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GUIDANCE DOCUMENT

Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) January 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2022-D-0099
Issued by:
Guidance Issuing Office
Human Foods Program

As originally enacted in 1938, section 403(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that the label of a food that is fabricated from two or more ingredients declare each ingredient by its common or usual name (except that spices, flavorings, and certain colors can be declared as such) (21 U.S.C. 343(i)).  However, consumers may be unfamiliar with the common or usual name of an ingredient and may not recognize that certain ingredients contain or are derived from a food allergen.  The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) was enacted in August 2004 and, in part, amended the FD&C Act by defining the term “major food allergen” (section 201(qq) of the FD&C Act (21 U.S.C. 321(qq))) and stating that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived.  Section 403(w)(1) of the FD&C Act sets forth the requirements for declaring the presence of each major food allergen on the product label.  In addition, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) (Public Law 117-11) was enacted in April 2021 and, in part, amended the definition of major food allergen in section 201(qq) of the FD&C Act to include sesame.

This is a revision of the fifth edition of this guidance document that adds the questions and answers from the draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), that are now being finalized.  Editorial changes, such as renumbering and organizational changes have also been made in this revision.  FDA expects to continue to issue subsequent editions of this guidance document by revising existing questions and answers and by adding new questions and answers.

For more information related to food allergens, please see Food Allergens/Gluten-Free Guidance Documents & Regulatory Information.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word “should” in FDA guidances means that something is suggested or recommended, but not required.

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