On November 29, the FDA issued an updated draft guidance document about food allergen labeling requirements: Questions and Answers Regarding Food Allergens, Including Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry. The draft guidance includes the following updates:

• New questions and answers about food allergen labeling requirements, including the labeling of sesame, milk, and eggs, the labeling of major food allergens on dietary supplement labels, and other technical issues;

• Revised questions and answers to update and clarify information included in earlier editions of the guidance, such as the labeling of tree nuts, fish, and crustacean shellfish; and

• Example images of labeling requirements.

The draft guidance is an update to the previous version (Edition 4). In addition to the update, the Agency also issued a final guidance with the same title (Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)) to preserve the questions and answers from the previous Edition 4 from 2006 that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

The FDA is accepting comments on the new and revised questions in the Edition 5 draft guidance until January 30, 2023.