The United States Food and Drug Administration (US FDA) has updated its allergen labelling guidance with new and revised questions and answers. The update replaces previous advice released in 2006 and reflects new information, including the requirement to label sesame which comes into effect on 1 January, 2023.
The new guidance is titled Questions and Answers Regarding Food Allergens, Including the Food Allergen Labelling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry.
Unlike previous editions of the guidance, questions and answers now appear in five distinct sections: A) General Information, B) Foods that Fall Under the Food Allergen Labelling Requirements of the FD&C Act, C) Food Sources, D) Food Allergen Labelling Requirements, and E) Dietary Supplements.
The final guidance document accompanies the draft guidance document, titled Questions and Answers Regarding Food Allergens, Including the Food Allergen Labelling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5). In this pair of guidance documents, FDA is calling for comments on the draft questions and answers. The period for submitting comments closes on 30 January 2023.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance’s describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Download the final guidance from the FDA website.
