January 27, 2023

FDA Issues Guidance on Requirements For Food Allergen Labeling

The FDA has issued new guidance for food allergen labeling. This new document will answer questions about label requirements, and update information that was in earlier editions of this final document. The FDA is seeking comments on this new guidance.

FDA Issues Guidance on Requirements For Food Allergen Labeling

There are nine major food allergens, according to the government. If one of these ingredients is present in the food, it must be listed in the ingredient list on the label, and in a special allergen statement that is put on every package. Those nine allergens are milk, soy, wheat, eggs, finfish, shellfish, tree nuts, peanuts, and sesame seeds. Sesame was added when the FASTER Act was passed in April 2021. Those allergens were chosen based on how common the reactions to them are, and their severity.

The draft guidance includes new questions and answers about food allergen labeling requirement. Some manufacturers may have questions about labeling sesame, milk, and eggs, while dietary supplement manufacturers need guidance about how to label their products.

It also includes revised questions and answers to update information on the labeling of allergens such as tree nuts fish, and shellfish. Images that show samples of labeling requirements are included in the document. Editorial changes are also included.

It’s important to note that guidance documents do not establish legally enforceable responsibilities. These documents describe the FDAs Curren thinking on a topic and are only recommendations, unless specific regulatory requirements are cited.

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