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: 09/18/2019
Type: DWPE

Import Alert Name:

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

Reason for Alert:

NOTE: The revision of this Import Alert dated 10/02/2015 updates the Alert to transition all charges currently reflected in Import Alert 99-20 "Detention without Physical Examination Of Imported Food Products Due to NLEA Violations" to this Import Alert. Import Alert 99-20 will be deactivated upon publication of this major revision. All firms currently listed on the RED LIST of IA 99-20 will be moved to the RED LIST of this alert. Changes are 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.

Note: ORS contact information updated on 08/16/2019

Guidance:

Districts may detain without physical examination the food products from the firms identified on the Red List for 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.

AND/OR

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, and 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.
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the manufacturer 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).

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.

***For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-6, "Detention without Physical Examination (DWPE)."***

If a firm and/or a representative thereof wishes 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/Import Operations and Maintenance Branch (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DCS/Import Compliance Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at (301) 796-6600 or oraorsprivatelabimportalerts@fda.hhs.gov

Questions or issues on policy, sample collection recommendations, or other any addition questions, should be addressed to CFSAN/Division of Enforcement's Labeling and Dietary Supplement Compliance Branch (HFS-608) at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov

COUNTRY: SEE RED LIST

FIRM(S): SEE RED LIST

Product Description:

Various Food Products

PRODUCT
CODE: GPI = FO and/or GPI = VI

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 code "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 Codes "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 Codes "LIST INGRE" or "JUICE %"

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(k) of the FD&C Act in that the food bears or contains artificial flavoring, artificial coloring, or chemical preservatives but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act(specify flavoring, coloring, or preservative). [Misbranding, Section 403(k)]"

OASIS Charge Codes "PRESERVLBL" or "FLAVRLBLG"

***And/Or

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"

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 within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim (specify). [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. [Misbranding, Section 403(s)(2)(A)]"

OASIS Charge Codes "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. [Misbranding, Section 403(s)(2)(B)]"

OASIS Charge Codes "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. [Misbranding, Section 403(s)(2)(C)]"

OASIS Charge Codes "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. [Misbranding, 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.


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: 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: 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. ;

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.


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: 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 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 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: 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: 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.

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.

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: 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.

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: 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.


BANGLADESH


Anraj Fish Products Industries, Ltd.
Date Published : 05/23/2018
West Sholashahar , 301 Hathazari Road , Chittagong, Chittagong 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
Date Published : 10/02/2015
Unit-A, Town Nowapara , Ibh Was Here, BD-05 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
Dhaka,Bangladesh. , 47 Dilkusha, Jaman Chamber , Dhaka, BD-13 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


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 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.


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


Agro Industrial Jandaia Ltda
Date Published : 10/02/2015
Rodovia BR 116 Km 52 - Sala A - Pacajus , Pacajus, BR-CE 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

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.

General Mills - Cambara Plant
Date Published : 08/04/2017
Rodovia BR 369 Km. 17/18 S/N , Bairro 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 116 Km 53 , Pacajus, 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: 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”.

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”.

Santa Helena Industria de Alimentos S.A.
Date Published : 01/10/2018
Rua Paraguai 1275 , Ribeirao Preto, Sao Paulo BRAZIL
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(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] because the product labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Specifically, the carton and wrapper bears the term, “diet,” and the carton label bears “no sugar” statements although the product does not meet the requirement for a “sugar free” claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition information (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 article is subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in 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)] because the product labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Specifically, the carton and wrapper bears the term, “diet,” and the carton label bears “no sugar” statements although the product does not meet the requirement for a “sugar free” claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition information (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 article is subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in 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

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: 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

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.


BULGARIA


Vemo 99 Ltd., Limited
Date Published : 10/02/2015
Rozhen Blvd. 88 , Sofia, Sofia-Grad BULGARIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Tribulus Terrestris VemoHerb Nutritional Supplement
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)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it 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 E - - 89 Tribulus (Herbal & Botanical Teas)
Date Published: 10/02/2015

Desc: Tribulus Terrestris VemoHerb Nutritional Supplement
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)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it 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 - - 89 Tribulus (Herbal & Botanicals, not Teas)
Date Published: 10/02/2015

Desc: Tribulus Terrestris VemoHerb Nutritional Supplement
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)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it 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: 10/02/2015

Desc: Tribulus Terrestris VemoHerb Nutritional Supplement
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)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it 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 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Tribulus Terrestris VemoHerb Nutritional Supplement
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)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it 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

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

Desc: Tribulus Terrestris VemoHerb Nutritional Supplement
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)(5)(F) of the Food, Drug and Cosmetic Act in that there is no Supplement Facts panel in accordance with 21 CFR 101.36. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Food, Drug and Cosmetic Act in that it 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


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, 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));

Union Camerounaise De Brasseries
Date Published : 10/02/2015
Rue Bassa 1 , Douala, CM-LT 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


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.

Bariatrix Nutrition Inc
Date Published : 10/02/2015
4905 Fairway St , Lachine, Quebec CANADA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Slimgenics Chocolate Caramel Granola Snack
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1) (B)of the Act in that the product label appears to bear an unauthorized health claim. Specifically; the label claim states the following Foods high in Fiber can; 1) Reduce the risk of Type 2 diabetes and heart disease; 2) Lower the risk of several forms of cancer; and 3) Improve cholesterol and blood pressure. The article is 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 product label bears a nutrient content claim but does not meet the requirements to make the claim. Specifically; the product bears the claim {H}igh in fiber but the product only contains 8% dietary fiber. In order to make a high; claim; the product must contain 20% or more of the nutrient. The article is 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 it fails to declare the sub-ingredients of the Enriched Flour in the ingredient statement (21 CFR 101.4(b)(15)) and 21 CFR 137.165 charges.

DESI MILLS INC.
Date Published : 10/02/2015
Unknown , Scarborough, ON 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: 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

Desi Mills Inc
Date Published : 10/02/2015
Unknown , Toronto, 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: 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.

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.

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

ITN Food
Date Published : 10/02/2015
40 Commander Boulevard , Toronto, ON 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: 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: 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

Jamieson Laboratories
Date Published : 03/27/2015
2 St Clair Ave W 16 Th Floor , Toronto, Ontario CANADA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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

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/Prosnack
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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, 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
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).

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
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
La Units 3 & 4 , Cambridge, ON 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.

Skjodt-Barrett Foods
Date Published : 10/16/2018
5 Precidio Crt , Brampton, Ontario CANADA
21 F - - 11 Berries and Core, Mixed Fruit Purees
Date Published: 10/16/2018

Desc: Blueberry Pear Purple Carrot Baby Food
Notes: The article is 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 because the amount of vitamin A present is not 190% of the daily value (DV) for that nutrient declared on the label. 21 CFR 101.9(g)(4).

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: 10/16/2018

Desc: Blueberry Pear Purple Carrot Baby Food
Notes: The article is 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 because the amount of vitamin A present is not 190% of the daily value (DV) for that nutrient declared on the label. 21 CFR 101.9(g)(4).

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)].

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 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 10/16/2018

Desc: Blueberry Pear Purple Carrot Baby Food
Notes: The article is 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 because the amount of vitamin A present is not 190% of the daily value (DV) for that nutrient declared on the label. 21 CFR 101.9(g)(4).

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: 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.

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.

Beijing Joant Biotech Co, Ltd
Date Published : 04/06/2015
25 Yanqi Street , Yanqi 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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 Choc/Special/Chew Gum
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
Wulu Cun , 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 Changle Yongxin Food Co., Ltd
Date Published : 10/02/2015
No. 150 Xin Dong Yang , Jinfeng Town , Changle, 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

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).

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: 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: 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: 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 ;

LianJiang Xulong Foods Co.,Ltd.
Date Published : 03/07/2017
NO. 271 Fuxing North Road , Town,Lianjiang County , Fuzhou, Fujian CHINA
16 A - - 99 Fish, N.E.C.
Date Published: 11/30/2018

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(f) because the product label contains information in a foreign language, therefore, all required information must be in both languages (i.e., the English language as well as the foreign language) as required by 21 CFR 101.15 (for examples, the product label fails to include a statement of identity in English); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the declared serving sizes do not appear to be based on the appropriate RACC; failure to declare serving size in common household measure; nutrition label is not provided in the foreign language; formatting violations for bolding, bars, and the heading "Serving per container"; declaration of 6700 mg sodium is questionalble.

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 11/30/2018

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(f) because the product label contains information in a foreign language, therefore, all required information must be in both languages (i.e., the English language as well as the foreign language) as required by 21 CFR 101.15 (for examples, the product label fails to include a statement of identity in English); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the declared serving sizes do not appear to be based on the appropriate RACC; failure to declare serving size in common household measure; nutrition label is not provided in the foreign language; formatting violations for bolding, bars, and the heading "Serving per container"; declaration of 6700 mg sodium is questionalble.

16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 03/07/2017

Desc: Frozen Fish Ball (Surimi) (4.5 lb package)
Notes: Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; Chinese; however; the label fails to declare all required information in both languages (i.e.; the English language as well as the foreign language). For example; the statement of identity; net quantity of contents; nutrition facts; ingredient statement; name and place of business are not declared in both the foreign language and English as required by 21 CFR 101.15(c)(2)

16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 03/07/2017

Desc: Frozen Fish Ball (Surimi) (400 gr package)
Notes: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically; testing shows that the product contains egg which is not declared in the ingredient statement. Further; the ingredient statement lists the ingredient "moray" which is not a sufficiently specific common or usual name for a word which represents many species of fish. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; Chinese; however; the label fails to declare all required information in both languages (i.e.; the English language as well as the foreign language). For example; the statement of identity; net quantity of contents; nutrition facts; ingredient statement; name and place of business are not declared in both the foreign language and English as required by 21 CFR 101.15(c)(2).

16 R - - 99 Other Engineered Seafood Products, N.E.C.
Date Published: 11/30/2018

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(f) because the product label contains information in a foreign language, therefore, all required information must be in both languages (i.e., the English language as well as the foreign language) as required by 21 CFR 101.15 (for examples, the product label fails to include a statement of identity in English); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the declared serving sizes do not appear to be based on the appropriate RACC; failure to declare serving size in common household measure; nutrition label is not provided in the foreign language; formatting violations for bolding, bars, and the heading "Serving per container"; declaration of 6700 mg sodium is questionalble.

16 Y - - 99 Fishery Products, N.E.C.
Date Published: 11/30/2018

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(f) because the product label contains information in a foreign language, therefore, all required information must be in both languages (i.e., the English language as well as the foreign language) as required by 21 CFR 101.15 (for examples, the product label fails to include a statement of identity in English); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the declared serving sizes do not appear to be based on the appropriate RACC; failure to declare serving size in common household measure; nutrition label is not provided in the foreign language; formatting violations for bolding, bars, and the heading "Serving per container"; declaration of 6700 mg sodium is questionalble.

Life Rising (Tianjin) Natural Product R&D Center LTD
Date Published : 12/12/2016
# 12 Luyuandao , Wuqing , Tianjin, Tianjin CHINA
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 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 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 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 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).

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 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 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 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 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 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 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 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).

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).

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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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
NO. 168 Henan Street,Weitang,Xiangcheng , District , Suzhou, Jiangsu CHINA
23 K - - 04 Sunflower Seed (Edible)
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)
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)
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.

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).

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)].

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 Imp & Exp Corp
Date Published : 01/13/2017
6 Tangshan Road , Tianjin, Tianjin CHINA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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.

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: 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.

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.

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 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)
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

jiangmen pengjiang huiming trading company
Date Published : 10/02/2015
Flat 11 , NO 13 Mingxinglu; Xinhui , Jiangmen, Guangdong 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


COLOMBIA


Alimentic Eu
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.

C.I Nutreo
Date Published : 06/28/2016
Parque Empresarial Multicentro - Bodegas 9 Y 10 , Rionegro, Antioquia COLOMBIA
03 H - - 06 Fruit Filled Plain Cookies,Biscuits and Wafers
Date Published: 06/28/2016

Desc: Beauty Cereal Bars
Notes: The product contains a greater total sugar content than that which is declared on the product label. The total sugar content of the product was found to be 2.83 g/serving (original) and 3.6 g/serving (check). These values are 283% and 360%, respectively, of the declared value of 1 g/serving. The product is labeled as “ORUZ Beauty Cereal Bars with Collagen and Vitamin C” but the nutrition information (e.g. Nutrition Facts Panel) declares 0% of Vitamin C per serving. The nutrition information (e.g. Nutrition Facts Panel) is not in the correct format as required by 21 CFR 101.9. Specifically, the serving size declaration of “23 (23g)” is incorrect. A description of the individual container or package must be as a common household measure or common household unit for single serving containers in accordance with 21 CFR 101.9(b)(5)(iv). The declaration of “23” is not a household measure. Because the serving size is incorrect, all of the nutrition information is potentially incorrect. The “Contains” statement, which includes “gluten,” “sesame seeds,” and “macadamia”, is not declared in accordance with the Food Labeling and Consumer Protection Act (FALCPA). The “Contains” statement must only include the name of the food source from which one or more of the eight major food allergens are derived. The ingredient statement includes the ingredient “macadamia” rather than “macadamia nut” in accordance with 21 CFR 101.4.

C.I. Sociedad Industrial de Grasas Vegetales Sigra
Date Published : 10/02/2015
Carrera 46 No. 13-95 , Bogota, Cundinamarca COLOMBIA
26 E - - -- Oleomargarine
Date Published: 10/02/2015

Desc: Margarine
Notes: Violation; Product is misbranded within the meaning of Sec. 403 in that the product is labeled as margarine but fails to meet the standard of identity for ?Margarine? under 21 CFR 166.110 because the product fails to contain vitamin A.

26 F - - 99 Vegetable Shortening, N.E.C.
Date Published: 10/02/2015

Desc: Margarine
Notes: Violation;Product is misbranded within the meaning ofSec. 403 in that theproduct is labeled asmargarine but failsto meet the standardof identity for ?Margarine? under 21CFR 166.110 becausethe product fails tocontain vitamin A.

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 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).

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).

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: 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 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 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: 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: 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).

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.                                                                                                                                                                                                                                                                                                                                                                


COSTA RICA


UL Costa Rica SCC, S.A.
Date Published : 10/02/2015
Del Cruce De San Antonio, 400m Oeste 800 Norte. Frente A Testigos De Jehova , Heredia, Heredia COSTA RICA
24 K - - 50 Tomatoes, with Sauce
Date Published: 10/02/2015

Desc: Tomato Sauce Cooking Base; 8oz (227g)
Notes: Misbranded 403(q); Serving size not expressed as Reference Amount Customarily Consumed (RACC); product declares 56g (2 Tablespoons); established RACC for Sauces; Major main entre sauces; e.g. spaghetti sauce is 125g (21CFR 101.12(b); Table 2). Misbranded 403(i)(2); Common or usual name of each ingredient not declared on the label (21CFR 101.4); seasonings contains two or more ingredients and must list all sub-ingredients.

24 K - - 50 Tomatoes, with Sauce
Date Published: 10/02/2015

Desc: Tomato Sauce Sofrito Criollo (Creole Sauce); 8oz (227g)
Notes: Misbranded 403(q); Serving size not expressed as Reference Amount Customarily Consumed (RACC); product declares 56g (2 Tablespoons); established RACC for Sauces; Major main entre sauces; e.g. spaghetti sauce is 125g (21CFR 101.12(b); Table 2). Misbranded 403(i)(2); Common or usual name of each ingredient not declared on the label (21CFR 101.4); seasonings contains two or more ingredients and must list all sub-ingredients.

24 K - - 50 Tomatoes, with Sauce
Date Published: 10/02/2015

Desc: Tomato Sauce ? Ranchera; 8oz (227g)
Notes: Misbranded 403(q); Serving size not expressed as Reference Amount Customarily Consumed (RACC); product declares 56g (2 Tablespoons); established RACC for ?Sauces; Major main entre sauces; e.g. spaghetti sauce is 125g (21CFR 101.12(b); Table 2). Misbranded 403(i)(2); Common or usual name of each ingredient not declared on the label (21CFR 101.4); seasonings contains two or more ingredients and must list all sub-ingredients.

37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 10/02/2015

Desc: Tomato Sauce Sofrito Criollo (Creole Sauce); 8oz (227g)
Notes: Misbranded 403(q); Serving size not expressed as Reference Amount Customarily Consumed (RACC); product declares 56g (2 Tablespoons); established RACC for Sauces; Major main entre sauces; e.g. spaghetti sauce is 125g (21CFR 101.12(b); Table 2). Misbranded 403(i)(2); Common or usual name of each ingredient not declared on the label (21CFR 101.4); seasonings contains two or more ingredients and must list all sub-ingredients.

37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 10/02/2015

Desc: Tomato Sauce Cooking Base; 8oz (227g)
Notes: Misbranded 403(q); Serving size not expressed as Reference Amount Customarily Consumed (RACC); product declares 56g (2 Tablespoons); established RACC for Sauces; Major main entre sauces; e.g. spaghetti sauce is 125g (21CFR 101.12(b); Table 2). Misbranded 403(i)(2); Common or usual name of each ingredient not declared on the label (21CFR 101.4); seasonings contains two or more ingredients and must list all sub-ingredients.

37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 10/02/2015

Desc: Tomato Sauce with Cheese (Salsita Lista de Tomate con Queso)
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(q) because; The product declares the serving size as 56 g (2 spoons); however the established Reference Amount Customarily Consumed (RACC) for Major main entre sauces; e.g.; spaghetti sauce[21 CFR 101.12(b); Table 2; under Sauces; Dips; Gravies and Condiments] is 125 g. therefore the nutrition information is not accurate per serving because it is not based on the established RACC provided for this product; The serving size is not expressed in a common household measure as required by 21 CFR 101.9(b)(5); The product fails to meet the requirements on rounding for the following nutrients; calories; saturated fat; cholesterol; carbohydrate; dietary fiber protein; Vitamin A; calcium and iron. In addition; the declaration for potassium does not follow the order of presentation of nutrient information because the declaration for potassium follows the declaration of iron rather than the declaration of sodium [21 CFR 101.9 (c)].

