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: 11/01/2017
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 Division of Field 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.


BRAZIL


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.

Yoki Alimentos Ltda.-Cambara Plant
Date Published : 08/04/2017
Rodovia BR 369 Km. 18 , Cambara, PR 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."


CANADA


Fit Foods
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


DALIAN SHENGHUA SEAFOOD CO.,LTD.
Date Published : 02/10/2017
2,SHUANGXING ROAD, JINZHOU DISTRICT, , DALIAN, LIAONING, CHINA , DALIAN, CN-21 CHINA
16 R - - 02 Crab, Imitation
Date Published: 02/10/2017

Desc:Imitation Crab Sticks (Frozen)

16 R - - 02 Crab, Imitation
Date Published: 02/10/2017

Desc:Imitation Crab Flakes (Frozen)

Jiangxi Golden Eagle Food Co., Ltd.
Date Published : 12/01/2014
Wangcheng , NO. 188 Yongqiang Road(North) , Nanchang, Jiangxi 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 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.

QINGDAO ZHENGJIN WEST COAST AQUATIC PRODUCT PROCESSING PLANT
Date Published : 07/05/2017
Zhengjin Industrial Park , NO. 18 Shuangyuan Road , Qingdao, Shandong CHINA
16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 07/05/2017

Desc:Imitation Crabmeat ***(flakes)***
Notes:The article is 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 article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the ingredient statement does not contain the presence of egg which is not declared in the ingredient statement.

16 R - - 02 Crab, Imitation
Date Published: 07/05/2017

Desc:Imitation Crabmeat ***(flakes)***
Notes:The article is 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 article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, the ingredient statement does not contain the presence of egg which is not declared in the ingredient statement.


COLOMBIA


Alimentic Eu
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.”

Yaral Group C.I.
Date Published : 10/25/2017
Modelia , Calle 25C # 80C-31 , Bogota, Distrito Capital de Bogota 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.                                                                                                                                                                                                                                                                                                                                                                

Yaral Group C.I. S.A.S.
Date Published : 11/01/2017
Calle 25 F No. 85c 76 , Bogota, 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.                                                                                                                                                                                                                                                                                                                                                                


DOMINICAN REPUBLIC


Alopecil Corporation, S.R.L.
Date Published : 11/10/2016
Autopista 30 de Mayo No. 111 , Haina, D.N. , Santo Domingo, DO-01 DOMINICAN REPUBLIC
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


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.


ITALY


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


JAPAN


Maruto Seika Co., LTD
Date Published : 01/13/2015
1532 Nakatsuhara , Miyuki-cho , Fukuyama-City, 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

Mikakuto Co.,Ltd.
Date Published : 09/18/2015
137-5 imagou-cho, , Yamatokooriyama-shi, Nara-ken 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.

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.

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
2-7-15 Yawara 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
4-11-8 Nishioizumi , Nerima Ku, Tokyo-to 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, REPUBLIC OF (SOUTH)


Lotte Confectionery Co., Ltd.
Date Published : 11/09/2012
Yongdungpogu 4 23 , Seoul, Seoul KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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.

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

Desc: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.


MALAYSIA


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.


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).

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.


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


POLAND


KUPIEC Sp. z o.o.
Date Published : 11/20/2014
Paprotnia , Ul. Kupiecka 17 , Krzymow, Wielkopolskie POLAND
03 J - - 02 Chocolate Filled/Iced Cookies,Biscuits and Wafers
Date Published: 11/20/2014

Desc:Rice cakes/rice wafers in Dark Chocolate
Notes:Article contains milk 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 Y - - 12 Rice Cakes
Date Published: 11/20/2014

Desc:Rice cakes/rice wafers in Dark Chocolate
Notes:Article contains milk proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a 'Contains' statement.

05 A - - 03 Rice Flakes,Puffs,Krispies,Loops Ready To Eat
Date Published: 11/20/2014

Desc:Rice cakes/rice wafers in Dark Chocolate
Notes:Article contains milk proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a 'Contains' statement.

05 A - - 99 Breakfast Foods Ready To Eat,N.E.C.
Date Published: 11/20/2014

Desc:Rice cakes/rice wafers in Dark Chocolate
Notes:Article contains milk proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a 'Contains' statement.

34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 11/20/2014

Desc:Rice cakes/rice wafers in Dark Chocolate
Notes:Article contains milk proteins; a major food allergen; which are not identified on the ingredient statement and there is no declaration of it in a 'Contains' statement.


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.


SPAIN


ALMENDRERA DEL SUR, Sdad. Coop. And.
Date Published : 03/25/2016
CAMINO DE LA ALMENDRERA, S/N , ESTACION DE CARTAMA, ES-MA 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).

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. ;

Mei Yuan Preserved Co.,LTD
Date Published : 09/04/2015
18-1 Mei Chou 1st Rd. , Yi Lan City, Tw-Ila TAIWAN
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.

Shin Ho Sing Ocean Enterprise Co., Ltd.
Date Published : 02/09/2017
No. 31 Fishing Harbour South 1st Road , Chien Chen District , Kaohsiung, TAIWAN
16 R - - 04 Lobster, Imitation
Date Published: 02/09/2017

Desc:Frozen Simulated Lobster Ball
Notes:The article is 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 the major food allergen present in the product as required by section 402(w)(1) of the Act. Specifically, testing of this product revealed that the product appeas to contain egg, which is a major food allergen and is not identified in the product’s ingredient or “Contains” statement.


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.

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
luwum , Kampala, UG-102 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.

26 A - - 09 Virgin Olive Oil, Crude
Date Published: 02/16/2017

Desc:Encapsulated Olive Oil
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 allergen soy as required by section 403(w)(1) of the Act. According to the formulation provided; the products appear to be manufactured using soy lecithin; which is not declared 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


CTY CP CB Hang Xuat Khau Cau Tre DBA: Joint Stock Company
Date Published : 01/20/2017
Tan Phu Dist. , 208 , Ho Chi Minh, 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.