The U.S. Food and Drug Administration (FDA) has published the revised Fifth Edition of its Food Allergen Q&A Guidance, titled, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act. The updated guidance was released in a searchable webpage format, enabling convenient navigation of its contents.

The Food Allergen Q&A Guidance is intended to help the food industry meet the legal requirements for listing the nine major food allergens (milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame) on the labels of FDA-regulated foods. It consolidates both the draft and final Food Allergen Q&A Guidance issued on November 30, 2022. The updates reflect FDA’s current thinking and contain new and revised questions and answers about various food allergen labeling topics.

Some of the updates to the guidance include information related to sesame as a major food allergen, as well as 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.

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 Fifth Edition of the Food Allergen Q&A Guidance.

FDA encourages firms to reference the updated Fifth Edition of the guidance to ensure their existing product label and manufacturing practices remain in compliance with the requirements for major food allergens, and to consider the food safety risk of their products and their practices in accordance with applicable requirements. FDA’s compliance approach is generally risk-based, and it evaluates each situation on a case-by-case basis. The updates to the Fifth Edition of the Food Allergen Q&A Guidance only impact the applicability of FDA’s requirements concerning major food allergens.