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: 01/15/2025

Type: DWPE

Import Alert Name:

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

Reason for Alert:

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

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

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

Guidance:

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

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

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

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

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

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

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

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

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

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

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

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

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov

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

Product Description:

Various Food Products

Charge:

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

OASIS Charge Code: FALSE

And/Or

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

OASIS Charge Code: LACKS FIRM

And/Or

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

OASIS Charge Code: LACKS N/C

And/Or

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

OASIS Charge Codes: NO ENGLISH or INCONSPICU

And/Or

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

OASIS Charge Code: STD IDENT

And/Or

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

OASIS Charge Code: STD NAME

And/Or

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

OASIS Charge Code: STD QUALIT

And/Or

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

OASIS Charge Code: STD FILL

And/Or

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

OASIS Charge Code: USUAL NAME

And/Or

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

OASIS Charge Code: LIST INGRE***

And/Or

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

OASIS Charge Code: JUICE %***

And/Or

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

OASIS Charge Code: PRESRV LBL***

And/Or

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

OASIS Charge Code: FLAVR LBLG***

And/Or

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

OASIS Charge Code: NUTRIT LBL

And/Or

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

OASIS Charge Code: HEALTH C

And/Or

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

OASIS Charge Code: DIETARYING

And/Or

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

OASIS Charge Code: DIETARYLBL

And/Or

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

OASIS Charge Code: PLANT PART

And/Or

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

OASIS Charge Codes "NCONTACT"

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

AFGHANISTAN

HAJI BASHIR AHMAD LTD

Date Published : 02/03/2017

Charagh Ali Market , Kabul, AF-KAB AFGHANISTAN

21 H - - 01 Apricot, Dried or Paste

Date Published: 02/03/2017

Desc: Whole Apricot

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

21 H - - 14 Plum, Dried or Paste

Date Published: 02/03/2017

Desc: Dried Plum

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

ALGERIA

CEBON SARL

Date Published : 01/25/2022

#129 Cete Meridji Fouka , W Tepiza, DZ-16 ALGERIA

36 A - - 99 Sugar Products, N.E.C.

Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)

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

36 B - - 08 Sugar Syrup, Beet and Cane (Liquid Sucrose, Simple Syrup)

Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)

36 C - - 04 Honey

Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)

Cebon El Mordjene

Date Published : 01/25/2022

129, Cite Meridji, Fouka , Wilaya, Tipaza ALGERIA

36 A - - 99 Sugar Products, N.E.C.

Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)

36 B - - 08 Sugar Syrup, Beet and Cane (Liquid Sucrose, Simple Syrup)

Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)

36 C - - 04 Honey

Date Published: 01/25/2022

Desc: Succedane de Miel (Honey substitute)

ARMENIA

ARSSI ALLIANCE LLC

Date Published : 08/25/2023

24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/25/2023

Desc: Immune Booster Antiviral

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

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 08/25/2023

Desc: Immune Booster Antiviral

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

AUSTRALIA

Homart Pharmaceuticals Pty. Ltd.

Date Published : 07/31/2024

59 Kirby St , Rydalmere, New South Wales AUSTRALIA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/31/2024

Desc: Aussie Kids Gummy Lutein (Berry Shaped NO Added Sugar)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (Berry Shaped, NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of �Nutrition Information� for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. 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. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/31/2024

Desc: Kids Genius Fish Oil

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Kids Genius Fish Oil dietary supplement products incorrectly display nutrition labeling under the heading of �Nutrition Information� for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. 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. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/31/2024

Desc: Propolis Liquid (alcohol free) 40%

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(b) of the Act. Labels fail to include the statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Propolis Liquid (alcohol free) 40% (outer and inner container labels) dietary supplement products incorrectly display nutrition labeling under the heading of �Nutrition Information� for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. 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. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/31/2024

Desc: SpringLeaf brand Inner Beauty Collagen 6 In 1

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Inner Beauty Collagen 6 in 1 dietary supplement products incorrectly display nutrition labeling under the heading of �Nutrition Information� for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. 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. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/31/2024

Desc: Aussie Kids Gummy Lutein (NO Added Sugar)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of �Nutrition Information� for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. 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. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements.

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

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)

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)

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)

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)

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)

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)

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)

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)

BAHAMAS

NEW LIFE NATURAL VEGETATION CELL

Date Published : 09/05/2017

Lucaya Shopping Cent 14 , Freeport City, BAHAMAS

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 09/05/2017

Desc: Nerve Tonic

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 09/05/2017

Desc: Bilberry Raspberry Tonic

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/05/2017

Desc: Iron Plus Formula

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/05/2017

Desc: Special Healing Tonic

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/05/2017

Desc: Male ThunderStrike

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/05/2017

Desc: Cat Island Restoration Tonic

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/05/2017

Desc: Sea Moss Bladderwrack Mix

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

56 G - - 99 Antifungal N.E.C.

Date Published: 09/05/2017

Desc: Draco Tonic

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

60 N - - 14 Testosterone (Androgen)

Date Published: 09/05/2017

Desc: Male ThunderStrike

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

62 C - - 99 Anti-Hypertensive N.E.C.

Date Published: 09/05/2017

Desc: Nerve Tonic

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

64 B - - 99 Diuretic N.E.C.

Date Published: 09/05/2017

Desc: Sea Moss Bladderwrack Mix

64 N - - 07 Iron Dextran (Inj) (Hematinic)

Date Published: 09/05/2017

Desc: Iron Plus Formula

66 S - - 40 Inositol Niacinate (Vasodilator)

Date Published: 09/05/2017

Desc: Chelation

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

Purity Bakery

Date Published : 11/19/2015

Market & McPherson Street , Nassau, BS-NP BAHAMAS

03 R - - 01 Cake Without Custard or Cream Filling

Date Published: 11/19/2015

Desc: Bacardi Rum Cake

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

03 R - - 01 Cake Without Custard or Cream Filling

Date Published: 11/19/2015

Desc: Chocolate Rum Cake

03 R - - 01 Cake Without Custard or Cream Filling

Date Published: 11/19/2015

Desc: Pina Colada Rum Cake

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

BANGLADESH

Anraj Fish Products Industries, Ltd.

Date Published : 05/23/2018

Opposit of Amin Jute Mil , Chittagong, Biozid Thana BANGLADESH

16 A - - 99 Fish, N.E.C.

Date Published: 05/23/2018

Desc: Lotiya Mix; Bombay Duck; Anchovy; Thryssa; Pink Shrimp; Harpadon nehereus; Coilia dussumien; Thryssa mystax; Pandalus borealis;

Notes: Problem(s): Principal Display Panel Nutrition Facts Panel; Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the statement of identity on the Principal Display Panel are not accurate as required under 21 CFR 101.3. Section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information is not declared in accordance with 21 CFR 101.9.

16 A - - 99 Fish, N.E.C.

Date Published: 05/23/2018

Desc: Meshali; Bata; Banded Gourami; Swamp Barb; Gangetic Leaffish; Labeo bata; Colisa fasciatus; Puntinus chola; Nandus nandus.

BAGERHAT SEAFOOD INDUSTRIES LIMITED

Date Published : 10/02/2015

Fakirhat Town Nowapara , Bagherhat, Khulna BANGLADESH

16 J - - 05 Shrimp & Prawns

Date Published: 10/02/2015

Desc: Raw Black Tiger Shrimp

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

16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products

Date Published: 10/02/2015

Desc: Raw Black Tiger Shrimp

BANOFUL & CO.

Date Published : 06/12/2024

93,east nasirabad , industrial area , CHITTAGONG, BD-10 BANGLADESH

03 A - - 13 Whole Wheat Bread/Rolls/Buns

Date Published: 06/12/2024

Desc: Banofil Special Toast

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. 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.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.

Date Published: 06/12/2024

Desc: Banofil Special Toast

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. 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.

03 Y - - 07 Zweiback, Toast

Date Published: 06/12/2024

Desc: Banofil Special Toast

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. 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.

Janata food

Date Published : 10/02/2015

Dalairbagh , Sonargaon, Narayanganj BANGLADESH

03 R - - 02 Cakes, filled (other than fruit or jelly)

Date Published: 10/02/2015

Desc: Date Cake

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

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 10/02/2015

Desc: Date Cake

22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.

Date Published: 10/02/2015

Desc: Date Cake

KN Agro Processor

Date Published : 03/05/2021

Jhawgora , Araihazar , Narayanganj, Dhaka BANGLADESH

38 C - - 99 Dried Soup, N.E.C.

Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai

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

38 Y - - 99 Soup, N.E.C.

Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai

Kishwan snacks limited

Date Published : 01/27/2023

Plot No.# A-6, A-7, Block# B, BSCIC 1/E, Sholosahar , Nasirabad, Chittagong BANGLADESH

03 A - - 13 Whole Wheat Bread/Rolls/Buns

Date Published: 06/12/2024

Desc: Banofil Special Toast

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. 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.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.

Date Published: 06/12/2024

Desc: Banofil Special Toast

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. 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.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.

Date Published: 01/27/2023

Desc: Special Toast Biscuits

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

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.

Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES

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

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.

Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES

03 Y - - 07 Zweiback, Toast

Date Published: 01/27/2023

Desc: Special Toast Biscuits

03 Y - - 07 Zweiback, Toast

Date Published: 06/12/2024

Desc: Banofil Special Toast

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. 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.

NESTLE BANGLADESH, LTD.

Date Published : 01/14/2021

RAJENDRAPUR CANTONMENT , SREEPUR , GAZIPUR, BANGLADESH

04 C - - 07 Noodles, Instant

Date Published: 01/14/2021

Desc: Maggi 2 Minute Noodles Masala

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

PRAN AGRO LTD

Date Published : 04/10/2024

Pran-Rfl Center , 105 Middle Badda , Dhaka, BANGLADESH

07 B - - 99 Fried Snack Foods, N.E.C.

Date Published: 04/10/2024

Desc: PRAN Chanachur Bombay Mix

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the product label is false and misleading. Section 403(f) of the Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language), as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act in that the nutrition facts information is not as defined in 21 CFR 101.9.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.

Date Published: 04/10/2024

Desc: PRAN Chanachur Bombay Mix

kishwan snacks ltd

Date Published : 06/08/2023

397, Sk. Mujib Road, Pathantooly , Agrabad , Chittagong, BD-10 BANGLADESH

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.

Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.

Date Published: 06/08/2023

Desc: SALTINE SALTED COOKIES

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

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

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners

Date Published: 02/12/2016

Desc: Recovery Drink Grapefruit

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners

Date Published: 02/12/2016

Desc: Recovery Drink Orange

BOLIVIA

Import & Export Santa Catalina INC.

