Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2022-D-0099]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

# SUMMARY:

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).

# DATES:

                        The announcement of the guidance is published in the                         **Federal Register**                         on January 7, 2025.                    

# ADDRESSES:

You may submit either electronic or written comments on FDA guidances at any time as follows:

### Electronic Submissions

Submit electronic comments in the following way:
      -  Federal eRulemaking Portal: https://www.regulations.gov.                      Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to                      https://www.regulations.gov                      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                      https://www.regulations.gov. 
      - 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”).

### Written/Paper Submissions

Submit written/paper submissions as follows:
      -  Mail/Hand Delivery/Courier (for written/paper submissions):                      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.”

*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                           ( print page 1134)                        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 https://www.regulations.gov.                      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:                      https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. 

*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.                

# FOR FURTHER INFORMATION CONTACT:

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.

# SUPPLEMENTARY INFORMATION:

## I. Background

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                           ( print 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.

## II. Paperwork Reduction Act of 1995

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.

## III. Electronic Access

                    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