Import Alert 99-22

(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 # 99-22
Published Date: 06/04/2021
Type: DWPE

Import Alert Name:

Detention Without Physical Examination Of Foods Containing Undeclared Major Food Allergens Or Foods That Fail To Properly Label Major Food Allergens

Reason for Alert:

A major food allergen is defined as any of the following: milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils or ingredients exempt from allergen labeling under the petition or notification process (Section 201(qq) of the Act). Petitions and notifications are listed on FDAs website at:
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/ExemptionsfromFoodAllergenLabelingPetitionNotificationProcess/default.htm

If a major food allergen is an ingredient, the label of the food must (1) include the common or usual name of this ingredient in the ingredient statement [403(i)(2) and 21 CFR 101.4]; and (2) include proper identification of the major food allergen source, either in the ingredient statement (e.g., whey (milk)),or in a Contains statement directly below the ingredient statement (e.g., Contains Milk)[403(w)(1)(A)]. In order to ensure uniformity in the presentation of major food allergens under the Act, if a "Contains" statement that immediately follows the ingredient list is elected, it must contain all food source names of the major food allergens in the food, even if they are also listed in the ingredient statement. The Contains statement may contain other ingredients, but should list the major food allergens first. See Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004.

If a major food allergen is present in food through insanitary conditions that lead to cross-contact (e.g., failure to clean equipment), the food is adulterated [402(a)(4)]. See CPG Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-Contamination of Common Food Allergens.

Questions may be directed to:
CFSAN, Office of Compliance/Division of Enforcement/Labeling Compliance Team. 301-436-2148

Guidance:

Districts may detain without physical examination the identified products offered for importation from the manufacturers and/or shippers listed on this import alerts RED LIST, citing the charges specified for the specific product.

When determining which charge to use for detention or recommending a product be added to this import alerts RED LIST:

Charge:

403(w) (ALLERGEN) when the product appears to contain a major food allergen that is declared in the ingredient statement, but the food source does not appear to be identified as required.

Example: The product label declares whey but the label does not identify the major food allergen - milk.

***

Charge:

403(i)(2) (LIST INGRE) or 402(a)(4)(ALRGN402a4) when the product appears to contain a major food allergen but the major food allergen is not listed in the ingredient statement. Also charge 403(w) (ALLERGEN) where a major food allergen is not identified on the ingredient statement and there is no declaration of it in a Contains statement.

Example: Laboratory analysis indicates the presence of a major food allergen that is not listed as an ingredient.

For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at (301)796-6600.

If a firm wishes to request removal of a product from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

Requests for removal from DWPE should be directed to FDA's Division of Import Operations and Policy at:

Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive ELEM Room 3109
Rockville, MD 20857
email: importalerts2@fda.hhs.gov

Product Description:

See RED LIST

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) in that it appears that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). [Misbranded, Section 403(w)]

OASIS Charge Code - ALLERGEN

and/or

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(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. [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) in that it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact. [Adulteration, Section 402(a)(4).

OASIS Charge Code - ALRGN402A4

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


BAHAMAS


Purity Bakery
Date Published : 11/05/2015
Market & McPherson Street , Nassau, BS-NP BAHAMAS
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 11/05/2015

Desc: Chocolate Rum Cake
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare a major food allergen present in the product; as required by section 403(w)(1). Specifically; "chocolate rum cake" fails to declare the allergen ingredients "eggs"; "milk"; "soy"; and "wheat"; "Bacardi rum cake" and "pina colada rum cake" fails to declare the allergen ingredients "whea" and "soy"; which are major food allergens under FALCPA.

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 11/05/2015

Desc: Pina Colada Rum Cake
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare a major food allergen present in the product; as required by section 403(w)(1). Specifically; "chocolate rum cake" fails to declare the allergen ingredients "eggs"; "milk;" "soy;" and "wheat"; "Bacardi rum cake" and "pina colada rum cake" fails to declare the allergen ingredients "wheat" and "soy"; which are major food allergens under FALCPA.

03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 11/05/2015

Desc: Bacardi Rum Cake
Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare a major food allergen present in the product; as required by section 403(w)(1). Specifically; "chocolate rum cake" fails to declare the allergen ingredients "eggs"; "milk"; "soy"; and "wheat"; "Bacardi rum cake" and "pina colada rum cake" fails to declare the allergen ingredients "whea" and "soy"; which are major food allergens under FALCPA.


BANGLADESH


KN Agro Processor
Date Published : 03/05/2021
35 Bijoy Nagar (1st Floor) , Dhaka, BANGLADESH
38 C - - 99 Dried Soup, N.E.C.
Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai
Notes:                                                                                                                                                                                                                                          The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act because the product label fails to declare major food allergens as required by Section 403(w)(1) of the Act. Specifically, the product label fails to list "shrimp," which is the name of the food source of the major food allergen, "prawn," in the ingredient list or a Contains statement. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute,""acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)].

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

Desc: Maggi Healthy Soups Thai
Notes:                                                                                                                                                                                                                                          The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act because the product label fails to declare major food allergens as required by Section 403(w)(1) of the Act. Specifically, the product label fails to list "shrimp," which is the name of the food source of the major food allergen, "prawn," in the ingredient list or a Contains statement. 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)].


BRAZIL


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: Ground 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(w) of the Act [21 U.S.C. §343(w)] in that the individual packets fail to declare the major food allergen; "peanuts" as required by section 403(w)(1) of the Act.

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

Desc: Corn Chips Ham Flavored (Yokitos)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act; in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically; the product is manufactured using "prepared condiment ham flavor;" which contains "milk."

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

Desc: Corn Chips Ham Flavored (Yokitos)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act; in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically; the product is manufactured using "prepared condiment ham flavor;" which contains "milk."

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

Desc: Corn Chips Ham Flavored (Yokitos)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act; in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically; the product is manufactured using "prepared condiment ham flavor;" which contains "milk."

Pamonharia do Aguinaldo Ltda.
Date Published : 09/16/2015
Rodovia 354 Km 9.5 , Patos De Minas, MG BRAZIL
37 B - - 21 Tamale (Multiple Food Specialities, Side Dishes and Desserts)
Date Published: 09/16/2015

Desc: Brazilian Corn Tamales (Traditional salt tamale mixture)
Notes: Finished product labels fail to declare the major food allergen; milk; as required by section 403(w)(l) of the Act. Specifically; your products are manufactured using "cheese" which contains "milk;" however; you fail to list "milk" on your finished product labels.

37 B - - 21 Tamale (Multiple Food Specialities, Side Dishes and Desserts)
Date Published: 09/16/2015

Desc: Brazilian Corn Tamales (Sweet tamale mixture)
Notes: Finished product labels fail to declare the major food allergen; milk; as required by section 403(w)(l) of the Act. Specifically; your products are manufactured using "cheese" which contains "milk;" however; you fail to list "milk" on your finished product labels.

Santa Helena Industria de Alimentos S.A.
Date Published : 01/11/2018
Rua Paraguai 1275 , Ribeirao Preto, Sao Paulo BRAZIL
33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate)
Date Published: 01/11/2018

Desc: Pacoquita Peanut Candy Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. ? 343(w)] in that the finished product labels fail to declare the major food allergen as required by section 403(w)(1) of the Act. Specifically; the finished product labels fail to declare the major food allergen ?peanuts? and ?wheat? is not declared in English on the wrapper labe

33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate)
Date Published: 01/11/2018

Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. ? 343(w)] in that the finished product labels fail to declare the major food allergen as required by section 403(w)(1) of the Act. Specifically; the finished product labels fail to declare the major food allergen ?peanuts? and ?wheat? is not declared in English on the wrapper labe.


CANADA


Fit Foods Ltd.
Date Published : 08/12/2016
1589 Kebet Way , Port Coquitlam, British Columbia CANADA
09 D - - 34 Whey Protein concentrate
Date Published: 08/12/2016

Desc: MUTANT MASS COOKIES AND CREAM WHEY 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 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Specifically, the product fails to declare "egg albumen" in either the ingredient statement or the "Contains" statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.

41 E - - 99 Meal Replacements (Not labeled for treatment of disease)
Date Published: 08/12/2016

Desc: MUTANT MASS COOKIES AND CREAM WHEY 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 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Specifically, the product fails to declare "egg albumen" in either the ingredient statement or the "Contains" statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.


CHINA


Guangzhou Peninsula Food Co., Ltd.
Date Published : 12/13/2019
Ping Dong Industrial Zone , Huadu District , Huashan Town, CHINA
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/13/2019

Desc: Bean Paste with Tangerine and Nuts
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because it has failed to declare major food allergens as required by Section 403(w) of the Act. Specifically, the label does not provide the "Contains" statement in accordance with FALCPA.

JIANGXI GOLDEN EAGLE FOOD CO,.LTD
Date Published : 12/01/2014
Yongqiang Road (North) , No. 188 Xinjian County; Wangcheng Town , Nanchang, Cn-Jx CHINA
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 12/01/2014

Desc: GIFT CHOCOLATES
Notes: The product contains major allergens milk and peanuts that were not declared in the label ingredient list; and no ?Contains? statement appeared on the label.

LianJiang Xulong Foods Co.,Ltd.
Date Published : 02/28/2017
NO. 271 Fuxing North Road , Town,Lianjiang County , Fuzhou, Fujian CHINA
16 A - - 99 Fish, N.E.C.
Date Published: 11/30/2018

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive); 403(w) in that it appears that the label fails to declare all major food allergens present in the product; as required (for example; the product label fails to declare major food allergens "egg" and the "specific species of crustacean shellfish"; "Contains" statement should include all of the major allergens "species of fish" in the food).

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

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive); 403(w) in that it appears that the label fails to declare all major food allergens present in the product; as required (for example; the product label fails to declare major food allergens "egg" and the "specific species of crustacean shellfish"; "Contains" statement should include all of the major allergens "species of fish" in the food).

16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 02/28/2017

Desc: Frozen Fish Ball (Surimi)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, egg, as required by section 403(w)(1) of the Act. The "Contains" statement incorrectly lists "fish" as an allergen rather than by the required name of the food source from which the major food allergen is derived, moray. Finally, the ingredient statement doesn't list the acceptable market name of the "fish" ingredient, thus failing to declare the specific species of fish.

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

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive); 403(w) in that it appears that the label fails to declare all major food allergens present in the product; as required (for example; the product label fails to declare major food allergens "egg" and the "specific species of crustacean shellfish"; "Contains" statement should include all of the major allergens "species of fish" in the food).