Date Published : 10/02/2015

Av. Petrolera Km. 4 1/2 # 1358 , Av. Ayacucho # 127 , Cochabamba, BO-C BOLIVIA

28 A - - 45 Spearmint, Whole (Spice)

Date Published: 10/02/2015

Desc: Spearmint Leaves

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

31 K - - 99 Tea, N.E.C.

Date Published: 10/02/2015

Desc: Q'uillquina (Dried herbs for tea)

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

BRAZIL

Amafil Ind. Com. Alimentos Ltda

Date Published : 07/24/2023

Estrada Para Cianorte Lote 294-A , Sao Lourenco Distrito de Cianorte , Cianorte, Parana BRAZIL

02 B - - 01 Corn, Bolted Meal or Flour

Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour

02 B - - 02 Corn, Plain Meal

Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)

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

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana

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

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)

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

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)

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

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava

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

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)

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

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi

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

02 E - - 13 Wheat Flour, Whole

Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)

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

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)

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

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)

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

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana

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

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi

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

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava

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

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Polvilho de Mandioca Especial para Pao de Queijo/Cassava Starch Special Cheese Bread

02 H - - 01 Tapioca Starch Product

Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)

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

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)

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

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Polvilho de Mandioca Especial para Pao de Queijo/Cassava Starch Special Cheese Bread

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)

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

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)

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

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana

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

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)

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

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava

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

02 H - - 05 Wheat Starch

Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi

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

03 C - - 99 Breads, Rolls, Buns, Etc N.E.C. Prepared Dry Mix Without Milk or Egg

Date Published: 07/24/2023

Desc: Polvilho de Mandioca Especial para Pao de Queijo/Cassava Starch Special Cheese Bread

03 S - - 01 Cake Prepared Dry Mix Without Custard or Cream Filling

Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour

03 Y - - 09 Tortillas

Date Published: 07/24/2023

Desc: Matuto Polvilho Azedo/Thin Sour Cassava Starch

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Bacon/Flavored Seasoned Cassava Flour (bacon flavor)

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

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Amafil Massa para Tapioca/Hydrated Tapioca Starch

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Baiana/Seasoned Cassava Flour Baiana

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

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Picanha Picante/Spicy Seasoned Cassava Flour (Picanha Picante beef flavor)

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

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Carne Seca/Flavored Seasoned Cassava Flour (dry beef flavor)

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

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Matuto Polvilho Doce/Thin Sweet Cassava Starch

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Polvilho Azedo Premium/Sour Cassava Starch Amafil Premium

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Galinha com Pequi/Seasoned Cassava Flour Chicken Flavor Pequi

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

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Tradicional/Traditional Seasoned Flour Cassava

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

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Farofa Pronta Suave sem pimento/Soft Seasoned Cassava Flour (w/o pepper)

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

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 07/24/2023

Desc: Polvilho Doce Premium/Cassava Starch Sweet Amafil Premium 02E[][]13

05 B - - 01 Corn Grits, Brewers Enriched White or Yellow Corn Grits,Corn Meal Mush, Quick or Instant Cooking

Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour

07 Q - - 03 Corn (Whole Kernel) Snacks, Vegetable Snacks (Other than Pulses) Baked

Date Published: 07/24/2023

Desc: Farofa Pronta Milho/Seasoned Corn Flour

Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda

Date Published : 05/14/2020

Rua Alcidio Paganelli, 412 , Bebedouro, Sao Paulo BRAZIL

36 C - - 04 Honey

Date Published: 05/14/2020

Desc: Compound of Honey Propolis Extract and Ginger Spray

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

36 C - - 04 Honey

Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Mallow Spray

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

36 C - - 04 Honey

Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Pomegranate Spray

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/14/2020

Desc: Brazilian Guarana Supplement in capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/14/2020

Desc: Compound of Honey Propolis Extract and Ginger Spray

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Pomegranate Spray

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/14/2020

Desc: Brazilian Guarana Supplement in powder (50g and 100g)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/14/2020

Desc: Compound of Honey Propolis Mint and Mallow Spray

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

Brassuco Industria de Produtos Alimenticios LTDA

Date Published : 12/05/2017

Avenida Doutor Ermelindo Maffei, 814 , Itu, Sao Paulo BRAZIL

33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate)

Date Published: 12/05/2017

Desc: Crushed Peanut Candy

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

COOCASTEL

Date Published : 12/13/2019

Rua Frederico Grassmann, 3556 , Sao Jose Dos Pinhais, Parana BRAZIL

02 G - - 99 Flours and Meals N.E.C.

Date Published: 12/13/2019

Desc: Banana flour

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

General Mills - Cambara Plant

Date Published : 08/04/2017

Highway BR 369, KM 17/18 , Santa Amalia , Cambara, Parana BRAZIL

03 A - - 99 Bread/Rolls/Buns, N.E.C.

Date Published: 08/04/2017

Desc: Corn Chips Ham Flavored (Yokitos)

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

07 A - - 02 Corn Chips, Baked

Date Published: 08/04/2017

Desc: Corn Chips Ham Flavored (Yokitos)

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.

Date Published: 08/04/2017

Desc: Corn Chips Ham Flavored (Yokitos)

Industrial E Comercial Jandaia Ltda

Date Published : 10/02/2015

Br 53 , Pacajus, Ceara BRAZIL

21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 10/02/2015

Desc: Acerola Juice

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

Industrial E Comercial Jandaia Ltda

Date Published : 10/02/2015

Br 53 , Pacajus, Ceara BRAZIL

21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 10/02/2015

Desc: Acerola Juice

PIRAQUE

Date Published : 12/16/2016

Rua Leopoldino De Oliveira, 335 , Turiacu , Rio De Janeiro, Rio de Janeiro BRAZIL

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers

Date Published: 12/16/2016

Desc: Sesame Crackers - Piraque Agua Gerglim

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

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers

Date Published: 12/16/2016

Desc: Guava Filling Cookie - Piraque Roladinho Goiabinha

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers

Date Published: 12/16/2016

Desc: Light Salted Crackers - Piraque Cream Crackers Light

Santa Helena Industria de Alimentos S.A.

Date Published : 01/10/2018

Rua Paraguai 1275 , Ribeirao Preto, Sao Paulo BRAZIL

23 B - - 07 Peanut, Shelled

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar

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

23 B - - 07 Peanut, Shelled

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet

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

33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar

33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet

33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate)

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet

33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate)

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar

33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate)

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet

33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate)

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar

33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate)

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet

33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate)

Date Published: 02/11/2020

Desc: Pacoquita Peanut Candy Bar

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

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

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

Vale D'Ouro Importacao & Exportacao S/A

Date Published : 12/13/2016

Rua Armindo Correa 77 , Planalto , Formiga, Minas Gerais BRAZIL

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers

Date Published: 12/13/2016

Desc: Sweet Cookies - Vale D'ouro Doce

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

03 H - - 08 Butter/Butter Flavored,Plain Cookies,Biscuits and Wafers

Date Published: 12/13/2016

Desc: Salted Cookies - Vale D'ouro Tradicional

BULGARIA

Philicon-97 S.A.

Date Published : 03/30/2020

Komatevsko Shose Blvd. 35 , Plovdiv, Plovdiv BULGARIA

20 K - - 06 Orange, Citrus Fruit Juices or Concentrates

Date Published: 03/30/2020

Desc: Orange Juice

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

20 S - - 01 Apple, Core Fruit Juices or Concentrates

Date Published: 03/30/2020

Desc: Apple Juice

21 V - - 07 Pineapple, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 03/30/2020

Desc: Pineapple Juice

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

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

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

Les Brasseries du Cameroun SABC

Date Published : 10/02/2015

Balli , Douala, CAMEROON

21 D - - 01 Fruit Coctail, Mixed Fruit, Juices or Concentrates

Date Published: 10/02/2015

Desc: Fruit Cocktail Drink

29 B - - 04 Soft Drink, Mixed Fruit Flavored, Carbonated

Date Published: 10/02/2015

Desc: Fruit Cocktail Drink

UNION CAMEROUNAISES BRASSERIES

Date Published : 10/02/2015

Rue Bassa 56 , Douala, CAMEROON

20 K - - 02 Grapefruit, Citrus Fruit Juices or Concentrates

Date Published: 10/02/2015

Desc: Grapefruit Drink

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

29 B - - 02 Soft Drink, Citrus Fruit Flavored, Carbonated

Date Published: 10/02/2015

Desc: Grapefruit Drink

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

CANADA

1965599 ONTARIO LTD

Date Published : 08/20/2024

2795 Kew Dr , Windsor, Ontario CANADA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/20/2024

Desc: BASE DAILY GREENS CHERRIES JUBILEE Dietary Supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false because it incorrectly declares �soy lecithin (Helianthus annuus)�. Section 403(i)(2) in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) and Section 403(q)(1)(A) because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 21 CFR 101.2.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/20/2024

Desc: BASE DAILY GREENS HIBISCUS GRAPE Dietary Supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false because it incorrectly declares �soy lecithin (Helianthus annuus)�. Section 403(i)(2) in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) and Section 403(q)(1)(A) because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 21 CFR 101.2.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/20/2024

Desc: BASE DAILY GREENS SUMMER PINEAPPLE Dietary Supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false because it incorrectly declares �soy lecithin (Helianthus annuus)�. Section 403(i)(2) in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) and Section 403(q)(1)(A) because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 21 CFR 101.2.

1965599 ONTARIO LTD.

Date Published : 09/20/2022

1-6360 Hawthorne Dr , Windsor, Ontario CANADA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/20/2022

Desc: DEBLOATING - DIGESTION

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

2119835 ONTARIO INC

Date Published : 06/24/2024

400 Spinnaker Way Unit 15 , Concord, Ontario CANADA

09 C - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor; French Vanilla Flavor; Pineapple Mango Flavor; Chocolate Wafer Crisp Flavor; Strawberry Flavor; Mocha Latte Cappuccino Flavor; Triple Rich Chocolate Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 C - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 C - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(k) of the Act. Product contains artificial coloring but fails to bear labeling stating that fact (21 CFR 101.22(c)). The color is not declared as required under 21 CFR 101.22(k)(2). The Strawberry Flavor label lists �beet root (natural color).� The label also declares �No Artificial Colors�. The Pineapple Mango label declares the ingredient �turmeric (natural color).� The label also declares �no artificial colors.�

09 D - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 D - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 D - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

09 E - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 E - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 E - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 C - - 11 L-Isoleucline (Protein)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 C - - 11 L-Isoleucline (Protein)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 11 L-Isoleucline (Protein)

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 99 Protein N.E.C.

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 99 Protein N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 99 Protein N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

BC HARVEST FOODS INC

Date Published : 02/22/2017

111-1551 Broadway St , Port Coquitlam, British Columbia CANADA

29 B - - 99 Carbonated Soft Drink, N.E.C.

Date Published: 02/22/2017

Desc: Yogurt Soda - Ziziphora (Kakooti)

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

BELIEVE SUPPLEMENTS

Date Published : 01/31/2024

405 Omer-Deserres St , Blainville, Quebec CANADA

21 T - - 07 Pineapple, Dried or Paste

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

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

21 T - - 07 Pineapple, Dried or Paste

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 A - - 99 Vitamin, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 A - - 99 Vitamin, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

Believe Supplements

Date Published : 01/31/2024

719 Boulevard Industriel , Suite 104 , Blainville, Quebec CANADA

21 T - - 07 Pineapple, Dried or Paste

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

21 T - - 07 Pineapple, Dried or Paste

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

45 K - - 99 Flavor Enhancers (Food Additives for Human Use)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 A - - 99 Vitamin, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

54 A - - 99 Vitamin, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

54 F - - 12 Ginseng (Herbal & Botanicals, not Teas)

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT PINEAPPLE MANGO

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 01/31/2024

Desc: SUPERFOODS & GREENS DIETARY SUPPLEMENT ORANGE VANILLA

CANADIAN PREMIER

Date Published : 08/20/2024

2795 Kew Dr Unit B , Windsor, Ontario CANADA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/20/2024

Desc: BASE DAILY GREENS SUMMER PINEAPPLE Dietary Supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false because it incorrectly declares �soy lecithin (Helianthus annuus)�. Section 403(i)(2) in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) and Section 403(q)(1)(A) because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 21 CFR 101.2.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/20/2024

Desc: BASE DAILY GREENS HIBISCUS GRAPE Dietary Supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false because it incorrectly declares �soy lecithin (Helianthus annuus)�. Section 403(i)(2) in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) and Section 403(q)(1)(A) because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 21 CFR 101.2.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/20/2024

Desc: BASE DAILY GREENS CHERRIES JUBILEE Dietary Supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the label is false because it incorrectly declares �soy lecithin (Helianthus annuus)�. Section 403(i)(2) in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) and Section 403(q)(1)(A) because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36, 101.9, and 21 CFR 101.2.

Celex Laboratories Inc.