37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 10/02/2015

Desc: Tomato Sauce Ranchera; 8oz (227g)
Notes: Misbranded 403(q); Serving size not expressed as Reference Amount Customarily Consumed (RACC); product declares 56g (2 Tablespoons); established RACC for Sauces; Major main entr?e sauces; e.g. spaghetti sauce is 125g (21CFR 101.12(b); Table 2). Misbranded 403(i)(2); Common or usual name of each ingredient not declared on the label (21CFR 101.4); seasonings contains two or more ingredients and must list all sub-ingredients.


CROATIA


Zdenka d.d
Date Published : 02/19/2015
Trg Kralja Tomislava , Veliki Zdenci, Bjelovarsko-bilogorska CROATIA
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: 10/09/2015

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 - - 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 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 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: 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 - - 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 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: 10/09/2015

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: 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: 10/09/2015

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: 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: 10/09/2015

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: 10/09/2015

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


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)
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: 05/14/2019

Desc: Sukrin Melis With Stevia
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(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. In accordance with 21 CFR 101.7(b)(1), statements of weight shall be in terms of avoirdupois pound and ounce. Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 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. Product contains the ingredient steviol glycosides. "Stevia" is not a common or usual name for a food ingredient, including steviol glycosides.

36 A - - 99 Sugar Products, N.E.C.
Date Published: 06/26/2019

Desc: Sukrin Zero Calorie Sweetener
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: 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 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 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 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 06/26/2019

Desc: Sukrin Zero Calorie Sweetener
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.

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: 05/14/2019

Desc: Sukrin Melis With Stevia
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(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. In accordance with 21 CFR 101.7(b)(1), statements of weight shall be in terms of avoirdupois pound and ounce. Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 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. Product contains the ingredient steviol glycosides. "Stevia" is not a common or usual name for a food ingredient, including steviol glycosides.

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 06/26/2019

Desc: Sukrin Zero Calorie Sweetener
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).

Lakrids By Johan Buelow
Date Published : 10/13/2017
Sydholmen 5 , Hvidovre, DENMARK
33 L - - 08 Licorice Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/13/2017

Desc: Salt and Caramel Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

33 L - - 08 Licorice Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/13/2017

Desc: Passion Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

33 L - - 08 Licorice Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/13/2017

Desc: Red Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

33 L - - 08 Licorice Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/13/2017

Desc: Dark and Coffee Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

33 L - - 08 Licorice Candy, Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/13/2017

Desc: Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/13/2017

Desc: Salt and Caramel Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/13/2017

Desc: Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/13/2017

Desc: Passion Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/13/2017

Desc: Dark and Coffee Chocolate Coated Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/13/2017

Desc: Red Licorice
Notes: 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. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents on the principal display panel (PDP) as required by 21 CFR 101.7(a) and in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1).

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


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
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). ; ;

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: 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 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: 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 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 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: 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 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: 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).


ECUADOR


Alimentos Superior Alsuperior
Date Published : 08/07/2018
Antigua Via Al Quinche Km 2.5 Guayllabamba , Ref: Huertos Familiares Puruhuanta , Quito, Pichincha ECUADOR
04 C - - 02 Noodles, Enriched
Date Published: 08/07/2018

Desc: Pasta Amancay (macaroni product)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'enriched macaroni'; but does not appear to meet the standard for iron (product was found through lab analysis to contain more than 16.5 mg of iron per pound of product).

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 08/07/2018

Desc: Pasta Amancay (macaroni product)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'enriched macaroni'; but does not appear to meet the standard for iron (product was found through lab analysis to contain more than 16.5 mg of iron per pound of product).

Alimentos Superior Alsuperior S.A.
Date Published : 08/07/2018
Av. La Prensa N56-87 Y Pasaje , Quito, Pichincha ECUADOR
04 C - - 02 Noodles, Enriched
Date Published: 08/07/2018

Desc: Pasta Amancay (macaroni product)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'enriched macaroni'; but does not appear to meet the standard for iron (product was found through lab analysis to contain more than 16.5 mg of iron per pound of product).

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 08/07/2018

Desc: Pasta Amancay (macaroni product)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'enriched macaroni'; but does not appear to meet the standard for iron (product was found through lab analysis to contain more than 16.5 mg of iron per pound of product).

Industrias Lacteas Toni 2
Date Published : 06/13/2019
Km 17.5 Cooperativa San Nicolas FTE , Pascuales Mz 429 Solar 1 , Guayaquil, Guayas ECUADOR
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.

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.

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: 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.

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.

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


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, EG-GZ 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.


EL SALVADOR


Laboratorios COMBISA
Date Published : 10/02/2015
KM 4 1/2 Carretera San Marcos # 428 , San Marcos, San Salvador EL SALVADOR
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 10/02/2015

Desc: Komilon Syrup
Notes: Problems: NLEA Violations; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated within the meaning of Section 402(a)(2)(C)(i) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §342(a)(2)(C)(i)] because the use of sodium saccharin as food additive is not in conformity with conditions in section 21 CFR 180.37. The label of an finished product that contains sodium saccharin must bear the amount of sodium saccharin, calculated as saccharin, in terms of the weight or serving size which shall be the quantity of food containing 30 milligrams or less of the additive [21 CFR 180.37(f)(2)(ii)(c)]. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears be misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. §343(q)(5)(F)] of the Federal Food, Drug and Cosmetic Act (the Act) in that the labels nutrition labeling (“Supplement Facts” panel) is not in an appropriate format as defined in 2 CFR 101.36. Specifically, the product is purported to be used by infants, children less than 4 years of age, and children between 4 to 12 years of age; however, the percent of Daily Value heading fails to present the %DV in separate columns for each intended groups in accordance with 21 CFR 101.36(b)(2)(ii)(E).


FIJI


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


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


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 Formula Product, 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.

PLANTAFOOD MEDICAL GMBH
Date Published : 09/18/2019
Am Sportplatz 3 , Leiningen, Rhineland-Palatinate GERMANY
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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).

Plantafood Medical Gmbh
Date Published : 09/18/2019
Horst-Uhlig-Str. 3 , Laudert, Rhineland-Palatinate GERMANY
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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).

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: 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: 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: 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.


GHANA


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

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 Tsoungari
Date Published : 04/14/2016
Interbalkan Area , Thessaloniki, 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-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.

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.

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
7 Av. 7-31 Zona 5 , Santa Cruz del Quiche, GUATEMALA
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 - - 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 - - 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


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
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
Flat D & F, 18/F , 49-51 Wong Chuk Hang Road; Kong , Wong Chuk Hang, Hong Kong Island HONG KONG
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
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).


ICELAND


GeoSilica Iceland
Date Published : 06/05/2018
Granasbraut 506 , Reykjanesba, ICELAND
54 A - - 99 Vitamin, N.E.C.
Date Published: 06/05/2018

Desc: Geosilica Silica Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

54 A - - 99 Vitamin, N.E.C.
Date Published: 06/05/2018

Desc: Recover Muscle and Nerves Minerals
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4.

54 B - - 99 Mineral N.E.C.
Date Published: 06/05/2018

Desc: Geosilica Silica Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/05/2018

Desc: Geosilica Silica Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/05/2018

Desc: Recover Muscle and Nerves Minerals
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4.


INDIA


Ancient Greenfields
Date Published : 02/28/2018
4/159-A2, Vadavalli to Kanuvai Road , Kalappanaickenpalayam , Coimbatore, Tamil Nadu INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued)
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 02/28/2018

Desc: Moringa Capsule
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.

BRITANNIA INDUSTRIES LIMITED
Date Published : 10/02/2015
5/1a, Hungerford Street , Kolkata , KOLKATA, IN-WB INDIA
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06 ;

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Cashew Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Nice Time Sugar Showered Coconut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04 ;

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: 50-50 Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Marie Gold Biscuits
Notes: Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

Bikaji Foods International Ltd.
Date Published : 01/10/2017
F-196-197 Bichhwal Industrial Area , Rico Industrial Area, Bikaji Road , Bikaner, Rajastan INDIA
21 A - - 99 Mixed Fruit, N.E.C.
Date Published: 12/13/2017

Desc: Khajoor Dry Fruit
Notes: Violation: 403(r)(1)(A): The product “Khajoor Dry Fruit Burfee” is labeled as “sugar free,” however the label bears ingredients “dates” which are generally understood by consumers to contain sugar. The ingredient “dates” is not accompanied by an asterisk with an appropriate statement of “adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietary insignificant amount of sugar,” and the labeling does not declare “not a reduced calorie food,” “not a low calorie food,” or “not for weight control” as required per 21 CFR 101.60(c). Violation 403(f): The product label contains information in multiple languages, but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c), 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. Violation 403(e)(2): The label fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Violation 403(q): The product labels fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure in accordance with Table 2 of 21 CFR 101.12. The reference amount for “grain-based bars with or without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars” has a reference amount of 40g. Alternatively, If the products are considered a sweet, a different product category would be “all other candies” which has the same reference amount of 40g. Title 21 CFR 101.9(b)(2)(i) states that for products in discrete unites, if a unit weighs 50 percent or less of the reference amount, the serving size must be the number of whole units that most closely approximates the reference amount for the product category.

33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without
Date Published: 12/13/2017

Desc: Khajoor Dry Fruit
Notes: Violation: 403(r)(1)(A): The product “Khajoor Dry Fruit Burfee” is labeled as “sugar free,” however the label bears ingredients “dates” which are generally understood by consumers to contain sugar. The ingredient “dates” is not accompanied by an asterisk with an appropriate statement of “adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietary insignificant amount of sugar,” and the labeling does not declare “not a reduced calorie food,” “not a low calorie food,” or “not for weight control” as required per 21 CFR 101.60(c). Violation 403(f): The product label contains information in multiple languages, but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c), 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. Violation 403(e)(2): The label fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Violation 403(q): The product labels fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure in accordance with Table 2 of 21 CFR 101.12. The reference amount for “grain-based bars with or without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars” has a reference amount of 40g. Alternatively, If the products are considered a sweet, a different product category would be “all other candies” which has the same reference amount of 40g. Title 21 CFR 101.9(b)(2)(i) states that for products in discrete unites, if a unit weighs 50 percent or less of the reference amount, the serving size must be the number of whole units that most closely approximates the reference amount for the product category.

33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 01/10/2017

Desc: Khajoor Dry Fruit
Notes: Violation: 403(r)(1)(A): The product “Khajoor Dry Fruit Burfee” is labeled as “sugar free,” however the label bears ingredients “dates” which are generally understood by consumers to contain sugar. The ingredient “dates” is not accompanied by an asterisk with an appropriate statement of “adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietary insignificant amount of sugar,” and the labeling does not declare “not a reduced calorie food,” “not a low calorie food,” or “not for weight control” as required per 21 CFR 101.60(c). Violation 403(f): The product label contains information in multiple languages, but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c), 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. Violation 403(e)(2): The label fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Violation 403(q): The product labels fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure in accordance with Table 2 of 21 CFR 101.12. The reference amount for “grain-based bars with or without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars” has a reference amount of 40g. Alternatively, If the products are considered a sweet, a different product category would be “all other candies” which has the same reference amount of 40g. Title 21 CFR 101.9(b)(2)(i) states that for products in discrete unites, if a unit weighs 50 percent or less of the reference amount, the serving size must be the number of whole units that most closely approximates the reference amount for the product category.

33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 01/10/2017

Desc: Anjeer Dry Fruit
Notes: Violation 403(r)(1)(A): The product “Anjeer Dry Fruit Burfee” is labeled as “sugar free,” however the label bears ingredients “figs” which are generally understood by consumers to contain sugar. The ingredient “figs” is not accompanied by an asterisk with an appropriate statement of “adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietary insignificant amount of sugar,” and the labeling does not declare “not a reduced calorie food,” “not a low calorie food,” or “not for weight control” as required per 21 CFR 101.60(c). Violation 403(f): The product label contains information in multiple languages, but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c), 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. Violation 403(e)(2): The label fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Violation 403(q): The product labels fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure in accordance with Table 2 of 21 CFR 101.12. The reference amount for “grain-based bars with or without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars” has a reference amount of 40g. Alternatively, If the products are considered a sweet, a different product category would be “all other candies” which has the same reference amount of 40g. Title 21 CFR 101.9(b)(2)(i) states that for products in discrete unites, if a unit weighs 50 percent or less of the reference amount, the serving size must be the number of whole units that most closely approximates the reference amount for the product category.

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 12/13/2017

Desc: Khajoor Dry Fruit
Notes: Violation: 403(r)(1)(A): The product “Khajoor Dry Fruit Burfee” is labeled as “sugar free,” however the label bears ingredients “dates” which are generally understood by consumers to contain sugar. The ingredient “dates” is not accompanied by an asterisk with an appropriate statement of “adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietary insignificant amount of sugar,” and the labeling does not declare “not a reduced calorie food,” “not a low calorie food,” or “not for weight control” as required per 21 CFR 101.60(c). Violation 403(f): The product label contains information in multiple languages, but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c), 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. Violation 403(e)(2): The label fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Violation 403(q): The product labels fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure in accordance with Table 2 of 21 CFR 101.12. The reference amount for “grain-based bars with or without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars” has a reference amount of 40g. Alternatively, If the products are considered a sweet, a different product category would be “all other candies” which has the same reference amount of 40g. Title 21 CFR 101.9(b)(2)(i) states that for products in discrete unites, if a unit weighs 50 percent or less of the reference amount, the serving size must be the number of whole units that most closely approximates the reference amount for the product category.

37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 01/25/2017

Desc: Badam Halwa
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but does not repeat all the required information in all languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

Deltas Pharma( Padmavati )
Date Published : 06/22/2017
Old Industrial Area , Haridwar, INDIA
28 C - - 04 Basil (Sweet Basil), Natural Extract or Flavor (Spice)
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares “solubiliser” along with other dietary ingredients, but this is not the common or usual name for an ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares “solubiliser” along with other dietary ingredients, but this is not the common or usual name for an ingredient.

E A Currim Pvt Ltd
Date Published : 10/02/2015
19 Kazi Sayed St Ground Flr , Mumbai, INDIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 10/02/2015

Desc: Umber SF Supplement
Notes: Product is labeled as a dietary supplement but fails to bear nutrition labeling ("Supplement Facts" panel) as required by Section 403(q)(5)(F) and 21 CFR 101.36. Product is misbranded within the meaning of Section 403(i)(2) of the Act because the label fails to list each ingredient, specifically, the capsule ingredients, in the ingredient statement (21 CFR 101.4(a)(1)). The label fails to identify the product using the term "dietary supplement" as part of the statement of identity on the principal display panel (21 CFR 101.3(a) and (g)). The product fails to provide the appropriate "Disclaimer" in accordance with 21 CFR 101.93(a-e).

Glaxo SmithKline Ltd
Date Published : 10/02/2015
Nobha , Patiyala Road , Nabha, Punjab INDIA
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 07/24/2019

Desc: Boost Drink Powder
Notes: 1/25/2016; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that it does not bear a Nutrition Facts label as required in 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) because many of the ingredients are not declared in accordance with 21 CFR 101.4. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act because the product fails to bear the common or usual name of the food [21 CFR 101.3(a)].

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 C - - 99 Foods (including Water) with Excessive Nutritional Claims
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

Glaxo SmithKline Ltd
Date Published : 10/02/2015
Nobha , Patiyala Road , Nabha, Punjab INDIA
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 C - - 99 Foods (including Water) with Excessive Nutritional Claims
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

Haldiram Snacks Pvt. Ltd.
Date Published : 07/15/2019
B - 1 Sector 63 , Noida, Uttar Pradesh INDIA
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 07/15/2019

Desc: Cham Cham
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in additional languages as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. The product has two Nutrition Facts labels; one appears to be for a different market.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 07/15/2019

Desc: Gulab Jamun
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in additional languages as required by 21 CFR 101.15(c)(2).

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 07/15/2019

Desc: Rasmalai
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in additional languages as required by 21 CFR 101.15(c)(2).

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 07/15/2019

Desc: Rasgulla
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in additional languages as required by 21 CFR 101.15(c)(2).

Hindustan Coca Cola Beverages Pvt Ltd
Date Published : 10/02/2015
1105/7/8/33 Gut No , Pirangut, Dist. Pune, Maharashtra INDIA
29 B - - 50 Soft Drink, Cola, Carbonated
Date Published: 10/02/2015

Desc: ?Thumbs Up? Carbonated Soft Drink
Notes: Charge; 403(q) The Trans Fat content is not declared as required by 21 CFR 101.9(c)(2)(ii); The serving size is listed in metrics rather than common household measure [21 CFR 101.9(b)(1) as defined in 21 CFR 101.9(b)(5)]; A Percent Daily Value must not be provided for sugars (21 CFR 101.9(d)(7)(ii)). The can declares a nutrition label in another country?s format (with different nutrition label values); which is not provided for in 21 CFR 101.9. We note that the product has a nutrition label sticker that appears to be in the U.S. format; however; the sticker does not cover up the incorrect format.

