Jun 11

FDA Publishes Food Allergen Labeling Guidelines

On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.” The draft guidance represents current thinking on the topic as previously discussed through the release of the October 2006 “Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance.” The guidance provides the FDA’s answers to commonly asked questions concerning the notification process for those seeking exemptions from the labeling of food allergens and updates the responses in the 2006 document. You can read the draft guidance on the FDA’s website, available here.

Major food allergens are defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as “[m]ilk, 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” and also as any food ingredients that contain protein derived from these foods. This definition currently excludes highly refined oil that has been derived from a major food allergen and any ingredient derived from such highly refined oil. The term “major food allergen” was first defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II of Public Law 108-282), which was incorporated into and amended the FFDCA.

Exemptions from the food allergen labeling requirements as found in section 403(w)(1) of the FFDCA, as amended by FALCPA, must be done through a petition and notification process. Such process includes a declaration by the petitioner that the ingredient for which exempted relief is being sought does not cause an allergic reaction, pose a significant risk to human health, or contain an allergenic protein. However, as explained in the guidance document, manufacturers of such products that wish to claim the exemptions must submit detailed petitions to the FDA before omitting major allergen labeling.

Understanding how to properly label foods with the necessary food allergen labeling information is important. Products that are improperly labeled (i.e. contains an undeclared allergen) often result in recalls and enforcement actions by the FDA. More information the consequences of failure to declare allergens in labeling may be accessed here.

If you have any questions about food labeling, including compliance with FDA requirements pertaining to major food allergen labeling, please contact us at: contact@giannamore-law.com.FDA Lawyer

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