Date Published : 08/15/2022

115-21600 Westminster Hwy , Richmond, British Columbia CANADA

54 B - - 07 Iron (Mineral)

Date Published: 08/15/2022

Desc: VORST IRON

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 08/15/2022

Desc: VORST IRON

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

Desi Mills Inc

Date Published : 10/02/2015

Unknown , Markham, Ontario CANADA

02 F - - 02 Farina, Wheat

Date Published: 10/02/2015

Desc: 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

24 A - - 20 Chana Dal

Date Published: 10/02/2015

Desc: Chana Dal

24 A - - 51 Peas

Date Published: 10/02/2015

Desc: Yellow Split Peas

24 E - - 70 Lentils, Bean and Pea Sprouts

Date Published: 10/02/2015

Desc: Mooth Whole Haleen Mix Mixed Lentils

24 E - - 70 Lentils, Bean and Pea Sprouts

Date Published: 10/02/2015

Desc: Red Lentils

24 E - - 70 Lentils, Bean and Pea Sprouts

Date Published: 10/02/2015

Desc: Brown Lentils

28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)

Date Published: 10/02/2015

Desc: Crushed Chili

Desi Mills Inc

Date Published : 10/02/2015

Unknown , Markham, Ontario CANADA

02 F - - 02 Farina, Wheat

Date Published: 10/02/2015

Desc: Suji Fine Farina Wheat

02 F - - 99 Wheat, Milled Product, N.E.C.

Date Published: 10/02/2015

Desc: Pearled Soft White Winter Wheat

24 A - - 19 Adzuki beans

Date Published: 10/02/2015

Desc: Adzuki Beans

24 A - - 20 Chana Dal

Date Published: 10/02/2015

Desc: Chana Dal

24 A - - 51 Peas

Date Published: 10/02/2015

Desc: Yellow Split Peas

24 E - - 70 Lentils, Bean and Pea Sprouts

Date Published: 10/02/2015

Desc: Red Lentils

24 E - - 70 Lentils, Bean and Pea Sprouts

Date Published: 10/02/2015

Desc: Brown Lentils

24 E - - 70 Lentils, Bean and Pea Sprouts

Date Published: 10/02/2015

Desc: Mooth Whole Haleen Mix Mixed Lentils

28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice)

Date Published: 10/02/2015

Desc: Crushed Chili

GENEX NUTRACEUTICALS

Date Published : 06/24/2024

15-400 Spinnaker Way , Concord, Ontario CANADA

09 C - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 C - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

09 C - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 D - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 D - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

09 D - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 E - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

09 E - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

09 E - - 34 Whey Protein concentrate

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 11 L-Isoleucline (Protein)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 11 L-Isoleucline (Protein)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 C - - 11 L-Isoleucline (Protein)

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 99 Protein N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 C - - 99 Protein N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 C - - 99 Protein N.E.C.

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/24/2024

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Strawberry Flavor; Pineapple Mango Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/24/2024

Desc: Diesel New Zealand Whey Isolate Protein Powder Drink Mix (Salted Caramel Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. �New Zealand Whey Protein Isolate� is not an appropriate common or usual name. �Salt (as Sodium Citrate)� is not an appropriate common or usual name.

HERBALAND NATURALS INC

Date Published : 11/10/2022

13330 Maycrest Way , Richmond, British Columbia CANADA

54 A - - 99 Vitamin, N.E.C.

Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies

Herbaland Naturals Inc

Date Published : 11/10/2022

12340 Horseshoe Way , Richmond, British Columbia CANADA

54 A - - 99 Vitamin, N.E.C.

Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 11/10/2022

Desc: Prenatal DHA Folate Dietary Supplement Gummies

ITN Food

Date Published : 02/02/2024

40 Commander Boulevard , Toronto, ON CANADA

28 A - - 70 Pomegranate (Spice)

Date Published: 02/02/2024

Desc: KALONJI POWDER Nigella Seeds Powder

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

28 B - - 99 Spices, Ground, Cracked, Etc., N.E.C.

Date Published: 02/02/2024

Desc: KALONJI POWDER Nigella Seeds Powder

28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C.

Date Published: 02/02/2024

Desc: TANDOORI MASALA PASTE

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

37 K - - 23 Curry Paste

Date Published: 02/02/2024

Desc: TANDOORI MASALA PASTE

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

37 K - - 99 Pastes, n.e.c.

Date Published: 02/02/2024

Desc: TANDOORI MASALA PASTE

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

Innotech Nutrition Solutions, Ltd.

Date Published : 10/10/2024

104 Durand Rd , Winnipeg, Manitoba CANADA

54 A - - 99 Vitamin, N.E.C.

Date Published: 10/10/2024

Desc: Fasting Days (Mixed Berry Flavor)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. Section 403(q) of the Act [21 U.S.C. �343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient.

54 A - - 99 Vitamin, N.E.C.

Date Published: 10/10/2024

Desc: Fasting Days (Raspberry Lime Flavor)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 10/10/2024

Desc: Cardioflex Q10

54 Y - - 08 Coenzyme Q10 (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 10/10/2024

Desc: Cardioflex Q10

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 10/10/2024

Desc: Nature Pro Whey Protein

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 10/10/2024

Desc: Fasting Days (Raspberry Lime Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 10/10/2024

Desc: Cardioflex Q10

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 10/10/2024

Desc: Fasting Days (Mixed Berry Flavor)

Jamieson Laboratories

Date Published : 03/27/2015

2 St Clair Ave W 16 Th Floor , Toronto, Ontario CANADA

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

Date Published: 03/27/2015

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

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 03/27/2015

Desc: Jamieson Calcium Magnesium Caplets

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

LES PRODUITS DE JARDIN DE GAIA

Date Published : 12/13/2019

7225 Marconi St Suite 101 , Montreal, Quebec CANADA

02 G - - 99 Flours and Meals N.E.C.

Date Published: 12/13/2019

Desc: Banana flour

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

31 M - - 99 Blended Teas, N.E.C.

Date Published: 04/13/2016

Desc: 14 Day Detox Tea

31 P - - 99 Tea Substitutes, N.E.C.

Date Published: 04/13/2016

Desc: 14 Day Detox Tea

Medicap Laboratories

Date Published : 06/25/2024

3190 Devon Dr , Windsor, Ontario CANADA

54 E - - 99 Herbals & Botanical Teas, N.E.C.

Date Published: 06/25/2024

Desc: Edica EZestro 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. Nutritional information does not comply with 21 CFR Part 101.36. Label fails to declare: Quantitative amount by weight specified for the proprietary blend (EstroG-100) shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term �Proprietary Blend� or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section (21 CFR 101.36(c)(3)). The other dietary ingredients in descending order of predominance by weight, in a column or linear fashion, and indented under the term �Proprietary Blend� or other appropriately descriptive term or fanciful name (21 CFR 101.36 (c)(2)). The other ingredients list fails to be placed immediately below the Supplement Facts label (21 CFR 101.4(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 06/25/2024

Desc: Edica EZestro Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/25/2024

Desc: Edica EZestro Supplement

Naturally Splendid Enterprises Ltd

Date Published : 10/02/2015

108-19100 Airport Way , Pitt Meadows, British Columbia CANADA

18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C.

Date Published: 10/02/2015

Desc: Hemp Protein Powder

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

41 G - - 02 Nutrtionally Incomplete Formulations (Protein, carbohydrate or fat modulars)

Date Published: 10/02/2015

Desc: Hemp Protein Powder

54 C - - 99 Protein N.E.C.

Date Published: 10/02/2015

Desc: Hemp Protein Powder

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

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 10/02/2015

Desc: Hemp Protein Powder

Nestle Canada, Inc. - North York Head Office

Date Published : 03/27/2015

1700-25 Sheppard Ave W , North York, Ontario CANADA

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

Date Published: 03/27/2015

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

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 03/27/2015

Desc: Nestle Materna Pre-natal-Postpartum Vitamin & Mineral Supplement

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

Newco Enterprise Inc.

Date Published : 10/02/2015

402-5793 10th St NE , Calgary, Alberta CANADA

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 10/02/2015

Desc: Brocco Gen 10 Sulforaphane Glucosinolate Capsules Dietary Supplements

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

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 10/02/2015

Desc: Brocco Gen 10 Sulforaphane Glucosinolate Capsules Dietary Supplements

Norcan Seeds,Inc.

Date Published : 05/02/2016

Ne5-24-1w , Fisher Branch, Manitoba CANADA

02 G - - 99 Flours and Meals N.E.C.

Date Published: 05/02/2016

Desc: Flax meal

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

23 R - - 20 Flax Seed (Edible Seed Paste)

Date Published: 05/02/2016

Desc: Flax meal

71 L - - 99 Oilseed Byprod N.E.C.

Date Published: 05/02/2016

Desc: Flax meal

71 Y - - 99 Byprod For Animal, N.E.C.

Date Published: 05/02/2016

Desc: Flax meal

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

Nutracrea Inc.

Date Published : 06/14/2023

486 Bergeron St , Sainte-Eulalie, Quebec CANADA

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ

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

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE

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

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH

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

54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE

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

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 06/14/2023

Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH

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

Nutralab Canada Corp.

Date Published : 09/26/2024

980 Tapscott Rd , Scarborough, Ontario CANADA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Noor Vitamins; Vitamin D3 Softgels

Notes: The products are subject to refusal of admission pursuant to section 801(a)(3), in that they appear to be misbranded within the meaning of section 403 of the Act, including 403(a)(1) [21 U.S.C. � 343(a)(1)], 403(i)(2) [21 U.S.C. � 343(i)(2)], 403(q)(5)(F) [21 U.S.C. � 343(q)(5)(F)], 403(s)(2)(c) [21 U.S.C. � 343(s)(2)(c)], and 403(y) [21 U.S.C. 343 (y)].

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Daily Greens Boost Powder (Pineapple Coconut Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Detox Powder (Natural Pineapple Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Noor Vitamins; Hair & Skin Softgels

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Active Green Pro; Fiber Boost; Prebiotic Probiotic Powder (Unflavored)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Vitality & Brain Powder (Natural Pineapple Coconut Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Immune & Antioxidants Powder (Natural French Vanilla Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Daily Greens Boost Powder (Raspberry Lemon Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Active Green; Plant Based Formula; Energy & Stamina Powder (Natural Pineapple Flavor)

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/26/2024

Desc: Noor Vitamins; Prenatal DHA Ginger Softgels

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Noor Vitamins; Prenatal DHA Ginger Softgels

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Vitality & Brain Powder (Natural Pineapple Coconut Flavor)

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Active Green; Plant Based Formula; Energy & Stamina Powder (Natural Pineapple Flavor)

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Noor Vitamins; Hair & Skin Softgels

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Noor Vitamins; Vitamin D3 Softgels

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Detox Powder (Natural Pineapple Flavor)

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Daily Greens Boost Powder (Raspberry Lemon Flavor)

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Active Green Pro; Fiber Boost; Prebiotic Probiotic Powder (Unflavored)

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Daily Greens Boost Powder (Pineapple Coconut Flavor)

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/26/2024

Desc: Active Green Pro; Plant Based Formula; Immune & Antioxidants Powder (Natural French Vanilla Flavor)

Omega Alpha Pharmaceuticals

Date Published : 07/06/2020

795 Pharmacy Ave , Scarborough, Ontario CANADA

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/06/2020

Desc: Aeolus Lung Cleanse

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

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/06/2020

Desc: Lung Flush

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/06/2020

Desc: Maculex

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/06/2020

Desc: Aeolus Lung Cleanse

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/06/2020

Desc: Maculex

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/06/2020

Desc: Lung Flush

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 07/06/2020

Desc: Maculex

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 07/06/2020

Desc: Lung Flush

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 07/06/2020

Desc: Aeolus Lung Cleanse

PROVITA NUTRITION AND HEALTH INC

Date Published : 04/18/2023

1102-1225 Kingsway Ave , Port Coquitlam, British Columbia CANADA

54 E - - 91 Boswellia (Herbal & Botanical Teas)

Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules

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

54 F - - 50 Hawthorn (Herbal & Botanicals, not Teas)

Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules

54 F - - 58 Saw Palmetto (Herbal & Botanicals, not Teas)

Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 04/18/2023

Desc: Prostate Pro Dietary Supplements Capsules

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 04/18/2023

Desc: Nervine Herbal Supplement Capsules

Pharmalab 1982 Inc. Dba. Ideal Protein

Date Published : 02/14/2023

8750 Guillaume-Couture Blvd , Levis, Quebec CANADA

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)

Date Published: 02/14/2023

Desc: Ideal Protein; Multi Vita Multi Vitamin and Mineral Supplement

54 B - - 99 Mineral N.E.C.

Date Published: 02/14/2023

Desc: Ideal Protein; Multi Vita Multi Vitamin and Mineral Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 02/14/2023

Desc: Ideal Protein; Multi Vita Multi Vitamin and Mineral Supplement

Pharmaline

Date Published : 12/10/2021

2835 Argentia Rd Unit 5 , Mississauga, Ontario CANADA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 12/10/2021

Desc: FULVIC CARE POWDER

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

Polar Foods,Inc.

