FDA updates its Food Allergen Labeling Questions and Answers guidance

U.S – The U.S. Food and Drug Administration (FDA) has released a new guidance document on food 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 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).

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) was enacted in August 2004 and, in part, amended the FD&C Act by defining the term “major food allergen”.

It stated that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived. 

This law identified eight foods as major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

To retain the questions and responses from Edition 4 that were not altered, the FDA also released a final directive with the same name.

Sesame is considered a food allergen in the proposed guidance because, beginning of January 1, 2023, the FASTER Act will add sesame to the list of major food allergens.

On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the 9th major food allergen recognized by the United States.

The draft guidance includes additional questions and answers with regard to food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of significant food allergens in the labeling of dietary supplement products; and other technical labeling concerns.

Questions and answers that update and clarify information offered in earlier iterations of the final guideline, such as the labeling of tree nuts, fish, and crab and shellfish, have also been modified in the draft guidance.

Last but not least, the proposed guidance contains pictures that illustrate various labeling requirements.

The FDA is calling on stakeholders to give their feedback on the draft guidance within 60 days of the notice being published.

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