03 U - - 04 Demiglace Icings and Icing Mixes
Date Published: 09/11/2019

Desc: Sugar Paste; Pink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the net quantity of contents in terms of US measure or list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9.

21 C - - 09 Other Fruits, Mixed, Flavored Jams, Jellies, Preserves, Marmalades, Butters and Candied
Date Published: 09/11/2019

Desc: Jello Powder Mix; Kiwi
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to declare if "Kiwi Flavoured Jelly" product is artificial. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages. Name of the product is not on the principal display panel in any of the foreign languages.

22 C - - 09 Korean Melon
Date Published: 09/11/2019

Desc: Jello Powder Mix; Kiwi
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to declare if "Kiwi Flavoured Jelly" product is artificial. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages. Name of the product is not on the principal display panel in any of the foreign languages.

22 J - - 99 Other Fruit and Fruit Products, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 09/11/2019

Desc: Jello Powder Mix; Kiwi
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to declare if "Kiwi Flavoured Jelly" product is artificial. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages. Name of the product is not on the principal display panel in any of the foreign languages.

35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 09/11/2019

Desc: Jello Powder Mix; Kiwi
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels' net quantity of contents statements fail to be in compliance with 21 CFR 101.7]. Label fails to list the complete term "net weight" or "net wt" in English. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that their ingredients are not listed in accordance with 21 CFR 101.4. Ingredient lists include terms such as "emulsifier," "raising agents," "thickening agents," "thickener," "humectant," and/or "E" numbers. Labels fail to declare if "Kiwi Flavoured Jelly" product is artificial. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information does not comply with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in more than one language, but do not repeat all the required information in all languages. Name of the product is not on the principal display panel in any of the foreign languages.


UGANDA


African market
Date Published : 08/24/2015
Luwumu street 24089 , Kampala, UGANDA
23 Y - - 99 Nuts or Edible Seeds Not Mentioned Elsewhere, N.E.C.
Date Published: 08/24/2015

Desc: Grinded G Nuts
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(1) of the Act in that the statement of identity; ?G nuts;? is not an appropriate common or usual name or an appropriately descriptive term as required by 21 CFR 101.3;The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act in that the nutrition information does not include all of the required nutrients and is not in an appropriate format as defined in 21 CFR 101.9. Published on 08/24/2015

23 Y - - 99 Nuts or Edible Seeds Not Mentioned Elsewhere, N.E.C.
Date Published: 08/24/2015

Desc: Whole G Nuts
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(1) of the Act in that the statement of identity, "G nuts," is not an appropriate common or usual name or an appropriately descriptive term as required by 21 CFR 101.3; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act in that the nutrition information does not include all of the required nutrients and is not in an appropriate format as defined in 21 CFR 101.9. Published on 08/24/2015


UKRAINE


Capsular
Date Published : 02/16/2017
Zheleznodorogniy Lane 3/4 , Dergachi, Kharkivska Oblast UKRAINE
16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 02/16/2017

Desc: Imitation Caviar
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 02/16/2017

Desc: Imitation Caviar
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

20 D - - 04 Cranberry Juice, Berry Juice or Concentrates
Date Published: 02/16/2017

Desc: Cranberry Juice Filler in Jelly Balls
Notes: Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

20 D - - 14 Strawberry Juice, Berry Juice or Concentrates
Date Published: 02/16/2017

Desc: Strawberry Juice Filler in Jelly Balls
Notes: Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

20 K - - 06 Orange, Citrus Fruit Juices or Concentrates
Date Published: 02/16/2017

Desc: Orange Juice Filler in Jelly Balls
Notes: Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

26 A - - 09 Virgin Olive Oil, Crude
Date Published: 02/16/2017

Desc: Encapsulated Olive Oil
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

27 V - - 04 Balsamic Vinegar (sweet, fruity flavor)
Date Published: 02/16/2017

Desc: Balsamic Vinegar/Encapsulated Sauce
Notes: Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

27 Y - - 99 Condiments, N.E.C.
Date Published: 02/16/2017

Desc: Encapsulated Mustard Sauce
Notes: Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