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

Desc: Fish Balls
Notes: The article appears to be misbranded within the meaning of the following sections of the Act (examples are not all inclusive); 403(w) in that it appears that the label fails to declare all major food allergens present in the product; as required (for example; the product label fails to declare major food allergens "egg" and the "specific species of crustacean shellfish"; "Contains" statement should include all of the major allergens "species of fish" in the food).

Liangcheng Shuguo Subsidiary Foodstuffs Factory
Date Published : 05/16/2019
New Stone Dry Mountain, Wenpi Village , Wenheng Town, Liancheng County , Wenheng, Fujian CHINA
25 L - - 06 Potato, Dried or Paste
Date Published: 05/16/2019

Desc: Dried Sweet Potato
Problems: SULFUR DIOXIDE;

Tianjin Zhanhe Vegetable Co.,
Date Published : 11/04/2019
Wuqing District , 8 Xixiaozhuang Village; Chagugang Town , Tianjin City, Tianjin CHINA
03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 11/04/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because it fails to declare the major food allergen "milk." The product label declares the ingredient "white chocolate," which is a standardized food under 21 CFR 163.124 that is made with the major food allergen milk.

03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 11/04/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because it fails to declare the major food allergen "milk." The product label declares the ingredient "white chocolate," which is a standardized food under 21 CFR 163.124 that is made with the major food allergen milk.

03 D - - 99 Bread, Rolls, Buns, Etc N.E.C. Heat/Serve
Date Published: 11/04/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because it fails to declare the major food allergen "milk." The product label declares the ingredient "white chocolate," which is a standardized food under 21 CFR 163.124 that is made with the major food allergen milk.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 11/04/2019

Desc: Walnut Bun
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because it fails to declare the major food allergen "milk." The product label declares the ingredient "white chocolate," which is a standardized food under 21 CFR 163.124 that is made with the major food allergen milk.


COLOMBIA


ALIMENTIC SAS
Date Published : 10/27/2017
Calle 64a 103 18 , Bogota, Cundinamarca COLOMBIA
03 A - - 03 Biscuits
Date Published: 10/27/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically; the label declares the ingredient "fresh curd;" but fails to declare the major food allergen milk. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. Specifically; the ingredient statement on label declares fresh curd; but the sub-ingredients for fresh curd are not declared.

07 A - - 03 Cheese Puffs, Baked
Date Published: 10/27/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically; the label declares the ingredient "fresh curd;" but fails to declare the major food allergen milk. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. Specifically; the ingredient statement on label declares fresh curd; but the sub-ingredients for fresh curd are not declared.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/27/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically; the label declares the ingredient "fresh curd;" but fails to declare the major food allergen milk. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. Specifically; the ingredient statement on label declares fresh curd; but the sub-ingredients for fresh curd are not declared.

07 B - - 03 Cheese Puffs, Fired
Date Published: 10/27/2017

Desc: Achiras Huilenses Celio Cheese Biscuit
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically; the label declares the ingredient "fresh curd;" but fails to declare the major food allergen milk. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. Specifically; the ingredient statement on label declares fresh curd; but the sub-ingredients for fresh curd are not declared.

GRASCO LTDA.
Date Published : 10/25/2017
Pensilvania , Carrera 35 7 - 50 , Bogota, Cundinamarca COLOMBIA
26 E - - 99 Oleomargarine, N.E.C.
Date Published: 10/25/2017

Desc: La Fina Suave! Con Sal
Notes: The 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens; "milk" and "soy" as required by section 403(w)(1) of the Act. Specifically, the product labels declare "leche descremada en polvo" and "lecitina de soya" which translates to "skim milk powder" and "soy lecithin."

26 E - - 99 Oleomargarine, N.E.C.
Date Published: 10/25/2017

Desc: La Fina Margarina De Mesa Y Concina
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens; "milk" and "soy" as required by section 403(w)(1) of the Act. Specifically, the product labels declare "leche descremada en polvo" and "lecitina de soya" which translates to "skim milk powder" and "soy lecithin."

LAMERICA CI SAS
Date Published : 11/01/2017
Calle 85 76 , C , Bogota, Cundinamarca COLOMBIA
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(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergens soy and milk as required by section 403(w)(1) of the Act. Specifically, the product's label bears an ingredient statement in Spanish that declares the ingredients soy lecithin, powdered skim milk, and whole milk. However, the label's ingredient statement in English, which is applied to the package by use of a sticker, fails to list the allergens soy and milk.                                                                                                                                                                                                                                                                                                                                                                

Lamerica C.I. S.A.S.
Date Published : 10/25/2017
Carrera 102 # 25c-20 , Bogota, Cundinamarca COLOMBIA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/25/2017

Desc: Chokis/Chocolate Covered Corn Balls
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergens; "peanuts, milk and soy" as required by section 403(w)(1) of the Act. Specifically, the Chokis/Covered Corn Balls product label declares "leche en polvo" and "lecitina de soya" which translates to "milk powder" and "soy lecithin" in the Spanish ingredient statements on the outer and inner packages. However, these ingredients are not declared on the English ingredient statement. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the Chokis/Chocolate Covered Corn Balls product label fails to declare "milk powder" and "soy lecithin" in the English ingredient statement.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/25/2017

Desc: Mani Moto Limon Peanuts Covered with Wheat 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(w) of the Act in that the finished product label fails to declare the major food allergens; "peanuts, milk and soy" as required by section 403(w)(1) of the Act. Specifically, the Mani Moto Limon Peanuts Covered with Wheat Flour have "peanuts" as a part of the statement of identity on the outer packages; however, "peanuts" are not declared in the ingredient statements on both the outer and inner packages. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically, the Mani Moto Limon Peanuts covered with Wheat Flour fail to declare "peanuts" as an ingredient.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 10/25/2017

Desc: Mani Moto Peanuts Covered with Wheat 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(w) of the Act in that the finished product label fails to declare the major food allergens; "peanuts, milk and soy" as required by section 403(w)(1) of the Act. Specifically, the Mani Moto Peanuts Covered with Wheat Flour have "peanuts" as a part of the statement of identity on the outer packages; however, "peanuts" are not declared in the ingredient statements on both the outer and inner packages. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically, the Mani Moto Peanuts covered with Wheat Flour fail to declare "peanuts" as an ingredient.

07 Q - - 13 Corn Puffs (Flavored or Unflavored), Vegetable Snacks (Other than Pulses) Baked
Date Published: 10/25/2017

Desc: Chokis/Chocolate Covered Corn Balls
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergens; "peanuts, milk and soy" as required by section 403(w)(1) of the Act. Specifically, the Chokis/Covered Corn Balls product label declares "leche en polvo" and "lecitina de soya" which translates to "milk powder" and "soy lecithin" in the Spanish ingredient statements on the outer and inner packages. However, these ingredients are not declared on the English ingredient statement. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the Chokis/Chocolate Covered Corn Balls product label fails to declare "milk powder" and "soy lecithin" in the English ingredient statement.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/25/2017

Desc: Mani Moto Peanuts Covered with Wheat 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(w) of the Act in that the finished product label fails to declare the major food allergens; "peanuts, milk and soy" as required by section 403(w)(1) of the Act. Specifically, the Mani Moto Peanuts Covered with Wheat Flour have "peanuts" as a part of the statement of identity on the outer packages; however, "peanuts" are not declared in the ingredient statements on both the outer and inner packages. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically, the Mani Moto Peanuts covered with Wheat Flour fail to declare "peanuts" as an ingredient.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/25/2017

Desc: Chokis/Chocolate Covered Corn Balls
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergens; "peanuts, milk and soy" as required by section 403(w)(1) of the Act. Specifically, the Chokis/Covered Corn Balls product label declares "leche en polvo" and "lecitina de soya" which translates to "milk powder" and "soy lecithin" in the Spanish ingredient statements on the outer and inner packages. However, these ingredients are not declared on the English ingredient statement. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the Chokis/Chocolate Covered Corn Balls product label fails to declare "milk powder" and "soy lecithin" in the English ingredient statement.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 10/25/2017

Desc: Mani Moto Limon Peanuts Covered with Wheat 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(w) of the Act in that the finished product label fails to declare the major food allergens; "peanuts, milk and soy" as required by section 403(w)(1) of the Act. Specifically, the Mani Moto Limon Peanuts Covered with Wheat Flour have "peanuts" as a part of the statement of identity on the outer packages; however, "peanuts" are not declared in the ingredient statements on both the outer and inner packages. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically, the Mani Moto Limon Peanuts covered with Wheat Flour fail to declare "peanuts" as an ingredient.

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(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergens soy and milk as required by section 403(w)(1) of the Act. Specifically, the product's label bears an ingredient statement in Spanish that declares the ingredients soy lecithin, powdered skim milk, and whole milk. However, the label's ingredient statement in English, which is applied to the package by use of a sticker, fails to list the allergens soy and milk.                                                                                                                                                                                                                                                                                                                                                                

PRODUCTORA NACIONAL DE ALIMENTOS PRONAL S.A.S
Date Published : 06/26/2020
Cra 16 N. 69-70 , Dosquebradas, Risaralda COLOMBIA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/26/2020

Desc: Cheese Rings
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using cheese and milk is an ingredient in cheese.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/26/2020

Desc: Yellow Marbles Cheese Snacks
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using cheese and milk is an ingredient in cheese.


CZECH REPUBLIC


Emco Spol S R.O.
Date Published : 09/04/2015
Hrdly 1/2 , 1 , Bohusovice nad Ohri 1, CZECH REPUBLIC
05 Y - - 01 Granola Bars
Date Published: 09/04/2015

Desc: Chocolate Chip Granola Bars with Dark Chocolate
Notes: The product fails to declare milk in either the ingredient statement or the Contains statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.


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: Punch Natural
Notes: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

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: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016

Desc: Limpia Pecha Syrup
Notes: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016

Desc: Punch Natural
Notes: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

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: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016

Desc: Limpia Pecha Syrup
Notes: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

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: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

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: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.

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: From foreign inspection; CFSAN determined that these products are misbranded within the meaning of section 403(w) because the finished product label fails to declare the major food allergen coconut.


GERMANY


Ferrero Foods
Date Published : 05/16/2014
Neue Mainzer Str. 66-68 , Frankfurt Am Main, Hessen GERMANY
03 A - - 03 Biscuits
Date Published: 05/16/2014

Desc: Hanuta Wafer Cookie
Notes: Article contains wheat flour; milk; soy; and tree nuts (hazelnut); major food allergens which are not identified on the ingredient statement and there is not declaration of it in a Contains statement.

