FDA Drafting Wider Guidance on Food Allergens

FDA Major Food Allergens

The U.S. Food and Drug Administration has issued a draft guidance that, when finalized, will outline the agency's approach to the public health importance of food allergens that are not one of the major nine food allergens already identified by law in the U.S.

The guidance is part of the FDA’s effort to evaluate new evidence regarding food allergens “in a consistent and transparent manner,” said Susan Mayne, director of the Center for Food Safety and Applied Nutrition, in a release. “The nine major food allergens don't currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities,” she said.

The nine major food allergens consist of milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Sesame was made the ninth food allergen and will be officially listed on Jan. 1, 2023. The Food Allergy Safety, Treatment, Education and Research (FASTER) Act signed into law on April 23, 2021, declared sesame as the ninth major food allergen recognized by the U.S. The FDA noted, however, that more than 160 foods are known to cause food allergic reactions.

The new guidance describes the approach the FDA intends to take when evaluating the public health importance of a non-listed food allergen and including a discussion of the evidence that establishes the food as a cause of a food allergy. Key scientific factors, such as prevalence, severity and allergenic potency will also be discussed.

Comments on the draft guidance are be accepted within 120 days of its publication in the Federal Register. Comments can be submitted using Docket ID: FDA-2021-N-0553 at www.regulations.gov