Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications


Posted By: Selerant RSA

May 8, 2014; The U.S. Food and Drug Administration (FDA) released draft guidance, Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications, for industry with instructions on how to obtain a food allergen labeling exemption through submission of a petition or notification to FDA.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that food labels identify products containing major food allergens such as milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. Because ingredients derived from major food allergens may be modified to the extent that they do not trigger an allergic response, FALCPA provides for two pathways through which a manufacturer can obtain an exemption from allergen labeling. 

The draft guidance is intended to help industry prepare comprehensive submissions to allow FDA to expeditiously evaluate whether the ingredients meet the exemption standards in FALCPA.  Companies that have demonstrated to FDA that an ingredient qualifies for a labeling exemption are able to use that ingredient, derived from a major food allergen, in food products with no accompanying allergen declaration on the food label, and, as such, expand the variety of food products available to food-allergic consumers.

As discussed in more detail in the draft guidance, FDA is looking to inform manufacturers of the scientific evidence FDA needs to evaluate submissions in accordance with the standards defined in FALPCA; and help manufacturers evaluate whether to submit a petition or notification.                                                                             

Comments on the draft guidance are due September 5.

More information:

Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications; Availability