28 M - - 99 Imitation Flavor, N.E.C.
Date Published: 02/16/2017

Desc: Imitation Caviar
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient

Kyivhlib
Date Published : 02/28/2018
Mezhigirska Str. 83 , Kyiv, UKRAINE
03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Kievskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients. "baking powder" is a multi-ingredient foods, but label fails to declare sub-ingredients, and fails to declare the common or usual names for the "emulsifier" and "acidity regulator" ingredients. If citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). Percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). Sugar is listed twice in the ingredient statement. "artificial" by itself is not an appropriate common or usual name in accordance with 21 CFR 101.4 and 21 CFR 101.22(h). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Raduga
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Figured Zaporojskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Honey
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Podmoskovnye
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name for each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Mint
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. "vegetable mint butter" and "malange" are not common or usual names of ingredients. If citric acid is functioning as a preservative, then its function much be noted in the ingredient list 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Milk Filling
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] product fails to declare the common or usual name for the "acidity regulator" ingredient. If the citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). "baked milk" is not common or usual name of ingredients, and that the percentage for the ingredient "baked milk (15.2%)" is not declared to nearest percentage in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Northern
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient as required by 21 CFR 101.22(j), and percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c) and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Milk Taste
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name for 'acidity regulator' in accordance with 21 CFR 101.4, and function of citric acid as required by Section 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Northern
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient as required by 21 CFR 101.22(j), and percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c) and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Honey
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Milk Filling
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] product fails to declare the common or usual name for the "acidity regulator" ingredient. If the citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). "baked milk" is not common or usual name of ingredients, and that the percentage for the ingredient "baked milk (15.2%)" is not declared to nearest percentage in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Mint
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. "vegetable mint butter" and "malange" are not common or usual names of ingredients. If citric acid is functioning as a preservative, then its function much be noted in the ingredient list 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Figured Zaporojskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Milk Taste
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name for 'acidity regulator' in accordance with 21 CFR 101.4, and function of citric acid as required by Section 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Podmoskovnye
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name for each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Raduga
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Kievskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients. "baking powder" is a multi-ingredient foods, but label fails to declare sub-ingredients, and fails to declare the common or usual names for the "emulsifier" and "acidity regulator" ingredients. If citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). Percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). Sugar is listed twice in the ingredient statement. "artificial" by itself is not an appropriate common or usual name in accordance with 21 CFR 101.4 and 21 CFR 101.22(h). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Honey
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Milk Filling
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] product fails to declare the common or usual name for the "acidity regulator" ingredient. If the citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). "baked milk" is not common or usual name of ingredients, and that the percentage for the ingredient "baked milk (15.2%)" is not declared to nearest percentage in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Figured Zaporojskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Milk Taste
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name for 'acidity regulator' in accordance with 21 CFR 101.4, and function of citric acid as required by Section 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Kievskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients. "baking powder" is a multi-ingredient foods, but label fails to declare sub-ingredients, and fails to declare the common or usual names for the "emulsifier" and "acidity regulator" ingredients. If citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). Percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). Sugar is listed twice in the ingredient statement. "artificial" by itself is not an appropriate common or usual name in accordance with 21 CFR 101.4 and 21 CFR 101.22(h). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Raduga
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Mint
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. "vegetable mint butter" and "malange" are not common or usual names of ingredients. If citric acid is functioning as a preservative, then its function much be noted in the ingredient list 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Podmoskovnye
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name for each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 02/28/2018

Desc: Gingerbread Northern
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient as required by 21 CFR 101.22(j), and percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c) and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Mint
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. "vegetable mint butter" and "malange" are not common or usual names of ingredients. If citric acid is functioning as a preservative, then its function much be noted in the ingredient list 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Milk Taste
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name for 'acidity regulator' in accordance with 21 CFR 101.4, and function of citric acid as required by Section 21 CFR 101.22(j). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Raduga
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Figured Zaporojskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Northern
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient as required by 21 CFR 101.22(j), and percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c) and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Milk Filling
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] product fails to declare the common or usual name for the "acidity regulator" ingredient. If the citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). "baked milk" is not common or usual name of ingredients, and that the percentage for the ingredient "baked milk (15.2%)" is not declared to nearest percentage in accordance with 21 CFR 101.4(e). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Honey
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.

07 C - - 03 Bagel Snacks, Bread Snacks Baked
Date Published: 02/28/2018

Desc: Gingerbread Kievskie
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients. "baking powder" is a multi-ingredient foods, but label fails to declare sub-ingredients, and fails to declare the common or usual names for the "emulsifier" and "acidity regulator" ingredients. If citric acid is functioning as a preservative, then its function must be noted in the ingredient list 21 CFR 101.22(j). Percentage for "skimmed milk powder 0.3%" is not declared in accordance with 21 CFR 101.4(e). Sugar is listed twice in the ingredient statement. "artificial" by itself is not an appropriate common or usual name in accordance with 21 CFR 101.4 and 21 CFR 101.22(h). 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9. Reference Amount Customarily Consumed (RACC) for cookies is 30g; however, label declares the nutrients for "3 pcs (100g)." 403(f) of the Act [21 U.S.C. §343(f)] because product label contains information in two languages but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c), and English label sticker fails to declare the place of business, street address, city, state and zip code in accordance with 21 CFR 101.5.


UNITED ARAB EMIRATES


National Food Industries, LLC
Date Published : 09/19/2022
National Industries Park , Plot No. Tpo 10422 , Dubai, United Arab Emirates UNITED ARAB EMIRATES
07 B - - 06 Potato Chips,Fried
Date Published: 09/19/2022

Desc: Mr. Krisps Cheez Balls
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7.

07 B - - 06 Potato Chips,Fried
Date Published: 09/19/2022

Desc: Mr. Krisps Salad Chips
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. Section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain artificial colorings, but the product labels fail to declare the colors.

07 B - - 06 Potato Chips,Fried
Date Published: 09/19/2022

Desc: Mr. Krisps Pizza Flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. Section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain artificial colorings, but the product labels fail to declare the colors. Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the label fails to bear the common or usual name of the food, as required by 21 CFR 101.3(b).

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 09/19/2022

Desc: Mr. Krisps Cheez Balls
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 09/19/2022

Desc: Mr. Krisps Pizza Flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. Section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain artificial colorings, but the product labels fail to declare the colors. Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the label fails to bear the common or usual name of the food, as required by 21 CFR 101.3(b).