Date Published : 05/02/2016

Ne5-24-1w , Fisher Branch, MB CANADA

02 G - - 99 Flours and Meals N.E.C.

Date Published: 05/02/2016

Desc: Flax meal

23 R - - 20 Flax Seed (Edible Seed Paste)

Date Published: 05/02/2016

Desc: Flax meal

71 L - - 99 Oilseed Byprod N.E.C.

Date Published: 05/02/2016

Desc: Flax meal

71 Y - - 99 Byprod For Animal, N.E.C.

Date Published: 05/02/2016

Desc: Flax meal

QPharm Inc

Date Published : 08/11/2017

4-1000 Bishop St N , Cambridge, Ontario CANADA

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 08/11/2017

Desc: Health Supplement Rhoziva

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

RHEMA HEALTH PRODUCTS Limited

Date Published : 10/11/2022

601-19055 Airport Way , Pitt Meadows, British Columbia CANADA

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)

Date Published: 10/11/2022

Desc: Meal Replacement Powder

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

Rubicon Food Prod

Date Published : 09/27/2019

5-2220 Midland Ave , Scarborough, Ontario CANADA

21 V - - 04 Guava, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 09/27/2019

Desc: GUAVA DRINK

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

21 V - - 05 Mango, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 09/30/2019

Desc: MANGO DRINK

21 V - - 12 Passion Fruit, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 09/27/2019

Desc: PASSION DRINK

21 V - - 19 Lychee, Lichee, Litchi, Leechee, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 09/27/2019

Desc: LYCHEE DRINK

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

SNAKE BRANDS INC

Date Published : 06/15/2020

25 Glenside Dr Sw , Calgary, Alberta CANADA

54 B - - 11 Potassium (Mineral)

Date Published: 06/15/2020

Desc: ELECTROLYTE POWDER - SNAKE JUICE

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

STAY WYLD ORGANICS LTD

Date Published : 07/27/2022

1911 Hwy 99 , Pemberton, BC CANADA

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/27/2022

Desc: Immunity Boost Capsules

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

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/27/2022

Desc: Cordyceps Militaris Capsules/ Powder

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

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/27/2022

Desc: Daily Immunity Mushroom Blend Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/27/2022

Desc: Reishi Mushroom Capsules

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/27/2022

Desc: Chaga Mushroom Capsules/Powder

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/27/2022

Desc: Turkey Tail Mushroom Capsules/Powder

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 07/27/2022

Desc: Lions Mane Mushroom Capsules/Powder

Skjodt-Barrett Foods

Date Published : 10/16/2018

5 Precidio Crt , Brampton, Ontario CANADA

21 F - - -- Mixed Fruit Purees

Date Published: 08/30/2019

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

40 E - - 20 Mixed Fruit (Baby)

Date Published: 08/30/2019

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

40 E - - 20 Mixed Fruit (Baby)

Date Published: 04/01/2019

Desc: Banana Pumpkin Organic Baby Food

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

Soylutions Inc.

Date Published : 10/02/2015

1629 Des Affaires Ave , Quebec, Quebec CANADA

14 B - - 01 Imitation Milk, Fluid Milk Type Product

Date Published: 10/02/2015

Desc: Unsweetened Original Hemp Bliss Organic Hemp Milk

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

14 B - - 01 Imitation Milk, Fluid Milk Type Product

Date Published: 10/02/2015

Desc: Hemp Dream Hemp Drink

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

14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.

Date Published: 10/02/2015

Desc: Hemp Dream Hemp Drink

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

14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.

Date Published: 10/02/2015

Desc: Unsweetened Original Hemp Bliss Organic Hemp Milk

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

Subi Foods Inc.

Date Published : 07/26/2024

605-6595 Bonsor Ave , Buzz 20 , Burnaby, British Columbia CANADA

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.

Date Published: 07/26/2024

Desc: Vegetable Drink Powder

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act. The labeling is false or misleading because the product was found to contain 32.4% (check analysis 34.4%) of the declared vitamin C content. Section 403(q) of the Act. 21 CFR 101.9 does not provide for the use of another country�s Nutrition Facts label format. serving size of �1 scoop 6.6g� does not appear to be based on the appropriate RACC for beverage. In accordance with 21 CFR 101.12(b), Table 2, the RACC for the �Drink mixes (without alcohol): All other types (e.g., flavored syrups and powdered drink mixes)� product category is the amount to make 360 mL drink (without ice). The label direction provides that 1 scoop of product is used to make 400 mL of the beverage. Section 403(f) of the Act. The label bears a foreign language, but not all required information is provided in both English and the foreign language as required by 21 CFR 101.15(c)(2). The statement of identity is not provided in the foreign language.

54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)

Date Published: 07/26/2024

Desc: Vegetable Drink Powder

54 Y - - 13 Vegetable and Whole Grain Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Anim

Date Published: 07/26/2024

Desc: Vegetable Drink Powder

54 Y - - 17 Vegetable Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 07/26/2024

Desc: Vegetable Drink Powder

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 07/26/2024

Desc: Vegetable Drink Powder

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

55 P - - 01 Glucosamine (Pharmaceutic Necessity)

Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate

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

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 06/21/2016

Desc: Glucosamine and Chondroitin Sulfate

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

CHILE

Nestle Chile S.A.

Date Published : 07/21/2017

Ave. Las Condes No. 11.287 , Comuna de Las Condes , Santiago, Fca Graneros, CHILE

05 B - - 99 Breakfast Food Quick or Instant Cooking, N.E.C.

Date Published: 07/21/2017

Desc: Oatmeal Cereal Cerevita

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

CHINA

ANHUI NEW SELECT FOOD S&T DEVELO

Date Published : 03/07/2017

No 30 Yi Feng Rd Anhui , Huaibei, Anhui CHINA

33 M - - 01 Gel Cups, Fruit Flavored

Date Published: 03/07/2017

Desc: Jelly Fruity Snack; Assorted Flavor (Konjac Jelly)

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

33 M - - 01 Gel Cups, Fruit Flavored

Date Published: 03/07/2017

Desc: Bursting Jelly; Picante (Konjac Jelly)

Beijing Joant Bio-Tech Co., Ltd.

Date Published : 04/06/2015

25 Yanqi Street; Economic Development Zone , Huairou, Beijing CHINA

54 A - - 17 Biotin (Vitamin H, Coenzyme R)

Date Published: 04/06/2015

Desc: Biotin

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

54 E - - 48 Ginkgo biloba (Herbal & Botanical Teas)

Date Published: 04/06/2015

Desc: Gingkgo Biloba

54 E - - 58 Saw Palmetto (Herbal & Botanical Teas)

Date Published: 04/06/2015

Desc: Saw Palmetto

54 F - - 48 Ginkgo biloba (Herbal & Botanicals, not Teas)

Date Published: 04/06/2015

Desc: Gingkgo Biloba

54 F - - 58 Saw Palmetto (Herbal & Botanicals, not Teas)

Date Published: 04/06/2015

Desc: Saw Palmetto

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

Date Published: 04/06/2015

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

CHENGHAI NATIVE PRODUCE IMP.&EXP.COMPANY OF GUANGDONG

Date Published : 10/02/2015

Zhongshan Middle Rd , Chaoyang , Shantou, Guangdong CHINA

33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums

Date Published: 10/02/2015

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

Changle Yongxin Food Co., Ltd.

Date Published : 10/02/2015

Liulin Jenfeng , Changle City, Fujian CHINA

23 A - - 07 Peanut, In Shell

Date Published: 10/02/2015

Desc: Peanuts in Shell

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

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)

Date Published: 10/02/2015

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

DALIAN HUALIAN FOOD CO.LTD

Date Published : 02/28/2018

Xinglinsalian 101 , Jia Heyuan 4 ; 2 No.62; Kaifa , Dalian, Liaoning CHINA

16 W - - 27 Stuffed Pasta with mixed seafood products (n.e.c.), Mixed Fishery/Seafood Products

Date Published: 02/28/2018

Desc: Frozen Tuna Dumpling

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

DANDONG JUNAO FOODSTUFF

Date Published : 05/23/2018

No. 96 Pingancun , Fengcheng , Dandong, Liaoning CHINA

24 A - - 13 Soybeans (See Industry 37 for 'Bean Curd')

Date Published: 05/23/2018

Desc: Edamame

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

Dalian Hualian Food Co.,Ltd.

Date Published : 02/28/2018

Wulucun , Wuluzhen Zhuanghe , Dalian, Liaoning CHINA

16 W - - 27 Stuffed Pasta with mixed seafood products (n.e.c.), Mixed Fishery/Seafood Products

Date Published: 02/28/2018

Desc: Frozen Tuna Dumpling

Dong Wan Hen Hua Cookies Co., Ltd.

Date Published : 10/02/2015

Sang Yuan Industrial Area,Building26, , Guangdong, CHINA

03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C.

Date Published: 10/02/2015

Desc: Sesame Cracker (Cookie)

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

FUJIAN RUIYUN FOODS CO.,LTD

Date Published : 01/06/2022

FUXI NORTH ROAD AOJIANG DISTRICT , LIANJIANG ECONOMIC DEVELOPMENT ZONE , LIANJIANG COUNTY,FUZHOU CITY, Fujian CHINA

16 C - - 56 Filefish, Cakes, Balls, Etc.

Date Published: 01/06/2022

Desc: FISH BALLS (5 LB)

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

16 C - - 56 Filefish, Cakes, Balls, Etc.

Date Published: 01/06/2022

Desc: FISH BALLS (14 OZ)

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

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.

Date Published: 01/06/2022

Desc: FISH BALLS (5 LB)

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

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.

Date Published: 01/06/2022

Desc: FISH BALLS (14 OZ)

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

16 W - - 29 Fish Dumplings, Mixed Fishery/Seafood Products

Date Published: 01/06/2022

Desc: FISH BALLS (5 LB)

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

16 W - - 29 Fish Dumplings, Mixed Fishery/Seafood Products

Date Published: 01/06/2022

Desc: FISH BALLS (14 OZ)

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

Fujian Changle Yongxin Food Co., Ltd

Date Published : 10/02/2015

No. 150 Xin Dong Yang , Jinfengzhen Changle , Fuzhou, Fujian CHINA

23 A - - 07 Peanut, In Shell

Date Published: 10/02/2015

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)

Date Published: 10/02/2015

Fuzhou Pujing Fastfood Co., Ltd.

Date Published : 10/24/2024

No. 9 Middle Road 5, Phase 1 Minhou Economic and Technological Development Zone , Jingxi, Minhou County , Fuzhou, Fujian CHINA

02 D - - 99 Rice, Processed (Packaged) N.E.C.

Date Published: 10/24/2024

Desc: Rice Flakes

03 A - - 03 Biscuits

Date Published: 10/24/2024

Desc: Rice Flakes

03 F - - 07 Rice Crackers

Date Published: 10/24/2024

Desc: Rice Flakes

04 C - - 99 Noodles And Noodle Products, N.E.C.

Date Published: 10/24/2024

Desc: Rice Flakes

05 A - - 03 Rice Flakes,Puffs,Krispies,Loops Ready To Eat

Date Published: 10/24/2024

Desc: Rice Flakes

07 B - - 99 Fried Snack Foods, N.E.C.

Date Published: 10/24/2024

Desc: Rice Flakes

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)

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)

Guangzhou Peninsula Food Co., Ltd.

Date Published : 09/25/2019

Ping Dong Industrial Zone , Huadu District , Huashan Town, CHINA

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.