03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 05/16/2014

Desc: Hanuta Wafer Cookie
Notes: Article contains wheat flour; milk; soy; and tree nuts (hazelnut); major food allergens which are not identified on the ingredient statement and there is not declaration of it in a Contains statement.

03 J - - 05 Nut Filled/Iced Cookies,Biscuits and Wafers
Date Published: 05/16/2014

Desc: Hanuta Wafer Cookie
Notes: Article contains wheat flour; milk; soy; and tree nuts (hazelnut); major food allergens which are not identified on the ingredient statement and there is not declaration of it in a Contains statement.

Opptha
Date Published : 02/24/2017
Neugablonzer Str. 7 , Neutraubling, Bavaria GERMANY
29 B - - 99 Carbonated Soft Drink, N.E.C.
Date Published: 02/24/2017

Desc: NTS Shoring Power - The Original Limited Edition Energy 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(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the major food allergen, milk, as required by section 403(w)(1) of the Act. ;The article is subject 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)]. There is no statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. NTS Shoring Power - The Original Limited Edition is not an appropriately descriptive term, even though the information panel states "Energy Drink".;The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it 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..;The article is subject 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 nutrition facts information is not consistent with the labeling requirements, as defined in 21 CFR 101.9. ;The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1).


GREECE


Biscotti Tsoungari
Date Published : 04/12/2016
Interbalkan Area , Thessaloniki, Thessaloniki GREECE
03 N - - 03 Pastry (Eclairs, Cream Puffs) Custard or Cream Filled
Date Published: 04/12/2016

Desc: Greek Cannoli
Notes: The 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(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the product declares butter as an ingredient; but fails to declare "milk" in either the ingredient statement or the "Contains" statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.


INDIA


Bambino Agro Ind.Ltd.
Date Published : 05/10/2019
4e Surya Towers , Sardar Patel Road , Secunderabad, Telangana INDIA
02 F - - 04 Semolina, Wheat
Date Published: 05/10/2019

Desc: Roasted Suji Coarse Grain Semolina Wheat 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(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen "wheat," as required by section 403(w)(1) of the Act. Specifically, the product contains wheat but fails to declare this major food allergen.

Bikaji Foods International Ltd.
Date Published : 12/17/2018
F-196-197 Bichhwal Industrial Area , Rico Industrial Area, Bikaji Road , Bikaner, Rajastan INDIA
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/17/2018

Desc: Frozen Mix Sweet (Assorted Sweets)
Notes: The article appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. We note that the product label declares "clarified butter" but fails to declare milk, in accordance with FALCPA..

K-Pra Foods Private Limited
Date Published : 01/09/2018
1348 A V Bhat Co Building , Chimnya Ganapati , Pune, Maharashtra INDIA
23 F - - 07 Peanut, Topping
Date Published: 01/09/2018

Desc: GROUND NUT CHATNI (CHUTNEY)
Notes: The article 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(w) of the Act [21 USC 343(w)] because the product label fails to declare major food allergens as required by Section 403(w)(1) of the Act. Specifically; the product fails to declare the source of all major food allergens present in the product; such as ?peanuts? or specific type of tree nut(s).

Raghuvanshi Exports
Date Published : 05/21/2019
Plot no. 32 33 Jignesh , Palghar, Maharashtra INDIA
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 05/21/2019

Desc: Fried Poha Chiwda
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen "almonds," as required by section 403(w)(1) of the Act. Specifically, the product contains almonds but fails to declare this major food allergen.

07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C.
Date Published: 05/21/2019

Desc: Fried Poha Chiwda
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen "almonds," as required by section 403(w)(1) of the Act. Specifically, the product contains almonds but fails to declare this major food allergen.

THE GRAND SWEETS & SNACKS ADYAR
Date Published : 10/30/2020
6/2 Selag Kumaran Street , Chennai, Tamil Nadu INDIA
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/30/2020

Desc: Thirunaveli Halwa
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act; the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Product label declares clarified butter and rava (semolina) but fails to declare the respective name of the food source from which the major allergen is derived, milk and wheat, such as within the ingredients or in a "Contains" statement.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/30/2020

Desc: Adhirasam
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act; the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Product label declares clarified butter and rava (semolina) but fails to declare the respective name of the food source from which the major allergen is derived, milk and wheat, such as within the ingredients or in a "Contains" statement.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/30/2020

Desc: Mini Athirasam
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act; the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Product label declares clarified butter and rava (semolina) but fails to declare the respective name of the food source from which the major allergen is derived, milk and wheat, such as within the ingredients or in a "Contains" statement.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 10/30/2020

Desc: Rava Laddu
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act; the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Product label declares clarified butter and rava (semolina) but fails to declare the respective name of the food source from which the major allergen is derived, milk and wheat, such as within the ingredients or in a "Contains" statement.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 10/30/2020

Desc: Adhirasam
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act; the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Product label declares clarified butter and rava (semolina) but fails to declare the respective name of the food source from which the major allergen is derived, milk and wheat, such as within the ingredients or in a "Contains" statement.

The Grand Sweets And Snacks
Date Published : 06/22/2016
24 2'nd Main Road , Chennai, Tamil Nadu INDIA
07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/22/2016

Desc: Baked Snack Yellu Urandai
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of 403(w) of the Act [21 U.S.C. ?343(w)] in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the product label fails to declare peanuts in the ingredient statement.

Unique Fragrances
Date Published : 06/26/2017
B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA
03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

03 Y - - 07 Zweiback, Toast
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

Unique Fragrances
Date Published : 06/26/2017
395 Food Park , Rai, Haryana INDIA
03 A - - 99 Bread/Rolls/Buns, N.E.C.
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

03 H - - 05 Nut Plain Cookies,Biscuits and Wafers
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

03 Y - - 07 Zweiback, Toast
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

07 A - - 99 Baked Snack Food, N.E.C.
Date Published: 06/26/2017

Desc: Eggless Toast; Suji Rusk
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product contain wheat but it's not declared in the ingredient statement or in a "Contains" statement.

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

Desc: HALWASAN (WHEAT FLOUR PATTIES COOKED WITH SUGAR)
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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product labels fail to declare the major food allergens; ?wheat? and ?tree nuts? as required by section 403(w)(1) of the Act. Specifically; according to the entry documents; the Halvasan and Halvasan Pak products are ?Wheat Flour Patties Cooked with Sugar? and the Dry Fruit Chips product is ?Chopped and Almonds Pistachios.? Additionally; based on the photographs of the Halvasan and Halvasan Pak products; they also appear to contain nuts. Therefore; the Halvasan and Halvasan Pak products fail to declare ?wheat? and ?tree nuts? and the Dry Fruit Chips product fails to declare ?tree nuts? on their finished product labels. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. ?343(i)(2)]; in that they are fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically; the product labels fail to include ingredient statements.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/15/2017

Desc: Sweet Khaja
Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens; "wheat" and "tree nuts" as required by section 403(w)(1) of the Act. Specifically, according to the entry documents, the Halvasan products are "Wheat Flour Patties Cooked with Sugar" and the Dry Fruit Chips product is "Chopped and Almonds Pistachios." The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that they are fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the product labels fail to declare any ingredients.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 12/15/2017

Desc: Halwo
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens; "wheat" and "tree nuts" as required by section 403(w)(1) of the Act. Specifically, according to the entry documents, the Halvasan products are "Wheat Flour Patties Cooked with Sugar" and the Dry Fruit Chips product is "Chopped and Almonds Pistachios." The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that they are fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the product labels fail to declare any ingredients.

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

Desc: HALWASAN PAK (WHEAT FLOUR PATTIES COOKED WITH SUGAR)
Notes: The 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens; "wheat" and "tree nuts" as required by section 403(w)(1) of the Act. Specifically, according to the entry documents, the Halvasan and Halvasan Pak products are "Wheat Flour Patties Cooked with Sugar" and the Dry Fruit Chips product is "Chopped and Almonds Pistachios." Additionally, based on the photographs of the Halvasan and Halvasan Pak products, they also appear to contain nuts. Therefore, the Halvasan and Halvasan Pak products fail to declare "wheat" and "tree nuts" and the Dry Fruit Chips product fails to declare "tree nuts" on their finished product labels. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that they are fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically, the product labels fail to include ingredient statements.

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

Desc: DRYFRUIT CHIPS (Sliced Pistachios and Almonds)
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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product labels fail to declare the major food allergens; ?wheat? and ?tree nuts? as required by section 403(w)(1) of the Act. Specifically; according to the entry documents; the Halvasan and Halvasan Pak products are ?Wheat Flour Patties Cooked with Sugar? and the Dry Fruit Chips product is ?Chopped and Almonds Pistachios.? Additionally; based on the photographs of the Halvasan and Halvasan Pak products; they also appear to contain nuts. Therefore; the Halvasan and Halvasan Pak products fail to declare ?wheat? and ?tree nuts? and the Dry Fruit Chips product fails to declare ?tree nuts? on their finished product labels. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. ?343(i)(2)]; in that they are fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Specifically; the product labels fail to include ingredient statements.


IRELAND


Butlers Chocolates Ltd.
Date Published : 05/13/2020
Parkgate Business Centre , Parkgate Street , Dublin 8, Co. DUBLIN IRELAND
34 F - - 03 Chocolate Covered Candy Bar, without Nuts and Fruit
Date Published: 05/13/2020

Desc: Irish Whiskey Dark Chocolate with Irish Whiskey Bar
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared,packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact. [Adulteration, Section 402(a)(4)]

34 F - - 03 Chocolate Covered Candy Bar, without Nuts and Fruit
Date Published: 05/13/2020

Desc: 70% DARK CHOCOLATE
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared,packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact. [Adulteration, Section 402(a)(4)]


ITALY


FRANTOIO BONAMINI SRL
Date Published : 05/14/2019
Via Santa Giustina 9/A , Illasi, Verona ITALY
27 Y - - 99 Condiments, N.E.C.
Date Published: 05/14/2019

Desc: Pesto
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of section 403(w) of the FD&C Act [21 U.S.C. 343(w)] in that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). Specifically, the label fails to declare the major food allergens, milk, egg and tree nuts in accordance with FALCPA.