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 09/19/2022

Desc: Mr. Krisps Salad Chips
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. Section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain artificial colorings, but the product labels fail to declare the colors.

07 Q - - 07 Potato Snacks (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked
Date Published: 09/19/2022

Desc: Mr. Krisps Pizza Flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. Section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain artificial colorings, but the product labels fail to declare the colors. Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the label fails to bear the common or usual name of the food, as required by 21 CFR 101.3(b).

07 Q - - 07 Potato Snacks (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked
Date Published: 09/19/2022

Desc: Mr. Krisps Cheez Balls
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7.

07 Q - - 07 Potato Snacks (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked
Date Published: 09/19/2022

Desc: Mr. Krisps Salad Chips
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts Labels) do not comply with requirements in 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7. Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. Section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain artificial colorings, but the product labels fail to declare the colors.


UNITED KINGDOM


Cambridge Commodities Ltd
Date Published : 06/27/2018
203 Lancaster Way Business Park , Ely, Cambridgeshire UNITED KINGDOM
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/27/2018

Desc: Sneak Preworkout Shake (Gaming Supplement)
Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(y) of the FD&C Act in that it is a dietary supplement that appears to be misbranded in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.

DARK LABS
Date Published : 03/16/2023
Craven House , 40/44 Uxbridge Road , London, EAL UNITED KINGDOM
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/16/2023

Desc: CRACK DIETARY SUPPLEMENT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents as required by section 21 CFR 101.7. Section 403(e)(1) of the Act for the failure of the label to declare the name and place of business of manufacturer, packer, or distributor. The place of business must include the street address, city, state, and ZIP code as required by section 21 CFR 101.5(d). Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 03/16/2023

Desc: CRACK DIETARY SUPPLEMENT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents as required by section 21 CFR 101.7. Section 403(e)(1) of the Act for the failure of the label to declare the name and place of business of manufacturer, packer, or distributor. The place of business must include the street address, city, state, and ZIP code as required by section 21 CFR 101.5(d). Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Eurocaps Limited
Date Published : 03/18/2016
Crown Business Park , Tredegar, None of the above UNITED KINGDOM
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/18/2016

Desc: Lumity Morning; Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because the Vitamin D3 content is less than 50% of the amount that is declared on the label. The content of Vitamin D3 in the product was found to be 134.4 IU/serving (original) and 136.6 IU/serving (check). These values are 44.8% and 45.5%, respectively, of the declared value of 300 IU/serving;Under Title 21, Code of Federal Regulations, Part 101, specifically 21 CFR101.9(g)(4)(i), a food product is misbranded if the content of the added nutrient (in this case, Vitamin D3) is not at least equal to the value of the nutrient declared on the label of the product.

FITNESS FACTORY GROUP
Date Published : 04/07/2017
Unit 108, Brunswick Business Park , Tower Street, , Liverpool, UNITED KINGDOM
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/07/2017

Desc: Clomadex
Notes: The product appears to be misbranded within the meaning of; Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. The product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/07/2017

Desc: TESTAFLEX Hormone Augmentation
Notes: The product appears to be misbranded within the meaning of; Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. The product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of; Section 403(s)(2)(C) of the Act in that the product label fails to identify the part of the plant (e.g.; root; leaves) from which each botanical dietary ingredient in the product is derived; as required by 21 CFR 101.4(h)(1). The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/07/2017

Desc: Clomadex
Notes: The product appears to be misbranded within the meaning of; Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. The product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.
Date Published: 04/07/2017

Desc: TESTAFLEX Hormone Augmentation
Notes: The product appears to be misbranded within the meaning of; Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. The product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of; Section 403(s)(2)(C) of the Act in that the product label fails to identify the part of the plant (e.g.; root; leaves) from which each botanical dietary ingredient in the product is derived; as required by 21 CFR 101.4(h)(1). The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

Hairburst Ltd
Date Published : 10/05/2015
4 Allerton Hill , Leeds, UNITED KINGDOM
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/05/2015

Desc: Hairburst Food Supplement
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q)(5) (F) of the Act (21 U.S.C. 343 (q)(5)(F))in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically, • The product label fails to bear the title "Supplements Facts Panel," as well declare the nutritional information in the appropriate format, in accordance with 21 CFR 101.36(e). • The source of your ingredient Marine Collagen is not provided as required by 21 CFR 101.36(d).

Hipp Uk Ltd
Date Published : 03/30/2016
New Greenham Park , Berkshire, UNITED KINGDOM
40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 03/30/2016

Desc: HiPP Organic Combiotic Growing Up Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(g) of the FD&C Act in that the product represents itself as 'Milk' but the product does not fit the definition and standard identity of milk [21 CFR 131.110]; (2)Section 403(r)(1)(A) of the Act in that the label bears a nutrient content claim 'Contains Praebiotik' but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are provided for in 21 CFR 101, 105, or 107 [21 CFR 101.13(b)(3)]; (3)Section 403(q) of the Act in that the nutrition information is not presented in the proper format [21 CFR 101.9(j)(5)]; (4) Section 403(e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared [21 CFR 101.5(c)].