Date Published: 09/25/2019

Desc: Chinese Moon Cake- Red Bean Paste Moon Cake with Tangerines and Nuts

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

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 09/25/2019

Desc: Chinese Moon Cake- Red Bean Paste Moon Cake with Tangerines and Nuts

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 09/25/2019

Desc: Chinese Moon Cake- Red Bean Paste Moon Cake with Tangerines and Nuts

HANGZHOU XIAOSHAN HEZHUANGSHUCAI JIANGPIN CO., LTD

Date Published : 02/02/2017

43 Zhejiang Xiaoshan , River Town Village , Hangzhou, Zhejiang CHINA

25 L - - 07 Radish, Dried or Paste

Date Published: 02/02/2017

Desc: Dried Vegetable (Dried Radish)

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

Hainan Resurgence Natural Healthy F

Date Published : 10/02/2015

105 Numbersof , Guangzhou Cityguangzhou City, CHINA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 10/02/2015

Desc: Fruta Bio Dietary Supplement

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

Haoliyou(shanghai)Food Co

Date Published : 01/25/2022

Qingpu Industrial Park , No. 5151 Waiqingsong Road; Qingpu , Shanghai, Shanghai CHINA

07 A - - 06 Potato Chips,Baked

Date Published: 01/25/2022

Desc: POTATO CHIPS (Honey Flavor)

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

07 B - - 06 Potato Chips,Fried

Date Published: 01/25/2022

Desc: POTATO CHIPS (Honey Flavor)

07 B - - 99 Fried Snack Foods, N.E.C.

Date Published: 01/25/2022

Desc: POTATO CHIPS (Honey Flavor)

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)

54 F - - 92 Codonopsis tangshen

Date Published: 04/24/2017

Desc: Mulberry Twig Combo Tea Extract (Guan Jie Bi Tong Wan)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 04/24/2017

Desc: Calmex Tablets

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

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 04/24/2017

Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement tablets

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)

54 F - - -- Herbal & Botanicals(other than teas)

Date Published: 04/24/2017

Desc: Rehmannia Root Combo Tea Extract (Xiao Feng Wan)

JILIN PROVINCE YANGTIANZHENG SPECIAL LOCAL PRODUCTS CO.LTD.

Date Published : 07/17/2024

Beigang Village, Beigang , Town, Fusong County , Baishan, Jilin CHINA

54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas)

Date Published: 07/17/2024

Desc: ASTRAGALI RADIX

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. � 343(e)(2)] and [15 U.S.C. 1453(a)(2) and (3)] of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of U.S. customary units on the PDP in accordance with 21 CFR 101.7. For example, the units appear to be only declared in grams, not standard US measurements and the net quantity of contents is declared as �net wt: (450�5)g� which is not an accurate statement. We also note that the plus-minus sign is not provided for in 21 CFR 101.7. Section 403(q) of the Act [21 U.S.C. �343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.

Jiangmen Pengjiang Huiming Trading Company

Date Published : 10/02/2015

Unit A,12/F,Dongxing Ge,Donghua , Building,128 Gangkou Road,China , Jiangmen, CN-NOTA CHINA

23 A - - 07 Peanut, In Shell

Date Published: 10/02/2015

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

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)

Date Published: 10/02/2015

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

Jiangmen Xinhui Green Day Food Co., Ltd

Date Published : 12/02/2020

No. 1 Donggua Hill, Beitou Village, Qibao , Xinhui District , Jiangmen City, Guangdong CHINA

25 S - - 10 Fungus, White, Fungi Products, N.E.C.

Date Published: 01/07/2022

Desc: INDIAN BUEAD

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

25 S - - 99 Fungi Products Not Mentioned Elsewhere, N.E.C.

Date Published: 01/07/2022

Desc: INDIAN BUEAD

33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate)

Date Published: 12/02/2020

Desc: Mix Gummy candy

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

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)

Date Published: 12/02/2020

Desc: Mix Gummy candy

33 J - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Fruit (without Chocolate)

Date Published: 12/02/2020

Desc: Mix Gummy candy

33 L - - 06 Flavored Candy, Soft (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)

Date Published: 12/02/2020

Desc: Mix Gummy candy

33 Y - - 99 Candy Without Chocolate N.E.C.

Date Published: 12/02/2020

Desc: Mix Gummy candy

Jk Tea Co., Ltd

Date Published : 11/17/2020

No.3 Chun Hong Room 2ST , 803 Baiyundadao; Baiyun , Guangzhou, Guangdong CHINA

31 K - - 02 Tea, Green

Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum

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

31 K - - 99 Tea, N.E.C.

Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum

31 M - - 99 Blended Teas, N.E.C.

Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum

54 E - - 03 Angelica (Herbals & Botanical Teas)

Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum

54 E - - 99 Herbals & Botanical Teas, N.E.C.

Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 11/17/2020

Desc: Immortal Tea JIAOGULAN LEAF Gynostemma Pentaphyllum

Kaiping Qinghui Food Co., Ltd.

Date Published : 07/18/2022

Number 12 Industrial Avenue, New District, Huanggang Town , Kaiping , Jiangmen City, Guangdong Province CHINA

03 A - - 03 Biscuits

Date Published: 07/18/2022

Desc: Binji Ox Ear Biscuits

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

Kunming Aoqun Bio-Tech Co,. Ltd

Date Published : 11/21/2024

Kunming National High & New Room 2nd , Floor;209 2188 No. Kegao Road , Kunming, Yunnan CHINA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 11/21/2024

Desc: Muscle Ease dietary supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. 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 article�s �Suggested Use� instructions state �For the best results, take 2-3 capsules daily, or as required�. The serving size should be 3 capsules. Nutrition information on the labeling does not comply with 21 CFR 101.36 and 101.9. �Supplements Facts�, is not set at full width of the nutrition label (21 CFR101.36(e)(1)). No provision in the regulation to include the heading �ingredients� within the Supplement Facts label. A heavy bar is not placed beneath the subheading �Servings Per Container� (21 CFR 101.36(e)(6)(i)), and beneath the final (b)(2)-dietary ingredient (21 CFR 101.36(e)(6)(ii)). Dietary ingredients that comprise the proprietary blend do not appear to be indented (21 CFR 101.36(c)(2)). Missing hairline rules centered between the lines of text to separate the dietary ingredients above from the dietary ingredients below (21 CFR 101.36(c)(2) and (e)(5)). Section 403(i)(2) of the Act. Label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4(h). Label lists �Panax Notoginseng�, but this is not the standardized common name (SCN) in the reference Herbs of Commerce (HOC). Section 403(s)(2)(C) of the Act. Labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h), botanical dietary ingredients �Turmeric� and �Tart Cherry� do not list the plant part.

Life Rising (Tianjin) Natural Product R&D Center LTD

Date Published : 12/12/2016

# 12 Luyuan Street , Wuqing, Tianjin CHINA

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising YANT Throat Support

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

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising GMD Licorice Wheat & Date Formula

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising B Chest Circulation Support

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)

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising HB Nose Regulator-H

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising EAR-CALM Ear Calm-DH

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising GH Regulate Liver

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising UT-DBS Urine Tract Cleanser

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising DHT-INT Intestine Support

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising PDL Cool Regulator

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising HWDZ Stomach Regulator

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising PROST-IF Prostate Regulator-IF

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising Qi-Yin Up Energy Support

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 12/12/2016

Desc: Life Rising HNSH Kidney Herb

MICO FOODSTUFF CO., LTD

Date Published : 07/18/2022

NO. 806 No3 West 4th Block , Longhu District , Shantou City, Guangdong CHINA

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

Qingdao Heritage Food Co., Ltd.

Date Published : 12/26/2024

No. 61 Hongkong Road , Pingdu , Qingdao, Shandong CHINA

20 B - - 14 Strawberries, Dried or Paste

Date Published: 12/26/2024

Desc: DRIED FANCY STRAWBERRIES

Notes: The article is subject 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)] because it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption. Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient (21 CFR 101.4). Section 403(i)(1) of the Act [21 U.S.C. � 343(i)(1)] because the products do not appear to bear appropriate statements of identity (21 CFR 101.3) The products appear to be �dehydrated candied strawberry�. Section 403(e)(1) of the Act [21 U.S.C. � 343(e)(1)] because the dehydrated strawberries 5kg carton label does not include the full address of the manufacturer, packer, or distributor (21 CFR 101.5(d)). Label only states that it is a product of China.. Section 403(k) of the Act [21 U.S.C. � 343(k)] because the ingredient �red cabbage� is being used for color, but color is not being declared in the ingredient statement by common or usual name or by an informative term e.g., �Artificial Color� (21 CFR 101.22(k)(2)).

S&A TRADING LIMITED

Date Published : 03/21/2016

Unit 17,5/F,Sing Win Factory BLDG,15-17 , Shing Yip ST.,Kwun Tong,Kowloon,HK , Kowloon, CN-91 CHINA

03 J - - 10 Creme Filled/Iced Cookie,Biscuit,Wafer

Date Published: 03/21/2016

Desc: Milk Biscuits (cookies)

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q); 403(i)(2); and 403(f).

SHANDONG GAOTANG HAOJIAJIA FOOD CO.,LTD

Date Published : 10/26/2020

West Of Renhe Road, Gaotang County , Liaocheng, Shandong CHINA

03 A - - 03 Biscuits

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - STRAWBERRY FLAVOR

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(a)(1) of the Act in that the label is false and misleading because the amount of Total Sugars present is greater than 20% in excess than the value for that nutrient declared on the label (21 CFR 101.9(g)(5)). Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

03 A - - 03 Biscuits

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS- SOYMILK FLAVOR

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

03 A - - 03 Biscuits

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - ORIGINAL FLAVOR

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 B - - 99 Fried Snack Foods, N.E.C.

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - STRAWBERRY FLAVOR

07 B - - 99 Fried Snack Foods, N.E.C.

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS- SOYMILK FLAVOR

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 B - - 99 Fried Snack Foods, N.E.C.

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - ORIGINAL FLAVOR

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 S - - 99 Starch Snacks, n.e.c., Baked

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - STRAWBERRY FLAVOR

07 S - - 99 Starch Snacks, n.e.c., Baked

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS- SOYMILK FLAVOR

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

07 S - - 99 Starch Snacks, n.e.c., Baked

Date Published: 10/26/2020

Desc: SOYMILK BISCUITS - ORIGINAL FLAVOR

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act because the ingredient statements do not meet the requirements in 21 CFR 101.4

SHANDONG YI QI WANG FOOD CO LTD

Date Published : 10/14/2020

1 West Of Renhe Road , Liaocheng, CHINA

21 V - - 14 Tamarind, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 10/14/2020

Desc: Yogurt Ice Pop Original

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(i)(2)] because all required information does not appear to be presented in all languages on the label (21 CFR 101.15(c)(2)). Section 403(k) of the Act [21 U.S.C. � 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(g) of the Act [21 U.S.C. � 343(g)] because the product purports to be a food for which a definition and standard of identity has been prescribed by regulation, but fail to conform to such definition and standard. Section 403(q) of the Act [21 U.S.C. �343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9.

21 V - - 14 Tamarind, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 10/14/2020

Desc: Yogurt Ice Pop Strawberry Flavor

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(i)(2)] because all required information does not appear to be presented in all languages on the label (21 CFR 101.15(c)(2)). Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Section 403(k) of the Act [21 U.S.C. � 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(g) of the Act [21 U.S.C. � 343(g)] because the product purports to be a food for which a definition and standard of identity has been prescribed by regulation, but fail to conform to such definition and standard.

21 V - - 14 Tamarind, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Date Published: 10/14/2020

Desc: Yogurt Ice Pop Passion Fruit

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(i)(2)] because all required information does not appear to be presented in all languages on the label (21 CFR 101.15(c)(2)). Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. Section 403(k) of the Act [21 U.S.C. � 343(k)] because the product contains an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(g) of the Act [21 U.S.C. � 343(g)] because the product purports to be a food for which a definition and standard of identity has been prescribed by regulation, but fail to conform to such definition and standard.

