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; Availability

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2022-D-0099]</DEPDOC> <SUBJECT>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; Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of availability. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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). </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The announcement of the guidance is published in the <E T="04">Federal Register</E> on January 7, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit either electronic or written comments on FDA guidances at any time as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> 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 <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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 <E T="02">SUPPLEMENTARY INFORMATION</E> section for electronic access to the guidance. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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 T="03">e.g.,</E> bass, flounder, or cod), Crustacean shellfish ( <E T="03">e.g.,</E> crab, lobster, or shrimp), tree nuts ( <E T="03">e.g.,</E> 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 <E T="04">Federal Register</E> 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 co ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 12k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━