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 04/06/2016

Desc: HiPP Organic Combiotic Hungry Infant Milk
Notes: The product appears to be misbranded within the meaning of;(1)Section 403 (r)(1)(A) of the FD&C Act in that the label bears nutrient content claims such as With added vitamins and minerals; Contains Praebiotik; and Contains added Omega 3 (DHA) and Omega 6(AA)LCPs but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are those that are specifically provided for in 21 CFR 101; 105; or 107 [21 CFR 101.13(b)(3)]; (2)Section 403(q) of the Act in that the nutrition information is not presented in the proper format as required by 21CFR107.10(a) and 21CFR107.100(a).

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 04/06/2016

Desc: HiPP Organic Combiotic First Infant Milk
Notes: The product appears to be misbranded within the meaning of;(1)Section 403 (r)(1)(A) of the FD&C Act in that the label bears nutrient content claims such as Contains Praebiotik but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are those that are specifically provided for in 21 CFR 101; 105; or 107 [21 CFR 101.13(b)(3)]; (2)Section 403(q) of the Act in that the nutrition information is not presented in the proper format as required by 21CFR107.10(a) and 21CFR107.100(a).

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 07/06/2016

Desc: HiPP Organic Combiotic Follow On Milk
Notes: The product appears to be misbranded within the meaning of;(1)Section 403(r)(1)(A) of the FD&C Act in that the label bears nutrient content claims such as "With added vitamins and minerals"; "Contains Praebiotik"; and "Contains added Omega 3 (DHA) and Omega 6(AA)LCPs" but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are those that are specifically provided for in 21 CFR 101; 105; or 107 [21 CFR 101.13(b)(3)]; (2)Section 403(q) of the Act in that the nutrition information is not presented in the proper format as required by 21CFR107.10(a) and 21CFR107.100(a).

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 03/30/2016

Desc: HiPP Organic Combiotic Growing Up Milk
Notes: The product appears to be misbranded within the meaning of: (1)Section 403(g) of the FD&C Act in that the product represents itself as 'Milk' but the product does not fit the definition and standard identity of milk [21 CFR 131.110]; (2)Section 403(r)(1)(A) of the Act in that the label bears a nutrient content claim 'Contains Praebiotik' but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are provided for in 21 CFR 101, 105, or 107 [21 CFR 101.13(b)(3)]; (3)Section 403(q) of the Act in that the nutrition information is not presented in the proper format [21 CFR 101.9(j)(5)]; (4) Section 403(e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared [21 CFR 101.5(c)].

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 04/06/2016

Desc: HiPP Organic Combiotic Hungry Infant Milk
Notes: The product appears to be misbranded within the meaning of;(1)Section 403 (r)(1)(A) of the FD&C Act in that the label bears nutrient content claims such as With added vitamins and minerals; Contains Praebiotik; and Contains added Omega 3 (DHA) and Omega 6(AA)LCPs but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are those that are specifically provided for in 21 CFR 101; 105; or 107 [21 CFR 101.13(b)(3)]; (2)Section 403(q) of the Act in that the nutrition information is not presented in the proper format as required by 21CFR107.10(a) and 21CFR107.100(a).

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 04/06/2016

Desc: HiPP Organic Combiotic First Infant Milk
Notes: The product appears to be misbranded within the meaning of;(1)Section 403 (r)(1)(A) of the FD&C Act in that the label bears nutrient content claims such as Contains Praebiotik but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are those that are specifically provided for in 21 CFR 101; 105; or 107 [21 CFR 101.13(b)(3)]; (2)Section 403(q) of the Act in that the nutrition information is not presented in the proper format as required by 21CFR107.10(a) and 21CFR107.100(a).

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula
Date Published: 07/06/2016

Desc: HiPP Organic Combiotic Follow On Milk
Notes: The product appears to be misbranded within the meaning of;(1)Section 403(r)(1)(A) of the FD&C Act in that the label bears nutrient content claims such as "With added vitamins and minerals"; "Contains Praebiotik"; and "Contains added Omega 3 (DHA) and Omega 6(AA)LCPs" but the only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are those that are specifically provided for in 21 CFR 101; 105; or 107 [21 CFR 101.13(b)(3)]; (2)Section 403(q) of the Act in that the nutrition information is not presented in the proper format as required by 21CFR107.10(a) and 21CFR107.100(a).

Juicemaster Ltd
Date Published : 10/02/2015
Unit 4 , Shepheards Close; Aylsham Business Estate , Norwich, NFK UNITED KINGDOM
54 A - - 01 Vitamin A
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

Kellogg Wrexham
Date Published : 07/12/2018
Bryn Lane , Wrexham, Clwyd, Noth Wales UNITED KINGDOM
05 A - - 05 Mixed Cereal Flakes,Shredded and Other Forms Ready To Eat
Date Published: 07/12/2018

Desc: All Bran Cereal
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading. FDA analysis found 22.7(%DV), and label declares 35(%DV). The findings are 64.9% of declared amount for phosphorus.

05 A - - 06 Bran Flakes,Shredded and Other Forms Ready To Eat
Date Published: 07/12/2018

Desc: All Bran Cereal
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading. FDA analysis found 22.7(%DV), and label declares 35(%DV). The findings are 64.9% of declared amount for phosphorus.

