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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1133-1135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31533]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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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

[[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

[[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
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