Import Alert 99-22

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

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

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

See RED LIST

"The article is 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