Kendal Nutricare Ltd.
Date Published : 12/08/2017
1 Mint Bridge Road , Kendal, Cumbria UNITED KINGDOM
09 C - - 09 Milk, Plain
Date Published: 01/08/2024

Desc: Toddler Milk
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403 (g)(2) of the FD&C Act in that the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Section 403 (q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 01/08/2024

Desc: Toddler Milk
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403 (g)(2) of the FD&C Act in that the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Section 403 (q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

40 P - - 07 Toddler Milk Based Formula/Drink Product (12-36 months), Powder Formula
Date Published: 01/08/2024

Desc: Toddler Milk
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403 (g)(2) of the FD&C Act in that the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Section 403 (q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

40 R - - 99 Other Formula Products for Sample Testing (not for sale), N.E.C.
Date Published: 01/08/2024

Desc: Toddler Milk
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403 (g)(2) of the FD&C Act in that the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Section 403 (q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

40 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 01/08/2024

Desc: Toddler Milk
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403 (g)(2) of the FD&C Act in that the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Section 403 (q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

Kiki Ltd.
Date Published : 10/02/2015
Unit , Norwich, Norfolk UNITED KINGDOM
54 A - - 01 Vitamin A
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

Kiki Ltd.
Date Published : 10/02/2015
Unit , Norwich, Norfolk UNITED KINGDOM
54 A - - 01 Vitamin A
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2);

54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Powergreens food supplement
Notes: VIOLATIONS: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;

Nestle
Date Published : 07/21/2017
24 Haxby Road , Box 203 , York, UNITED KINGDOM
40 B - - 06 Wheat Cereal (Baby)
Date Published: 07/21/2017

Desc: Nestle Cerelac Infant Wheat Cereal with Milk
Notes: Section 403(r)(1)(A) of the FD&C Act in that the label or labeling bears an unauthorized nutrient content/health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(e)(2) of the Act and 15 USC 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). Section 403(q) of the FD&C Act in that the required nutrition information is not in the appropriate format in accordance with 21 CFR 101.9.

40 B - - 99 Cereal, N.E.C. (Baby)
Date Published: 07/21/2017

Desc: Nestle Cerelac Infant Wheat Cereal with Milk
Notes: Section 403(r)(1)(A) of the FD&C Act in that the label or labeling bears an unauthorized nutrient content/health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(e)(2) of the Act and 15 USC 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). Section 403(q) of the FD&C Act in that the required nutrition information is not in the appropriate format in accordance with 21 CFR 101.9.

Nutricia
Date Published : 10/02/2015
White Horse Business Park , Wilshire, UNITED KINGDOM
40 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 10/02/2015

Desc: Aptamil Breast Milk Substitute
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1) (A) of the Act in that the label bears an unauthorized nutrient content claim, "…with increased levels of LCPs (Omega 3 & Omega 6)", on the label under the heading "Our unique blend of ingredients". The only nutrient content claims that may appear on foods intended for use by infants and children less than two years of age are those that are specifically permitted by regulation [21 CFR§101.13(b)(3)]. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act, in that the nutrition information is not presented in the proper format as required in 21 CFR 107.10(a) and 107.100(a). For example: • The label fails to bear the infant formula's nutrition information as required by 21 CFR 107.10(a). • The proper units are not used to declare the nutrients as specified by 21 CFR 107.10(a) and 107.100(a).

Nutrition Group PLC.
Date Published : 05/26/2020
Transcontinental House , Olympic Way; Lancashire , Blackpool, UNITED KINGDOM
21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 11/05/2020

Desc: SKINADE Derma Defense A & D Boost
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: ; Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020

29 C - - 99 Nonalcoholic Beverages, n.e.c.
Date Published: 11/05/2020

Desc: SKINADE Derma Defense A & D Boost
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: ; Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/26/2020

Desc: Skinade Clear CE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 11/05/2020

Desc: SKINADE Derma Defense A & D Boost
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: ; Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 05/26/2020

Desc: Skinade Cellulite
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/05/2020

Desc: SKINADE Derma Defense A & D Boost
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: ; Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 05/26/2020

Desc: Skinade Cellulite
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 05/26/2020

Desc: Skinade Clear CE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 05/26/2020

Desc: Skinade Clear CE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

46 Y - - 99 Food Additives For Human Use, N.E.C.
Date Published: 05/26/2020

Desc: Skinade Cellulite
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/26/2020

Desc: Skinade Clear CE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/26/2020

Desc: Skinade Cellulite
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/05/2020

Desc: SKINADE Derma Defense A & D Boost
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: ; Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/26/2020

Desc: Skinade Clear CE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/26/2020

Desc: Skinade Cellulite
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/26/2020

Desc: Skinade Cellulite
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/26/2020

Desc: Skinade Clear CE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

Panesar Foods Ltd
Date Published : 10/02/2015
Black Lake Works , Black Lake; House , West Bromwich, West Midlands UNITED KINGDOM
37 K - - 99 Pastes, n.e.c.
Date Published: 10/02/2015

Desc: Harissa Hot Chile Paste

Power Health Products Ltd
Date Published : 10/27/2022
Airfield Estate , Pocklington Industrial Estate; E. , York, UNITED KINGDOM
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 10/27/2022

Desc: Emu Oil Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid.