37 J - - 99 Sauces, n.e.c.
Date Published: 01/24/2020

Desc: Pesto
Notes: 1/24/2020

Lodato Gennaro & C S.p.A.
Date Published : 08/27/2013
Via Santa Maria , Castel San Giorgio, Salerno ITALY
38 A - - 02 Bean Soup
Date Published: 08/27/2013

Desc: Zuppa Di Farro
Notes: Undeclared Allergen; Wheat

38 A - - 09 Cereal Grain Soup
Date Published: 08/27/2013

Desc: Zuppa Di Farro
Notes: Undeclared Allergen; Wheat

38 A - - 99 Soup, N.E.C.
Date Published: 08/27/2013

Desc: Zuppa Di Farro
Notes: Undeclared Allergen; Wheat

38 Y - - 99 Soup, N.E.C.
Date Published: 08/27/2013

Desc: Zuppa Di Farro
Notes: Undeclared Allergen; Wheat


JAMAICA


Gk Food & Services, Ltd - National Processors Division
Date Published : 12/04/2019
Jidc Industrial Estate , Temple Hall, St. Andrew JAMAICA
38 C - - 04 Vegetable Beef Soup, Dried
Date Published: 12/04/2019

Desc: Grace Fish Tea Flavored Soup 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(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, as required by section 403(w)(1) of the Act. Specifically, the article is labeled to contain "fish powder" but the common or usual name of the fish is not listed in the ingredient statement or the "contains" statement.

38 C - - 11 Chicken Soup, Plain, Dried
Date Published: 12/04/2019

Desc: Grace Fish Tea Flavored Soup 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(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, as required by section 403(w)(1) of the Act. Specifically, the article is labeled to contain "fish powder" but the common or usual name of the fish is not listed in the ingredient statement or the "contains" statement.

38 C - - 12 Vegetable Chicken Soup, Dried
Date Published: 12/04/2019

Desc: Grace Fish Tea Flavored Soup 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(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, as required by section 403(w)(1) of the Act. Specifically, the article is labeled to contain "fish powder" but the common or usual name of the fish is not listed in the ingredient statement or the "contains" statement.

38 C - - 28 Mixed Vegetable Soup, Dried
Date Published: 12/04/2019

Desc: Grace Fish Tea Flavored Soup 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(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, as required by section 403(w)(1) of the Act. Specifically, the article is labeled to contain "fish powder" but the common or usual name of the fish is not listed in the ingredient statement or the "contains" statement.

38 C - - 29 Vegetable (Single Ingredient Not Mentioned Elsewhere) Soup, Dried
Date Published: 12/04/2019

Desc: Grace Fish Tea Flavored Soup 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(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, as required by section 403(w)(1) of the Act. Specifically, the article is labeled to contain "fish powder" but the common or usual name of the fish is not listed in the ingredient statement or the "contains" statement.

38 C - - 99 Dried Soup, N.E.C.
Date Published: 12/04/2019

Desc: Grace Fish Tea Flavored Soup 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(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, as required by section 403(w)(1) of the Act. Specifically, the article is labeled to contain "fish powder" but the common or usual name of the fish is not listed in the ingredient statement or the "contains" statement.


JAPAN


Maruto Seika Co., LTD
Date Published : 01/13/2015
Nakatsuhara 1532 , Miyuki-Cho , Fukuyama, Hiroshima JAPAN
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 01/13/2015

Desc: Butter Cake #639735 and #62106
Notes: Articles contain egg and soy proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a Contains statement.

03 R - - 61 Cheese Cake
Date Published: 01/13/2015

Desc: Cheese cake #639734 and #62104
Notes: Articles contain egg and soy proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a Contains statement.

03 S - - 01 Cake Prepared Dry Mix Without Custard or Cream Filling
Date Published: 01/13/2015

Desc: Butter Cake #639735 and #62106
Notes: Articles contain egg and soy proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a Contains statement.

03 S - - 61 Cheese Cake
Date Published: 01/13/2015

Desc: Cheese cake #639734 and #62104
Notes: Articles contain egg and soy proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a Contains statement.

03 T - - 01 Cake Dough or Batter Without Custard or Cream Filling
Date Published: 01/13/2015

Desc: Butter Cake #639735 and #62106
Notes: Articles contain egg and soy proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a Contains statement.

03 T - - 61 Cheese Cake
Date Published: 01/13/2015

Desc: Cheese cake #639734 and #62104
Notes: Articles contain egg and soy proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a Contains statement

NAGAYAMA FOODS FACTORY CO.,LTD.
Date Published : 01/26/2015
NO.1-15-17, MATSUSHIMA, , HIGASHIKU, , Fukuoka-shi, Fukuoka-ken JAPAN
25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 01/26/2015

Desc: Pickled Vegetable (Fukujinduke)
Notes: Undeclared Allergen Wheat

25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 01/26/2015

Desc: Pickled Takana (kizami Takanaduke)
Notes: Undeclared Allergen Wheat

25 J - - 27 White Radish (Root & Tuber Vegetable)
Date Published: 01/26/2015

Desc: Pickled Radish (Kizami Tsuboduke)
Notes: Undeclared Allergen Wheat

Ohori Co. Ltd.
Date Published : 12/11/2015
4447 , Ashio-Machi , Nikko, Tochigi JAPAN
25 E - - 99 Mixed Vegetables, N.E.C.
Date Published: 12/11/2015

Desc: Edible Wild Plants
Notes: This product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare the major food allergens, fish, as required by section 403(w)(1) of the Act. The "Edible Wild Plants" product is manufactured with the ingredient "Fish Sauce;" however, your labels fail to declare the major allergen fish.

25 J - - 22 Burdock, Gobo (Root & Tuber Vegetable)
Date Published: 12/11/2015

Desc: Burdock Salada
Notes: This product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare the major food allergens, fish, as required by section 403(w)(1) of the Act. The "Burdock Salada" product is manufactured with an ingredient that contains dried bonito powder.

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

Desc: Chinese Yama Kurage
Notes: This product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare the major food allergens, fish, as required by section 403(w)(1) of the Act. The "Chinese Yama Kurage" product is manufactured with the ingredient "Fish Sauce;" however, your labels fail to declare the major allergen fish.

TOWANI CO LTD
Date Published : 02/21/2018
Shinko 723-1 , Shinkonishi , Ishikari, Hokkaido JAPAN
24 K - - 01 Egg Plant, with Sauce
Date Published: 02/21/2018

Desc: Soy Marinated Eggplant
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(w) of the Act [21 U.S.C. §343(w)] because the product label fails to declare major food allergens as required by Section 403(w)(1) of the Act. Specifically, the product appears to contain the major food allergen "soy," as evidenced by the product name, "Soy Marinated Egg Plant," but fails to declare this major food allergen in the ingredient list or a Contains statement.

UHA Mikakuto Co.,Ltd.
Date Published : 09/18/2015
137-5 , Imago-Cho , Yamatokoriyama, Nara JAPAN
33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate)
Date Published: 09/18/2015

Desc: Uha Puccho Stick Nama Muscat
Notes: Problem(s): The product fails to declare "milk" in either the ingredient statement or the "Contains" statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.

YAMAKI SHOKUHIN CO.,LTD.
Date Published : 02/18/2015
258 , Kamiyama; Nishi , Niigata, Niigata JAPAN
25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 02/18/2015

Desc: Pickled Radish (Hitokuchi Shoyu Takuan)
Notes: The original product labeling contains the allergen ingredient; wheat; which is not declared on the added stick-on English label. Further; the Pickled Radish (Hitokuchi Ume katsuo Takuan) original Japanese label states the product contains ?dried Bonito? which is also a major food allergen (fish) which is not declared on the added stick-on English label.

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 02/18/2015

Desc: Pickled Radish (Hitokuchi Ume katsuo Takuan)
Notes: The original product labeling contains the allergen ingredient; wheat; which is not declared on the added stick-on English label. Further; the Pickled Radish (Hitokuchi Ume katsuo Takuan) original Japanese label states the product contains ?dried Bonito? which is also a major food allergen (fish) which is not declared on the added stick-on English label.

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 02/18/2015

Desc: Pickled Radish (hitokuchi Miso Daikon)
Notes: The original product labeling contains the allergen ingredient; wheat; which is not declared on the added stick-on English label. Further; the Pickled Radish (Hitokuchi Ume katsuo Takuan) original Japanese label states the product contains ?dried Bonito? which is also a major food allergen (fish) which is not declared on the added stick-on English label.

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 02/18/2015

Desc: Pickled Radish by Salt (HItokuchikiri Takuan)
Notes: The original product labeling contains the allergen ingredient; wheat; which is not declared on the added stick-on English label. Further; the Pickled Radish (Hitokuchi Ume katsuo Takuan) original Japanese label states the product contains ?dried Bonito? which is also a major food allergen (fish) which is not declared on the added stick-on English label.

Yamasanshokuhin
Date Published : 01/26/2015
2 Chome 7-15 , Yahara , Nerima, Tokyo JAPAN
25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 01/26/2015

Desc: Pickled Radish (Tokyo Takuan Mini Half)
Notes: Undeclared Allergen Wheat

25 J - - 26 Chinese Radish (Daikon) (Root & Tuber Vegetable)
Date Published: 01/26/2015

Desc: Pickled Radish (Tokyo Takuan Semi Half)
Notes: Undeclared Allergen Wheat

Yamayoshi Shokuhin Kogyo
Date Published : 02/18/2015
4 Chome 11-8 , Nishioizumi , Nerima, Tokyo JAPAN
25 J - - 27 White Radish (Root & Tuber Vegetable)
Date Published: 02/18/2015

Desc: Pickled Radish (Nerimanokaori Nerimatakuan)
Notes: The original product labeling contains the allergen ingredient; wheat and bonito (fish); which is not declared on the added stick-on English label.


JORDAN


Levant Food Products Company Ltd.
Date Published : 10/05/2017
AL-HASSAN Industrial Estate , AL-MAFRAQ st. Block#9 Sections 1,2,3 4 , Al-hasan Industrial City P. O, Irbid JORDAN
02 F - - 07 Wheat, Milled (Crushed, Coarse Ground or Cracked)
Date Published: 10/05/2017

Desc: GREEN GROUNDED FRIKE
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the product fails to declare "wheat" in English in either the ingredient statement or the "Contains" statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.