Hindustan Unilever Ltd
Date Published : 01/05/2017
A-5, Phase II-B, Focal Point , Rajpura, DISTT, Patiala , Punjab, INDIA
21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.
Date Published: 01/05/2017

Desc: Mango Jam
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

21 U - - 05 Mango, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 01/05/2017

Desc: Mango Jam
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to bear the required nutrition information. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

INDO NISSAN FOODS LIMITED
Date Published : 10/02/2015
CENTENARY BUILDING 28 M.G. ROAD , Bangalore, Karnataka INDIA
04 C - - 07 Noodles, Instant
Date Published: 10/02/2015

Desc: Top Ramen Curry Noodles
Notes: Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09

K-Pra Foods Private Limited
Date Published : 01/10/2018
1348 A V Bhat Co Building , Chimnya Ganapati , Pune, Maharashtra INDIA
23 F - - 07 Peanut, Topping
Date Published: 01/10/2018

Desc: GROUND NUT CHATNI (CHUTNEY)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) of the Act [21 USC 343(q)] because the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. 403(i)(2) of the Act [21 USC 343(i)(2)] because the product label fails to declare all ingredients by the common or usual name, as required by 21 CFR 101.4. 403(f) of the Act [21 USC 343(f)] because the product label contains information in two languages (English and Hindi) but does not repeat all of the required information in Hindi.

KOCHI KITCHEN EXPORTS
Date Published : 01/12/2018
23/1777 Binny Road , Kochi, Kerala INDIA
20 A - - 08 Gooseberries (Berry)
Date Published: 01/12/2018

Desc: AMLA (INDIAN GOOSEBERRY)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21U.S.C. 343(a)(1)] because the label is false and misleading. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21U.S.C. 343(r)(1)(A)] because the label bears the claim “Eastern sources the finest Alma, helping you maintain a diet rich in vitamin C, iron and zinc.” The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(B) of the Act [21U.S.C. 343(r)(1)(B)] because the label bears an unauthorized health claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not using the correct serving size as defined in 21 CFR 101.9. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that product label contains information in three foreign languages in addition to English but does not repeat all the required label information in all languages.

21 S - - 34 Amla, Subtropical and Tropical Fruit
Date Published: 01/12/2018

Desc: AMLA (INDIAN GOOSEBERRY)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21U.S.C. 343(a)(1)] because the label is false and misleading. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21U.S.C. 343(r)(1)(A)] because the label bears the claim “Eastern sources the finest Alma, helping you maintain a diet rich in vitamin C, iron and zinc.” The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(r)(1)(B) of the Act [21U.S.C. 343(r)(1)(B)] because the label bears an unauthorized health claim. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information is not using the correct serving size as defined in 21 CFR 101.9. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act in that product label contains information in three foreign languages in addition to English but does not repeat all the required label information in all languages.

Kamala International Exim
Date Published : 05/22/2017
7-4-112/1, Madhuban Colony Road , Kattedan , Hyderabad, IN-TG INDIA
03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 05/22/2017

Desc: "King Dutch" Wafer Rolls; Hazelnut flavor
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. The label appears to include the nutrient content claim ?0 trans-fat? on the information panel but does not declare the levels of mono- and polyunsaturated fat in the nutrition label in accordance with the requirements of 21 CFR 101.9 (c)(2)(iii) and (iv).. Based on the quality of the photo of the label we were provided; we cannot tell if there is also a claim on the Principal Display panel.

Keval Exports Pvt Ltd
Date Published : 09/14/2015
D 8/7 T T C Industrial Area , T T C Industrial Turbhe D Block Road , Navi Mumbai, Maharashtra INDIA
28 A - - 18 Fennel, Whole (Spice)
Date Published: 09/14/2015

Desc: SUGAR COATED FENNEL
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the product appears to be misbranded under section 403(k) of the Act because it contains artificial coloring and fails to bear labeling stating that fact. FD&C Red No. 40; FD&C Yellow No. 5; and FD&C Blue No. 1 are not declared by their listed names or appropriate abbreviations. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that the product appears to be misbranded under section 403(i)(2) of the Act because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient; as required under 21 CFR 101.4 Specifically; the product label contains no information about the ingredients contained therein

Legacy Foods Pvt. Ltd.
Date Published : 10/02/2015
17km Pinjore Nalagarh Highway , P.O. Baddi , Distt. Solan 1730205 (HP), INDIA
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 C - - 99 Foods (including Water) with Excessive Nutritional Claims
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

MAPRO FRUIT BAR LLP
Date Published : 07/24/2019
117 - 121 , Mapro Fruit Bar Llp; Wai , Shendurjane, Maharashtra INDIA
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 07/24/2019

Desc: Guava Chews
Notes: 9/17/2015; NOTE; Mapro Foods Private Limited was declared as the manufacturer of products; labels show manufactured by Mapro Fruit Bar LLP.                                                                                                                                                                                                                                                                                                        Orange Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient; as required under 21 CFR 101.4. Specifically; "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally; Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 07/24/2019

Desc: Orange Chews
Notes: 9/17/2015; NOTE; Mapro Foods Private Limited was declared as the manufacturer of products; labels show manufactured by Mapro Fruit Bar LLP.                                                                                                                                                                                                                                                                                                        Orange Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient; as required under 21 CFR 101.4. Specifically; "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally; Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

Mapro Foods Pvt Ltd
Date Published : 09/17/2015
122, Shendurjane , Dist. Satara , Wai, Maharashtra INDIA
33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Mango Chews
Notes: Mango Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 08/09/2018

Desc: Vanilla Nutritional Shake Powder
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the amount of Calcium is at 22.7%, Iron is at 19.5% and Zinc is at 6.6% of the label declaration in the Vanilla Nutritional Shake Powder.; Also, The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages. Title 21 CFR 101.15(c) states that if a product contains any representation in a foreign language, all words, statements and other information required by or under authority of the Act appear on the label must appear in the foreign language.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Raw Mango Chews
Notes: Raw Mango Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Guava Chews
Notes: Guava Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Allura Red AC (E-129) must be declared by the common or usual name FD&C Red 40.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Strawberry Chews
Notes: Strawberry Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Allura Red AC (E-129) must be declared by the common or usual name FD&C Red 40.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 08/09/2018

Desc: Strawberry Nutritional Shake Powder
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the amount of Calcium is at 25.1%, Iron is at 19.6% and Zinc is at 5.6% of the label declaration in the Strawberry Nutritional Shake Powder. Also, The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages. Title 21 CFR 101.15(c) states that if a product contains any representation in a foreign language, all words, statements and other information required by or under authority of the Act appear on the label must appear in the foreign language.

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)
Date Published: 09/17/2015

Desc: Orange Chews
Notes: Orange Chews are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, "thickener (E-440(i))" is not the common or usual name for pectin and "citric acid (E-330)" is not the common or usual name for citric acid. Finally, Food Color Tartrazine (E-1 02)" must be declared by the common or usual name FD&C Yellow No. 5.

Marico Limited
Date Published : 02/28/2018
Plot No 8 Ind. Arealodhimajra, Tehsil , Solan, INDIA
26 C - - 99 Refined Vegetable Oil, Single Ingredient, N.E.C.
Date Published: 02/28/2018

Desc: Saffola Gold Vegetable Oil
Notes: Section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents in terms of fluid measure as required by 21 CFR 101.7.

26 D - - 99 Blended Vegetable Oils, Refined, N.E.C.
Date Published: 02/28/2018

Desc: Saffola Gold Vegetable Oil
Notes: Section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents in terms of fluid measure as required by 21 CFR 101.7.

26 Y - - 99 Vegetable Oils Not Mentioned Elsewhere, N.E.C.
Date Published: 02/28/2018

Desc: Saffola Gold Vegetable Oil
Notes: Section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents in terms of fluid measure as required by 21 CFR 101.7.

Mehrotra Consumer Products Private Limited
Date Published : 04/02/2019
Ecotech 1 , 26g Sector 31 , Greater Noida, Uttar Pradesh INDIA
25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C.
Date Published: 04/02/2019

Desc: Organic Tattva Triphala Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears nutrient content claims, but the product does not meet the requirements to make such claims. Claim: "Rich in Vitamin C and Antioxidants", but product does not list Vitamin C in the Nutrition Facts. Claim "rich in nutrients," but the product does not contain any nutrients that would meet the definition of "rich in" in accordance with 21 CFR 101.54(b). Claim: "antioxidant" must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). Missing name of nutrient(s) with recognized antioxidant activity, as required by 21 CFR 101.54(g)(4) Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear an appropriate statement of identity. The term "Triphala" is foreign (Indian) term meaning three fruits. Product appears to be intended to be mixed with water to be consumed as a beverage; however, the statement of identity does not indicate that it is used to make a beverage; for example, a beverage mix or a tea. Section 403(i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and the ingredients are not declared appropriately, as required under 21 CFR 101.4. The ingredient list appears to declare two terms for each ingredient. There are no provisions in 21 CFR 101.4 for declaring multiple terms for each ingredient in a food product. The terms used in the ingredient list appear to be foreign terms.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/02/2019

Desc: Organic Tattva Triphala Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears nutrient content claims, but the product does not meet the requirements to make such claims. Claim: "Rich in Vitamin C and Antioxidants", but product does not list Vitamin C in the Nutrition Facts. Claim "rich in nutrients," but the product does not contain any nutrients that would meet the definition of "rich in" in accordance with 21 CFR 101.54(b). Claim: "antioxidant" must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). Missing name of nutrient(s) with recognized antioxidant activity, as required by 21 CFR 101.54(g)(4) Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear an appropriate statement of identity. The term "Triphala" is foreign (Indian) term meaning three fruits. Product appears to be intended to be mixed with water to be consumed as a beverage; however, the statement of identity does not indicate that it is used to make a beverage; for example, a beverage mix or a tea. Section 403(i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and the ingredients are not declared appropriately, as required under 21 CFR 101.4. The ingredient list appears to declare two terms for each ingredient. There are no provisions in 21 CFR 101.4 for declaring multiple terms for each ingredient in a food product. The terms used in the ingredient list appear to be foreign terms.

Mondelez India Foods Limited
Date Published : 10/31/2018
Mondelez House , 210th Floor Unit No 2001; Tower - 3 , Mumbai, Maharashtra INDIA
02 J - - 99 Malt Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 Y - - 99 Cereal Preparations Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

32 A - - 99 Malt Beverages, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 J - - 99 Imitation Chocolate and Cocoa Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

Nestle India Limited
Date Published : 01/30/2017
M Block , Jacaranda Marg , Gurgaon, Haryana INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nestle India Limited
Date Published : 01/30/2017
P.B. No. 24, Industrial Area , Nanjangud, Mysore Dist, Karnataka , Nanjangud, Karnataka INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nestle India Limited
Date Published : 10/02/2015
Village Maulinguem , Bicholim Taluka, Goa INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 10/02/2015

Desc: Maggi Noodles Masala with Tastemaker
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 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.

Nestle India Limited - Moga Factory
Date Published : 10/02/2015
Pb No.11, , Ludhiana-ferozepur Road, , Moga, IN-PB INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 10/02/2015

Desc: Maggi Noodles Masala with Tastemaker
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 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.

Nestle India Ltd
Date Published : 01/30/2017
Ludhiana Firojpur Road , Atari, Punjab INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nestle India Ltd
Date Published : 01/30/2017
Industrial Area Tahliwal , Nangal Kalan, Himachal Pradesh INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nestle India Ltd
Date Published : 10/02/2015
M-5a Connaught circus , New Delhi , New Delhi, Delhi INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 10/02/2015

Desc: Maggi Noodles Masala with Tastemaker
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 Also; product fails to declare the source of all the major food allergens present in this product; such as; a specific tree nut(s). Specifically; the ingredient list declares the ingredient ¿Hydrolysed groundnut protein¿ but does not identify the specific ¿nut¿ ingredient by its common or usual name. Also; the food is fabricated from two or more ingredients and the label fails to list the common or usual name of each ingredient. Specifically; the product fails to declare the common or usual name of the vegetable oil [see 21 CFR 101.4(b)(14)) and Mineral (170(i)); hydrolysed groundnut protein; edible starch; acidifying agent (330); Colour (150d); Flavour enhancers (627 & 631) and raising agent (500 (ii)) as required under 21 CFR 101.4 Also; the net quantity of contents is not declared as specified under 21 CFR 101.105. The statement of weight must be in terms of avoirdupois pound and ounce as specified under 21CFR 101.105(b)(1). Also; the food purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations but fails to conform to such definition and standard. Specifically; the product purports to be a ¿noodle" product; which is defined under 21CFR 139.150; but fails to contain any egg ingredient(s). Also; the label appears to bear a foreign language. We note that 21 CFR 101.15(c) states that if any representation is made on the label in a foreign language; all the required elements must be presented in the foreign language; in addition to the required English.

Nestle India, Pantnagar
Date Published : 01/30/2017
Plot No 1,Sector No1A Integrated , Industry Estate,SIDCUL , Pantnagar, Uttaranchal INDIA
04 - - - -- Macaroni/Noodle Prod
Date Published: 01/30/2017

Desc: Maggi Masala
Notes: The article are subject to refusal of admission pursuant to Section 801(a)(3) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 383] in that they appear to be misbranded within the meaning of: 1. Section 403(f) of the Act [21 U.S.C. § 343(f) 2. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 3. Section 403(q) of the Act [21 U.S.C. § 343(q)] 4. Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]

Nisarga Biotech Pvt Ltd
Date Published : 02/14/2017
J2/1 Addl. Midc , Satara, Maharashtra INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/14/2017

Desc: Ocimum Sanctum Extract
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that the labeling is false or misleading in any particular. Specifically, the product label fails to indicate the presence of ricinine.

Nisarga Biotech Pvt Ltd
Date Published : 02/14/2017
J2/1 Addl. Midc , Satara, Maharashtra INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 02/14/2017

Desc: Ocimum Sanctum Extract
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], in that the labeling is false or misleading in any particular. Specifically, the product label fails to indicate the presence of ricinine.

P. J. Exports
Date Published : 10/02/2015
Shri Arihant Compound , Reti Bunder Road , Kalyan, Maharashtra INDIA
04 C - - 07 Noodles, Instant
Date Published: 10/02/2015

Desc: Top Ramen Curry Noodles
Notes: Product is misbranded within the meaning of Section 403(i)(2) in that the label fails to bear required information as required in 21 CFR 101.4(a)(1); e.g. common or usual name of each ingredient; label fails to declare sodium as required in 21 CFR 101.9(g) in that the nutrient content is greater than 20% in excess of the declared value on the label. Product fails to declare iron are required by CFR 101.9(g)(4)(ii). 2/9/09

PATEL RETAIL PVT.LTD.
Date Published : 12/22/2016
M - 2 Additional M.I.D.C. , Anand Nagar, Ambernant East, Tahsil Kalyan, Dist Thane , Ambernant East, Maharashtra INDIA
28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 12/22/2016

Desc: Mukhwas
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages.; As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. ; The statement of identity, nutrition information, ingredient statement, and name and place of business of the manufacturer, packer, or distributor are not declared in English on the individual retail packets.

Padmavati Pharmaceuticals
Date Published : 06/22/2017
F/52 Industrial Area , Haridwar, INDIA
28 C - - 04 Basil (Sweet Basil), Natural Extract or Flavor (Spice)
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares “solubiliser” along with other dietary ingredients, but this is not the common or usual name for an ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/22/2017

Desc: Deltas Pancha Tulasi Drops Basils - 5
Notes: Section 403(y) of the Act in that the product label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The address must include a street address or the label must bear a domestic phone number. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36. Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Additionally, the net contents should be located in the bottom 30% of the principal display panel. Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient, as required by 21 CFR 101.36 and 21 CFR 101.4. Label declares “solubiliser” along with other dietary ingredients, but this is not the common or usual name for an ingredient.

Ponmurugan Dhall Mills
Date Published : 10/02/2015
SF No. 159, Trichy Main Road, , Kannampalayam PO, Sulur , Coimbatore, Tamil Nadu INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 10/02/2015

Desc: Mayil Mark - Samba Ravia; ?Deluxe Samba Wheat Brokens?
Notes: Problem(s); The product fails to properly declare the serving size in a common household measure as specified by 21 CFR 101.9(d)(3)(i). ; The serving size of 167g is not expressed as an ?amount customarily consumed? that is appropriate to the food as defined within 21 CFR 101.12(b); Table 2 and required by 21 CFR 101.9(b). Based on the following preparation instructions on the principle display panel ?Just add water & Ready to Cook;? the product appears to be a dry wheat product which is prepared and served similar to rice. The established Reference Amount Customarily Consumed (RACC) for ?Grains; e.g. rice; barley; plain? is 140g prepared; 45g dry.; The total caloric content per serving is expressed in Kcal which is not in accordance with 21 CFR 101.9(c)(l).; The Calories from Fat content per serving is expressed in gm which is not listed in accordance with 21 CFR 101.9(c)(l)(ii).; The product label fails to declare the number of servings per container as specified in 101.9(b)(8) & 101.9(d)(3)(ii).; The quantitative amount of nutrients are not rounded in accordance with the regulations for Total Fat (101.9(c)(2)); Saturated Fat (101.9(c)(2)(i)); and Sodium (101.9(c)(4)).

Ponmurugan Dhall Mills
Date Published : 10/02/2015
S F No 118 , 159 160 Main Road , Coimbatore, Tamil Nadu INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 10/02/2015

Desc: Mayil Mark - Samba Ravia; ?Deluxe Samba Wheat Brokens?
Notes: Problem(s); The product fails to properly declare the serving size in a common household measure as specified by 21 CFR 101.9(d)(3)(i). ; The serving size of 167g is not expressed as an ?amount customarily consumed? that is appropriate to the food as defined within 21 CFR 101.12(b); Table 2 and required by 21 CFR 101.9(b). Based on the following preparation instructions on the principle display panel ?Just add water & Ready to Cook;? the product appears to be a dry wheat product which is prepared and served similar to rice. The established Reference Amount Customarily Consumed (RACC) for ?Grains; e.g. rice; barley; plain? is 140g prepared; 45g dry.; The total caloric content per serving is expressed in Kcal which is not in accordance with 21 CFR 101.9(c)(l).; The Calories from Fat content per serving is expressed in gm which is not listed in accordance with 21 CFR 101.9(c)(l)(ii).; The product label fails to declare the number of servings per container as specified in 101.9(b)(8) & 101.9(d)(3)(ii).; The quantitative amount of nutrients are not rounded in accordance with the regulations for Total Fat (101.9(c)(2)); Saturated Fat (101.9(c)(2)(i)); and Sodium (101.9(c)(4)).

