US FDA issues Guidance for Industry re: Q/As on Food Allergen's and Food Labeling (3rd Ed.)

From: Pamela Tom (pdtom@ucdavis.edu)
Date: Fri Apr 07 2006 - 21:48:39 PDT

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    Fr: Pamela Tom
         Sea Grant Extension Program
         University of California
         Davis, CA USA

    On April 6, 2006 the US Food and Drug Administration issued "Guidance for
    Industry, Questions and Answers Regarding Food Allergens, including the
    Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004"
    (Edition 3): http://www.cfsan.fda.gov/~dms/alrguid3.html

    Of the 24 questions and answers in the latest Guidance. here are answers
    of interest to the seafood processing and retail industries:

    - A major food allergen includes: milk, egg, FISH, CRUSTACEAN SHELLFISH,
    tree nuts, wheat, peanuts and soybeans.

    - The species must be declared for fish (e.g., bass, flounder, or cod) and
    Crustacean shellfish (crab, lobster, or shrimp).

    - Under FALCPA, Crustacean shellfish (such as crab, lobster, or shrimp),
    and ingredients that contain protein derived from Crustacean shellfish,
    are major food allergens, but molluscan shellfish (such as oysters, clams,
    mussels, or scallops) are not.

    - FALCPA's requirements apply to all packaged foods sold in the U.S. that
    are regulated under the Federal Food, Drug, & Cosmetic Act, including both
    domestically manufactured and imported foods (except meat products,
    poultry products, and egg products).

    - A company and its management may be subject to civil sanctions, criminal
    penalties, or both under the Federal Food, Drug, and Cosmetic Act if one
    of its packaged food products does not comply with the FALCPA labeling
    requirements. FDA may also request seizure of food products where the
    label of the product does not conform to FALCPA's requirements. In
    addition, FDA is likely to request that a food product containing an
    undeclared allergen be recalled by the manufacturer or distributor.

    - FALCPA's labeling requirements extend to foods packaged by a retail or
    foodservice establishment that are offered for human consumption. However,
    FALCPA's labeling requirements do not apply to foods provided by a retail
    food establishment that are placed in a wrapper or container in response
    to a consumer's order - such as the paper or box used to convey a sandwich
    that has been prepared in response to a consumer's order.

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