60 L - - 99 Analgesic, N.E.C.
Date Published: 10/27/2022

Desc: Emu Oil Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid.

62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 10/27/2022

Desc: Emu Oil Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/19/2023

Desc: Emu Oil Capsules
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. 10/27/2022


UNITED STATES


Ferrero USA Inc.
Date Published : 10/02/2015
600 Cottontail Ln , Somerset, NJ 08873-1233 UNITED STATES
34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut)
Date Published: 10/02/2015

Desc: Christmas Bell and Easter Hazelnut Chocolates
Notes: Reason: Nutrition label is on a hang tag and not on the product

34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C.
Date Published: 10/02/2015

Desc: Christmas Bell and Easter Hazelnut Chocolates
Notes: Reason; Nutrition label is on a hang tag and not on the product


VIETNAM


CJ CAUTRE FOODS JOINT STOCK COMPANY BRANCH LONG AN
Date Published : 01/19/2017
125/208 Luong The Vinh Street , Tan Thoi Hoa Ward , Ho Chi Minh City,, VIETNAM
16 E - - 02 Clams
Date Published: 01/19/2017

Desc: Clam Linguine with Garlic; Herbs and Natural Clam Juice
Notes: Section 403(i)(2) of the FD&C Act in that they are fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice; but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

16 J - - 05 Shrimp & Prawns
Date Published: 01/19/2017

Desc: Prawn Dumplings with Soy Ginger Sauce
Notes: Section 403(i)(2) of the FD&C Act in that they are fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice; but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.

16 J - - 05 Shrimp & Prawns
Date Published: 01/19/2017

Desc: Thai Style Spicy Shrimp Noodles
Notes: Section 403(i)(2) of the FD&C Act in that they are fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice; but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

Co So San Xuat Keo Yen Nhung DBA: Yeng Candy
Date Published : 03/01/2017
2/17 Block 1, Tan Mai Ward , 2/21 BLOCK 1, TAN MAI WARD , Bien Hoa City, Dong Nai Province VIETNAM
33 A - - 99 Hard Candy with Nut or Nut Products, N.E.C. (without Chocolate)
Date Published: 03/01/2017

Desc: Assorted Nut Candies
Notes: Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Specifically, the place of business is incorrectly displayed on the label. ; Section 403(f) of the FD&C Act in that the labels contain information in multiple languages but do not repeat all of the required information in all languages.; Section 403(i)(2) of the FD&C Act in that each ingredient or sub-ingredient is not declare on the respective label. ; Section 403(q) of the FD&C Act in that they fail to include all necessary nutrition information in the proper format.

33 A - - 99 Hard Candy with Nut or Nut Products, N.E.C. (without Chocolate)
Date Published: 03/01/2017

Desc: Cashew Nut Cookies
Notes: Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Specifically, the place of business is incorrectly displayed on the label. ; Section 403(f) of the FD&C Act in that the labels contain information in multiple languages but do not repeat all of the required information in all languages.; Section 403(i)(2) of the FD&C Act in that each ingredient or sub-ingredient is not declare on the respective label. ; Section 403(q) of the FD&C Act in that they fail to include all necessary nutrition information in the proper format.

Eurasian Agricultural
Date Published : 04/10/2020
Tan Phu Trung Commune, Cu Chi Disttrict , 333, Nguyen Thi Lang Street , Ho Chi Minh, VIETNAM
25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Pineapple Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Orange Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Strawberry Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Passion Fruit Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 01 Soft Drink, Berry Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Strawberry Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 02 Soft Drink, Citrus Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Pineapple Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 02 Soft Drink, Citrus Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Orange Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Orange Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Passion Fruit Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 07 Soft Drink, Subtropical or Tropical Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Pineapple Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Pineapple Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Orange Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Passion Fruit Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 04/10/2020

Desc: Aloe Vera Strawberry Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Pineapple Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Orange Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Passion Fruit Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 04/10/2020

Desc: Aloe Vera Strawberry Flavored Drink
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that its labeling is false or misleading. The labeling of each product identifies the product as a "dietary supplement", while also describing it as a "drink." Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically, the product's label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically, the ingredient "stabilizer" does not specify the actual ingredient performing this function. Section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically, the product's label bears a Supplement Facts panel rather than a Nutrition Facts panel as required by 21 CFR 101.9.

Hua Heong Food Industries (Vietnam) CO., Ltd
Date Published : 01/17/2023
D3a-D3b Le Minh Xuan, Industrial Zone , Binh Chanh District , Ho Chi Minh, Vn-65 VIETNAM
16 E - - 02 Clams
Date Published: 01/17/2023

Desc: Razor clam with shell
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. The product is labeled as “cooked”, but it is not fully cooked. Section 403(f) of the Act because outer box and retail unit contain information in information in at least one additional language; therefore, all required information must be in each of the languages (i.e., the English language as well as the foreign language). The Nutrition Facts and all other required statements must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(q) of the FD&C Act in that the nutrition facts information is not as defined in 21 CFR 101.9 with respect to serving size (21 CFR 101.12(b) Table 2). The percent DV for protein, if declared, must be the corrected amount of protein and calculated as required in 21 CFR 101.9(c)(7)(ii). Nutrient declaration must be accurate for all nutrients.

