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: 02/23/2024
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 , Bagerhat, 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: 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 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: 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 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 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: 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: 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 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.

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

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 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: 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 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: 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: 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: 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 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.

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 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)).

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)).

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)).

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)).

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 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 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: 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 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).

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).

Alnost Guatemala S.A
Date Published : 11/02/2023
Avenida 12-60 Zona 14 Edificio Avita 10 , Guatemala, Guatemala GUATEMALA
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).

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).

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 lis