FDA: the Final Guidance on Food Allergen Labeling Exemption

Posted By: Selerant RSA


The U.S. Food and Drug Administration has announced the availability of the final guidance, entitled Food Allergen Labeling Exemption Petitions and Notifications”. This guidance intends to help food manufacturers provide adequate data to support exemptions from the labeling requirements for ingredients derived from major food allergens through submission of either a petition or a notification.

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).

However, food manufacturers may be able to modify an ingredient derived from a major food allergen so that it no longer presents a risk to people suffering from food allergies. These modifications may provide consumers who have a specific allergy with more foods to choose from, without fear of inducing an allergic reaction.

Manufacturers that are able to demonstrate to the FDA that an ingredient qualifies for a labeling exemption do not need to place an allergen declaration on the food label for that ingredient.

For more information:

Federal Register Notice

Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications

FDA Issues Guidance on Food Allergen Labeling Exemptions