KOREA (THE REPUBLIC OF)


GOLDENHILL CO., LTD
Date Published : 02/26/2018
Noan-Myun , 455-90 Noan-Ro; Noan-Myeon , Naju, Jeonranam KOREA (THE REPUBLIC OF)
02 G - - 08 Soybean Flour, Meal, or Powder
Date Published: 02/26/2018

Desc: Roasted Soybean 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(w) of the Act; in that the finished product label fails to declare the major food allergen ?soy? as required by section 403(w)(1) of the Act. Specifically; the product is roasted soybean powder; but is labeled as ?Roasted Bean Powder.?

14 B - - 04 Imitation Milk, Cheese Type Product (Soy Cheese, Etc.)
Date Published: 02/26/2018

Desc: Roasted Soybean 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(w) of the Act; in that the finished product label fails to declare the major food allergen ?soy? as required by section 403(w)(1) of the Act. Specifically; the product is roasted soybean powder; but is labeled as ?Roasted Bean Powder.?

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

Desc: Margaret Cookies; Choco Pie
Notes: Problem(s): Based on analytical evidence; the Kancho Choco Biscuit ; Kancho Choco Biscuit and Kancho Cup products contain peanut but fail to declare this major food allergen on the product label. Based on analytical evidence; the Choco Pie Cacao and Choco Pie products contain almond but fail to declare this major food allergen on the product label.

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

Desc: Kancho Choco Biscuit
Notes: Problem(s): Based on analytical evidence; the Kancho Choco Biscuit ; Kancho Choco Biscuit and Kancho Cup products contain peanut but fail to declare this major food allergen on the product label. Based on analytical evidence; the Choco Pie Cacao and Choco Pie products contain almond but fail to declare this major food allergen on the product label.

03 H - - 07 Mixed Plain Cookies,Biscuits and Wafers
Date Published: 06/24/2020

Desc: Cacao Cake Cookies
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated within the meaning of: -Section 402(a)(4) because it appears that the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact. - Section 403(i)(2) of the Act [21 U.S.C § 343(i)(2)] in that that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4, specifically; the labels declare "vegetable oil" however, it fails to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b)(14), and the ingredients "Cocoa (milk)" and "Shortening" appear to be multi-component ingredient, therefore, the sub-ingredients must be listed in accordance with 21 CFR 101.4(b)(2).

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

Desc: Kancho Choco Biscuit
Notes: Problem(s): Based on analytical evidence; the Kancho Choco Biscuit ; Kancho Choco Biscuit and Kancho Cup products contain peanut but fail to declare this major food allergen on the product label. Based on analytical evidence; the Choco Pie Cacao and Choco Pie products contain almond but fail to declare this major food allergen on the product label

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

Desc: Margaret Cookies; Choco Pie
Notes: Problem(s): Based on analytical evidence; the Kancho Choco Biscuit ; Kancho Choco Biscuit and Kancho Cup products contain peanut but fail to declare this major food allergen on the product label. Based on analytical evidence; the Choco Pie Cacao and Choco Pie products contain almond but fail to declare this major food allergen on the product label.

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

Desc: Kancho Cup products
Notes: Problem(s): Based on analytical evidence; the Kancho Choco Biscuit ; Kancho Choco Biscuit and Kancho Cup products contain peanut but fail to declare this major food allergen on the product label. Based on analytical evidence; the Choco Pie Cacao and Choco Pie products contain almond but fail to declare this major food allergen on the product label.

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

Desc: Choco Pie
Notes: Problem(s): Based on analytical evidence; the Kancho Choco Biscuit ; Kancho Choco Biscuit and Kancho Cup products contain peanut but fail to declare this major food allergen on the product label. Based on analytical evidence; the Choco Pie Cacao and Choco Pie products contain almond but fail to declare this major food allergen on the product label.

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

Desc: Choco Pie Cacao
Notes: Problem(s): Based on analytical evidence; the Kancho Choco Biscuit ; Kancho Choco Biscuit and Kancho Cup products contain peanut but fail to declare this major food allergen on the product label. Based on analytical evidence; the Choco Pie Cacao and Choco Pie products contain almond but fail to declare this major food allergen on the product label.

Lotte Confectionery Co., Ltd.
Date Published : 11/09/2012
Yongdungpogu 4 23 , Seoul, Seoul KOREA (THE REPUBLIC OF)
03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 11/09/2012

Desc: Korean Pie (Momgchel Tongtong)
Notes: NOTE; Article contains eggs; a major food allergen which is not identified on the ingredient statement and there is not declaration of it in a Contains statement.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 11/09/2012

Desc: Korean Pie (Momgchel Tongtong)
Notes: NOTE; Article contains eggs; a major food allergen which is not identified on the ingredient statement and there is not declaration of it in a Contains statement.

Samheung Company
Date Published : 11/09/2012
135-1 Sun-Dong , Hanam City, Keyonggi-Do KOREA (THE REPUBLIC OF)
03 R - - 02 Cakes, filled (other than fruit or jelly)
Date Published: 11/09/2012

Desc: Korean Pie (Momgchel Tongtong)
Notes: NOTE; Article contains eggs; a major food allergen which is not identified on the ingredient statement and there is not declaration of it in a Contains statement.

07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 11/09/2012

Desc: Korean Pie (Momgchel Tongtong)
Notes: NOTE; Article contains eggs; a major food allergen which is not identified on the ingredient statement and there is not declaration of it in a Contains statement.

Sejun Food Co., Ltd
Date Published : 10/30/2019
63 Gamaeul-Gil , Gonjiam-Eup , Gwangju, Gyeonggi KOREA (THE REPUBLIC OF)
29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 10/30/2019

Desc: Ginger Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergens soy as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using black soy bean, but soy is not declared as an ingredient in the product.

29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C.
Date Published: 10/30/2019

Desc: Ginger Sweet Rice Drink
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergens soy as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using black soy bean, but soy is not declared as an ingredient in the product.

Seonil INT Co.,Ltd.
Date Published : 04/24/2015
Mansokdong 1 41 , Dong-Gu , Inchon, INCHON KOREA (THE REPUBLIC OF)
03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 04/24/2015

Desc: Gyeran Cracker
Notes: The 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(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the product fails to declare "milk and egg" in English in either the ingredient statement or the "Contains" statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.

03 F - - 99 Crackers (Non Filled) N.E.C.
Date Published: 04/24/2015

Desc: Tayo Cracker
Notes: The 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(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the product fails to declare "milk and egg" in English in either the ingredient statement or the "Contains" statement as required by the Act as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.


LEBANON


Nafez Albert Farah
Date Published : 06/04/2021
Kfar Saroun High Way , Koura, LB-AS LEBANON
21 U - - 03 Fig, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 06/04/2021

Desc: Fig Jam with Nuts
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The statement of identity is “Fig With Nuts” and the principal display panel has a vignette of what appears to be various types of nuts or seeds, and ingredients that appear to be walnuts and sesame seeds are apparent in the product, but are not declared in the label’s ingredient list as required by 21 CFR 101.4. Section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen walnuts as required by section 403(w)(1) of the Act. Examination of the product reveals that the product contains walnuts, but walnuts are not declared in the ingredient statement or in a Contains statement.


MALAYSIA


CAVERFLO TEXAS TRADING
Date Published : 11/29/2017
117 Lorong Bunga Raya 5 , Sungai Petani, Kedah MALAYSIA
31 A - - -- Coffee
Date Published: 11/29/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "milk", as required by section 403(w)(1) of the Act. Specifically, FDA sample analysis of FDA sample number 994135 found evidence of milk allergens in the product, which is not declared on the product's outside container or individual product packet labeling.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/29/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "milk", as required by section 403(w)(1) of the Act. Specifically, FDA sample analysis of FDA sample number 994135 found evidence of milk allergens in the product, which is not declared on the product's outside container or individual product packet labeling.

65 P - - 02 Sildenafil Citrate (Regulator)
Date Published: 11/29/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "milk", as required by section 403(w)(1) of the Act. Specifically, FDA sample analysis of FDA sample number 994135 found evidence of milk allergens in the product, which is not declared on the product's outside container or individual product packet labeling.

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/29/2017

Desc: Caver Flo Natural Herbal Coffee
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "milk", as required by section 403(w)(1) of the Act. Specifically, FDA sample analysis of FDA sample number 994135 found evidence of milk allergens in the product, which is not declared on the product's outside container or individual product packet labeling.

Kawan Food Manufacturing Sdn Bhd
Date Published : 03/13/2015
Lot 20 , 19 Jalan Pengapit 15 19 15 , Shah Alam, Selangor MALAYSIA
03 E - - 99 Doughs for Bread,Rolls,Muffins, and Buns, N.E.C.
Date Published: 03/13/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the Allergen Contains statement is incomplete. The product is made with margarine which contains soy lecithin; therefore; soy must be included in the Allergen Contain statement

03 R - - 30 Pastry Shells Without Custard or Cream Filling
Date Published: 03/13/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the Allergen Contains statement is incomplete. The product is made with margarine which contains soy lecithin; therefore; soy must be included in the Allergen Contain statement. ;

03 T - - 25 Pastry (other than Fruit or Jelly Filled) Dough or Batter Without Custard or Cream Filling
Date Published: 03/13/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the Allergen Contains statement is incomplete. The product is made with margarine which contains soy lecithin; therefore; soy must be included in the Allergen Contain statement

03 T - - 30 Pastry Shell Dough or Batter Without Custard or Cream Filling
Date Published: 03/13/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the Allergen Contains statement is incomplete. The product is made with margarine which contains soy lecithin; therefore; soy must be included in the Allergen Contain statement. ;

03 Y - - 11 Lumpia wrappers (includes pastry wrappers and sheets)
Date Published: 03/13/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the Allergen Contains statement is incomplete. The product is made with margarine which contains soy lecithin; therefore; soy must be included in the Allergen Contain statement.

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 03/13/2015

Desc: Aman Kerala Porotta (frozen pastry product)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the Allergen Contains statement is incomplete. The product is made with margarine which contains soy lecithin; therefore; soy must be included in the Allergen Contain statement.

Nestle Manufacturing (MALAYSIA) SDN BHD, Shah Alam Complex
Date Published : 03/05/2021
Jalan Playar 15/1 , Shah Alam, Selangor MALAYSIA
38 C - - 99 Dried Soup, N.E.C.
Date Published: 03/05/2021

Desc: Maggi Healthy Soups Thai
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act because the product label fails to declare major food allergens as required by Section 403(w)(1) of the Act. Specifically, the product label fails to list "shrimp," which is the name of the food source of the major food allergen, "prawn," in the ingredient list or a Contains statement. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute,""acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)].

