FDA Issues Draft Guidance for Industry on Food Allergen Labeling Exemption Petitions and Notifications

CFSAN Constituent Update

May 7, 2014

The U.S. Food and Drug Administration (FDA) is issuing draft guidance, Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications, that is intended to help industry prepare submissions that seek exemptions from the labeling requirements for ingredients derived from major food allergens.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that food labels identify products containing major food allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans). Because an ingredient derived from a major food allergen may be modified to such an extent that it does not contain allergenic protein or does not cause an allergic response that poses a risk to human health, FALCPA provides for two processes through which a manufacturer can obtain an exemption from this labeling requirement for a specific ingredient.

The draft guidance is intended to help industry prepare comprehensive submissions to allow FDA to expeditiously evaluate whether the ingredients meet the exemption standards in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As discussed in more detail in the draft guidance, FDA is: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. 

Submit comments electronically to the FDA docket through FDA-2014-D-0052, starting May 8, 2014.

To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852 

All submissions must include the agency name and docket number.

For more information:

Page Last Updated: 06/06/2014
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