The FDA has issued two guidance documents about food allergen labeling requirements to help the food industry meet the need to list any significant food allergen on the labels of FDA-regulated foods.

The agency is seeking public and industry comments on the guidance. Directions on how to comment are below.

Federal law identifies eight foods as major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. The Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), among other things, add sesame to the list of major food allergens effective Jan. 1, 2023, which will make it the ninth major food allergen recognized on the U.S.

“Food labels are a powerful tool to help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic or sensitive to in a food by looking for specific allergen labeling and reading the ingredient list,” according to the Food and Drug Administration.

The new draft guidance includes: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 updat 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.

“Food allergies and other types of food hypersensitivities affect millions of Americans and their families. Food allergies occur when the body’s immune system reacts to certain proteins in food. Food allergic reactions vary in severity from mild symptoms involving hives and lip swelling to severe, life-threatening symptoms, often called anaphylaxis, that may involve fatal respiratory problems and shock,” according to the FDA.

”While promising prevention and therapeutic strategies are being developed, food allergies currently cannot be cured. Early recognition and learning how to manage food allergies, including which foods to avoid, are important measures to prevent serious health consequences.”

One of the new FDA guidance documents is a draft guidance titled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition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.” This draft guidance updates the previous edition (Edition 4) with new and revised questions and answers related to the labeling of food allergens, including requirements in the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).

FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C 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.

The FDA has also issued final guidance to preserve the questions and answers from the previous edition (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

To Submit Comments:
Comments about the draft guidance should be submitted within 60 days of publication of the notice in the Federal Register announcing the availability of the draft guidance to ensure the FDA considers your comment before it begins work on the final guidance. 

Submit comments electronically on www.regulations.gov. 

If unable to submit comments online, please mail written comments to:

Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s Docket ID: FDA-2022-D-0099.

For Additional Information:

• Federal Register Notice of Availability
• Draft Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)
• Final Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)
• Food Allergies
• Food Allergens/Gluten-Free Guidance documents & Regulatory Information
• FASTER Act Video – Includes basic information about the FASTER Act and helps answer frequently asked questions the FDA has received from the food industry and other stakeholders