Hung Phat Tea Corporation
Date Published : 11/07/2016
Group 4, Ward 8, Binh My Commune , Cu Chi District , Ho Chi Minh, VIETNAM
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 11/07/2016

Desc: Pure Noni Juice
Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading. The product label includes the statement "100% natural herb tea" on a juice product with the statement of identity "Noni Juice" and therefore appears to be a false statement. Section 403(f) of the Act [21 U.S.C. §343(f)] in that it contains information in other languages; therefore, all required information must be in each language (i.e., the English language as well as the foreign languages). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] in that it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.105. The net quantity of content statement only includes the metric. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) does not include all information, as required by 21 CFR 101.9(b). Section 403(i)(2) of the Act in that (a) The product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. and (b) It is a product that purports to be a beverage containing vegetable or fruit juice but fails to contain a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food, as required by 21 CFR 101.30.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/07/2016

Desc: Pure Noni Juice
Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading. The product label includes the statement "100% natural herb tea" on a juice product with the statement of identity "Noni Juice" and therefore appears to be a false statement. Section 403(f) of the Act [21 U.S.C. §343(f)] in that it contains information in other languages; therefore, all required information must be in each language (i.e., the English language as well as the foreign languages). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] in that it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.105. The net quantity of content statement only includes the metric. Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) does not include all information, as required by 21 CFR 101.9(b). Section 403(i)(2) of the Act in that (a) The product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. and (b) It is a product that purports to be a beverage containing vegetable or fruit juice but fails to contain a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food, as required by 21 CFR 101.30.

Huong Vinh Co.,LTD
Date Published : 10/02/2015
404, Auco Street,Ward 10,Tan Binh Dist , Ho Chi Minh, VIETNAM
33 G - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts or Nut Products (without Chocolate)
Date Published: 10/02/2015

Desc: Black and White Sesame Candy
Notes: Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts? Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).

33 K - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Black and White Sesame Candy
Notes: Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts¿ Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).

33 L - - 03 Fondant Candy Bar, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/02/2015

Desc: Black and White Sesame Candy
Notes: Product is misbranded within the meaning of Sec. 403(w)(1) of the Act because the label fails to declare the presence of the major food allergen peanuts? Product is further misbranded in that the information required by the Act must appear in both English and the foreign language (21 CFR 101.15(c)).

INTERFOOD SHAREHOLDING COMPANY
Date Published : 10/02/2015
Tan Tien Sub-district , 5, No.9 Road , Bien Hoa, Dong Nai VIETNAM
21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 10/02/2015

Desc: Coconut water w/pulp (meat)
Notes: Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.

30 Y - - 02 Coconut Milk Beverage Base
Date Published: 10/02/2015

Desc: Coconut water w/pulp (meat)
Notes: Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.

Interfood Shareholding
Date Published : 10/02/2015
Tam Phuoc Industrial Zone , Lot 13; Tam Phuoc Commune , Bien Hoa, Dong Nai VIETNAM
21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 10/02/2015

Desc: Coconut water w/pulp (meat)
Notes: Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15(c)(2); all required information must appear in these languages.

30 Y - - 02 Coconut Milk Beverage Base
Date Published: 10/02/2015

Desc: Coconut water w/pulp (meat)
Notes: Product is misbranded within the meaning of Section 403(a)(1) of the Act in that the amount of magnesium (12%) is less than 80% of the declared amount; Product is also misbranded within the meaning of Section 403(i)(2) in that the label fails to bear the percent (%) juice declaration as required by 21 CFR 101.30; Also; the product label does not comply with the nutrition labeling format Requirements in 21 CFR 101.9; e.g. rounding; type size; indenting. Also; the product label bears a percent Daily Value (DV) for trans fat on the Nutrition Facts panel. Trans fat may only be listed with a gram amount because a DV for trans fat has not been established. Also; the product label contains three Nutrition Facts panels (two in English and one in French). The regulations allow for the use of separate nutrition labels for each language represented on the label but the nutrition information must be in the format specified in 21 CFR 101.9(d). Also; the product label appears to contain statement of identity and ingredient statements in four languages. According to 21 CFR 101.15 (c)(2); all required information must appear in these languages.

KINH DO CORPORATION
Date Published : 10/02/2015
Thu Duc District , 134; 6, 13th National Road , Ho Chi Minh, VN-65 VIETNAM
03 F - - 02 Flavored or Party Crackers
Date Published: 10/02/2015

Notes: Round Crackers; Mini Round Crackers; Cr3eatures of the Sea Crackers; Mini butter-Cheese Crackers

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Notes: Round Crackers; Mini Round Crackers; Cr3eatures of the Sea Crackers; Mini butter-Cheese Crackers

Lucky Shing Company Ltd
Date Published : 08/03/2015
An Thanh Village, Ben Luc District , No. 3, 108/1, Road No. 830, Hamlet , Long An Province, VIETNAM
37 J - - 99 Sauces, n.e.c.
Date Published: 08/03/2015

Desc: VEGETARIAN SAUCE
Notes: Problem(s): - Undeclared cyclamate. - Declared Potassium Sorbate lacks function declaration. - The labels fail to declare the common or usual name of each ingredient. - The label bears information in at least two foreign languages; however it does not appear that all required label information is presented in each of these foreign languages. NOTE: If pineapple sauce is a multicomponent ingredient; the sub-ingredients must be declared.