SHANGHAI AB FOOD & BEVERAGES LTD.

Date Published : 10/02/2015

No.8 LANCUN RD.,MINHANG ECON,TECH& , DEV.ZONE , Shanghai, Shanghaishi CHINA

34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C.

Date Published: 10/02/2015

Desc: Ovaltine

Notes: VIOLATION (IN NOTES): 1. 403(r)(1)(A) ; 403(q) 1. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(r)(1)(A) in that the label or labeling bears an unauthorized nutrient content claim. For example, the label declares that it contains high amounts of calcium and vitamin A. However, based on the serving size information provided, these nutrients are not present at 20 percent or more of the RDI or the DRV per reference amount customarily consumed (RACC) [21 CFR 101.54(b)];2. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(q) in that the label or labeling fails to comply with the nutrition labeling format requirements in 21 CFR 101.9. For example: The serving size is not declared in common household measure or common household unit in accordance with 21 CFR 101.9(b)(5); The declaration of Nutrition Information is not presented using the nutrient names specified and in the order and format specified in 21 CFR 101.9(c); The label is not formatted (e.g., bolding, indenting, and rounding) appropriately as specified in 21 CFR 101.9(d);3. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of 403(i)(2): The ingredients are not declared in accordance with 21 CFR 101.4. For example, vegetable fat must be declared by its specific common or usual name of the individual vegetable fat in parenthesis [21 CFR 101.4 (b)(14)] and the term acidity regulator (E504i) is not the common or usual name of this ingredient.

SHEN ZHEN EVERGREEN BIO-HEALTH TECHNOLOGY

Date Published : 09/12/2024

Block D Room 1105 , Longcheng Street , Shenzhen, CHINA

41 Y - - 99 Dietary Conventional Foods, N.E.C.

Date Published: 09/12/2024

Desc: Chlorella 1000 Tablets (250g) dietary supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(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 products do not comply with 21 CFR 101.36 and 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. �343(r)(1)(A)] in that the labeling of the article does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b) and (c). Section 403(s)(2)(B) of the Act [21 U.S.C. �343(s)(2)(B)] in that the label fails to include a statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(y) of the Act [21 U.S.C. �343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in Section 761 of the Act [21 U.S.C. 379aa-1].

41 Y - - 99 Dietary Conventional Foods, N.E.C.

Date Published: 09/12/2024

Desc: Chlorella Powder 8 oz dietary supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the label is false or 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. 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 products do not comply with 21 CFR 101.36 and 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. �343(r)(1)(A)] in that the labeling of the article does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b) and (c). Section 403(s)(2)(B) of the Act [21 U.S.C. �343(s)(2)(B)] in that the label fails to include a statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(y) of the Act [21 U.S.C. �343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in Section 761 of the Act [21 U.S.C. 379aa-1].

54 Y - - 03 Chlorella (tablet), Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, n.e.c.)

Date Published: 09/12/2024

Desc: Chlorella 1000 Tablets (250g) dietary supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/12/2024

Desc: Chlorella Powder 8 oz dietary supplement

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the label is false or 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. 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 products do not comply with 21 CFR 101.36 and 21 CFR 101.9. Section 403(r)(1)(A) of the Act [21 U.S.C. �343(r)(1)(A)] in that the labeling of the article does not meet the requirements to bear the claims in accordance with the requirements under 21 CFR 101.54(b) and (c). Section 403(s)(2)(B) of the Act [21 U.S.C. �343(s)(2)(B)] in that the label fails to include a statement of identity as a �dietary supplement� on the principal display panel, except that the word �dietary� may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(y) of the Act [21 U.S.C. �343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in Section 761 of the Act [21 U.S.C. 379aa-1].

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/12/2024

Desc: Chlorella 1000 Tablets (250g) dietary supplement

SSG (CHINA)

Date Published : 08/14/2017

No. 26 Jianguomen Nei Da Jie , 5th Floor, Beijing News Plaza , Beijing, Tianjin CHINA

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

Date Published: 08/14/2017

Notes: Life Minerals Liquid; Section 403(s)(2)(B) of the Act in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement" in accordance with 21 CFR 101.3(g). Section 403(a)(1) of the Act in that the label is false and misleading in any particular. Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(r)(1)(A) of the Act because the product label bears a nutrient content claim, but fails to meet the requirements to bear the claim. Section 403(i)(2) of the Act [21 U.S.C.�343(i)(2)], in that it is fabricated from two or more ingredients but, the product label fails to declare the source ingredient for the listed dietary ingredients as required by 21CFR 101.4(a)(1) and (g). Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages as required by 21CFR 101.15(c).

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 08/14/2017

Desc: Life Minerals Liquid

Notes: Section 403(s)(2)(B) of the Act in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement" in accordance with 21 CFR 101.3(g). Section 403(a)(1) of the Act in that the label is false and misleading in any particular. Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(r)(1)(A) of the Act because the product label bears a nutrient content claim, but fails to meet the requirements to bear the claim. Section 403(i)(2) of the Act [21 U.S.C.�343(i)(2)], in that it is fabricated from two or more ingredients but, the product label fails to declare the source ingredient for the listed dietary ingredients as required by 21CFR 101.4(a)(1) and (g). Section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages as required by 21CFR 101.15(c).

SUZHOU TAISHAN FOOD INDUSTRY CO.,LTD

Date Published : 04/27/2016

Ang,Xiangcheng , No. 168 He South Street; Weitangzhen Xiangcheng , Suzhou, Jiangsu CHINA

23 K - - 04 Sunflower Seed (Edible Seed)

Date Published: 04/27/2016

Desc: Original Flavored Sunflower Seeds

23 K - - 04 Sunflower Seed (Edible Seed)

Date Published: 04/27/2016

Desc: Spicy Flavored Sunflower Seeds

23 K - - 05 Melon Seeds (Edible Seed)

Date Published: 04/27/2016

Desc: Licorice Flavored Melon Seeds

Notes: The product labels fail to declare the net quantity of contents on the PDP in English in U.S. measurements (21 CFR 101.105) followed in parenthesis with the metric equivalent. [15 U.S.C. 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. The product labels display incorrect placement and prominence of the statement of identity that is not in accordance with 21 CFR 101.3. The product labels list no street address of the distributor and no address or city of the manufacturer. We would comment to the firm that the street address may be omitted only if the business is shown in a current city directory or telephone directory [21 CFR 101.5(d)]. The product labels contain a statement "Allergy Information contains sulfite; sun flower seeds (black melon seeds; pumpkin seeds); salt" which is not provided for under Food Allergen Labeling and Consumer Protection Act. The Licorice Melon Seeds (Package & Container) list the incorrect common or usual names for "saccharin sodium" and "potassium acesulfame." The ingredients should be listed as "sodium saccharin" and "acesulfame potassium." (21 CFR 101.4). The amount of calcium (50% DV) declared on the nutrition label for the Licorice Melon Seeds (package and container) appears to be incorrectly declared.

Saint Honore Cake Shop (Shenzhen), Ltd.

Date Published : 12/07/2021

Hengfeng Industrial City , Hezhou, Xixiang , Baoan, Shenzhen, Guandong CHINA

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Low Sugar Egg Yolk White Lotus Seed Paste

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.

Date Published: 12/07/2021

Desc: Moon cake; Double Yolk White Lotus Seed Paste

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. �343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(e)(2) of the Act [21 U.S.C. �343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m).

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Assorted nuts

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. �343(e)(2)] because it fails to bear a statement of the net quantity of contents that complies with the requirements of 21 CFR 101.7. See examples in 21 CFR 101.7(m). Section 403(f) of the Act [21 U.S.C. �343(f)] because all required statements are not written in English as required by 21 CFR 101.15(c)(1). The products appear to be wrapped inside the outer container and those inner wrappings include labeling, such as a statement of identity. As such, all required statements should also be present in English. Section 403(i)(2) of the Act [21 U.S.C. � 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example, this product is labeled to contain �Orange Peel Jam, Rose Wine, Honey Grapefruit Jam� which would appear to themselves be comprised of multiple ingredients (sub-ingredients) which are not listed in the ingredient statement. component ingredients (or �sub-ingredients�) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; White Lotus Seed Paste

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Egg Yolk White Lotus Seed Paste

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Assorted; mini

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; White Lotus Seed Paste

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Low Sugar Egg Yolk White Lotus Seed Paste

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Assorted nuts

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Egg Yolk White Lotus Seed Paste

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Assorted; mini

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.

Date Published: 12/07/2021

Desc: Moon cake; Double Yolk White Lotus Seed Paste

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Low Sugar Egg Yolk White Lotus Seed Paste

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 12/07/2021

Desc: Moon cake; Double Yolk White Lotus Seed Paste

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Assorted; mini

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Egg Yolk White Lotus Seed Paste

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; White Lotus Seed Paste

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 12/07/2021

Desc: Moon Cake; Assorted nuts

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

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.

Date Published: 10/02/2015

Desc: Mixed Vegetable Chips

Shanghai Xin Chen Da Industrial Development Co. Ltd.

Date Published : 02/02/2021

Room 1301, Building 1, No.1318, Zhouzhugong Road , Pudong New Area , Shanghai, Shanghai CHINA

16 A - - 99 Fish, N.E.C.

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages, 21 CFR 101.15(c). The Nutrition Facts label is not in the foreign language. 21 CFR 101.15(c)(2) and 21 CFR 101.9(d)(14). Section 403(i)(1) of the FD&C Act of the Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Product "Fish with Pickled Mustard-Green" fails to declare the ingredient "Pickled Mustard-Green" as ingredient. Statement of identity must be in a size reasonably related to most prominent printed matter on such panel and must be in lines generally parallel to the base of package as it is designed to be displayed. 21 CFR 101.3(d). Section 403 (i)(2) of the FD&C Act in that the product is fabricated from two or more ingredients and common or usual name of each ingredient is not declared on label. 21 CFR 101.4. "Black fish" is not an appropriate common or usual name for a seafood ingredient [21 CFR 101.4] and FDA's Seafood List. Black Fish Fillets ingredient statement declares "vegetable oil" but fails to list the source of the oil 21 CFR 101.4(b)(14). Ingredient "MSG" is not declared by its common or usual name 21 CFR 101.22(h)(5). MSG used as an ingredient in food must be declared by its common or usual name "monosodium glutamate." "Food Enrich" is not an appropriate common or usual name in the ingredient statement. Sub-ingredients of "Food Enrich" appear to be different. If citric acid, sodium pyrosulfite or any other ingredient are functioning as a chemical preservative, then function must be declared in accordance with 21 CFR 101.22(j). Incorrectly grouped under a collective name, include, but are not limited to: compound acidity regulator, water retention agent, sauerkraut ingredients, and baked wattle

16 W - - 11 Fish fillet sandwiches, Mixed Fishery/Seafood Products

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

16 W - - 15 Fish chowder/soup/stew/bisque, Mixed Fishery/Seafood Products

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

Suzhou MyLand Pharm&Nutrition Inc.

Date Published : 02/12/2016

China (Jiangsu) Pilot Free Trade Zone Second Floor , China (Jiangsu) Pilot Free Trade Zone; Bachengzhen Kunshan , Suzhou, Jiangsu CHINA

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 02/12/2016

Desc: Blueberry extract

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

Suzhou Shui Tian Tang Food Production Co., Ltd.

Date Published : 02/02/2021

No 11 Guanshan Road , High-Tech District , Suzhou, Jiangsu CHINA

16 A - - 99 Fish, N.E.C.

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

16 W - - 11 Fish fillet sandwiches, Mixed Fishery/Seafood Products

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

16 W - - 15 Fish chowder/soup/stew/bisque, Mixed Fishery/Seafood Products

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.

Date Published: 02/02/2021

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"

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

Tianjin Medicines & Health Products Import & Export Corp.

Date Published : 01/13/2017

Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao , Tianjin, Tianjin CHINA

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

Date Published: 01/13/2017

Notes: All Dietary Supplements; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Act [21 U.S.C. � 343 (y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. �343(q)(1)(A)] because the serving size declared on the labels are incorrect.

