FDA Issues Draft Guidance for Food Allergen Labeling

FDA has issued two guidance documents regarding food allergen labeling. One of the documents is a draft guidance that includes requirements from the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and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). The agency is seeking comment on

FALCPA amended the Federal Food, Drug, and Cosmetic Act by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act, among other elements, adds sesame to the list of major food allergens and is effective on January 1, 2023. The act makes it the ninth major food allergen recognized in the U.S.

The draft guidance includes: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.
• Revised 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.
• Images that show examples of labeling requirements.

The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

Comments about the draft guidance can be submitted at www.regulations.gov.