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

Desc: Maggi Healthy Soups Thai
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(w) of the Act because the product label fails to declare major food allergens as required by Section 403(w)(1) of the Act. Specifically, the product label fails to list "shrimp," which is the name of the food source of the major food allergen, "prawn," in the ingredient list or a Contains statement. 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)].


MEXICO


ALEX
Date Published : 12/23/2013
sur111 No. 1123 , colonia aeronautica militar , mexico d.f., MX-DIF MEXICO
23 Y - - 99 Nuts or Edible Seeds Not Mentioned Elsewhere, N.E.C.
Date Published: 12/23/2013

Desc: Sugar Coated Peanuts

Cafe del Pacifico
Date Published : 08/09/2017
Blvd. Enrique Mazon Lopez 626 , Col. Cuartel Xx Cafe Combate , Hermosillo, Sonora MEXICO
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/09/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/09/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 08/10/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically; the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 02 Coffee, Ground
Date Published: 08/09/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 02 Coffee, Ground
Date Published: 08/09/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 02 Coffee, Ground
Date Published: 08/10/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 03 Coffee, Instant
Date Published: 08/09/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 03 Coffee, Instant
Date Published: 08/10/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 03 Coffee, Instant
Date Published: 08/09/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 99 Coffee, N.E.C.
Date Published: 08/09/2017

Desc: De Leon Cafe Weight Loss Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 99 Coffee, N.E.C.
Date Published: 08/10/2017

Desc: De Leon Cafe Original Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

31 A - - 99 Coffee, N.E.C.
Date Published: 08/09/2017

Desc: De Leon Cafe Collagen Formula Cappuccino
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient "sodium caseinate" but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

Herbal Solution's Health S.A. de C.V.
Date Published : 03/15/2019
Calzada Insurgentes Poniente No. 322 , Barrio Barrio De Santa Anita, Irapuato , Irapuato, Guanajuato MEXICO
54 F - - 47 Garcinia cambogia (Herbal & Botanicals, not Teas)
Date Published: 03/15/2019

Desc: Active CL Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient bovine colostrum but the product labels fail to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/15/2019

Desc: Active CL Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient bovine colostrum but the product labels fail to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/15/2019

Desc: Active CL Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient bovine colostrum but the product labels fail to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

Herbal Solution's Health, S.A. de C.V.
Date Published : 03/15/2019
Comunidad Guadalupe De Paso , Blanco Lot 10 , Irapuato, Guanajuato MEXICO
54 F - - 47 Garcinia cambogia (Herbal & Botanicals, not Teas)
Date Published: 03/15/2019

Desc: Active CL Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient bovine colostrum but the product labels fail to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/15/2019

Desc: Active CL Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient bovine colostrum but the product labels fail to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/15/2019

Desc: Active CL Dietary Supplement
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product contains the ingredient bovine colostrum but the product labels fail to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

MARCO ANTONIO MORENO PRESIADO
Date Published : 06/29/2018
Juarez # 13 , Ures , Pueblo Guadalupe, Sonora MEXICO
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 06/29/2018

Desc: Jamoncillos Milk Candy Canister w/ 48 PCS
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. ?343(w)] because it has failed to declare major food allergens as required by Section 403(w) of the Act. Specifically; the product contains the major food allergen almond but fails to declare this major food allergen through a Contains statement or an ingredient list.

Olnatura, S. A. de C. V.
Date Published : 11/02/2015
Sur, Mnz. 40 Pb 8 , Civac , Jiutepec, Morelos MEXICO
54 F - - 24 Senna (Herbal & Botanicals, not Teas)
Date Published: 11/02/2015

Desc: Biofiberex
Notes: The Biofiberex product is misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. 343(w)]; in that the finished product labels fail to declare the major food allergen; soy; as required by section 403(w)(1) of the Act. Specifically; Biofiberex product is manufactured using soy lecithin but the label (Supplement Facts panel) only states "lecithin?.


NEPAL


Aashirbad Trading
Date Published : 08/14/2017
Gongabu-7 , Kathmandu, Kathmandu NEPAL
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 08/14/2017

Desc: Furundana (Nepali Snacks Chanachur)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergens present in the product as required by section 403(w)(1) of the Act. The major food allergen peanut is present in the product, but is not declared as an ingredient on the product label.


NETHERLANDS


The Magic Touch of The Dutch MTD BV
Date Published : 11/19/2018
Flevolaan 14 , Weesp, Noord-Holland NETHERLANDS
03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/19/2018

Desc: Syrup Waffles in Tin; Sunflowers
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fail to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. We note that the inner package declares "butter" but fails to declare milk; in accordance with FALCPA. Furthermore; the outer tins fail to declare the major allergens wheat and egg.

03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C.
Date Published: 11/19/2018

Desc: Syrup Waffles in Tin; Almond Blossom
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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product label fail to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. We note that the inner package declares "butter" but fails to declare milk; in accordance with FALCPA. Furthermore; the outer tins fail to declare the major allergens wheat and egg.

36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 11/19/2018

Desc: Syrup Waffles in Tin; Almond Blossom
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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product label fail to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. We note that the inner package declares "butter" but fails to declare milk; in accordance with FALCPA. Furthermore; the outer tins fail to declare the major allergens wheat and egg.

36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 11/19/2018

Desc: Syrup Waffles in Tin; Sunflowers
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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product label fail to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. We note that the inner package declares "butter" but fails to declare milk; in accordance with FALCPA. Furthermore; the outer tins fail to declare the major allergens wheat and egg.


PAKISTAN


Golden Harvest Foods Pvt Ltd
Date Published : 08/25/2017
24-Plot 33 Sector , Karachi, Sindh PAKISTAN
03 A - - 09 Non-Standard Bread/Rolls/Buns
Date Published: 08/25/2017

Desc: Anarakali Whole Wheat Paratha
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen; "milk" as required by section 403(w)(1) of the Act. Specifically, the product was sampled and found to contain milk protein. The article is subject 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 it is fabricated from two or more ingredients and each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. For example, the product label fails to declare the ingredient that is the source of the milk allergen.

Ken Exporters
Date Published : 11/15/2013
813, C.R DASS Road.Newtown Jamshed Road. , Karachi. , Karachi, PK-SD PAKISTAN
37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 11/15/2013

Desc: Akhrot Halwa
Notes: NOTE; Undeclared Allergen; Walnuts

Rehmat-e-Shereen
Date Published : 11/15/2013
Shams Centre, Main Tariq Road , Karachi, Sindh PAKISTAN
37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C.
Date Published: 11/15/2013

Desc: Akhrot Halwa
Notes: NOTE; Undeclared Allergen; Walnuts


PHILIPPINES


HDR FOODS CORPORATION
Date Published : 01/31/2020
2 L16 B4 Mountview Industrial Complex Ph , Cavite, Calabarzon PHILIPPINES
16 Y - - 13 Oyster Sauce, Fishery Products, n.e.c.
Date Published: 01/31/2020

Desc: Andok's Litson Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because the finished product label fails to declare the major food allergen "wheat" as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using bread crumbs, which contain "wheat." The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it is fabricated from two or more ingredients, but the label fails declare each ingredient by its common or usual name, as required by 21 CFR 101.4. Specifically, the product is manufactured using the multicomponent ingredient "bread crumbs" but fails to declare the sub-ingredients. Additionally, the ingredient "hydrolyzed vegetables protein" and "modified starch" are not common or usual names for these ingredients. "Hydrolyzed vegetable protein" is not acceptable because it does not identify the food source of the protein [21 CFR 102.22]. The common or usual name of "modified starch" is "food starch - modified" [21 CFR 172.892]. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(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)(2).

37 J - - 02 Barbecue Sauce
Date Published: 01/31/2020

Desc: Andok's Litson Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because the finished product label fails to declare the major food allergen "wheat" as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using bread crumbs, which contain "wheat." The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it is fabricated from two or more ingredients, but the label fails declare each ingredient by its common or usual name, as required by 21 CFR 101.4. Specifically, the product is manufactured using the multicomponent ingredient "bread crumbs" but fails to declare the sub-ingredients. Additionally, the ingredient "hydrolyzed vegetables protein" and "modified starch" are not common or usual names for these ingredients. "Hydrolyzed vegetable protein" is not acceptable because it does not identify the food source of the protein [21 CFR 102.22]. The common or usual name of "modified starch" is "food starch - modified" [21 CFR 172.892]. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(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)(2).

37 J - - 07 Steak and Other Meat Sauce
Date Published: 01/31/2020

Desc: Andok's Litson Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because the finished product label fails to declare the major food allergen "wheat" as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using bread crumbs, which contain "wheat." The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it is fabricated from two or more ingredients, but the label fails declare each ingredient by its common or usual name, as required by 21 CFR 101.4. Specifically, the product is manufactured using the multicomponent ingredient "bread crumbs" but fails to declare the sub-ingredients. Additionally, the ingredient "hydrolyzed vegetables protein" and "modified starch" are not common or usual names for these ingredients. "Hydrolyzed vegetable protein" is not acceptable because it does not identify the food source of the protein [21 CFR 102.22]. The common or usual name of "modified starch" is "food starch - modified" [21 CFR 172.892]. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(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)(2).

37 J - - 08 Tomato Sauce (with Other Ingredients)
Date Published: 01/31/2020

Desc: Andok's Litson Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because the finished product label fails to declare the major food allergen "wheat" as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using bread crumbs, which contain "wheat." The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it is fabricated from two or more ingredients, but the label fails declare each ingredient by its common or usual name, as required by 21 CFR 101.4. Specifically, the product is manufactured using the multicomponent ingredient "bread crumbs" but fails to declare the sub-ingredients. Additionally, the ingredient "hydrolyzed vegetables protein" and "modified starch" are not common or usual names for these ingredients. "Hydrolyzed vegetable protein" is not acceptable because it does not identify the food source of the protein [21 CFR 102.22]. The common or usual name of "modified starch" is "food starch - modified" [21 CFR 172.892]. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(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)(2).

37 J - - 99 Sauces, n.e.c.
Date Published: 01/31/2020

Desc: Andok's Litson Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] because the finished product label fails to declare the major food allergen "wheat" as required by section 403(w)(1) of the Act. Specifically, the product is manufactured using bread crumbs, which contain "wheat." The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it is fabricated from two or more ingredients, but the label fails declare each ingredient by its common or usual name, as required by 21 CFR 101.4. Specifically, the product is manufactured using the multicomponent ingredient "bread crumbs" but fails to declare the sub-ingredients. Additionally, the ingredient "hydrolyzed vegetables protein" and "modified starch" are not common or usual names for these ingredients. "Hydrolyzed vegetable protein" is not acceptable because it does not identify the food source of the protein [21 CFR 102.22]. The common or usual name of "modified starch" is "food starch - modified" [21 CFR 172.892]. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be misbranded within the meaning of section 403(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)(2).