QUALITY SPICES & FOOD EXPORTS PVT.LTD.
Date Published : 06/19/2017
Plot No. M-1, Additional Ambernath M.I.D.C. , Anand Nagar , Ambernath (E), Maharashtra INDIA
21 T - - 14 Tamarind, Dried or Paste
Date Published: 06/19/2017

Desc: Tamarind
Notes: Section 403(q) of the Act in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.9.

Quantum Naturals India Private Limited
Date Published : 01/18/2017
42 Plot No , Gurgaon, Haryana INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenRex Capsules -Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenRex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenRex product blister pack label does not bear a domestic address or domestic phone number

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenAlc Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenAlc product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenAlc product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: Zen Fem Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFem product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFem product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: Zen Hab Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenHab product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenFlex Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFlex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). And, the ZenFlex product label does not declare the source of the dietary ingredient Curcumin in accordance with 21 CFR 101.36(d). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 01/18/2017

Desc: ZenJoy Capsules-Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenJoy product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenJoy product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenAlc Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenAlc product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenAlc product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: Zen Hab Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenHab product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenFlex Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFlex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). And, the ZenFlex product label does not declare the source of the dietary ingredient Curcumin in accordance with 21 CFR 101.36(d). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenJoy Capsules-Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenJoy product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenJoy product blister pack label does not bear a domestic address or domestic phone number.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: ZenRex Capsules -Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenRex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenRex product blister pack label does not bear a domestic address or domestic phone number

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/18/2017

Desc: Zen Fem Capsules- Herbal Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFem product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. Specifically, the ZenFem product blister pack label does not bear a domestic address or domestic phone number.

RUCHI SOYA INDSUTRIES LIMITED
Date Published : 10/02/2015
Po Mangaliagaon , A B Road , Indore, Madhya Pradesh INDIA
02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Chunks
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

02 Y - - 99 Milled Grain Products, N.E.C.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Granules
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

37 C - - 99 Food Pack Requir Mix/Cook, n.e.c.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Granules
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

37 C - - 99 Food Pack Requir Mix/Cook, n.e.c.
Date Published: 10/02/2015

Desc: Nutrela High Protein Soya Chunks
Notes: Product is misbranded under 403(q)in that the format of the nutrition label does not comply with 21CFR101.9. 5/31/07

SAKTHI CASH AND CARRY EXPORTS
Date Published : 10/02/2015
10 A, SASTHAN KOIL STREET , VADIVEESWARAM , Nagercoil, Tamil Nadu INDIA
02 G - - 99 Flours and Meals N.E.C.
Date Published: 10/02/2015

Desc: ?Mayil Mark? Samba Ravia; ?Deluxe Samba Wheat Brokens?
Notes: Problem(s); The product fails to properly declare the serving size in a common household measure as specified by 21 CFR 101.9(d)(3)(i). ; The serving size of 167g is not expressed as an ?amount customarily consumed? that is appropriate to the food as defined within 21 CFR 101.12(b); Table 2 and required by 21 CFR 101.9(b). Based on the following preparation instructions on the principle display panel ?Just add water & Ready to Cook;? the product appears to be a dry wheat product which is prepared and served similar to rice. The established Reference Amount Customarily Consumed (RACC) for ?Grains; e.g. rice; barley; plain? is 140g prepared; 45g dry.; The total caloric content per serving is expressed in Kcal which is not in accordance with 21 CFR 101.9(c)(l).; The Calories from Fat content per serving is expressed in gm which is not listed in accordance with 21 CFR 101.9(c)(l)(ii).; The product label fails to declare the number of servings per container as specified in 101.9(b)(8) & 101.9(d)(3)(ii).; The quantitative amount of nutrients are not rounded in accordance with the regulations for Total Fat (101.9(c)(2)); Saturated Fat (101.9(c)(2)(i)); and Sodium (101.9(c)(4)).

SHRI MAHILA GRIHA UDYOG LIJJAT PAPAD
Date Published : 10/02/2015
3rd Floor , Orcale Point , Mumbai, Maharashtra INDIA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 10/02/2015

Desc: Cumin Papads
Notes: REASON; The product?s label has numerous NLEA and other violations. See CMS case #413400 for lengthy explanation of all violations

SHRI SHYAM GRAH UDHYOG
Date Published : 03/04/2019
Jaipur Rajasthan , Jaipur, Rajasthan INDIA
23 K - - 99 Edible Seeds, N.E.C.
Date Published: 03/04/2019

Desc: MUKHWAAS-FENNEL SEEDS SNACK
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&CA in that it appears to be adulterated because it contains a food additive that is unsafe within the meaning of Section 409 of the Act [21 U.S.C. 348]. According to both the product label as well as an analysis of the product, it contains betel nut, an unsafe food additive. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in more than one language but does not repeat all the required information in all languages as required by 21 CFR 101.15(c). The label fails to bear all required statements in either the foreign language or in English. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&CA in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the FD&CA in that the label fails to bear the required nutrition information. Missing Nutrition Facts.

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 03/04/2019

Desc: MUKHWAAS-FENNEL SEEDS SNACK
Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&CA in that it appears to be adulterated because it contains a food additive that is unsafe within the meaning of Section 409 of the Act [21 U.S.C. 348]. According to both the product label as well as an analysis of the product, it contains betel nut, an unsafe food additive. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because the product label contains information in more than one language but does not repeat all the required information in all languages as required by 21 CFR 101.15(c). The label fails to bear all required statements in either the foreign language or in English. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&CA in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the FD&CA in that the label fails to bear the required nutrition information. Missing Nutrition Facts.

Shree Warana Sahakari Dudh Utpaadak Prakriya Sangh Ltd.
Date Published : 10/31/2018
Tatyasaheb Korenagar , Warananger, INDIA
02 J - - 99 Malt Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

05 Y - - 99 Cereal Preparations Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

09 Y - - 99 Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

32 A - - 99 Malt Beverages, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

34 J - - 99 Imitation Chocolate and Cocoa Products, N.E.C.
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/31/2018

Desc: Cadbury Bourn Vita Malted Mix (Malt Based Food)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(1) in that the label fails to bear the common or usual name of the food (for example, the label declares 'Bourn Vita'); 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the product label fails to declare 'acidity regulator' by its common name; the terms 'potassium hydrogen carbonate', 'sodium hydrogen carbonate', 'milk solids', and 'extracted solids' do not appear to be appropriate common names); 403(q) in that the nutrition facts information is not provided for as defined in 21 CFR 101.9 (for example, the listing of various Vitamin B ingredients; failure to declare serving size in common household measure); 403(e)(2) in that the product label does not declare the net quantity of contents in the format required and is not located in the bottom 30% of the PDP.

Shri Mahila Griha Udyog
Date Published : 10/02/2015
General Delivery , Mumbai, INDIA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 10/02/2015

Desc: Cumin Papads
Notes: REASON; The product?s label has numerous NLEA and other violations. See CMS case #413400 for lengthy explanation of all violations.

Tastel
Date Published : 10/02/2015
2, Veena Vihar, Dayal Das Road , Vile Parle East , Mumbai, IN-MH INDIA
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 01 Vanilla Plain Cookie,Biscuit and Wafer
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Cashew Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Good Day Choco-nut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Nice Time Sugar Showered Coconut Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils/hydrogenated vegetable oils; raising agents [E 500(ii); 503(ii); 450(i)]; emulsifiers (E322;471); antioxidant (INS319); and synthetic food colours (E102;124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 8/28/06

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: 50-50 Biscuits
Notes: Product is misbranded under Sec.403(i)(2) in that the ingredient statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; dough conditioner (E223); acidity regulator (E330); improvers (E1100; 1101); antioxidant (INS319); and synthetic Food colours (E102; 124) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Marie Gold Biscuits
Notes: Product is misbranded under Sec. 403(i)(2) in that the ingredient Statement fails to identify each ingredient by its common or usual name. For example; edible vegetable oils; raising agent; emulsifier (E471); dough conditioner (E223); antioxidant (INS319); and natural & synthetic food colours (E102; 124; 150) are not listed by their common or usual names. Product is further misbranded in that the nutrition label does not provide all of the information required by 21CFR101.9; and is not in the required format. 7/3/06

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Vita Maria Gold Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2) labeling fails to bear an ingredient statement that lists common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted color; antioxidant and edible vegetable oils are not listed by their common or usual names and the sub ingredients are not listed 5/24/04

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Jacob's Thin Arrowroot Biscuits (Britannia Brand)
Notes: Product is misbranded under Sec. 403(i)(2)labeling fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. milk and milk products; dough conditioner; permitted antioxidant; edible color; vegetable oils and edible starches are not listed by their common or usual names and the sub-ingredients are not listed; product is further misbranded because label does not bear nutrition information in the proper format. 5/24/04

Tropicana World Trade Pvt Ltd.
Date Published : 10/02/2015
16/453 Thoppumpady Cochin , Kerala, INDIA
16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

16 Y - - 17 Sauce, seafood (n.e.c.), Fishery Products, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

16 Y - - 99 Fishery Products, N.E.C.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

37 J - - 05 Soy Sauce
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

37 J - - 23 Curry Sauce
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

37 J - - 99 Sauces, n.e.c.
Date Published: 10/02/2015

Desc: Kerala Fish Curry Sauce
Notes: Product is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded in that the declared value for sodium in the Nutrition Facts label does not meet the compliance requirements of 21 CFR 101.9)g)(5). Label declares a 65 g serving contains 240 mg of sodium; analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. 3/31/04

VISNUKUMAR TRADERS PVT LTD
Date Published : 10/02/2015
28a Padur Main Road , Kuthambakkam , Chennai, Tamil Nadu INDIA
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 02 Chocolate Dairy Mix
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 C - - 99 Foods (including Water) with Excessive Nutritional Claims
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 10/02/2015

Desc: Horlicks Drinks
Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

Vijay Sweets
Date Published : 11/30/2017
L - 4 Nr Haripura Bus Stand , Ahmedabad, Gujarat INDIA
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/19/2017

Desc: Halwo
Notes: The Halwo article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b). The statement of identity of the Halwo product is not adequate because it is not in English. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The Halwo article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the label contains information in a foreign language but does not repeat all the required information in the foreign language.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/19/2017

Desc: Sweet Khaja
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. ?343(i)(1)] in that the labels fail to bear the common or usual name of the food as required by 21 CFR 101.3(b). The Sweet Khaja label lacks any statement of identity. The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. ?343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/30/2017

Desc: HALWASAN (WHEAT FLOUR PATTIES COOKED WITH SUGAR)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)], because the products do not have appropriate common or usual names as required by 21 CFR 101.3. Specifically, the names Halvasan and Halvasan Pak are not appropriate common or usual names for a food, and the name Dry Fruit Chips does not appear to accurately describe an almond and pistachio product, which do not appear to contain any fruit. -Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)], because the product labels do not bear the name and place of business of the manufacturer, packer or distributor, as required by 21 CFR 101.7. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], because the product labels do not bear a net quantity of contents statement as required by 21 CFR 101.7.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/30/2017

Desc: HALWASAN PAK (WHEAT FLOUR PATTIES COOKED WITH SUGAR)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)], because the products do not have appropriate common or usual names as required by 21 CFR 101.3. Specifically, the names Halvasan and Halvasan Pak are not appropriate common or usual names for a food, and the name Dry Fruit Chips does not appear to accurately describe an almond and pistachio product, which do not appear to contain any fruit. -Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)], because the product labels do not bear the name and place of business of the manufacturer, packer or distributor, as required by 21 CFR 101.7. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], because the product labels do not bear a net quantity of contents statement as required by 21 CFR 101.7.

23 H - - 99 Mixed Nuts, Shelled, N.E.C.
Date Published: 11/30/2017

Desc: DRYFRUIT CHIPS (Sliced Pistachios and Almonds)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)], because the products do not have appropriate common or usual names as required by 21 CFR 101.3. Specifically, the names Halvasan and Halvasan Pak are not appropriate common or usual names for a food, and the name Dry Fruit Chips does not appear to accurately describe an almond and pistachio product, which do not appear to contain any fruit. -Section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)], because the product labels do not bear the name and place of business of the manufacturer, packer or distributor, as required by 21 CFR 101.7. -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], because the product labels do not bear a net quantity of contents statement as required by 21 CFR 101.7.


INDONESIA


P.T. Star
Date Published : 05/09/2016
Kupang Baru I/71 , Surabaya, ID-JI INDONESIA
07 G - - 08 Tropical/Subtropical Fruit Snacks, Fruit Snack Foods, Baked
Date Published: 05/09/2016

Desc: Gnetum Gnemon Chips
Notes: The articles are subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format; as required by 21 CFR 101.9. In addition; it appears to be misbranded within the meaning of Section 403 (i)(2) in that the labeling fails to bear an ingredient statement as required by 21 CFR 101.4. In addition; it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count in accordance with Section 403(e)(2) of the FD&C Act. In addition; appears to be misbranded within the meaning of Section 403 (e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer; packer; or distributor. In addition; it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word; statement; or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words; statements; designs; or devices; in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. The label contains information in a foreign language but fails to repeat all required information; including the statement of identity; in English in accordance with 21 CFR 101.15 (c)(1).

PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
Date Published : 10/02/2015
Jl. Raya Cimareme 131 Padalarang , Bandung, Jawa Barat INDONESIA
21 T - - 05 Mango, Dried or Paste
Date Published: 10/02/2015

Desc: Mango Slice (Manisan Mangga)
Notes: Product is misbranded within the meaning of section 403(q) of the Act for failing to declare sodium as required by 21 CFR 101.9(c)(4) and trans fat as required by 21 CFR 101.9(c)(2)(ii). Also Vitamin A; Calcium and Iron are incorrectly declared as 0.1%; 0.2% or 1% rectively. 1/28/08

Pt. Mikie Oleo Nabati Industri
Date Published : 01/08/2016
Bojong , 9 Jln. Berlian Raya; KM. , Bekasi, Jabotabek INDONESIA
26 F - - 99 Vegetable Shortening, N.E.C.
Date Published: 01/08/2016

Desc: Bulk Shortening
Notes: The article is subject to refusal of admission pursuant to Section 801(a)3) for the following: “It appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format in accordance with 21 CFR 101.9.” “It appears to be misbranded within the meaning of section 403(i)(1) [21 U.S.C. 343(i)(l)] in that the product label does not contain a statement of identity as required by 21 CFR 101.3.” “It appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example, your product label declares "antioxidant (E319)" and "Emulsifiers (E471, E322)" in the ingredient statement; however, these are not the common or usual names of these ingredients.


ISRAEL


Angel Bakeries
Date Published : 10/02/2015
1 Kaneif Nesharim Stpo Box 201 , Jerusalem, ISRAEL
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

03 J - - 09 Fruit/Fruit Flavored Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

Angel Confectionery Ltd
Date Published : 10/02/2015
Industrial Area , Beit Shemesh, ISRAEL
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ;1.The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically;2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically;3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

03 J - - 09 Fruit/Fruit Flavored Filled/Iced Cookies,Biscuits and Wafers
Date Published: 10/02/2015

Desc: Strawberry Hamantashen
Notes: VIOLATION (IN NOTES); 1. 403(r)(1)(A); 2. 403(i)(2); 3. 403(q) ; 1. The article appears to be misbranded within the meaning of section 403(r)(1)(A) because the label bears an unauthorized nutrient content claim Sugar Free. Specifically; 2. The article appears to be misbranded within the meaning of section 403(i)(2) in that the label or labeling fails to bear required information. Specifically; 3. The article appears to be misbranded within the meaning of section 403(q) in that the label or labeling fails to bear the required nutrition facts information in an appropriate format;

Arza Winery LTD
Date Published : 10/02/2015
Maale Adumim, Yerushalayim , 15, Kharuvit , Ma'ale Adumim, ISRAEL
20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates
Date Published: 10/02/2015

Desc: Grape Juice
Notes: Violation(s): The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the article purports to be a beverage containing fruit or vegetable juice and the label fails to bear a percent juice declaration as required by 21 CFR 101.30. Also, the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the product is false and misleading in that it bears a Natural claim but fails to meet the requirements to bear such claim. FDA has not established a regulatory definition for the term natural; however, the Agency has a long-standing policy that restricts the use of the term ¿natural¿ when a product is formulated with added color, synthetic substances, and flavors as stated in 21 CFR 101.22 (see 58 FR 2407 (January 6, 1993)). Among other things, this policy states that the term natural means that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. This product appears to contain sulfur dioxide, which is listed in the ingredient statement as a preservative. Therefore, the product name can not include the term Natural. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product label does not contain a complete name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

B&H soft drinks ltd
Date Published : 01/23/2019
10, Hamadpisim st , Jerusalem, Jerusalem ISRAEL
29 A - - 04 Soft Drink, Mixed Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 60 Soda Water, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 B - - 11 Soda Water with Fruit Flavor, Carbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

Country Pie
Date Published : 10/02/2015
42, Uruguay , Jerusalem, ISRAEL
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cakes (Chocolate Party Cake)
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cakes (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes (Chocolate Party Cake)
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

Kapulsky
Date Published : 10/02/2015
P.O Box 8172 , Netanya, ISRAEL
03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cake (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E- 415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Cakes Chocolate Party Cake
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes (Black Forest Torte)
Notes: Product is misbranded within the meaning of 403(r)(1)(a) in that the labeling is false. Specifically; the label bears the unauthorized nutrient content claim trans fat-free;In addition; the article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because the sub-ingredients of multi-component ingredients such as non-dairy creamer and sugared cherries are not declared in accordance with 21 CFR 101.4(b)(2);In addition; several ingredients (e.g. gelling agents; cemacao; E-435; E-491; E-471; E-481; E-475; E-415; E-464; E-460; E-466; E-327; E-202) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(l) and the collective declaration of emulsifiers and stabilizers and the parenthetical declaration of acid and preservatives is not permitted as required by 21 CFR 101.4; Lastly; the ingredient statement bears the term sugars. It is not clear whether this is intended to mean sucrose obtained from sugar cane or sugar beets or if it is being used as a collective term for sweeteners from various sources. If it is cane or beet sugar; it must be declared in accordance with 21 CFR 10 1.4(b)(20). The collective declaration of sweeteners from various sources is not permitted as required by 21 CFR 101.4;

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cakes Chocolate Party Cake
Notes: VIOLATION (IN NOTES): 403(r)(1)(A); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(r)(1)(A) because the label bears an undefined nutrient content claim Trans Fat Free. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) in that the label or labeling fails to bear required information. Specifically: 1. The sub-ingredients of multi-component ingredients such as non-dairy creamer, Bittersweet chocolate and Cemacao are not declared in accordance with 21 CFR101.4(b)(2); 2. The term Cemacao is not a common or usual name that is recognized in the U.S. [21 CFR 101.4(a)(1)]; 3. Several ingredients (i.e., Starches E-1422, E-1412, E-1414, E-1442; Vegetable stabilizers E-410, E-415, E-412, E-460(i), E-414, E-401, E-464, E-439) are not declared by their common or usual names in accordance with 21 CFR 101.4(a)(1); 4. Glucose is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(1). Glucose must be declared as either glucose syrup or dried glucose syrup (21 CFR 168.120 or 168.121) depending on the form of the ingredient used; 5. The individual fat and/or oil ingredients shall be declared by its specific common or usual name (i.e., partially hydrogenated vegetable oils (soybean, cottonseed, and palm oils) in accordance with 21 CFR 101.4(b)(14); 6. The term sugars is declared in the ingredient list. If it is cane or beet sugar, it must be declared in accordance with 21 CFR 101.4(b)(20).