Minh Nguyet Trading Co., LTD
Date Published : 07/29/2020
C7/27 A1 Pham Hung Street , Hamlet 4, Binh Hung Ward, Binh Chanh Dis , Ho Chi Minh City, VIETNAM
21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 07/29/2020

Desc: SWEET DRIED COCONUT
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages As required by 21 CFR 101.15(c).

23 B - - 05 Coconut, Shelled
Date Published: 07/29/2020

Desc: SWEET DRIED COCONUT
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages As required by 21 CFR 101.15(c).

Nam Phong Trading Company
Date Published : 12/12/2023
12 Le Thi Nga Street, Group 3 , Phuoc Vinh An Commune; Cu Chi District , Ho Chi Minh City, VIETNAM
25 J - - 25 Onion Bulb (Yellow, White, Red, Etc.) (Root & Tuber Vegetable)
Date Published: 12/12/2023

Desc: Dried Onion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2),[21 U.S.C. § 343(i)(2)] the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k),[21 U.S.C. § 343(k)], the product bears or contains chemical preservative but does not bear labeling stating that fact. Section 403(f),[21 U.S.C. §343(f)] it contains information in a foreign language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(q),[21 U.S.C. § 343(q)] the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. a. The serving size is not based on the reference amount customarily consumed (RACC) (21 CFR 101.9(b)(2)). The product label declares 1 oz (28 g); however, the appropriate RACC for this product is 4 g (21 CFR 101.12). Possible label statements include “__ piece(s) (_ g)” or “_ tbsp(s) (_ g) for chopped products.” b. The serving size is not expressed in a common household measure that is appropriate to the food as required by 21 CFR 101.9(b)(7). c. The % Daily Value for calcium and potassium are not listed in the correct increments as required by 21 CFR 101.9(c)(8)(iii) d. The quantitative amount for Calcium is not declared in accordance with 21 CFR 101.9(c)(8)(iii) using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv). See comments below. e. The declaration for Calories is not listed in the correct increment as required by 21 CFR 101.9(c)(1).

25 L - - 25 Onion Bulb (Yellow, White, Red, Etc.), Dried or Paste
Date Published: 12/12/2023

Desc: Dried Onion
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(2),[21 U.S.C. § 343(i)(2)] the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k),[21 U.S.C. § 343(k)], the product bears or contains chemical preservative but does not bear labeling stating that fact. Section 403(f),[21 U.S.C. §343(f)] it contains information in a foreign language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(q),[21 U.S.C. § 343(q)] the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. a. The serving size is not based on the reference amount customarily consumed (RACC) (21 CFR 101.9(b)(2)). The product label declares 1 oz (28 g); however, the appropriate RACC for this product is 4 g (21 CFR 101.12). Possible label statements include “__ piece(s) (_ g)” or “_ tbsp(s) (_ g) for chopped products.” b. The serving size is not expressed in a common household measure that is appropriate to the food as required by 21 CFR 101.9(b)(7). c. The % Daily Value for calcium and potassium are not listed in the correct increments as required by 21 CFR 101.9(c)(8)(iii) d. The quantitative amount for Calcium is not declared in accordance with 21 CFR 101.9(c)(8)(iii) using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv). See comments below. e. The declaration for Calories is not listed in the correct increment as required by 21 CFR 101.9(c)(1).

Rita Food And Drink Co., Ltd
Date Published : 04/07/2023
No. 8, Thong Nhat Boulevard , Song Than 2 Industrial Park , Di An Ward, Di An District VIETNAM
14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 04/07/2023

Desc: OKA Milk Original Coconut Milk Sweetened
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). The statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

14 B - - 01 Imitation Milk, Fluid Milk Type Product
Date Published: 04/07/2023

Desc: OKA Milk Cashew Milk with Avocado
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3): In that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4(b)(2). In that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because they contain information in a second language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). The statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

21 K - - 02 Avocado, Juice, Pit Fruit Juices or Concentrates
Date Published: 04/07/2023

Desc: OKA Milk Cashew Milk with Avocado
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3): In that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4(b)(2). In that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because they contain information in a second language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). The statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

21 V - - 39 Cashew Fruit, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 04/07/2023

Desc: OKA Milk Cashew Milk with Avocado
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3): In that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4(b)(2). In that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because they contain information in a second language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). The statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 04/07/2023

Desc: OKA Milk Cashew Milk with Avocado
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3): In that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4(b)(2). In that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because they contain information in a second language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). The statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 04/07/2023

Desc: OKA Milk Original Coconut Milk Sweetened
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). The statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

30 Y - - 02 Coconut Milk Beverage Base
Date Published: 04/07/2023

Desc: OKA Milk Original Coconut Milk Sweetened
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). The statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

Song Huong, Inc.
Date Published : 12/23/2015
4 , 237, Hoa Binh, P. Hiep Tan, Q. Tan Phu , Ho Chi Minh, Vn-65 VIETNAM
25 J - - 03 Leek (a Type of Onion) (Root & Tuber Vegetable)
Date Published: 12/23/2015

Desc: Pickled Scallion Heads
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the food is in package form and the label fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the packages do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.