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FDA Issues Two New Guidances on Food Allergen Labeling Requirements

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The draft guidance includes new questions and answers about food allergen labeling requirements and the labeling of major food allergens in dietary supplement products; clarifies information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish; and includes images that show examples of labeling requirements.

The FDA has issued two new guidance documents on food allergen labeling requirements.

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 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).

The 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. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act adds sesame to the list of major food allergens effective January 1, 2023.

The draft guidance includes: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 (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

Stakeholders can submit comments about the draft guidance within 60 days of the November 30 publication of the notice in the Federal Register. Submit comments electronically on www.regulations.gov or by mail:

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.

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