Materna Industries, Limited Partnership
Date Published : 10/02/2015
Kibbutz Maabarot , Ma'abarot, IL-NOTA ISRAEL
40 B - - -- Cereal (Baby)
Date Published: 10/02/2015

Desc: Infant Cereal
Notes: Notes;The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 MANUFACTURER; Materna Laboratorios Ltd; 11/12/09

40 B - - -- Cereal (Baby)
Date Published: 07/24/2019

Desc: Infant cereal;
Notes: The label fails to bear nutritional information as required by Section 403(q) of the FD&C Act and 21 CFR 101.9; The label fails to bear an ingredient statement that lists the common or usual name of all ingredients; i.e. minerals; dietary fiber; and vitamins 403(i)(2). 2/5/07 SHIPPER; Maabarot Products Ltd. 10/2/2015

40 N - - 01 Milk Base Formula Product, Ready to Feed
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 N - - 99 Other Formula Products, N.E.C., Ready to Feed
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 O - - 01 Milk Base Formula Product, Liquid Concentrate
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.

40 O - - 99 Other Formula Products, N.E.C., Liquid Concentrate
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients; as required by 21 CFR 101.4.

40 P - - 01 Milk Base Formula Product, Powder Formula
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 P - - 99 Other Formula Products, N.E.C., Powder Formula
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

40 Y - - 99 Baby and Junior Food N.E.C.
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ¿ 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ¿ 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

41 G - - 01 Nutritionally Complete Formulations
Date Published: 10/02/2015

Desc: Materna Mehadrin Stage 3 Toddler Formula 1 yr and up
Notes: VIOLATION (IN NOTES); 403(q); 403(i)(2) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(q) of the Act [21 U.S.C. ? 343 (q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. AND The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that it is fabricated from two or more ingredients; but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub- ingredients; as required by 21 CFR 101.4.

Ramat Hagolan Dairies LTD
Date Published : 01/23/2019
Industrial Zone , Ta Do'ar 95 , Katsrin, ISRAEL
29 A - - 04 Soft Drink, Mixed Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 60 Soda Water, Noncarbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 B - - 11 Soda Water with Fruit Flavor, Carbonated
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/23/2019

Desc: EasyDrink Coffee Flavored Beverage
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive): 403(i)(2) because the label fails to declare the common or usual name of each ingredient (for example, the ingredient statement lists, "vitamins and minerals", but fails to list each vitamin and mineral added to the product); 403(q) in that the nutrition information does not comply with the requirements in 21 CFR 101.9 (for example, failure to declare serving size in common household measure and failure to list the servings per container); 403(r)(1)(A) in that the product promotional website, www.easyline.co.il, bears unauthorized nutrient content claims (for example, the website claims, "Contains 91% canola oil, which is rich in monounsaturated fatty acids", but a product must contain 20% or more of the RDI or DRV of the nutrients that are subject to the claim to bear the term "rich in"; however, an RDI or DRV has not been established for monounsaturated fatty acids).


ITALY


AZIENDA AGRICOLA MALVIRA
Date Published : 10/02/2015
Case Sparse 144 , Canale, Cuneo ITALY
32 B - - 02 Wine, Red (Still)
Date Published: 10/02/2015

Desc: Malvira Red Birbet Wine
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. ?343(q)] because they lack nutrition information as required by 21 CFR 101.9. The products are diluted wine products with alcohol content of less than 7% and their manufacturers are not exempted under the Small Business Nutrition Labeling Exemption.

Azienda Agricola Vigin
Date Published : 10/02/2015
Via Meruzzano 32a , Treiso, Cuneo ITALY
32 B - - 01 Wine, White (Still)
Date Published: 10/02/2015

Desc: Virgin Primadonna Moscato d Asti
Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Act in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] because they lack nutrition information as required by 21 CFR 101.9. The products are diluted wine products with alcohol content of less than 7% and their manufacturers are not exempted under the Small Business Nutrition Labeling Exemption.

COREX
Date Published : 02/02/2017
Zona Industriale Snc , Battipaglia, Salerno ITALY
04 A - - 05 Spaghetti
Date Published: 02/02/2017

Desc: Tri Colored Fusilli Springs
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is less than the standard of identity for enriched macaroni products; 03/06/2015 ;

04 A - - 99 Macaroni and Spaghetti Products,N.E.C.
Date Published: 02/02/2017

Desc: Tri Colored Fusilli Springs
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is less than the standard of identity for enriched macaroni products; 03/06/2015

Cascina la Ghersa
Date Published : 10/02/2015
Regione Chiarina 2 , Moasca, Asti ITALY
32 B - - 01 Wine, White (Still)
Date Published: 10/02/2015

Desc: Giorgia Moscato D'asti White Wine
Notes: VIOLATIONS 403(q) AND 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the label fails to provide nutrition labeling (?Nutrition Facts? panel) which is required under 21 CFR 101.9 and the firm is not exempt from this requirement. 2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the act because there is no designation of ingredients on the product label in accordance with 21 CFR 101.4.

IRC WILLIAM DI CARLO SRL
Date Published : 10/02/2015
Viale del Lavoro 15 17 , Sulmona, L Aquila ITALY
34 C - - 02 Chocolate Candy Pieces, with Nuts or Nut Products (not Coconut)
Date Published: 10/02/2015

Notes: (Sugared Nuts) Product is misbranded under Section 403(q) in that the labeling (Nutrition Facts Panel) does not comply with nutritional labeling format requirements (21 CFR 101.9(d)); does not list the net quantity of contents (21 CFR 101.105); and all required statements; such as the statement of identity are not in both Italian and English (21 CFR 101.15(c)) NOTE; this product is also indicated for detention because its labeling fails to declare the presence of the major food allergen

Norda Spa
Date Published : 07/03/2018
Via Roncale 1 , Lecco, Lecco ITALY
29 R - - 05 Mineral Water, Noncarbonated (Nonmedicinal)
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Mossa)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

29 R - - 05 Mineral Water, Noncarbonated (Nonmedicinal)
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Ferma)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Mossa)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

29 W - - 02 Bottled Spring or Mineral Water
Date Published: 07/03/2018

Desc: SanFermo Mineral Water (Ferma)
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(g)(1) as the product is represented as the standardized food 'mineral water'; but does not appear to meet the standard for total dissolved solids; 403(q) as the product label fails to list the required nutrition information (i.e. Nutrition Facts statement); 403(e)(2) as the product label fails to declare the net quantity of contents on the principal display panel and fails to list the net contents in US measurements; 403(f) as the product label is predominately in a foreign language and lacks an English translation.

PHARMA GREEN S.R.L.
Date Published : 01/08/2018
Strada Degli Angariari,25 , Falciano, ITALY
54 C - - 02 L-Arginine (Protein)
Date Published: 01/08/2018

Desc: MASC Supplement
Notes: 4039(i)(2) - Failure to list ingredients and common names. 403(q) - Failure to list a supplement facts panel. 403(s)(2)(b) - Failure to declare dietary supplement 403(y) - Failure to list a domestic address or phone number on label.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/20/2018

Desc: CEP Food Supplement
Notes: The article appears to be misbranded within the meaning of the following sections of the Act; 403(i)(2) product label fails to declare common name of each ingredient (i.e. color ingredients listed by E-number); 403(q)(5)(F) product label fails to list the required nutrition information within a supplement facts label; 403(y) product label fails to bear a domestic address or phone number through which reports of serious adverse events can be made; 403(i)(1) and 403(s)(2)(B) product label fails to identify the product using the term "dietary supplement"; 403(r)(6) product label makes structure/function claims but fails to bear dietary supplement disclaimer.

Pastificio Fabianelli S.P.A.
Date Published : 02/02/2017
Via Sant'Antonino No. 107 , Castiglion Fiorentino, Arezzo ITALY
04 A - - 01 Macaroni Enriched
Date Published: 04/12/2019

Desc: MEZZI RIGATONI TRADITIONAL CUT
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: Spaghetti Bronze Cut
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: Cavatappi Traditional Cut
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: Fettuccine Nests Bronze Cut
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

04 A - - 05 Spaghetti
Date Published: 04/12/2019

Desc: MEZZI RIGATONI TRADITIONAL CUT
Notes: The article appears to be misbranded within the meaning of the following sections of the FD&C Act (examples are not all inclusive):403(r)(1)(A) in that the labels bear implied "high protein" nutrient content claims but the foods do not meet the requirements to bear these claims in accordance with 21 CFR 101.54(b). Specifically, the labels bear the claim "Alma's pasta is produced . . . using high protein 100% Italian durum wheat semolina . . ." which is an implied claim for the entire food. However, the labels declare 7 g of protein per serving (56 g) which does not amount to at least 20% of the DRV for protein (7/50*100=14%) per RACC (55 g).; 403(q) in that the nutrition information (e.g. Nutrition Facts label) does not comply with 21 CFR 101.9(c)(7). Specifically, the labels bear nutrient content claims for protein. However, the nutrition labels do not declare a statement of the corrected amount of protein per serving, as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value.

Pastificio Gallo Natale E. F. LLI
Date Published : 02/02/2017
Via Albert Einstein 3 , Mazara del Vallo, Trapani ITALY
04 A - - 01 Macaroni Enriched
Date Published: 04/02/2018

Desc: Fusilli Coti Col Buco
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products.

Pastificio Riscossa - F.ill Mastromauro spa
Date Published : 02/26/2015
Strada Statale 98 Km 48,360 , Corato, Bari ITALY
04 A - - 01 Macaroni Enriched
Date Published: 02/02/2017

Desc: Penne Zite Rigate
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is below the standard of identity for enriched macaroni products; 12/19/2014

04 A - - 05 Spaghetti
Date Published: 02/26/2015

Desc: Enriched Linguine Product
Notes: PROBLEM- Iron less than label declared

04 C - - 01 Noodles, Chow Mein
Date Published: 02/02/2017

Desc: Italian Pasta Penne Zite
Notes: The product appears to be misbranded within the meaning of; Section 403(g)(1) of the Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard; % Iron is above the standard of identity for enriched macaroni products; 01/08/2016

Rebecchi Fratelli Valtrebbia S.P.A.
Date Published : 06/30/2015
Via Giuseppe Ungaretti 7 , Rivergaro, Piacenza ITALY
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/30/2015

Desc: mini macaroons
Notes: Mini Macaroons product is misbranded within the meaning of section 403(i) (2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4. For example; the ingredient armelline is not declared by its common or usual name in accordance with 21 CFR 101.4(a) (l). Additionally; the leavening agents E500 and E503 are declared as European numbers and not their common or usual ingredient names in accordance with 21 CFR 1 01. 4(b )( 16). The article is subject to refusal of admission pursuant to FDA’s food labeling regulations in Section 21 CFR Part 101 (21 CFR Part 101). Based on the firm’s failure to comply with 21 CFR Part 101, the labels appear to be misbranded within the meaning of Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Published on 07/14/2015

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/30/2015

Desc: mini macaroons
Notes: Mini Macaroons product is misbranded within the meaning of section 403(i)(2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4. For example; the ingredient armelline is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(l). Additionally; the leavening agents E500 and E503 are declared as European numbers and not their common or usual ingredient names in accordance with 21 CFR 1 01. 4(b )( 16).

03 U - - 01 Icing and Icing Mixes Without Chocolate or Nuts
Date Published: 10/09/2015

Desc: Mix for Custard Cream Cold-Preparation
Notes: The article is subject to refusal of admission pursuant to FDA?s food labeling regulations in Section 21 CFR Part 101 (21 CFR Part 101). Based on the firm?s failure to comply with 21 CFR Part 101; the labels appear to be misbranded within the meaning of Section 403(q) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. ? 343]. Published on 07/14/2015

03 U - - 99 Icings And Icing Mixes, N.E.C.
Date Published: 06/30/2015

Desc: silver pearls
Notes: Silver Pearls are misbranded within the meaning of section 403(e)(1)-ofthe Act [21 U.S.C. 343(e)(1)] in that the product label does not contain the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5 (a). The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer; packer; or distributor. The article is subject to refusal of admission pursuant to FDA’s food labeling regulations in Section 21 CFR Part 101 (21 CFR Part 101). Based on the firm’s failure to comply with 21 CFR Part 101, the labels appear to be misbranded within the meaning of Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Published on 07/14/2015

03 U - - 99 Icings And Icing Mixes, N.E.C.
Date Published: 06/30/2015

Desc: mix for custard cream cold-preparation-CREMA PASTICERRA CUSTARD
Notes: Mix for Custard Cream Cold-Preparation product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.105(b)(l). For example; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "2x70g=140g"). Further; if your product is a multiunit retail package; which it appears to be; a statement of the quantity of contents shall appear on the outside of the package and shall include the number of individual units; the quantity of each individual unit; and; in parentheses; the total quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces in accordance with 21 CFR 101.1 05( s ). We also note that the net quantity of contents declaration does not appear on the principal display panel (PDP) as required by 21 CFR 101.105(a).

21 D - - 02 Citrus, Mixed, Juices or Concentrates
Date Published: 06/30/2015

Desc: orange blossom water
Notes: Orange Blossom Water product is misbranded within the meaning of section 403(i)(2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(l). Specifically; the preservative E211 is declared as a European number and not its common or usual ingredient name (i.e.; sodium benzoate). Further; the ingredient "essence of flowers" is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(l). Orange Blossom Water product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.1 05(b )(2). Specifically; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "85ml").

28 O - - 99 Essential Oils for Flavoring, n.e.c.
Date Published: 06/30/2015

Desc: Orange Blossom Water
Notes: Orange Blossom Water product is misbranded within the meaning of section 403(i)(2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(l). Specifically; the preservative E211 is declared as a European number and not its common or usual ingredient name (i.e.; sodium benzoate). Further; the ingredient "essence of flowers" is not declared by its common or usual name in accordance with 21 CFR 101.4(a)(l). Orange Blossom Water product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e) (2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.1 05(b )(2). Specifically; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "85ml").

35 C - - 99 Custard Pudding (Pie) Mix, N.E.C.
Date Published: 06/30/2015

Desc: mix for custard cream cold-preparation-CREMA PASTICERRA CUSTARD
Notes: Mix for Custard Cream Cold-Preparation product sold to individual customers is misbranded within the meaning of section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the product label does not provide an accurate statement of the quantity of contents in terms of weight in the U.S. customary system of ounces; pounds; or fluid ounces as required by 21 CFR 101.105(b)(l). For example; the label collected at the time of inspection declares the net weight only in metric units (i.e.; "2x70g=140g"). Further; if your product is a multiunit retail package; which it appears to be; a statement of the quantity of contents shall appear on the outside of the package and shall include the number of individual units; the quantity of each individual unit; and; in parentheses; the total quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces in accordance with 21 CFR 101.1 05( s ). We also note that the net quantity of contents declaration does not appear on the principal display panel (PDP) as required by 21 CFR 101.105(a).

Spumador Spa
Date Published : 10/02/2015
Via Alla Fonte 13 , Cadorago, CO ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Orange Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Cranberry Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).

Spumador Spa
Date Published : 10/02/2015
Via Dordone 43vimodrone , Felegarafelegara, ITALY
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Orange Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Venga Calorie Burn Cranberry Flavor
Notes: VIOLATION (IN NOTES): 1. 403(q)(5)(F) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q)(5)(F) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.36 (e.g., The amounts of vitamins included in one serving of the product are not declared and "zero" amounts of nutrients are listed in the "Supplement Facts" panel).


