2022-26110: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; and Questions and Answers Regarding Food Allergens,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
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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry." The draft guidance, when finalized, will explain FDA's current thinking on a number of issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act). The draft guidance is a revision of a currently issued guidance, entitled "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)." This draft guidance is not final nor is it in effect at this time. In addition, the FDA is announcing availability of a final guidance entitled "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." This final guidance includes the questions and answers from the currently issued guidance that remain substantively unchanged.
The agency’s own summary, as published.
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