Tianjin Medicines & Health Products Import & Export Corp.

Date Published : 01/13/2017

Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao , Tianjin, Tianjin CHINA

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)

Date Published: 01/13/2017

Notes: All Dietary Supplements;The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(y) of the Act [21 U.S.C. � 343 (y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. �343(q)(1)(A)] because the serving size declared on the labels are incorrect.

Tianjin Zhanhe Vegetable Co.,

Date Published : 10/30/2019

Wuqing District , 8 Xixiaozhuang Village; Chagugang Town , Tianjin City, Tianjin CHINA

03 A - - 09 Non-Standard Bread/Rolls/Buns

Date Published: 10/30/2019

Desc: Walnut Bun

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act 21�343(i)(2)-it is fabricated from two/more ingredients,but fails to declare each one(21CFR101.4).LBL declares "white chocolate" as an ingredient,but fails to list sub ingredients(21CFR101.4(b)(2);"vegetable oil"-if an individual ingredient,it is not declared by its common/usual name and if a blend, it is not declared by their common/usual names(21CFR101.4(b)(14);and "starch acetate" is not declared by its common/usual name. Section 403(f) of the Act (21U.S.C. �343(f)-LBL bears information in a foreign language,but fails to repeat all required information in this language(21CFR101.15(c)(2). Section 403(q) of the Act [21�343(q)-nutrition information is not presented as per 21CFR101.9."Nutrition Facts" must be set the full width of the box (21CFR 101.9(d)(2)."Servings Per Container" is not declared(21 CFR 101.9(d)(3)(ii)."Amount" must be declared as "Amount Per Serving"(21CFR101.9(d)(4).Calories must be expressed to the nearest 10-calorie increment(21CFR101.9(c)(1)."Calories from fat" is not declared (21CFR101.9(c)(1)(ii)."Fat" must be declared as "Fat,total" or "Total fat" and expressed to the nearest gram(21CFR101.9(c)(2).(21 CFR101.9(c)(2)(ii) does not provide for a "+" before "Trans" and %DV cannot be declared for saturated fat and trans-fat combined because there is no DRV established for trans-fat.21CFR101.9 does not provide for the combine %DV declaration for two nutrients."Carbohydrate" must be declared as "Carbohydrate,total" or "Total carbohydrate" and expressed to the nearest gram(21CFR101.9(c)(6)."Fiber" must be declared as "Dietary fiber" and expressed to the nearest gram(21CFR101.9(c)(6)(i).Sugars must be expressed to the nearest gram(21CFR101.9(c)(6)(ii).%DV for Vitamins A/C must be expressed to the nearest 2% increment(21CFR101.9(c)(8)(iii).Footnote is not declared(21CFR101.9(d)

03 A - - 99 Bread/Rolls/Buns, N.E.C.

Date Published: 10/30/2019

Desc: Walnut Bun

03 D - - 99 Bread, Rolls, Buns, Etc N.E.C. Heat/Serve

Date Published: 10/30/2019

Desc: Walnut Bun

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 10/30/2019

Desc: Walnut Bun

Weihai Baihe Biology Technological Co., Ltd.

Date Published : 04/24/2023

No. 552 Chengda Road , Chengshanzhen Rongcheng , Weihai, Shandong CHINA

36 C - - 99 Honey, N.E.C.

Date Published: 04/24/2023

Desc: Honey Complex Beverage

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that each component product appears to be misbranded within the meaning of Section 403(i)(2) in that the component product labels fail to declare all the common or usual names of each ingredient. For example, the product label lists �Hedera Helix extract�, but this is not the common or usual name of the dietary ingredient. Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived. Section 403(q)(1)(A) because the serving size declared on the Supplement Facts label is not declared for each intended group. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label. Section 403(e)(2) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce. The net quantity of contents statement, expressed in terms of fluid measure, must specify both metric (i.e., milliliters) and U.S. Customary System (i.e., fluid ounces). Section 403(q)(5)(F) and 403(q)(1)(A) in that the presentation of the nutrition information on the labeling of your products does not comply. Section 403(r)(6) because the required dietary supplement disclaimer which is preceded by a linking symbol, fails to be linked to the structure function claims on the product.

XINXING COUNTY HONGBAO FOOD CO., LTD

Date Published : 10/10/2018

Taiping Town , Gongcheng Dalang District , Jiangmen City, Guangdong CHINA

21 H - - 14 Plum, Dried or Paste

Date Published: 10/10/2018

Desc: Plum; 168g package

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(e)(1) of the Act [21 U.S.C. �343(e)(1)] in that the product labels fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. -Section 403(e)(2) of the Act [21 U.S.C. �343(e)(2)] and 15 U.S.C. � 1453(a)(2) and 15 U.S.C. � 1453(a)(3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1), followed by the metric equivalent in parenthesis [15 U.S.C. � 1453(a)(2) of FPLA]. -Section 403(i)(1) of the Act [21 U.S.C. �343(i)(1)] in that each ingredient is not declared with an appropriate statement of identity in accordance with 21 CFR 101.3. -Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)] in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. -Section 403(f) of the Act [21 U.S.C. �343(f)] because the product label contains information in two or more languages but does not repeat all the required information in both languages. - Section 403(k) of the Act [21 U.S.C. � 343(k)]. Because the product label is not in accordance with 21 CFR 182.3640 and 182.3766 respectively, these ingredients are both chemical preservatives. Therefore, their function must be declared in accordance with 21 CFR 101.22(j), -Section 403(q) of the Act [21 U.S.C. �343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.

21 H - - 14 Plum, Dried or Paste

Date Published: 10/10/2018

Desc: Dried Plums; 4.9 oz jar

21 H - - 14 Plum, Dried or Paste

Date Published: 10/10/2018

Desc: Preserved Plum; 88g package

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

ZHONGSHAN CITY HONGWANG FOOD

Date Published : 11/08/2022

Fuxing Industrial District , Lv Yun Road , Zhongshan, CN-44 CHINA

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 11/08/2022

Desc: Almond Cake; 500g

Notes: - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. �343(f)] because it contains information in a second language, Chinese. - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. � 343(e)(1)] in that the product label lists the US firm name and address but fails to state the name of the firm qualified by a phrase that reveals the connection such person has with such food. - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. � 343(q)] - The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1)/201(n) of the Act [21 U.S.C. � 343(a)(1)/321(n)] in that the product label fails to reveal the material fact that the identified flavor is, in part, artificially derived.

ZHONGSHAN HONGWANG FOOD CO LTD

Date Published : 11/08/2022

No. 21 Lvyun Road , Xiaolan Town , Xhongshan City, CHINA

03 Y - - 99 Other Bakery Products, N.E.C.

Date Published: 11/08/2022

Desc: Almond Cake; 500g

Zhongshan Kunbo Foodstuff Import & Export Corp. Ltd.

Date Published : 10/02/2015

NO. 32 Changyi Road , Changmingshui Village, Wuguishan , Zhongshan, Guangdong CHINA

22 A - - 07 Winter Melon (Vine Fruit)

Date Published: 10/02/2015

Desc: Sweet Wintermelon

Notes: The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07

23 K - - 06 Lotus Seed (Edible Seed)

Date Published: 10/02/2015

Desc: Sweet Lotus Nuts

Notes: The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii). 6/6/07

Zhuhai Economic Special Zone General Non-Staple Food Corp.

Date Published : 10/02/2015

1092 Jiuzhou Road , Zhuhai, Guangdong CHINA

25 J - - 14 Turnip (Root & Tuber Vegetable)

Date Published: 10/02/2015

Desc: Salted Turnip

guangzhou p'product

Date Published : 04/05/2023

Chadong Industry Panyu , Shi Ji , Guangzhou, Guangdong CHINA

54 E - - 99 Herbals & Botanical Teas, N.E.C.

Date Published: 04/05/2023

Desc: Herba Plantaginis (Plantain Herb)

Notes: The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act, in that it appears to be misbranded as defined in: Section 403(a)(1) of the Act, in that the article's labeling appears to be false or misleading. Section 403(i)(2) of the Act, in that it appears to be a food fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. Firm previously listed on deactivated Import Alert 54-08 due to the presence of Digitalis. DWPE date: 04/06/2007.

jiangmen pengjiang huiming trading company

Date Published : 10/02/2015

Flat 11 , 116 Mingxinglu; Jiangmen,Guangdong,China , Jiangmnsh, Yandong CHINA

23 A - - 07 Peanut, In Shell

Date Published: 10/02/2015

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

33 J - - 07 Jellied Candy, Soft (Jelly Beans, Gum Drops, Etc.), with Fruit (without Chocolate)

Date Published: 10/02/2015

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

mico foodstuff co., ltd.

Date Published : 07/18/2022

Building 19, Xinghucheng, No.179 Room 1701 , Jinsha Road; Longhu District , Shantou, Guangdong CHINA

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 01/27/2023

Desc: CHALLENGE FRUIT SHAPE JELLIES (Fruit Shape CC Jelly)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, as required by 21 CFR 101.22(j). Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived, as required by 21 CFR 101.22(i)(2).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

21 N - - 04 Mixed Fruit Flavored Imitation Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 01/27/2023

Desc: CHALLENGE FRUIT SHAPE JELLIES (Fruit Shape CC Jelly)

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

30 Y - - 01 Grass Jelly Drink Beverage Base

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 J - - 09 Marshmallow Candy, Soft, with Fruit (without Chocolate)

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Bear Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Girl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Pig Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Tiger Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 11/17/2022

Desc: Cat Jar Assorted Flavor Fruit Jelly Bite Snack

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived. the characterizing flavors are not declared, 21 CFR 101.22(i)(2). Section 403(f) of the Act in that the label appears to be placed on the bottom of the container instead of on the principal display panel or the on the information panel 21 CFR 101.2(b) and 21 CFR 101.15(a). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name, 21 CFR 101.4. Label lists list a warning statement �WARNING: THIS PRODUCT CONTAINS FRUIT CHUNKS�.� However, no actual fruit is declared as ingredient. �Edible� in �Edible Artificial Color� is not part of the common or usual name of the ingredients. All color ingredients must be declared individually in descending order of predominance within the ingredient list. Section 403(k) of the Act in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact, 21 CFR 101.22(j).

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Owl Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

33 M - - 06 Jelly Fruit Poppers Candy

Date Published: 07/18/2022

Desc: Assorted Fruit Jellies in Boy Jar

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. �343(k)] in that the products contain an artificial coloring, flavoring, or a chemical preservative but do not bear labeling stating that fact. Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] and section 201(n) of the Act [21 U.S.C. �321(n)] in that the label is false or misleading because it fails to reveal the material fact that the identified flavor is artificially derived.

COLOMBIA

ALIMENTIC SAS

Date Published : 11/06/2017

Calle 64a 103 18 , Bogota, Cundinamarca COLOMBIA

03 A - - 03 Biscuits

Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit

Notes: Section 403 (e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight; measure; or numerical count. Section 403 (i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient.

07 A - - 03 Cheese Puffs, Baked

Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit

07 B - - 03 Cheese Puffs, Fired

Date Published: 11/06/2017

Desc: Achiras Huilenses Celio Cheese Biscuit

GRASCO LTDA.

Date Published : 10/25/2017

Pensilvania , Carrera 35 7 - 50 , Bogota, Cundinamarca COLOMBIA

26 E - - 99 Oleomargarine, N.E.C.

Date Published: 10/25/2017

Desc: La Fina Margarina De Mesa Y Concina

Notes: The product appears to be misbranded within the meaning of: (1) Section 403(f) of the Act [21 U.S.C. �343(f)] because the labels bear representations in a foreign language; however, all of the required information does not appear to be provided in both languages. (2) Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. �343(r)(1)(A)] because the product labels bear nutrient content claims, but fail to meet the requirements to bear the claim.. (3) Section 403(i)(1) of the Act [21 U.S.C. �343(i)(1)] in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b).