JAPAN


BEST LINKAGE
Date Published : 03/14/2017
876-1 , Nakaishiki; Inami-Cho , Kako-Gun, Hyogo JAPAN
33 L - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 03/14/2017

Desc: Jelly Candy (Kuru Kuru Bozu Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages.

33 M - - 01 Gel Cups, Fruit Flavored
Date Published: 03/14/2017

Desc: Jelly Candy (Kuru Kuru Bozu Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages.

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 03/14/2017

Desc: Jelly Candy (Kuru Kuru Bozu Jelly)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages.

DR.BAELTZ CO.,LTD
Date Published : 10/02/2015
2 Chome 3-23 , Senzui , Asaka, Saitama JAPAN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 10/02/2015

Desc: Puerafica Anti-Aging Supplement
Notes: VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling (Supplement Facts panel) in the proper format, which is required under 21 CFR 101.36. For example: The caloric content is expressed in kcal rather than Calories. The Percent Daily Value for dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) are not declared. Specifically, the product does not list the percent daily values for Vitamin A, Vitamin C, Vitamin D, Vitamin E, thiamin(Vitamin B1), niacin (Vitamin B3), folate (folic acid), Vitamin B12, pantothenic acid as required by 21 CFR 101.36(b)(2)(iii). The quantitative amount by weight per serving for each dietary ingredient are not declared as required by 21 CFR 101.36(b)(2) and 101.36(b)(3). The correct nomenclature for some of the dietary ingredients is not declared, as required by 21 CFR 101.36(b)(2)(B). For example, niacin is incorrectly listed as nicotinamide. The dietary ingredients are not listed in the proper order. Specifically, Vitamin B6, Vitamin E, sodium, Vitamin C, niacin, pantothenic acid, thiamin, folic acid, Vitamin B12, Vitamin A, and Vitamin Dare not in the correct order, as required by 21 CFR 10 1.36(b )(2)(i)(B).

Japan Bio Science Laboratory Co Ltd
Date Published : 06/11/2019
1159 , Naka Hozumi Ibaraki Shi , Osaka, JAPAN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/11/2019

Desc: ORGANIC ASHITABA AOJIRU
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the nutrition information (Nutrition Facts label) on the product label is not in accordance with 21 CFR 101.9. 403(i)(2) in that the product label lists the ingredient "stevia." The term "stevia" is not a common or usual name for a food ingredient. 403 (r)(1)(A) because the product labeling bears nutrient content claims, but the product does not meet the requirements to make such claims. 403 (e)(2) for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce 403(f) because the product label contains information in two languages but does not repeat all the required information in both languages.

Maruto Seika Co., LTD
Date Published : 10/02/2015
Nakatsuhara 1532 , Miyuki-Cho , Fukuyama, Hiroshima JAPAN
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 N - - 01 Cake,Custard or Cream Filled
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Butter cake) K019
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #62106
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is manufactured using starch according to the formulation; however; you fail to list this ingredient on your finished product label. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8) (i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #639735
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Butter cake #62106
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is manufactured using starch according to the formulation; however; you fail to list this ingredient on your finished product label. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8) (i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cake (Maruto Butter cake) K019
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Butter cake #639735
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii). ;

03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 61 Cheese Cake
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 R - - 61 Cheese Cake
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 R - - 61 Cheese Cake
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #639735
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods.This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #639734
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Cheese cake) #K009
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Butter cake) #F126007
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Wheat cake (Cheese cake) #F126006
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Butter cake #62106
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; soy lecithin; and spices according to the formulation; however; you fail to list these ingredients on your finished product labels. This product labels declare artificial flavor; however; the ingredient appears to be spices. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is manufactured using starch according to the formulation; however; you fail to list this ingredient on your finished product label. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8) (i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cake (Maruto Butter cake) K019
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels declare a serving size of 30g; however; they do not meet the requirements in 21 CFR 101.9(b)(2)(ii). There is no provision in 21 CFR 101.12(b); Table 2 for a 30g reference amount customarily consumed for cakes. This product labels fail to declare an appropriate visual unit of measure for the serving size as required by 21 CFR 101.9(b)(5)(iii).

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 10/02/2015

Desc: Cheese cake #62104
Notes: This product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label; as required by 21 CFR 101.4. This product is manufactured using eggs; however; you fail to list this ingredient on your finished product label. This product is manufactured using margarine; cream cheese; cheese; and baking powder; however; you fail to list all the sub-ingredients on your finished product labels. We note that margarine and cream cheese are standardized foods. This product is misbranded within meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. This product labels fail to declare the serving size in a common household measure or an appropriate visual unit of measure as required by 21 CFR 101.9(b)(5) and 101.9(b)(7); the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i); and fails to list the full footnote as required by 21 CFR 101.9(d)(9).

Mirei International
Date Published : 10/02/2015
92-24 , Oazaanse; Wakamatsu , Kitakyushu, Fukuoka JAPAN
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 10/02/2015

Desc: Inner 7
Notes: The product appears to be misbranded because the label fails to identify the product as a dietary supplement or some other appropriately descriptive name; (2) the label contains information in two languages but does not repeat all the required label information in both languages and (3) the label fails to declare the common or usual name of each ingredient; Specifically; Deep Ocean Salt Water is not an appropriate common or usual name for water.

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

Desc: Inner 7
Notes: The product appears to be misbranded because the label fails to identify the product as a dietary supplement or some other appropriately descriptive name; (2) the label contains information in two languages but does not repeat all the required label information in both languages and (3) the label fails to declare the common or usual name of each ingredient; Specifically; Deep Ocean Salt Water is not an appropriate common or usual name for water.

NAGAYAMA FOODS FACTORY CO.,LTD.
Date Published : 03/10/2015
NO.1-15-17, MATSUSHIMA, , HIGASHIKU, , Fukuoka-shi, Fukuoka-ken JAPAN
25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 03/10/2015

Desc: Pickled Takana (kizami Takanaduke)

25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 03/10/2015

Desc: Pickled Vegetable (Fukujinduke)

25 J - - 27 White Radish (Root & Tuber Vegetable)
Date Published: 03/10/2015

Desc: Pickled Radish (Kizami Tsuboduke)

Ohori Co. Ltd.
Date Published : 12/03/2015
4447 , Ashio-Machi , Nikko, Tochigi JAPAN
25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 12/03/2015

Desc: Edible Wild Plants
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Edible Wild Plants" product fails to declare: - the specific food source from which the protein, “Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. The "Edible Wild Plants" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Edible Wild Plants" product is misbranded within the meaning of section 403(i) (l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 J - - 14 Turnip (Root & Tuber Vegetable)
Date Published: 12/11/2015

Desc: Prepared Tsatasi
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Prepared Tsatasi" product fails to bear/declare: - the sub-ingredients for the Umami Seasoning, which is a multi- component ingredient; - the specific food source from which the protein, “Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. - the common or usual name of the specific "vegetable" to be identified in parenthesis, e.g., "vegetable oil (soybean)," as required by 21 CFR 101.4(b)(l4). The "Prepared Tsatasi" product bear: - "sweetener" as an ingredient, which is not an appropriate common or usual name as required by 21 CFR 10 1.4(b ), in that the name of the ingredient must be a specific name and not a collective (generic) name. The "Prepared Tsatasi" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Prepared Tsatasi" product is misbranded within the meaning of section 403(i) (l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 J - - 22 Burdock, Gobo (Root & Tuber Vegetable)
Date Published: 12/03/2015

Desc: Burdock Salada
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The formulation sheet for the "Burdock Salada" product lists water, "IG," citric acid, malic acid, "SK-CR," disodium glycyrrhizinate, "fureshu," and mayonnaise as ingredients; however, these ingredients are not listed in the ingredient statement. The sub-ingredients for the mayonnaise, which is incorrectly declared as "semi solid dressing" in the ingredient statement and the sub-ingredients of some of the other ingredients on the formulation sheet are not properly declared. The "Burdock Salada" product fails to declare: - the specific food source from which the protein, “Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. The "Burdock Salada" product bear: - "sweetener" as an ingredient, which is not an appropriate common or usual name as required by 21 CFR 10 1.4(b ), in that the name of the ingredient must be a specific name and not a collective (generic) name. The "Burdock Salada" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Burdock Salada" product is misbranded within the meaning of section 403(i)(l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 Q - - 99 Mushrooms and Other Fungi Products, Pieces and Stems, Sliced, N.E.C.
Date Published: 12/03/2015

Desc: Chinese Yama Kurage
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Chinese Yama Kurage" product fails to bear/declare: - the sub-ingredients for the Umami Seasoning, which is a multi- component ingredient; - the sub-ingredients for the Soy Sauce, which is a multi-component ingredient; - the specific food source from which the protein, “Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22; - the common or usual name of the specific "vegetable" to be identified in parenthesis, e.g., "vegetable oil (soybean)," as required by 21 CFR 101.4(b)(l4). The "Chinese Yama Kurage" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The "Chinese Yama Kurage" product is misbranded within the meaning of section 403(i)(l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

25 Q - - 99 Mushrooms and Other Fungi Products, Pieces and Stems, Sliced, N.E.C.
Date Published: 12/11/2015

Desc: Pickled Nozawana
Notes: This product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 10 1.4(b )(2). The "Pickled Nozawana" product fails to bear/declare: - the sub-ingredients for the Umami Seasoning, which is a multi- component ingredient; - the specific food source from which the protein, “Hydrolyzed Vegetable Protain [sic}," was derived for the hydrolyzed vegetable protein, as required by 21 CFR 1 02.22. - the common or usual name of the specific "vegetable" to be identified in parenthesis, e.g., "vegetable oil (soybean)," as required by 21 CFR 101.4(b)(l4). The "Pickled Nozawana” product bear: - "sweetener" as an ingredient, which is not an appropriate common or usual name as required by 21 CFR 10 1.4(b ), in that the name of the ingredient must be a specific name and not a collective (generic) name. The "Pickled Nozawana" product is misbranded within the meaning of section 403( q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition labeling ("Nutrition Facts" panel), which is required under 21 CFR 1 01 .9, and they are not exempt from this requirement. The " Pickled Nozawana" product is misbranded within the meaning of section 403(i) (l) of the Act [21 U.S.C. § 343(i)(l)] in that the labels do not bear an appropriate common or usual name of the food or an appropriately descriptive term, if there is none, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food, as required by 21 CFR 101.3(b).

SANKOUFOODS CO.,LTD
Date Published : 12/02/2016
Ma2204 , Noma; Shodoshima-Cho , Shozu-Gun, Kagawa JAPAN
16 E - - 02 Clams
Date Published: 12/02/2016

Desc: Clams with Garlic Tsukudani
Notes: Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c) (2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6) (ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1) (iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas;

16 E - - 02 Clams
Date Published: 12/02/2016

Desc: Asari Clams Tsukudami
Notes: Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c)(2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6)(ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1)(iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas;

TAANE
Date Published : 12/10/2015
Nakano Miyagino , 5chome-7-15; Nakano; Miyagino , Sendai, Miyagi JAPAN
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 12/10/2015

Desc: Active Hydride Plasma
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3)for the following: It appears to be misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The “Suggested use” states to take 2-6 capsules daily and the Serving Size is identified as 3 capsules. It appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically, the label lists a “Proprietary blend” but fails to list all of the ingredients of the blend. It appears to be misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count on the principal display panel as required by 21 CPR 101.105. It appears to be misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. It appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages, as required by 21 CFR 101.15(c).

TOWANI CO LTD
Date Published : 02/12/2018
Shinko 723-1 , Shinkonishi , Ishikari, Hokkaido JAPAN
24 K - - 01 Egg Plant, with Sauce
Date Published: 02/12/2018

Desc: Soy Marinated Eggplant
Notes: The product appears to be misbranded within the meaning of: (1) Section 403(q) of the Act [21 U.S.C. §343(q)] because the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. (2) Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because each ingredient is not declared in accordance with 21 CFR 101.4. (3) Section 403(k) of the Act [21 U.S.C. §343(k)] in that the product contains a chemical preservative but does not bear labeling stating that fact as required by 21 CFR 101.22(j). Specifically, the product declares the ingredient “Sodium Nitrite” but fails to include its function.

UHA Mikakuto Co.,Ltd.
Date Published : 10/07/2015
137-5 , Imago-Cho , Yamatokoriyama, Nara JAPAN
33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 10/07/2015

Desc: Uha Puccho Stick Grape
Notes: Product is misbranded within the meaning of Section 403(k) of the FD&C Act in that the food bears or contains artificial flavoring, artificial coloring, or chemical preservatives but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act(specify flavoring, coloring, or preservative). [Misbranding, Section 403(k)]

33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 10/07/2015

Desc: Uha Puccho Stick Nama Muscat
Notes: Product is misbranded within the meaning of Section 403(k) of the FD&C Act in that the food bears or contains artificial flavoring, artificial coloring, or chemical preservatives but does not bear labeling stating that fact, unless exempt in accordance with Section 403(k) of the FD&C Act(specify flavoring, coloring, or preservative). [Misbranding, Section 403(k)]

YAMAKI SHOKUHIN CO.,LTD.
Date Published : 03/24/2015
258 , Kamiyama; Nishi , Niigata, Niigata JAPAN
25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish (Hitokuchi Shoyu Takuan)

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish (Hitokuchi Ume Katsuo Takuan)

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish by Salt (Hitokuchikiri Takuan)

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/24/2015

Desc: Pickled Radish (Hitokuchi Miso Daikon)

Yamasanshokuhin
Date Published : 03/10/2015
2 Chome 7-15 , Yahara , Nerima, Tokyo JAPAN
25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 03/10/2015

Desc: Pickled Radish (Tokyo Takuan Semi Half); Pickled Radish (Tokyo Takuan Mini Half) ;
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act[21 U.S.C.§ 343(i)(2) because they fail to list the ingredients noted in the original labeling. Further, some of these ingredients, such as amino acid and antioxidant, do not appear to be declared by an appropriate or common usual name. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act[21 U.S.C.§ 343(q) in that the nutrition information is not provided as required by 21 CFR 101.9. Published on 03/10/2015

Yamayoshi Shokuhin Kogyo
Date Published : 03/13/2015
4 Chome 11-8 , Nishioizumi , Nerima, Tokyo JAPAN
25 J - - 27 White Radish (Root & Tuber Vegetable)
Date Published: 03/13/2015

Desc: Pickled Radish (Nerimanokaori Nerimatakuan)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they fail to list the ingredients noted in the original labeling. Further; the sub-ingredients for the soy sauce are not included in either the original Japanese label or on the stick-on English label. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. ? 343(q)] in that the nutrition information is not provided as required by 21 CFR 101.9. Published on 03/13/2015


JORDAN


Levant Food Products Company Ltd.
Date Published : 10/06/2017
AL-HASSAN Industrial Estate , AL-MAFRAQ st. Block#9 Sections 1,2,3 4 , Al-hasan Industrial City P. O, Irbid JORDAN
02 F - - 07 Wheat, Milled (Crushed, Coarse Ground or Cracked)
Date Published: 10/06/2017

Desc: GREEN GROUNDED FRIKE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of; Section 403(f) of the FD&C Act in that the label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food; if any there be. Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts; Supplement Facts; and serving size information). [Misbranded; Section 403 (q)].


KOREA, REPUBLIC OF (SOUTH)


BIO PORT KOREA,INC.
Date Published : 04/06/2015
#304 MARINE BIOTECHNOLOGY CENTER SAN1-1, , GWAEBOP-DONG , Sasang-gu, PUSAN KOREA, REPUBLIC OF (SOUTH)
54 D - - -- Unconv Diet Spec (No Vit/Min Stmt)
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor. ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor. ;

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: Problem(s); The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor. ;

Bioport Korea, Inc.
Date Published : 04/06/2015
#207 Marine Bio-industry , development center, 27 Hoenggye-ri , Ilgwang-myeon Gijang-gun, PUSAN KOREA, REPUBLIC OF (SOUTH)
54 D - - -- Unconv Diet Spec (No Vit/Min Stmt)
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                             

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                                ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                               

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/06/2015

Desc: Pine Needle Extract
Notes: The label or labeling fails to identify the product by using the term "dietary supplement". The product label fails to include a supplement facts panel. The product label fails to declare the net quantity of contents on the principal display panel. The product label contains information in two languages; but does not repeat all the required information in both languages. The product label fails to list the name and place of business of the manufacturer; packer; or distributor.                                                                                                                                                                                                                                                                             ;

Busan Fishcake Co. Ltd
Date Published : 08/14/2019
69-25 Junam-ro , Yangsan-si, Gyeongsangnam-do KOREA, REPUBLIC OF (SOUTH)
37 J - - 99 Sauces, n.e.c.
Date Published: 08/14/2019

Desc: Cheddar Cheese Sauce
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the products fail to declare all ingredients for mayonnaise in accordance with 21 CFR 101.4. Mayonnaise is a multi-component ingredient and product labels fail to declare all sub-ingredients. "high fructose" and "sodium di-tiadate" are not appropriate common or usual names. Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] Product bears the term "Cheese Sauce" in the name but fails to contain or be cheese, thereby rendering the labeling false and misleading.

CHEONGJUNGNARU FOOD
Date Published : 10/02/2015
316-1 SONGDAE-RI OCHANG-MYEON , CHEONGWON-GUN CHUNGBUK PROVINCE , Chungcheongbukdo, KR-43 KOREA, REPUBLIC OF (SOUTH)
16 E - - 02 Clams
Date Published: 10/02/2015

Desc: Salted Clams; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08

16 E - - 03 Oysters
Date Published: 10/02/2015

Desc: Salted Seasoned Oyster; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.

