/>i- On January 6, 2025, FDA released two final guidance documents concerning food allergens. The guidance documents represent the Agency’s current thinking related to producing and labeling food products with both major food allergens and non-listed food allergens.
- 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) revises previous versions of guidance on food allergen labeling, consolidating and finalizing the draft and final guidance published in November 2022. The final guidance contains questions and answers about food allergen labeling requirements. Some changes from the draft guidance include:
- Expanding FDA’s historical interpretation of the terms “milk” and “eggs” for the purposes of the definition of a “major food allergen.” In the food allergen context, FDA now considers “milk” as milk from domesticated cows, goats, sheep, or other ruminants, and “eggs” as eggs from domesticated chickens, ducks, geese, quail, and other fowl.
- Revising the list of tree nuts that FDA considers as major food allergens. “Tree nuts” include almond, black walnut, Brazil nut, California walnut, cashew, filbert/hazelnut, heartnut/Japanese walnut, macadamia nut/Bush nut, pecan, pine nut/pinon nut, pistachio, and English and Persian walnut. Notably, FDA no longer considers coconut to be a tree nut in this context. Other nuts removed from the list of tree nuts include beech nut, butternut, chestnut, chinquapin, gingko nut, hickory nut, pili nut, and shea nut.
- Revising several questions and answers to update and clarify information in previous editions.
- Final Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act provides FDA’s general approach when evaluating the public health importance of food allergens other than a “major food allergen,” including identifying the scientific factors and other information relevant to labeling and production, as well as recommendations for how to identify and evaluate the body of evidence of a non-listed food allergen.
FDA Issues Two Final Guidance Documents on Allergens
Tuesday, January 7, 2025
Current Public Notices
Published: 6 January, 2025
Published: 6 January, 2025
Published: 26 December, 2024
Published: 9 December, 2024
