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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.” The guidance explains FDA's current thinking on a number of issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act).
The announcement of the guidance is published in the Federal Register on January 7, 2025.
You may submit either electronic or written comments on FDA guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2022-D-0099 for “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the ( printed page 1134) Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.
Carol D'Lima, Office of Nutrition and Food Labeling (HFS-800), Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Denise See, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
We are announcing the availability of a guidance for industry entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
FALCPA (Pub. L. 108-282) was enacted in August 2004 and, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by defining the term “major food allergen” and requiring that the presence of any major food allergen be declared on the labels of FDA-regulated foods. FALCPA defined a major food allergen as milk, egg, fish ( e.g., bass, flounder, or cod), Crustacean shellfish ( e.g., crab, lobster, or shrimp), tree nuts ( e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans and as a food ingredient that contains protein derived from these foods (section 201(qq) of the FD&C Act (21 U.S.C. 321(qq))). In addition, the FASTER Act (Pub. L. 117-11) was enacted in April 2021 and, in part, amended the definition of major food allergen in the FD&C Act to include sesame.
Since the passage of FALCPA, FDA has received numerous questions about food allergen labeling requirements. To explain FALCPA's requirements as well as FDA's current thinking on issues relating to the regulation of food allergens, on October 5, 2005, FDA issued the first edition of a guidance entitled “Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004.” We subsequently updated the guidance in December 2005 (Edition 2), April 2006 (Edition 3), and October 2006 (Edition 4).
In the Federal Register of November 30, 2022 (87 FR 73561), FDA issued a draft guidance for industry entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5).” The draft guidance was a revision of Edition 4 originally entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004” that contained revised and new questions and answers relating to food allergens, including questions and answers about FALCPA and the FASTER Act. We gave interested parties an opportunity to submit comments for us to consider before beginning work on the final version of the guidance. We received numerous comments on the draft guidance and have made modifications in this final guidance where appropriate. On November 30, 2022, FDA also issued a final guidance, “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5),” that contained the questions and answers from Edition 4 that remained unchanged, with the exception of editorial changes such as renumbering and organizational changes, and therefore were reissued as final guidance. The revised final guidance announced in this notice consolidates both the draft and final guidance that issued on November 30, 2022.
The revised final guidance contains questions and answers about food allergen labeling requirements, including the labeling of sesame, milk, eggs, incidental additives, highly refined oils, dietary supplement products, and certain specific packing and labeling situations ( e.g., individual units within a multiunit package). We have made some changes from the draft guidance. For example, we have expanded our historical interpretation of the terms “milk” and “eggs;” for purposes of the definition of a “major food allergen” under section 201(qq) of the FD&C Act and for purposes of complying with the food allergen labeling requirements of the FD&C Act. FDA has historically interpreted “milk” as milk from the domesticated cow and “eggs” as eggs from the domesticated chicken. However, the final guidance sets forth that for purposes of the definition of a “major food allergen” under section 201(qq) of the FD&C Act, FDA considers “milk” as milk from domesticated cows, goats, sheep, or other ruminants and FDA considers “eggs” as eggs from domesticated chickens, ducks, geese, quail, and other fowl. In addition, the final guidance ( printed page 1135) revises the list of tree nuts that FDA considers as major food allergens.
We also have revised several questions and answers to update and clarify information presented in previous editions, including questions related to the labeling of fish and Crustacean shellfish.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in section 403(w) of the FD&C Act (21 U.S.C. 343(w)) have been approved under OMB control number 0910-0792.
Persons with access to the internet may obtain the guidance document at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31533 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P