16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Salted Clams; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d). 3/4/08

16 X - - 32 Oysters, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/02/2015

Desc: Salted Seasoned Oyster; Frozen
Notes: Product is misbranded within the meaning of Section 403 in that the labeling (Nutrition Facts panel) does not comply with format requirements of 21 CFR 101.9(d) 3/4/08 NOTE; The oyster product is also indicated for detention in that the ingredient statement declares ingredients not found in the product per the manufacturing process statement [Section 403(a)(1)]. The label declares Millet Jelly; Garlic; and Ginger; but Salt and Red Pepper Powder are the only ingredients added in the manufacturing statement.

DONG LIM TRADING
Date Published : 11/10/2016
9 JIN-NAM-RO-572-BEON-GIL , PUSAN-JIN-GU , PUSAN, KR-26 KOREA, REPUBLIC OF (SOUTH)
29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 11/10/2016

Desc: Sweet Fruit Drink Apple
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) for the following: It appears to be misbranded within the meaning of Section 403(c)(f) of the Food, Drug, & Cosmetic Act (the Act) [21 U.S.C. § 343(e)(1)] in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. It appears to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c) (2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). Specifically, the single product unit containers do not contain all information in both English and the foreign language(s). Other labeling violations were also noted as follows; The principal display panel of a food in a package form shall bear as one of its principal features a statement of the identity of the commodity in accordance with 21 CFR 101.3(a). It appears the statement of identity on the label applied to the outer plastic shrink wrap covering of the multiunit package, Sweet Fruit Drink (Apple), and the one on the single product unit containers, Demi Soda Apple, are different.

Daedong Korea Ginseng Co., Ltd.
Date Published : 10/22/2015
Gunbuk-myun , 586 Gunbuk-ro , Geumsan-gun, Chungcheongnam-do KOREA, REPUBLIC OF (SOUTH)
25 M - - 31 Ginseng, Juice or Drink (Root & Tuber Vegetable)
Date Published: 10/22/2015

Desc: Korean Red Ginseng Extract Gold
Notes: View case for multiple labeling violations including but not limited to; The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare a serving size in a common household measure as required by 21 CFR 101.9(b)(7). The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii).

25 M - - 31 Ginseng, Juice or Drink (Root & Tuber Vegetable)
Date Published: 10/22/2015

Desc: Korean Red Ginseng Extract Liquid
Notes: View case for multiple labeling violations including but not limited to; The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare a serving size in a common household measure as required by 21 CFR 101.9(b)(7). The Korean Red Ginseng Extract Gold and Korean Red Ginseng Extract Liquid product labels fail to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii).

Farmers Guild's Corps. Cheongmaesil
Date Published : 03/23/2015
55 Jimag1-Gil , Daap-Myeon , Gwangyang, Jeonranam KOREA, REPUBLIC OF (SOUTH)
21 H - - 14 Plum, Dried or Paste
Date Published: 03/23/2015

Desc: Plum Concentration Gold product (330 g)
Notes: Plum Concentration Gold product (330 g) appears to be sold as a gift set but the label fails to provide the total quantity of contents on the PDP; as required by 21 CFR 101.105(s);HongSsangRi CheongMaeSilWon plum beverage products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they contain some form of plum pulp, puree, juice, or concentrate, but the labels do not contain declarations of the percentage of juice in the products, as required by 21 CFR 101.30(a); Published on 03/24/2015

21 H - - 14 Plum, Dried or Paste
Date Published: 03/23/2015

Desc: HongSsangRi CheongMaeSilWon (undiluted solution of plum)
Notes: HongSsangRi CheongMaeSilWon (undiluted solution of plum) 63.76 fl. oz. product is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. The product is represented for use as a conventional food; however; the label falsely identifies the product as a dietary supplement. HongSsangRi CheongMaeSilWon plum products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the labels fail to bear a statement of identity on the Principal Display Panel (PDP); in accordance with 21 CFR 101.3(a) and (d). HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)] because the products fail to completely or accurately declare the place of business; street address; city; state and zip code as required by 21 CFR 101.5. HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the outer container for your products sold to individual customers does not provide the net quantity of contents in terms of the U.S. customary system of measurement; as required under 21 CFR 101.105(a). HongSsangRi CheongMaeSilWon plum products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because your product labels contain information in two languages but do not repeat all the required label information in both languages; HongSsangRi CheongMaeSilWon (undiluted solution of plum) beverage products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; Published on 03/24/2015

21 K - - 14 Plum, Juice, Pit Fruit Juices or Concentrates
Date Published: 03/23/2015

Desc: Plum Concentration Gold product (330 g)
Notes: Plum Concentration Gold product (330 g) appears to be sold as a gift set but the label fails to provide the total quantity of contents on the PDP; as required by 21 CFR 101.105(s);Plum Concentration Gold product (330 g) Notes:HongSsangRi CheongMaeSilWon plum beverage products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they contain some form of plum pulp, puree, juice, or concentrate, but the labels do not contain declarations of the percentage of juice in the products, as required by 21 CFR 101.30(a). Published on 03/24/2015

21 K - - 14 Plum, Juice, Pit Fruit Juices or Concentrates
Date Published: 03/23/2015

Desc: HongSsangRi CheongMaeSilWon (undiluted solution of plum)
Notes: HongSsangRi CheongMaeSilWon (undiluted solution of plum) 63.76 fl. oz. product is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. The product is represented for use as a conventional food; however; the label falsely identifies the product as a dietary supplement. HongSsangRi CheongMaeSilWon plum products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the labels fail to bear a statement of identity on the Principal Display Panel (PDP); in accordance with 21 CFR 101.3(a) and (d). HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)] because the products fail to completely or accurately declare the place of business; street address; city; state and zip code as required by 21 CFR 101.5. HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the outer container for your products sold to individual customers does not provide the net quantity of contents in terms of the U.S. customary system of measurement; as required under 21 CFR 101.105(a). HongSsangRi CheongMaeSilWon plum products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because your product labels contain information in two languages but do not repeat all the required label information in both languages;HongSsangRi CheongMaeSilWon (undiluted solution of plum) beverage products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343 (q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9; Published on 03/24/2015

30 B - - 05 Beverage Base, Pit Fruit, Liquid
Date Published: 03/23/2015

Desc: Plum Concentration Gold product (330 g)
Notes: Plum Concentration Gold product (330 g) appears to be sold as a gift set but the label fails to provide the total quantity of contents on the PDP; as required by 21 CFR 101.105(s);Plum Concentration Gold product (330 g) Notes:HongSsangRi CheongMaeSilWon plum beverage products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they contain some form of plum pulp, puree, juice, or concentrate, but the labels do not contain declarations of the percentage of juice in the products, as required by 21 CFR 101.30(a). Published on 03/24/2015

30 B - - 05 Beverage Base, Pit Fruit, Liquid
Date Published: 03/23/2015

Desc: HongSsangRi CheongMaeSilWon (undiluted solution of plum)
Notes: HongSsangRi CheongMaeSilWon (undiluted solution of plum) 63.76 fl. oz. product is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. The product is represented for use as a conventional food; however; the label falsely identifies the product as a dietary supplement. HongSsangRi CheongMaeSilWon plum products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the labels fail to bear a statement of identity on the Principal Display Panel (PDP); in accordance with 21 CFR 101.3(a) and (d). HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)] because the products fail to completely or accurately declare the place of business; street address; city; state and zip code as required by 21 CFR 101.5. HongSsangRi CheongMaeSilWon plum products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the outer container for your products sold to individual customers does not provide the net quantity of contents in terms of the U.S. customary system of measurement; as required under 21 CFR 101.105(a). HongSsangRi CheongMaeSilWon plum products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because your product labels contain information in two languages but do not repeat all the required label information in both languages;HongSsangRi CheongMaeSilWon (undiluted solution of plum) Notes:HongSsangRi CheongMaeSilWon (undiluted solution of plum) beverage products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 03/24/2015

HAITAI CONFECTIONERY @FOODS CO., LTD
Date Published : 10/02/2015
15/F., SANHAK FOUNDATION BLDG., , 1337-31, SEOCHO-DONG, SEOCHO-GU, , Seoul, SEOUL KOREA, REPUBLIC OF (SOUTH)
03 F - - 02 Flavored or Party Crackers
Date Published: 10/02/2015

Desc: Almond Crackers
Notes: VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 10/02/2015

Desc: Almond Crackers
Notes: VIOLATION: Product is misbranded within the meaning of Section 403(q) in that the Label format does not meet the following requirements, as specified in 21 CFR 101.9. Specifically, the serving size is not expressed as a common household measure (21 CFR 101.9(b)(7)), the percent of calories from fat is not provided (21 CFR 101.9(c)(1)(ii)), the heading "Amount per Serving" is not provided (21 CFR 101.9(d)(4)), the amounts of vitamins and minerals are not expressed only as percent of Daily Value in accordance with 21 CFR 101.9(c)(8)), and the quantitative amounts of the nutrients and the percent Daily Values are not rounded in accordance with the requirements in 21 CFR 101.9(c). In addition, the article is subject to refusal of admission pursuant to section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) because the required name and place of business are not provided, as required by 21 CFR 101.5.

Han Poong Pharm
Date Published : 08/14/2017
11 Guretdeul 3-Gil Deokjin-Gu , Jeonju Jeonbuk, KOREA, REPUBLIC OF (SOUTH)
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 08/14/2017

Notes: DaChaiHe Tang (also known as DaChaiHu Tang); Section 403(s)(2)(B) of the Act in that the label of the dietary supplement fails to identify the product by using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(i)(2) of the Act [21 U.S.C.§343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4 Section 403(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21CFR 101.36. Section 403(s)(2)(C) of the Act because the label fails to identify the part of the plant from which all the botanical dietary ingredients in the product are derived as required by 21CFR 101.4(h)(1). Section 403(q) of the FD&C Act in that the required nutrition information is not in the appropriate format in accordance with 21 CFR 101.9. Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages as required by 21CFR 101.15(c). Section 403(e)(2) of the Act because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7.

KOLMAR BNH CO.,LTD.(SBT)
Date Published : 03/08/2018
22-15 Sandan-Gil , Jeonui-Myeon , Sejong, Sejong KOREA, REPUBLIC OF (SOUTH)
54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 03/08/2018

Desc: Hemo Him Herbal Extract Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 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 product does not comply with 21 CFR 101.36. 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 21 CFR 101.4(h)(1). 403(f) of the Act [21 U. S. C. §343(f)] in that the primary packaging (individual packet) contains information in a foreign language and does not repeat all the information in both languages, as required by 21 CFR 101.15(c). 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredients listed on the firm’s website for the product are not consistent with the Supplement Facts Panel and “other ingredient” statement of the packaged product. 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that they are fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4(a)(1). 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] in that the 60 packets/box sold to individual customers does not provide the net quantity of contents in fluid ounces, as required under 21 CFR 101.7(b)(2).

KUKJE CONFECTIONERY CO.,LTD/
Date Published : 11/15/2016
188 Gwahaksaneob3-Ro; Cheongwon , Cheongju, Chungcheongbuk KOREA, REPUBLIC OF (SOUTH)
33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 11/15/2016

Desc: Fruit Stick Candy (Suckers)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) for the following: It appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the ingredients "blue color AC5113/gardenia blue," "shade lemon yellow/safflower color," "acidity regulator," "color preparation/cochineal color," and "shade strawberry red P(red cabbage [sic]" are not appropriate common or usual names for the subject ingredients. It appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. For example: "Calories from Fat” fails to be declared in accordance with 21 CFR 101.9(c)(1)(ii); the amount of dietary fiber fails to be declared in accordance with 21 CFR 101.9(c)(6)(i); the product does not contain a statement of the amount per serving of the vitamins and minerals, calculated as a percent of the Reference Daily Intake (RDI) and expressed as percent of Daily value, as required by 21 CFR 101.9(c)(iii).; the declaration of nutrients is not in the order as described in 21 CFR 101.9(c).; the bilingual format does not appear to meet the requirements in 21 CFR 101.9(d)(14) because the foreign language must follow English.; calorie content does not appear to be declared in accordance with 21 CFR 101.9(c)(1) because there is no provision for declaring calories as "kcal"; the label format does not appear to meet the requirements for bolding of certain nutrients and bars in 21 CFR 101.9(d).

LINK TRADING KOREA
Date Published : 08/14/2019
69-25 Junam-Ro , Yangsan-Si, Gyeongsangnam-Do KOREA, REPUBLIC OF (SOUTH)
37 J - - 99 Sauces, n.e.c.
Date Published: 08/14/2019

Desc: Cheddar Cheese Sauce
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the products fail to declare all ingredients for mayonnaise in accordance with 21 CFR 101.4. Mayonnaise is a multi-component ingredient and product labels fail to declare all sub-ingredients. "high fructose" and "sodium di-tiadate" are not appropriate common or usual names. Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] Product bears the term "Cheese Sauce" in the name but fails to contain or be cheese, thereby rendering the labeling false and misleading.

LOTTE CONFECTIONERY CO. LTD
Date Published : 06/29/2018
1158 Yangsandae-ro , Yangsan-si, Gyeongsangnam-do KOREA, REPUBLIC OF (SOUTH)
03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 06/29/2018

Desc: Kancho Choco Biscuit
Notes: Problem; The Kancho Choco Biscuit contains peanuts and is not on the label; Therefore it appears to be misbranded because it does include an appropriate statement of identity; in accordance with 21 CFR 101.3.

03 H - - 02 Chocolate Plain Cookies,Biscuits and Wafers
Date Published: 06/29/2018

Desc: Margaret Cookies; Choco Pie
Notes: Problem; The nutrition information does not comply with 21 CFR 101.9. The foreign language nutrition labels do not appear to be in a format required under 21 CFR 101.9(d).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Margaret Cookies; Choco Pie
Notes: Problem; The nutrition information does not comply with 21 CFR 101.9. The foreign language nutrition labels do not appear to be in a format required under 21 CFR 101.9(d).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Kancho Choco Biscuit
Notes: Problem; The Kancho Choco Biscuit contains peanuts and is not on the label; Therefore it appears to be misbranded because it does include an appropriate statement of identity; in accordance with 21 CFR 101.3.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Choco Pie Cacao
Notes: Problem(s) The nutrition information does not comply with 21 CFR 101.9. The foreign language nutrition labels do not appear to be in a format required under 21 CFR 101.9(d).

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 06/29/2018

Desc: Choco Pie
Notes: Problem(s) The foreign language nutrition labels on do not appear to be in a format required under 21 CFR 101.9(d).

Lotte Confectionery Co., Ltd.
Date Published : 04/06/2015
25 Yangpyung-Lo 21-Gil , Seoul, Youngdeungpo-Gu KOREA, REPUBLIC OF (SOUTH)
03 R - - 60 Waffles Without Custard or Cream Filling
Date Published: 04/06/2015

Desc: Lotte European Waffles
Notes: Charge: 403(i)(1) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because there is no accurate statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. We question the name of the product “Lotte Waffle” being an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food within the meaning of sections 21 CFR 101.3(b) and 21 CFR 102.5(a). The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. It appears that this product is not generally recognized by American consumers as a waffle, but may be similar to a snack cracker or cookie product. We also note that the statement of identity must be consistent wherever it appears on the label. Charge: 403(i)(2) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i) (2)] because they are fabricated from two or more ingredients but the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, Charge: 403(f) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded with the meaning of section 403(f) because the product labels contain information in two languages but do not repeat all the required label information in both languages. It appears a second language (possibly Korean) is declared on the label; therefore all words, statements, and other information required by or under authority of the act to appear on the label must also be represented in the foreign language in accordance with 21 CFR 101.15(c)(2).

03 S - - 60 Waffles Prepared Dry Mix Without Custard or Cream Filling
Date Published: 10/07/2015

Desc: The Lotte European Waffles
Notes: The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015

03 T - - 60 Waffle Dough or Batter Without Custard or Cream Filling
Date Published: 10/07/2015

Desc: The Lotte European Waffles
Notes: The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015

NATURETECH CO., LTD.
Date Published : 06/19/2017
(Ju)Neicheotek , 29-8 Yongjeong-Gil; Chopyeong-Myeon , Jincheon, Chungcheongbuk KOREA, REPUBLIC OF (SOUTH)
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/19/2017

Desc: Xperia Concentrate-Advanced Cell Renewal Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(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(a)(1) of the Act [21 U.S.C. §343 (a)(1)] because the labeling is false and misleading. 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.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 06/19/2017

Desc: Xperia Concentrate-Advanced Cell Renewal Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(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(a)(1) of the Act [21 U.S.C. §343 (a)(1)] because the labeling is false and misleading. 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.

Orion iksan factory
Date Published : 07/26/2016
317 Dongseo-ro , Igsan-si, Jeonrabug-do KOREA, REPUBLIC OF (SOUTH)
33 E - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, without Nuts and Fruit (without Chocolate)
Date Published: 07/26/2016

Desc: Korean Candy- Wang GGUM TUE RI
Notes: The product appears to be misbranded within the meaning of;(1)Section 403(q) of the Act; in that the nutrition information (e.g. Nutrition Facts Panel) does not meet the requirements under 21 CFR 101.9;(2)Section 403(f) of the Act because the product label contains information in two languages; but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The statement of identity; nutrition information; ingredient statement; and name and place of business of the manufacturer; packer; or distributor are not declared in English on the individual retail packets and the outer container fails to bear Korean for all words; statements; and other mandatory information as required by 21 CFR 101.15(c)(2);(3)Section 403(i)(2) of the Act; in that it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4.

