The U.S. Food and Drug Administration (FDA) has turned its attention to food allergen labeling requirements with the release of new guidance documents related to the agency’s Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry.

A new draft guidance updates the previous edition (Edition 4) of the Q&A guidance with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). FDA also issued a final guidance with the same title to preserve the questions and answers from Edition 4 that were not changed.

The draft guidance takes into account sesame as a food allergen, as the FASTER Act adds sesame to the list of major food allergens effective January 1, 2023.

Specifically, the draft guidance includes new questions and answers about food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of major food allergens in the labeling of dietary supplement products; and other technical labeling issues. Also revised in the draft guidance are questions and answers to update and clarify information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish. Finally, the draft guidance includes images that show examples of labeling requirements.

Comments about the draft guidance should be submitted within 60 days of publication of the notice in the Federal Register. Written comments, identified by Docket ID FDA-2022-D-0099, can also be mailed to: Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.