November 29, 2022
The FDA is issuing Edition 5 (Final Guidance) to replace Edition 4 (Final Guidance), released in 2006. Edition 5 (Final Guidance) contains the questions and answers from Edition 4 (Final Guidance) that remain unchanged, with the exception of minor or editorial changes. In addition, FDA is issuing an Edition 5 (Draft Guidance) to receive comments on the new or revised questions and answers. Note that some questions and answers that were in Edition 4 (Final Guidance) have been withdrawn and moved to the Edition 5 (Draft Guidance) for comment if the FDA determined that the question and answer should be revised in some respect.
As originally enacted in 1938, section 403(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that the label of a food that is fabricated from two or more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 noncertified 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” (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 allergens in section 201(qq) of the FD&C Act to include sesame, effective January 1, 2023.
This is a revision of the fourth edition of a guidance document originally entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004.” This revision contains questions and answers from the fourth edition that constitute final guidance, but with editorial changes, such as renumbering and organization. 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.
This final guidance document accompanies 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). In this pair of guidance documents, FDA is issuing the new or revised questions and answers in the draft guidance document, will receive comments on the draft questions and answers, and, as appropriate, will move the questions and answers to this final guidance document, after reviewing comments and incorporating suggested changes to the question and answer, when appropriate. Note that a question and answer that is in the final guidance document may be withdrawn and moved to a new or revised draft guidance document if FDA determines that the question and answer should be revised and reissued in draft for comment. A question and answer also may be withdrawn and removed from the guidance documents if, for instance, the issue addressed in the question and answer is addressed elsewhere. For ease of reference, a question and answer retains the same number when it moves from the draft guidance document to the final guidance document and we use the term “RESERVED” after each numbered question and answer, where appropriate, to facilitate this process.
For more information related to 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 the Agency’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.