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; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just released updated guidance to help food makers label allergens clearly and follow the latest rules from the Food Allergen Labeling and Consumer Protection Act and the FASTER Act. This update affects food companies who need to keep their labels safe and accurate for people with allergies. The new guidance is available now, and the FDA welcomes comments anytime, making it easier to stay on top of allergen safety.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Expanded 'milk' and 'eggs' definitions
The final guidance states that for the definition of a "major food allergen," FDA considers "milk" to include milk from domesticated cows, goats, sheep, or other ruminants and "eggs" to include eggs from domesticated chickens, ducks, geese, quail, and other fowl (announced January 7, 2025). If you have milk or egg allergies, this clarifies which animal sources FDA treats as allergens for labeling.
Revised list of tree nut allergens
The final guidance revises the list of tree nuts that the FDA considers to be major food allergens (published January 7, 2025). If you have a tree nut allergy, this guidance clarifies which tree nuts FDA treats as major allergens for labeling purposes.
Labeling Q&A on sesame, oils, supplements
The guidance includes questions and answers about labeling sesame, incidental additives, highly refined oils, dietary supplement products, fish and crustacean shellfish, and specific packing situations such as individual units within a multiunit package. These clarifications were published as part of Edition 5 on January 7, 2025 and are meant to help make allergen information on packaged foods clearer.
FDA issues updated allergen guidance
The FDA published a revised final guidance (Edition 5) on food allergen labeling on January 7, 2025. The guidance consolidates prior draft and final documents and answers questions about how to label allergens so labels are clearer for people buying food.
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