Ourhome Ltd.
Date Published : 06/26/2019
(Ju)Awohom , 26-21 Je1sandan-Ro; Duma-Myeon , Gyeryong, Chungcheongnam KOREA, REPUBLIC OF (SOUTH)
37 B - - 27 Bean curd, fresh - soft or hard (Multiple Food Specialties, Side Dishes and Desserts)
Date Published: 06/26/2019

Desc: Soft Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "100 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared. [21CFR101.9(d)(3)(i) and (b)(7), respectively].The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container (21 CFR 101.9(d)(3)(ii), or the full footnote (101.9(d)(9)); and it appears that Saturated Fat and Trans Fat have been added together to show one combined % DV.Saturated Fat/Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label. Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR101.9(c)(9)and(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).Specifically, the article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

37 B - - 27 Bean curd, fresh - soft or hard (Multiple Food Specialties, Side Dishes and Desserts)
Date Published: 06/26/2019

Desc: Soybean Cooking Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "60 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared 21CFR101.9(d)(3)(i) and (b)(7), respectively.The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container(21 CFR101.9(d)(3)(ii), or the full footnote 101.9(d)(9)); and it appears that Saturated Fat/Trans Fat have been added together to show one combined % DV.Saturated Fat and Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label.Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR 101.9(c)(9)(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each language.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).The article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

37 C - - 27 Bean curd, fresh - soft or hard (Package Contains Separate Components, Require Mix/Cook)
Date Published: 06/26/2019

Desc: Soybean Cooking Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "60 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared 21CFR101.9(d)(3)(i) and (b)(7), respectively.The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container(21 CFR101.9(d)(3)(ii), or the full footnote 101.9(d)(9)); and it appears that Saturated Fat/Trans Fat have been added together to show one combined % DV.Saturated Fat and Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label.Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR 101.9(c)(9)(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each language.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).The article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

37 C - - 27 Bean curd, fresh - soft or hard (Package Contains Separate Components, Require Mix/Cook)
Date Published: 06/26/2019

Desc: Soft Tofu
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(q) of the Act [21U.S.C.§343(q)] in that the nutrition facts information is not as defined in 21CFR101.9.The label declares the serving size as "100 g"; however, the serving size must be determined based on the RACC at 21CFR101.12(b)[21CFR101.9(b)(2)].The RACC for Bean cake (tofu), tempeh is 85 g.The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared.The serving size is not identified as such nor is the household unit of measure declared. [21CFR101.9(d)(3)(i) and (b)(7), respectively].The label does not include Calories from fat (21CFR101.9(b)(1)(ii)), servings per container (21 CFR 101.9(d)(3)(ii), or the full footnote (101.9(d)(9)); and it appears that Saturated Fat and Trans Fat have been added together to show one combined % DV.Saturated Fat/Trans Fat cannot be added together, nor can a "+" symbol be shown in front of Trans Fat in the nutrition label. Only Saturated Fat has a % DV; there is no % DV for Trans fat (21CFR101.9(c)(9)and(d). Section 403(f) of the Act [21U.S.C.§343(f)] because they contain information in multiple languages; therefore, all required information must be in each.The Nutrition Facts label must be declared in both the foreign languages and English as required by 21CFR 101.15(c)(2). Section 403(i)(2) of the Act [21U.S.C.§343(i)(2)] in that the product is fabricated from two or more ingredients and the common/usual name of each ingredient is not declared on the label, as required under 21CFR101.4(b)(14).Specifically, the article is labeled to contain "vegetable oil" but the plant source for the oil is not provided.

PUREPLUS CO., LTD
Date Published : 03/07/2018
11 Sudongnonggong-Gil, Sudong-Myeon , Hamyang-Gun, Gyeongnam, 50022 S. Korea , Hamyang, Gyeongnam KOREA, REPUBLIC OF (SOUTH)
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 03/07/2018

Desc: My Aloe Drink; Original
Notes: Problem(s): Nutrition Facts Panel Net Content Statement; Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information.; Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

Seonil INT Co.,Ltd.
Date Published : 04/24/2015
Mansokdong 1 41 , Dong-Gu , Inchon, INCHON KOREA, REPUBLIC OF (SOUTH)
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 04/24/2015

Desc: Tayo Cracker
Notes: The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] for failing to declare the common or usual name for each ingredient in accordance with 21 CFR 101.4. For example; the label in Korean declares “egg and milk” in the ingredient statement however; “egg and milk” are in declared in on the English ingredients statement. In addition; shortening on the ingredient statement of the Tayo Cracker is not a specific common or usual name as required by 21 CFR 101.4(b)(14) and Lemon Parfum on the ingredient statement of the Gyeran Cracker is not a specific common or usual food ingredient name. The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically it appears that the distributor name and address is not in the Korean language since it is provided by the exporter not the manufacturer. In addition; the nutrition information does not contain the same numerical values in the Korean declaration as the U.S. declaration.

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 04/24/2015

Desc: Gyeran Cracker
Notes: The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] for failing to declare the common or usual name for each ingredient in accordance with 21 CFR 101.4. For example; the label in Korean declares “egg and milk” in the ingredient statement however; “egg and milk” are in declared in on the English ingredients statement. In addition; shortening on the ingredient statement of the Tayo Cracker is not a specific common or usual name as required by 21 CFR 101.4(b)(14) and Lemon Parfum on the ingredient statement of the Gyeran Cracker is not a specific common or usual food ingredient name. The articles are subject to refusal of admission pursuant to Section 801 (a)(3) in that they appear to be misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; all words; statements; and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically it appears that the distributor name and address is not in the Korean language since it is provided by the exporter not the manufacturer. In addition; the nutrition information does not contain the same numerical values in the Korean declaration as the U.S. declaration.


MALAYSIA


Asian Secrets Sdn Bhd
Date Published : 03/22/2016
No. 5 Jalan 4/83a , Kuala Lumpur, Wilayah Persekutuan MALAYSIA
21 A - - 20 Citrus and Other Fruits, Mixed
Date Published: 03/22/2016

Desc: TUNJUK LANGIT (FRUCTUS SWIETENIA MACROPHYLLA) SKY FRUIT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)];and, The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim, but fails to meet the requirements to bear the claim.. [Misbranded,Section 403(r)(1)(A/B)];and, The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)]because the product label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The net quantity of contents statement is not declared in the foreign language. In addition, the statement of identity, Tunjuk Langit, is not in English and appears to be in Malay language. [Misbranded, Section 403 (f)] ;

21 S - - 99 Subtropical and Tropical Fruit, N.E.C.
Date Published: 03/22/2016

Desc: TUNJUK LANGIT (FRUCTUS SWIETENIA MACROPHYLLA) SKY FRUIT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)];and, The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim, but fails to meet the requirements to bear the claim.. [Misbranded,Section 403(r)(1)(A/B)];and, The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)]because the product label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The net quantity of contents statement is not declared in the foreign language. In addition, the statement of identity, Tunjuk Langit, is not in English and appears to be in Malay language. [Misbranded, Section 403 (f)]

CAVERFLO TEXAS TRADING
Date Published : 11/28/2017
117 Lorong Bunga Raya 5 , Sungai Petani, Kedah MALAYSIA
31 A - - -- Coffee
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product’s outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product’s outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product’s outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/28/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: Section 403(e)(1) of the FD&C Act [21 U.S.C. §343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the FD&C Act [21 U.S.C. §343(e)(2)] because the labeling for the product’s outside container fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(i)(2) of the FD&C Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition FD&C Act s Panel) is not correctly declared on the outside container and individual product packet labeling as required by 21 CFR 101.9.

Cocoaland Sdn Bhd
Date Published : 10/02/2015
Lot 100, Rawang Integrated Industrial , Rawang, Selangor MALAYSIA
33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 11/28/2017

Desc: MANGO FLAVORED CANDY
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and 15 U.S.C. § 1453(a)(2) and 15 U.S.C. § 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1), followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of FPLA]. -Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. -Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two or more languages, but does not repeat all the required information in both languages. -Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

33 Y - - 99 Candy Without Chocolate N.E.C.
Date Published: 10/02/2015

Desc: Herbal Candy Super Mint
Notes: VIOLATION (IN NOTES): 1. 403(q) ; 403(i)(2) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded under section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the nutrition information on the labels are provided in a format not consistent with the requirements under 21 CFR 101.9. Specifically, the nutrients are not listed in order as specified under 21 CFR 101.9 (c) and that ¿Calories¿ is not declared as required under 21 CFR 101.9(c)(1). Also, the %DVs are not declared under 21 CFR 101.9(d)(7)(ii). The nutrition information does not meet the formatting requirements under 21 CFR 101.9(d)(1)(i), which states, in part, that the nutrition must be printed on a white or other neutral contrasting background whenever practical. 2. The article is subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded under sections 403 (i)(2) of the Act, in that ingredient statement does not correctly label the ¿Flavour & Flavouring¿ ingredient in accordance with 21 CFR 101.22.

DYNAMIC NUTRITION SDN BHD
Date Published : 05/20/2019
No 12c Hedgeford Innovation Park Ja , Jalan Tandang , Petaling Jaya, Selangor MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 98 Bilberry (Herbal & Botanicals, not Teas)
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

Dynamic Nutrition
Date Published : 05/20/2019
18 Jalan Industri , Subang Jaya, MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

Kawan Food Manufacturing Sdn Bhd
Date Published : 03/17/2015
Lot 20 , 19 Jalan Pengapit 15 19 15 , Shah Alam, Selangor MALAYSIA
03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific “Raising Agent” is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 R - - 30 Pastry Shells Without Custard or Cream Filling
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific “Raising Agent” is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 T - - 25 Pastry (other than Fruit or Jelly Filled) Dough or Batter Without Custard or Cream Filling
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific “Raising Agent” is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 T - - 30 Pastry Shell Dough or Batter Without Custard or Cream Filling
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific “Raising Agent” is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 Y - - 11 Lumpia wrappers (includes pastry wrappers and sheets)
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific “Raising Agent” is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 03/17/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) in that ingredients declaration is not in compliance with 21 CFR 101.4. For example: Margarine is declared in the ingredient statement; however, it appears that the components of the margarine are not declared in the ingredient list. The specific “Raising Agent” is not declared in the ingredient list. The ingredient statement regulations do not allow for the use of European designation for ingredients (E500). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, the label fails to bear the serving size in common household measure as required by 21 CFR 101.9(b)(5). Published on 03/17/2015

Mellips SDN BHD
Date Published : 10/02/2015
Lot 28 , Jalan Tun , Melaka, Melaka MALAYSIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 10/02/2015

Desc: Ginseng Plus
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) in that the product label fails to bear the supplement facts in the appropriate format and fails to bear the required information of the common or usual name of the food and each ingredient in accordance with section 403(I)(2).

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

Desc: Ginseng Plus
Notes: VIOLATION (IN NOTES); The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q)(5)(F) in that the product label fails to bear the supplement facts in the appropriate format and fails to bear the required information of the common or usual name of the food and each ingredient in accordance with section 403(I)(2).

Reishilab Sdn Bhd
Date Published : 05/20/2019
No 5 Jalan P2/4 , Semenyih, Selangor MALAYSIA
54 A - - 99 Vitamin, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 03 Angelica (Herbal & Botanicals, not Teas)
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 05/20/2019

Desc: Ashiguard Capsules
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of sections: 403(q) in that the label fails to present nutrition information (Supplement Facts). 403(q) because the serving size is not declared on the product label. 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event. 403 (s)(2)(B) of the Act because the label fails to include a statement of identity. 403(i)(2) in that the product label fails to declare the common or usual name or Latin binomial of each ingredient.

Thomyam Food Industries Sdn.Bhd.
Date Published : 10/02/2015
Lot 76 , Jalan Industrial Semambu , Kuantan, Pahang MALAYSIA
35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Mini Pudding Tropical Fruit
Notes: Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement as required by 21CFR101.4. Specifically; sodium caseinate. Also; the product is misbranded under 403(q) in that the format for the nutrition facts label does not comply with 21CFR101.9. Product is further misbranded under 403(q) in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/4/07

35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Mango Pudding
Notes: Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common or usual name as required by 21CFR101.4. Specifically; sodium caseinate. Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07

35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Assorted Pudding
Notes: Product is misbranded under 403(i)(2) in that the listing of sodium caseinate as a sub-ingredient of the non-dairy creamer does not include a parenthetical term such as ?a milk derivative? as required by 21CFR101.4(d) Also; Product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3). 5/4/07

35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 10/02/2015

Desc: Dragonfly Brand Pandan Flavor Pudding
Notes: Product is misbranded under 403(i)(2) in that the label fails to declare all ingredients in the ingredient statement by their common of usual names required by 21CFR101.4. Specifically; sodium caseinate. Also; product is misbranded under 403(q) in that the label does not comply with the labeling requirements in 21CFR101.9. Specifically; the label does not list trans fat and the format of the nutrition information is incorrect. Product is further misbranded under 403(q)in that there is no French translation on the nutrition label as required by 21CFR101.15(b)(3) 5/5/07


MEXICO


API-ROYAL, S.A DE CV
Date Published : 10/02/2015
Calle 7a Altos #237 , Col. San Luis , San Luis Potosi, San Luis Potosi MEXICO
30 J - - -- Imit Flav Beverage Base
Date Published: 10/02/2015

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

30 J - - -- Imit Flav Beverage Base
Date Published: 10/02/2015

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

30 J - - -- Imit Flav Beverage Base
Date Published: 10/02/2015

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

30 Y - - -- Beverage Base N.E.C.
Date Published: 10/02/2015

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

30 Y - - -- Beverage Base N.E.C.
Date Published: 10/02/2015

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

30 Y - - -- Beverage Base N.E.C.
Date Published: 10/02/2015

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

54 I - - 99 Fiber, N.E.C.
Date Published: 10/02/2015

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

54 I - - 99 Fiber, N.E.C.
Date Published: 10/02/2015

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

54 I - - 99 Fiber, N.E.C.
Date Published: 10/02/2015

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

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

Desc: Ultra Manzana Lax powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 6% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. Canas Y Piloncillos 9/5/06

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

Desc: Ultra Pina Linzaa (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403 (q)]; The product contains less than 7% of the declared amountof riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

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

Desc: Linzaa powder (powder drink mix)
Notes: The nutritional information is not in the format specified by 21 CFR 101.36 [Misbranded; Section 403(q)]; The product contains less than 3% of the declared amount of riboflavin [Misbranded; Section 403(r)(1)(A)/(B)]. 9/5/06

Agrojugos, S.A. De C.V.
Date Published : 10/02/2015
Km. 15 Carretera A Bahia Kinc , Hermosillo, Sonora, MEXICO
24 T - - 99 Leaf & Stem Vegetables, N.E.C.
Date Published: 10/02/2015

Desc: Spicy Dried Cactus (Nopalitos Deshidratados)
Notes: VIOLATION: This product is misbranded within the meaning of 403(q). The statement of the number of grams of Trans Fat is not declared as required by section 21 CFR 101.9(c)(2)(ii). The Serving Size shall be expressed in common household measure and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters) 21 CFR 101.9(b)(7)

Aide concepcion ruiz mtz
Date Published : 10/02/2015
Morlos #33-C San Jeronimo Tlacochahuaya , Oaxaca, Mexico C.P. MEXICO
03 Y - - 09 Tortillas
Date Published: 10/02/2015

Desc: Handmade Tortillas
Notes: VIOLATION (IN NOTES); 1. 403(i)(2) 1. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded under Section 403(i)(2) of the Act because the food is fabricated from two or more ingredients; and the product label does not bear a list of ingredients

Alicia Alvarez Gutierres
Date Published : 10/02/2015
Chicalote 2620 , Mercado de Abastos , Guadalajara, Jal MEXICO
36 A - - 02 Brown Sugar (Sucrose from Cane)
Date Published: 10/02/2015

Desc: Brown Sugar
Notes: Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07

36 A - - 03 Cane Sugar (Sucrose)
Date Published: 10/02/2015

Desc: Brown Sugar
Notes: Product is misbranded under Section 403(a)(1) in that it does meet the label declaration for calcium; Product is further misbranded in that the nutrition label does not comply with format requirements in 21 CFR 101.9 (nutrition information is not set in a box by use of hairlines; nutrient order incorrect; incorrect increments; serving size not declared; serving per container not declared) 3/12/07

Apicola de Allende, S.A. de C.V.
Date Published : 04/24/2017
Lerdo de Tejada No. 202 Ote. , Col. CENTRO SECCION , Allende, Nuevo Leon MEXICO
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/24/2017

Desc: EspectiBron
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21CFR 101.36.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/24/2017

Desc: Propolis Capsules
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/24/2017

Desc: Propolis Liquid Extract Drops
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/24/2017

Desc: Royal Jelly
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. The product appears to be misbranded within the meaning of section 403(q)(1)(B) because the label fails to declare the servings per container in accordance with 21CFR 101.36(b)(1)(ii).

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/24/2017

Desc: Bee Pollen
Notes: The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The product appears to be misbranded within the meaning of 403(r)(2)(A) of the Act [21U.S.C. § 343 (r)(2)(A)] because the label makes a claim stating the absence of a nutrient which is not in accordance with 21CFR 101.13(e)(2).

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/24/2017

Desc: Royal Jelly Capsules
Notes: The product appears to be misbranded within the meaning of: section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in multiple languages, but do not repeat all the required information in all languages. The product appears to be misbranded within the meaning of: Section 403(y) of the Act in that the product labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

BARCEL, S.A. DE C.V
Date Published : 08/13/2018
Carretera Mexico - Toluca Km. 54 , Lerma , Pueblo Infonavit Lerma, Mexico MEXICO
33 S - - 06 Lollipop (without Chocolate)
Date Published: 08/13/2018

Desc: Paleton de Cajeta
Notes: The article is subjec