FDA issues Guidance for Allergen Exemptions

The U.S. Food and Drug Administration has issued final guidance to help food manufacturers provide adequate data to support exemptions from the labeling requirements for ingredients derived from major food allergens.

Modified Ingredients offer Consumers more Choice

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).

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

Process for Obtaining Exemption 

Under FALCPA, manufacturers who want to obtain an exemption from the labeling requirement for a specific ingredient must submit:

  • a petition that provides scientific information demonstrating that an ingredient derived from a major food allergen “does not cause an allergic response that poses a risk to human health”


  • a notification providing scientific information demonstrating that the ingredient “does not contain allergenic protein” (or providing information that that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act that the ingredient does not cause an allergic response that poses a risk to human health)

The guidance describes the types of comprehensive submissions that will help the FDA evaluate whether the ingredients meet the exemption standards in FALCPA. 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.

Further Information 

For more information:

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