PORTUGAL


Almerinda & Filhos Lda.
Date Published : 01/10/2017
Casal Pedro , Rua Da Nazare N. 3; Casal do Pardo , Alfeizerao, Leiria PORTUGAL
16 C - - 12 Cod, Cakes, Balls, Etc.
Date Published: 01/10/2017

Desc: Frozen Cod Fish Cakes
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen "wheat" as required by section 403(w)(1) of the Act.

16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 06/22/2018

Desc: Frozen Shrimp Cakes
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare all major food allergens present in the product, as required by section 403(w)(1) of the Act.


RUSSIA


Donskoy Konditer
Date Published : 04/25/2019
Ul. Belorusskaya 2a , Rostov-Na-Donu, Rostovskaya obl RUSSIA
03 A - - 03 Biscuits
Date Published: 04/25/2019

Desc: SUGAR COOKIES - CREAMY
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 A - - 03 Biscuits
Date Published: 04/25/2019

Desc: SUGAR COOKIES - JEWELRY
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 A - - 03 Biscuits
Date Published: 04/25/2019

Desc: SUGAR COOKIES - HONEY
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 A - - 03 Biscuits
Date Published: 04/25/2019

Desc: SUGAR COOKIES - ROSTOVSKOE
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 A - - 03 Biscuits
Date Published: 04/25/2019

Desc: SUGAR COOKIES - WILD STRAWBERRIES
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 04/25/2019

Desc: SUGAR COOKIES - HONEY
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 04/25/2019

Desc: SUGAR COOKIES - WILD STRAWBERRIES
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 04/25/2019

Desc: SUGAR COOKIES - CREAMY
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 04/25/2019

Desc: SUGAR COOKIES - ROSTOVSKOE
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

03 J - - 99 Filled/Iced Cookies,Biscuits and Wafers, N.E.C.
Date Published: 04/25/2019

Desc: SUGAR COOKIES - JEWELRY
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(w) of the Act [21 U.S.C. §343(w)] in that the finished product labels fail to declare the major food allergens. Specifically, the labels' fail to declare the major food allergen "Milk" in the ingredient statement or in the "Contains" statement in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

Lyubimiy Kray
Date Published : 03/08/2019
ul. Zheleznodorozhnaya 1 , Otradnoe, Leningradskaya obl RUSSIA
03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C.
Date Published: 03/08/2019

Desc: OATMEAL BISCUITS WITH BAKED MILK TASTE
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that the "Oatmeal Biscuits with Baked Milk Taste" product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the ingredient list declares whey but does not declare the major food allergen "milk" as required. Also, the advisory statement is incorrectly used because the product actually contains the wheat and soy allergens. If the advisory statement was meant to be a "Contains" statement, then the major food allergen should be declared as "soy" and not "soy lecithin." Furthermore, if the firm intends to use a Contains statement, it would need to include all major food allergens in the product, including milk.


SPAIN


Almendrera del Sur, S.Coop. And.
Date Published : 03/25/2016
Calle De Almeria S/N 29580 , Cartama, Malaga SPAIN
23 B - - 01 Almond, Shelled
Date Published: 03/25/2016

Desc: Peeled Fried Almonds
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the product label fails to declare almonds in the ingredient statement.


SRI LANKA


Nestle Lanka PLC
Date Published : 10/07/2016
Makandura , Kurunegala Factory , Gonawila, Kurunegala SRI LANKA
21 V - H 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars, Ntrl/Artfcl Dried
Date Published: 10/07/2016

Desc: Maggi Real Coconut Milk Powder; 300 gram box
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically, the secondary product label declares sodium caseinate, an ingredient that is derived from milk. However, the label fails to declare milk.

23 O - - 05 Coconut, Nut Flour/Meal
Date Published: 10/07/2016

Desc: Maggi Real Coconut Milk Powder; 300 gram box
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of 403(w) of the Act in that the finished product label fails to declare the major food allergen "milk" as required by section 403(w)(1) of the Act. Specifically, the secondary product label declares sodium caseinate, an ingredient that is derived from milk. However, the label fails to declare milk.


TAIWAN


Fu Chi Foods Co., Ltd. (FCE 09789)
Date Published : 09/26/2017
5 Guiyang St. , Taishan Dist. , New Taipei City, TAIWAN
25 J - - 07 Radish (Root & Tuber Vegetable)
Date Published: 09/26/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(w) of the FD&C Act in that the finished product label fails to declare the major food allergen "wheat" sub-ingredient. Section 403(i)(2) of the FD&C Act in that the ingredient statement on label declares soybean sauce; but the sub-ingredients of soybean sauce are not declared in accordance with 21 CFR 101.4(b)(2).

25 N - - 14 Turnip, with Sauce
Date Published: 09/26/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(w) of the FD&C Act in that the finished product label fails to declare the major food allergen "wheat" sub-ingredient. Section 403(i)(2) of the FD&C Act in that the ingredient statement on label declares soybean sauce; but the sub-ingredients of soybean sauce are not declared in accordance with 21 CFR 101.4(b)(2).

37 J - - 03 Chili Sauce
Date Published: 09/26/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(w) of the FD&C Act in that the finished product label fails to declare the major food allergen "wheat" sub-ingredient. Section 403(i)(2) of the FD&C Act in that the ingredient statement on label declares soybean sauce; but the sub-ingredients of soybean sauce are not declared in accordance with 21 CFR 101.4(b)(2).

37 J - - 99 Sauces, n.e.c.
Date Published: 09/26/2017

Desc: Salted Turnip Stripped In Dressing Sauce
Notes: Section 403(w) of the FD&C Act in that the finished product label fails to declare the major food allergen "wheat" sub-ingredient. Section 403(i)(2) of the FD&C Act in that the ingredient statement on label declares soybean sauce; but the sub-ingredients of soybean sauce are not declared in accordance with 21 CFR 101.4(b)(2).

Horng Chia Foods Co., Ltd
Date Published : 01/09/2020
Gang-Shan Township , Lane 1; No. 5 Chia Hsin E. Rd. , Kaohsiung City, TAIWAN
16 C - - 28 Pollack, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

16 C - - 28 Pollack, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

16 C - - 84 Threadfin, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

16 C - - 84 Threadfin, Cakes, Balls, Etc.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

16 P - - 99 Other Aquatic Animals, Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Cheese Fish Ball
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

16 P - - 99 Other Aquatic Animals, Cakes, Balls, Etc., N.E.C.
Date Published: 01/09/2020

Desc: Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. §343(w)] in that the products contain a major food allergen but fails to declare the source of the allergen on the product label. Specifically, product contains flying fish roe, but does not specifically declare the source of the major food allergen [21 U.S.C. §343(w)(2)].

Hsiang Ho Food
Date Published : 09/27/2017
NO. 706-14, 14 F. , Zhongzheng Rd.; Xinzhuang Dist. , New Taipei City, TAIWAN
14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 09/27/2017

Desc: Non-Dairy Creamer
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen; "milk" as required by section 403(w)(1) of the Act. Specifically; the product label declares "whey powder" and "sodium caseinate" in the ingredient statement which are milk derived ingredients.

30 A - - 06 Beverage Base, Subtropical or Tropical Fruit
Date Published: 09/27/2017

Desc: Passion Fruit Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen; "milk" as required by section 403(w)(1) of the Act. Specifically; the product label declares "whey powder" and "sodium caseinate" in the ingredient statement which are milk derived ingredients.

30 F - - 99 Beverage Base of Non-Fruit Origin, N.E.C.
Date Published: 09/27/2017

Desc: Shake Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen; "milk" as required by section 403(w)(1) of the Act. Specifically; the product label declares "whey powder" and "sodium caseinate" in the ingredient statement which are milk derived ingredients

30 F - - 99 Beverage Base of Non-Fruit Origin, N.E.C.
Date Published: 09/27/2017

Desc: Coffee Smoothie Powder
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act in that the finished product label fails to declare the major food allergen; "milk" as required by section 403(w)(1) of the Act. Specifically; the product label declares "whey powder" and "sodium caseinate" in the ingredient statement which are milk derived ingredients. ;

Jing Li Hwa Foods Co., Ltd.
Date Published : 12/05/2019
No. 5 Chien Chen District , Shin Ta Rd. , Kaohsiung, Kaohsiung - Special Municipali TAIWAN
16 C - - 28 Pollack, Cakes, Balls, Etc.
Date Published: 12/05/2019

Desc: Fish Ball with Fish Roe Filling
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. § 343(w)]. Labels fail to comply with section 403(w)(1) of the Act, ingredient list included "roe", but the labels fail to list the species of fish roe in either the ingredient list or the 'Contains' statement. 'Contains' statements lists "fish," but fails to list the species of fish(es). The term "Allergy Advice" is not a label requirement and is intervening material.

16 C - - 28 Pollack, Cakes, Balls, Etc.
Date Published: 12/05/2019

Desc: Golden Fried Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. § 343(w)]. Labels fail to comply with section 403(w)(1) of the Act, ingredient list included "roe", but the labels fail to list the species of fish roe in either the ingredient list or the 'Contains' statement. 'Contains' statements lists "fish," but fails to list the species of fish(es). The term "Allergy Advice" is not a label requirement and is intervening material.

16 C - - 84 Threadfin, Cakes, Balls, Etc.
Date Published: 12/05/2019

Desc: Fish Ball with Fish Roe Filling
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. § 343(w)]. Labels fail to comply with section 403(w)(1) of the Act, ingredient list included "roe", but the labels fail to list the species of fish roe in either the ingredient list or the 'Contains' statement. 'Contains' statements lists "fish," but fails to list the species of fish(es). The term "Allergy Advice" is not a label requirement and is intervening material.

16 C - - 84 Threadfin, Cakes, Balls, Etc.
Date Published: 12/05/2019

Desc: Golden Fried Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. § 343(w)]. Labels fail to comply with section 403(w)(1) of the Act, ingredient list included "roe", but the labels fail to list the species of fish roe in either the ingredient list or the 'Contains' statement. 'Contains' statements lists "fish," but fails to list the species of fish(es). The term "Allergy Advice" is not a label requirement and is intervening material.

