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, 1133-1135 [2024-31533]

Download as PDF Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911; Terri Cornelison, Center for Devices and Radiological Health,10903 New Hampshire Ave., Bldg. 66, Rm. 5516, Silver Spring, MD 20993–0002, 301– 796–5682; or Office of Women’s Health, 10903 New Hampshire Ave., Bldg. 32, Rm. 2333, Silver Spring, MD 20993– 0002, FDA-OWH@fda.hhs.gov. SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Study of Sex Differences in the Clinical Evaluation of Medical Products.’’ Analyzing sex-related differences in medical product response is an important component of assessing product safety and effectiveness, to help understand safety and effectiveness across the intended patient population, and can inform what goes into product labeling to improve patient care. Differences in physiology between females and males can lead to differences in disease manifestation, pharmacokinetics, pharmacodynamics, and response to treatment, among other things. Topics addressed in this guidance include: (1) practices to improve the recruitment, enrollment, and retention of females in clinical trials, to help ensure the generalizability of research results to intended patient populations; (2) statistical considerations for analyzing sex differences; and (3) reporting results based on analyses of sex differences. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Study of Sex Differences in the Clinical Evaluation of Medical Products.’’ 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. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; the collections of VerDate Sep<11>2014 18:44 Jan 06, 2025 Jkt 265001 information in 21 CFR part 314 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338; and the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078. Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: December 26, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–31537 Filed 1–6–25; 8:45 am] BILLING CODE 4164–01–P 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 Food and Drug Administration, HHS. ACTION: 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, SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 III. Electronic Access AGENCY: 1133 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 E:\FR\FM\07JAN1.SGM 07JAN1 ddrumheller on DSK120RN23PROD with NOTICES1 1134 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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-201509-18/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 selfaddressed 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., VerDate Sep<11>2014 18:44 Jan 06, 2025 Jkt 265001 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 E:\FR\FM\07JAN1.SGM 07JAN1 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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/regulatoryinformation/search-fda-guidancedocuments, 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–0278] Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ‘‘Action Levels for Lead in Processed Food Intended for Babies and Young Children.’’ The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:44 Jan 06, 2025 Jkt 265001 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: DATES: 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–0278 for ‘‘Action Levels for Lead in Processed Food Intended for Babies and Young Children; 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 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 1135 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-201509-18/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 Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two selfaddressed 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: Eileen Abt, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1700; or Holli Kubicki, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug E:\FR\FM\07JAN1.SGM 07JAN1

Agencies

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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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