26 E - - 99 Oleomargarine, N.E.C.

Date Published: 10/25/2017

Desc: La Fina Suave! Con Sal

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

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

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

07 Q - - 13 Corn Puffs (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked

Date Published: 10/27/2017

Desc: Gudiz Sweet Corn Balls

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)

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.

Date Published: 10/27/2017

Desc: Chokis Chocolate Covered Corn Balls

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.

Date Published: 10/27/2017

Desc: De Todito Paketon BBQ Chips

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.

Date Published: 10/27/2017

Desc: Gudiz Sweet Corn Balls

09 C - - 03 Milk, Concentrated, Evaporated and Condensed

Date Published: 11/24/2017

Desc: Tubito Sweetened Condensed Milk

34 K - - 04 Chocolate Bars

Date Published: 11/01/2017

Desc: Choco Brownie (Cookie Bagel)

PRODUCTORA NACIONAL DE ALIMENTOS PRONAL S.A.S

Date Published : 06/25/2020

Cra 16 N. 69-70 , Dosquebradas, Risaralda COLOMBIA

07 A - - 99 Baked Snack Food, N.E.C.

Date Published: 06/25/2020

Desc: Wheat Puff Snacks

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. �343(i)(2)], in that each ingredient is not declared by its common/usual name in accordance with 21 CFR 101.4. For example, "emulsifier" is not the common/usual name of an ingredient.

07 B - - 99 Fried Snack Foods, N.E.C.

Date Published: 06/25/2020

Desc: Natural Snack Mix

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. �343(a)(1)] in that the LBL is false or misleading. The statement "natural snack mix" is false and misleading. FDA considers the use of the term "natural" on a food LBL to be truthful and non-misleading when "nothing artificial or synthetic" has been included in, or has been added to, a food that would not normally be expected to be in the food." [58 FR 2302, 2407, January 6, 1993]. The ingredient statement for this product declares artificial colors, artificial flavors and synthetic substances such as propylene glycol.

CROATIA

DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.

Date Published : 05/21/2024

Production site: Sveta Nedjelja , Headquarters: Vijenac Frane Gotovca 8 , Zagreb-slobostina, Grad Zagreb CROATIA

25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.

Date Published: 05/21/2024

Desc: Lentifom Mushroom Extract

Notes: The 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(e)(1), 403(e)(2), 403(i)(2), 403(q)(5)(F), 403(y), and 403(s)(2)(B) of the FD&C Act. Product (outer box labels, and inner glass container label) does not bear the name and place of business of the manufacturer, packer, or distributor; 2) the net contents; 3) the common or usual name of each ingredient; 4) nutrition information; 5) the statement of identity of the product; and 6) a domestic address or phone number through which the responsible person, as described in section 761 [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplement. Each of the inner product labels is exempt from sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act [21 U.S.C. 343(e)(2), 343(i)(2), 343(q)(5)(F)] if each label bears the statement �This Unit Not Labeled For Retail Sale� [21 CFR 1.24(a)(14)]. Section 403(f) of the FD&C Act. Product labels contain information in two languages but do not repeat all required information in both languages. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language (21 CFR 101.15(c)). The outer box labels contain information in two languages, but do not repeat all required information in both languages.

25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.

Date Published: 05/21/2024

Desc: Myko San Agarikon.1 Medicinal Mushroom 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(e)(1) of the FD&C Act. Label does not bear the address for the manufacturer (21 CFR 101.5); specifically, the postal code is missing. Section 403(y) of the FD&C Act. 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.

25 S - - 01 Mushroom, Common (Agaricus Bisporus), Fungi Products, N.E.C.

Date Published: 05/21/2024

Desc: Myko San Agarikon Plus Mushroom Extract

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 05/21/2024

Desc: Lentifom Mushroom Extract

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 05/21/2024

Desc: Myko San Agarikon Plus Mushroom Extract

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 05/21/2024

Desc: Myko San Agarikon.1 Medicinal Mushroom Supplement

54 Y - - 19 Egg Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

Date Published: 05/21/2024

Desc: Myko San Agarikon.1 Medicinal Mushroom Supplement

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/21/2024

Desc: Lentifom Mushroom Extract

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/21/2024

Desc: Myko San Agarikon Plus Mushroom Extract

Zdenka d.d

Date Published : 02/19/2015

Trg Kralja Tomislava Square 15 , Bjelovar, Veliki Zdenci CROATIA

12 A - - 05 Cheese, Cheddar

Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, calories from fat, cholesterol, sugar, sodium, saturated fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 05 Cheese, Cheddar

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 A - - 05 Cheese, Cheddar

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)

12 A - - 05 Cheese, Cheddar

Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 05 Cheese, Cheddar

Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12.. Published on 03/09/2015

12 A - - 05 Cheese, Cheddar

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 05 Cheese, Cheddar

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 A - - 05 Cheese, Cheddar

Date Published: 02/19/2015

Desc: Cheese

Notes: Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded in that the nutrition information is not provided as specified under 21 CFR 101.9. Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they contain information in two languages but does not repeat all the required label information in both languages. For example; the Nutrition Facts and statement of identity information must be declared in both; the foreign language and English as required by 21 CFR 101.15(c)(2). Zdenka SPORT dimljeni; Zdenka SPORT polutvrdi sir; and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded because they fail to bear an accurate statement of the net quantity of contents in terms of weight; measure; or numerical count as required by 21 CPR 101.105.

12 A - - 10 Cheese, Cream

Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 16 Cheese, Gouda

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 16 Cheese, Gouda

Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 16 Cheese, Gouda

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)

12 A - - 16 Cheese, Gouda

Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)

Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)

Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)

12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)

12 A - - 52 Cheese, Semisoft

Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 A - - 52 Cheese, Semisoft

Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)

12 A - - 52 Cheese, Semisoft

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)

12 B - - 05 Pasteurized Cheese Spread

Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12.; Published on 03/09/2015

12 B - - 05 Pasteurized Cheese Spread

Date Published: 02/19/2015

Desc: Cheese

12 B - - 05 Pasteurized Cheese Spread

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12 Published on 03/09/2015

12 B - - 05 Pasteurized Cheese Spread

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 B - - 05 Pasteurized Cheese Spread

Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 B - - 09 Pasteurized Process Cheese Foods

Date Published: 02/19/2015

Desc: Cheese

12 B - - 09 Pasteurized Process Cheese Foods

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 B - - 09 Pasteurized Process Cheese Foods

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12 Published on 03/09/2015

12 B - - 09 Pasteurized Process Cheese Foods

Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 B - - 09 Pasteurized Process Cheese Foods

Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 B - - 13 Cheese, Pasteurized, Process (Standardized)

Date Published: 10/18/2021

Desc: Pastuerized Cheese Spread

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 10/09/2015

Desc: Zdenka SPORT dimljeni

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. Published on 03/09/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 10/18/2021

Desc: Zdenka SPORT polutvrdi sir trapist bez kore (Semi-hard cheese)

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 10/09/2015

Desc: Zdenka SPORT polutvrdi sir trapist bez kore

Notes: Serving size is not expressed as a reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12 Published on 03/09/2015

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 10/18/2021

Desc: Zdenka SPORT dimljeni (semi-hard smoked cheese)

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 02/19/2015

Desc: Cheese

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.

Date Published: 10/18/2021

Desc: Zdenka Trapist (Semi-hard cheese)

Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Section 403(f), the product label contains information in two languages but does not repeat all the required information in both languages 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Section 403 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Product label missing serving size, trans-fat, Vitamin A, Vitamin C, Calcium, and Iron. Product labels declare caloric content in units of Kcal or KJ.

DENMARK

Funksjonell Mat AS

Date Published : 05/14/2019

Emil Neckelmanns Vej 20 , So , Odense So, Syddanmark DENMARK

20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C.

Date Published: 06/26/2019

Desc: Fruit Spread Forest Fruits

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.

Date Published: 06/26/2019

Desc: Fruit Spread Forest Fruits

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

23 D - - 01 Almond, Paste

Date Published: 06/26/2019

Desc: Marzipan

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

23 M - - 99 Edible Seed Products, N.E.C.

Date Published: 06/26/2019

Desc: Sesam-mel Sesame Flour

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

23 O - - 07 Peanut, Nut Flour/Meal

Date Published: 06/26/2019

Desc: Peanottmel Peanut Flour

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

23 R - - 02 Sesame Seed (Edible Seed Paste)

Date Published: 06/26/2019

Desc: Sesam-mel Sesame Flour

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

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.

Date Published: 05/14/2019

Desc: Sugarfree chocolate

34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C.

Date Published: 05/14/2019

Desc: Sugarfree chocolate

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

36 A - - 99 Sugar Products, N.E.C.

Date Published: 02/12/2020

Desc: Sukrin Plus

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 B - - 99 Syrups and Molasses, N.E.C.

Date Published: 06/26/2019

Desc: Fiber Syrup Clear Liquid Sweetener

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Lower in calories than syrup'; website: 'Low calories', 'Low carb alternative'), but the product does not meet the requirements to make such a claim; 403(i)(1) because the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3 (product label implies syrup is derived from fiber, but FDA questions source of fiber based on ingredient statement); 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 B - - 99 Syrups and Molasses, N.E.C.

Date Published: 05/14/2019

Desc: Sukrin Syrup With Artificial Sweetener

36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.

Date Published: 02/12/2020

Desc: Sukrin Plus

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.

Date Published: 05/14/2019

Desc: Sukrin Syrup With Artificial Sweetener

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.

Date Published: 06/26/2019

Desc: Fiber Syrup Clear Liquid Sweetener

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.

Date Published: 02/12/2020

Desc: Sukrin Plus

Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.

Date Published: 05/14/2019

Desc: Sukrin Syrup With Artificial Sweetener

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

54 H - - 99 Fats and Lipid Substances, N.E.C.

Date Published: 06/22/2015

Desc: Hemp Oil

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.

Date Published: 06/22/2015

Desc: Hemp Oil

DOMINICAN REPUBLIC (THE)

Alopecil Corporation, S.R.L.

Date Published : 11/10/2016

Haina, D.N. , Autopista 30 De Mayo No. 111 , Santo Domingo Oeste, Santo Domingo DOMINICAN REPUBLIC (THE)

41 Y - - 99 Dietary Conventional Foods, N.E.C.

Date Published: 11/10/2016

Desc: Limpia Pecha Syrup

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i)(2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

41 Y - - 99 Dietary Conventional Foods, N.E.C.

Date Published: 11/10/2016

Desc: Balsamic Honey Syrup

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

41 Y - - 99 Dietary Conventional Foods, N.E.C.

Date Published: 11/10/2016

Desc: Punch Natural

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

41 Y - - 99 Dietary Conventional Foods, N.E.C.

Date Published: 11/10/2016

Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ; ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 11/10/2016

Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ; ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 11/10/2016

Desc: Punch Natural

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 11/10/2016

Desc: Balsamic Honey Syrup

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 11/10/2016

Desc: Limpia Pecha Syrup

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 11/10/2016

Desc: Limpia Pecha Syrup

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 11/10/2016

Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 11/10/2016

Desc: Balsamic Honey Syrup

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403(i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 11/10/2016

Desc: Punch Natural

Notes: After foreign inspection; CFSAN's review of the Balsamic Honey Syrup; Punch Natural; and Watercress and Onion Radish Honey Syrup product labels; has determined that these products are misbranded within the meaning of sections 403(a)(1); 403(q); 403(s)(2)(B); 403(y); and 403 (i) (2) of the Federal Food; Drug; and Cosmetic Act (the Act). Additionally; based on the review of the Limpia Pecha Syrup product label; we have determined that this product is misbranded within the meaning of sections 403(i)(1); 403(k); 403(a)(1); and 403(i)(2). ;

ECUADOR

INDUSTRIAS LACTEAS TONI S.A.

Date Published : 06/13/2019

Av. Francisco de Orellana km. 17,5, Coop. San Nicolas , Mz. 429 Solar 1 , Guayaquil, Guayas ECUADOR

09 D - - 11 Milk With Multivitamins Added,Low Fat

Date Published: 07/27/2020

Desc: VANILLA MILK DRINK

Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains informa