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 12/05/2019

Desc: Fish Ball with Fish Roe Filling
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. § 343(w)]. Labels fail to comply with section 403(w)(1) of the Act, ingredient list included "roe", but the labels fail to list the species of fish roe in either the ingredient list or the 'Contains' statement. 'Contains' statements lists "fish," but fails to list the species of fish(es). The term "Allergy Advice" is not a label requirement and is intervening material.

16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 12/05/2019

Desc: Golden Fried Fish Ball with Fish Roe
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(w) of the Act [21 U.S.C. § 343(w)]. Labels fail to comply with section 403(w)(1) of the Act, ingredient list included "roe", but the labels fail to list the species of fish roe in either the ingredient list or the 'Contains' statement. 'Contains' statements lists "fish," but fails to list the species of fish(es). The term "Allergy Advice" is not a label requirement and is intervening material.

Kugi Foods Co., Ltd.
Date Published : 03/13/2019
Sinjhuang District , NO. 22, 6f-9; Wuquan 2nd Rd. , New Taipei City, TW-TPQ TAIWAN
14 B - - 06 Imitation Milk, Dried Milk Type Product
Date Published: 03/13/2019

Desc: Hokkaide Flavor Powder (invoiced as Non-Dairy Creamer 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product was analyzed and generated responses characteristic of containing milk but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

14 B - - 06 Imitation Milk, Dried Milk Type Product
Date Published: 03/26/2019

Desc: HOKKAIDE FLAVOR POWDER
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: -Section 403(w) of the Act [21 U.S.C. §343(w)] in that it appears that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1) because the product was analyzed and generated responses characteristic of containing milk. -Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient. The product was analyzed to contain milk, but the label does not appear to declare milk or milk-containing ingredient. Further, the ingredient "glucose" is not a recognized common or usual name of an ingredient in the U.S. in accordance with 21 CFR 101.4(a)(1). If the ingredient is one of the standardized foods, Glucose Sirup (21 CFR 168.120) or Dried Glucose Sirup, it must be declared in accordance with the applicable standard.

14 B - - 99 Imitation Milk or Milk Type Product, N.E.C.
Date Published: 03/13/2019

Desc: Hokkaide Flavor Powder (invoiced as Non-Dairy Creamer 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product was analyzed and generated responses characteristic of containing milk but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

30 F - - 99 Beverage Base of Non-Fruit Origin, N.E.C.
Date Published: 03/13/2019

Desc: Hokkaide Flavor Powder (invoiced as Non-Dairy Creamer 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product was analyzed and generated responses characteristic of containing milk but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

30 N - - 99 Combination True and Imitation Fruit Flavored Beverage Bases, N.E.C.
Date Published: 03/13/2019

Desc: Hokkaide Flavor Powder (invoiced as Non-Dairy Creamer 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product was analyzed and generated responses characteristic of containing milk but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C.
Date Published: 03/13/2019

Desc: Hokkaide Flavor Powder (invoiced as Non-Dairy Creamer 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product was analyzed and generated responses characteristic of containing milk but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

35 A - - 99 Gelatin, N.E.C.
Date Published: 03/13/2019

Desc: Hokkaide Flavor Powder (invoiced as Non-Dairy Creamer 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen present in the product as required by section 403(w)(1) of the Act. Specifically, the product was analyzed and generated responses characteristic of containing milk but fails to declare the major food allergen "milk" in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).

Shang Dao Food Company, Ltd.
Date Published : 08/28/2018
Tucheng District , Lane 33; NO. 15 Rixin St. , New Taipei City, TW-TPQ TAIWAN
35 D - - 99 Pudding (Pie Filling) Mix, N.E.C. (Not Custard)
Date Published: 08/28/2018

Desc: Mango Pudding 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(w) of the Act [21 U.S.C. §343(w)] in that the finished product label fails to declare the major food allergen milk as required by section 403(w)(1) of the Act. Specifically, according to the product label the product contains creamer with sub-ingredients that include sodium caseinate. Sodium caseinate is a milk derivative, but the label fails to list milk as an ingredient.


THAILAND


BEST FOODS INTERTRADE CO.,LTD
Date Published : 02/12/2016
25/29 , Moo 4; Suksawad Road , Phra Pradaeng, Samut Prakan THAILAND
07 B - - 99 Fried Snack Foods, N.E.C.
Date Published: 02/12/2016

Desc: Crispy Peanut Snack (Hot and Sour)
Notes: The 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(w) of the Act; in that the label fails to declare all major food allergens present in the product; as required by section 403(w)(1). Specifically; the product label fails to declare peanuts in the ingredient statement.

Huychun (Thailand)
Date Published : 05/23/2019
16/3 Moo 2 Nongpaklong A. Muang , Nakornpatom, TH-73 THAILAND
29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Banana Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Strawberry Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Rose Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Mango Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Banana Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Rose Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Strawberry Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

29 A - - 99 Noncarbonated Soft Drink, N.E.C.
Date Published: 05/23/2019

Desc: Falooda Drink with Almond (Mango Flavor)
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: 403(w) of the Act [21 U.S.C. § 343(w)] in that they fail to declare appropriately all major food allergens, as required by section 403(w)(1) of the Act. Specifically, the product label bears images of almonds and states "Real Bites of Almond Inside" but fails to declare almonds within the ingredient list or through a Contains statement.

Phetdamfoods Co.,Ltd.
Date Published : 10/17/2019
Amphoe Maung , 193 Villeage No.5 Tambol Hui Pho , Kalasin, Kalasin THAILAND
16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 10/17/2019

Desc: Plala Fish Sauce
Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare the food source of the major food allergen present in the product, as required by section 403(w)(2) of the Act. Specifically, the ingredient list declares an ingredient statement that lists "Fish sauce", but the law (FALCPA) requires that food labels identify the food source names of all major food allergens used to make the food.

eastern Food Co., Ltd.
Date Published : 02/23/2016
209 Lardpro 53rd. , Lardpro Road, Vangthonglarn , Bangkok, TH-NOTA THAILAND
03 J - - 06 Fruit Filled Filled/Iced Cookies,Biscuits and Wafers
Date Published: 02/23/2016

Desc: PINEAPPLE BISCUIT
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)] in that the product contains butter but the ingredient statement fails to declare the allergenic ingredient, "milk".


UGANDA


African market
Date Published : 08/21/2015
Luwumu street 24089 , Kampala, UGANDA
23 B - - 07 Peanut, Shelled
Date Published: 10/05/2015

Desc: Grinded G Nuts (peanuts)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product is; or contains; peanuts but it's not declared as the statement of identity (if it is a single ingredient food) or in an ingredient statement or in a "Contains" statement.

23 B - - 07 Peanut, Shelled
Date Published: 10/05/2015

Desc: Whole G Nuts (peanuts)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product is; or contains; peanuts but it's not declared as the statement of identity (if it is a single ingredient food) or in an ingredient statement or in a "Contains" statement.

23 Y - - 99 Nuts or Edible Seeds Not Mentioned Elsewhere, N.E.C.
Date Published: 10/05/2015

Desc: Whole G Nuts (peanuts)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product is; or contains; peanuts but it's not declared as the statement of identity (if it is a single ingredient food) or in an ingredient statement or in a "Contains" statement.

23 Y - - 99 Nuts or Edible Seeds Not Mentioned Elsewhere, N.E.C.
Date Published: 10/05/2015

Desc: Grinded G Nuts (peanuts)
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(w) of the Act in that the product is; or contains; peanuts but it's not declared as the statement of identity (if it is a single ingredient food) or in an ingredient statement or in a "Contains" statement.


UKRAINE


Capsular
Date Published : 02/16/2017
Zheleznodorogniy lane 3/4 , Dergachi, Kharkivska Oblast UKRAINE
16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 02/16/2017

Desc: Imitation Caviar
Notes: 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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product labels fail to declare the major food allergens as required by section 403(w)(1) of the Act. According to the formulations provided; the products appear to be manufactured using salmon; sturgeon; and/or pike meat (depending on the flavor); but fail to declare the species of fish on the labels.

16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 02/16/2017

Desc: Imitation Caviar
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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product labels fail to declare the major food allergens as required by section 403(w)(1) of the Act. According to the formulations provided; the products appear to be manufactured using salmon; sturgeon; and/or pike meat (depending on the flavor); but fail to declare the species of fish on the labels.

28 M - - 99 Imitation Flavor, N.E.C.
Date Published: 02/16/2017

Desc: Imitation Caviar
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(w) of the Act [21 U.S.C. ?343(w)] in that the finished product labels fail to declare the major food allergens as required by section 403(w)(1) of the Act. According to the formulations provided; the products appear to be manufactured using salmon; sturgeon; and/or pike meat (depending on the flavor); but fail to declare the species of fish on the labels.


VIETNAM


CJ Cau Tre Foods Joint Stock Company
Date Published : 01/20/2017
125/208 Luong The Vinh Street, Tan Thoi Hoa Ward , Tan Phu District , Ho Chi Minh City, VN-65 VIETNAM
16 E - - 02 Clams
Date Published: 01/20/2017

Desc: Clam Linquine With Garlic; Herbs and Natural Clam 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(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. & 343(w)] in that it fails to declare a major food allergen (specifically "tree nut (coconut)" and "fish" – unknown food source).

Co So San Xuat Keo Yen Nhung DBA: Yeng Candy
Date Published : 02/28/2017
2/17 Block 1, Tan Mai Ward , 2/21 BLOCK 1, TAN MAI WARD , Bien Hoa City, Dong Nai Province VIETNAM
33 A - - 99 Hard Candy with Nut or Nut Products, N.E.C. (without Chocolate)
Date Published: 02/28/2017

Desc: Assorted Nut 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(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the major food allergen, tree nut coconut, as required by section 403(w)(1) of the Act. ; The article is subject 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 nutrition facts information is not consistent with the labeling requirements, as defined in 21 CFR 101.9. ; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically; the ingredient statement does not contain the presence of tree nut coconut, which is not declared in the ingredient statement.

33 A - - 99 Hard Candy with Nut or Nut Products, N.E.C. (without Chocolate)
Date Published: 02/28/2017

Desc: Cashew Nut 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(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the major food allergen, tree nut coconut, as required by section 403(w)(1) of the Act. ; The article is subject 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 nutrition facts information is not consistent with the labeling requirements, as defined in 21 CFR 101.9. ; The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically; the ingredient statement does not contain the presence of tree nut coconut, which is not declared in the ingredient statement.