FDA publishes webpage summarising revised food allergen labeling guidance
The frequently asked questions provide a direct summary of the key points in the revised guidance.
USA – The U.S. Food and Drug Administration (FDA) has published a webpage titled, Frequently Asked Questions: Food Allergen Labeling Guidance for Industry as a resource for the revised Fifth Edition of its Food Allergen Q&A Guidance.
The webpage provides a more direct summary of the key information in the revised final guidance released in January 2025 (Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act), which consolidates both the draft and final Food Allergen Q&A Guidance issued on November 30, 2022.
The revision was done to reflect the FDA’s current standpoint and contains new and revised questions and answers about various food allergen labeling topics.
Some of the updates include information on sesame as a major food allergen and the FDA’s expanded interpretations of milk and eggs as major food allergens, to include milk from ruminant animals other than cows and eggs from birds other than chickens.
“For food allergen labeling purposes, eggs and egg ingredients from birds other than chickens also should include the name of the bird source. If you choose to use the “Contains” statement, the statement would say, “Contains eggs, duck eggs,” and any other major food allergens used as ingredients in the product,” the FDA stated on their webpage, with the same applying for milk from ruminant animals other than cows.
Several tree nuts no longer considered major food allergens
Additionally, several tree nuts, including coconut, are no longer considered major food allergens and do not appear on the list of major food allergens in the revised 5th edition of the Food Allergen Q&A Guidance.
“In addition to coconut, other tree nuts that are no longer on the list of those considered major food allergens are beech nut, butternut, chestnut, chinquapin, cola/kola nut, ginkgo nut, hickory nut, palm nut, pili nut, shea nut, and lichee nut,” the agency added.
The FDA further instructs that unless an exemption applies, the above-mentioned tree nuts should not be included in the “Contains” statement, but must still be listed in the ingredients list by common or usual name when added as ingredients.
FDA encourages firms to consider the food safety risk of their products and their practices in accordance with applicable requirements. Their compliance approach is generally risk-based, and it evaluates each situation on a case-by-case basis.
The updates to the 5th edition of the Food Allergen Q&A Guidance only impact the applicability of FDA’s requirements concerning major food allergens.
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