Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory recall authority for cosmetics. It is intended to inform regulated industry about the Agency's current thinking on implementation of certain aspects, including the criteria, process, and expectations, for mandatory recalls of cosmetic products. The guidance announced in this notice finalizes the draft guidance of the same title published on December 18, 2025.

Full Text

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<title>Federal Register, Volume 91 Issue 204 (Friday, October 23, 2026)</title>
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[Federal Register Volume 91, Number 204 (Friday, October 23, 2026)]
[Notices]
[Pages 66851-66852]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21679]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-D-2246]


Questions and Answers Regarding Mandatory Cosmetics Recalls; 
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 Agency) is announcing 
the availability of a final guidance entitled ``Questions and Answers 
Regarding Mandatory Cosmetics Recalls: Guidance for Industry.'' The 
guidance document provides answers to common questions that might arise 
about FDA's mandatory recall authority for cosmetics. It is intended to 
inform regulated industry about the Agency's current thinking on 
implementation of certain aspects, including the criteria, process, and 
expectations, for mandatory recalls of cosmetic products. The guidance 
announced in this notice finalizes the draft guidance of the same title 
published on December 18, 2025.

DATES: The announcement of the guidance is published in the Federal 
Register on October 23, 2026.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
will be posted to

[[Page 66852]]

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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> 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 below (see ``Written/Paper Submissions'' and 
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> 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.
    <bullet> 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-2025-D-2246 for ``Questions and Answers Regarding Mandatory 
Cosmetics Recalls: Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
    <bullet> 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 
Division of Inspectorate Policy, Office of Inspections and 
Investigations, Food and Drug Administration, Element Building, 12420 
Parklawn Dr., Rockville, MD 20852. Send two self-addressed adhesive 
labels to assist the office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Peter Ajuonuma, Office of Inspections 
and Investigations, Food and Drug Administration, 10903 New Hampshire 
Avenue, Bldg. 71, Rm. 1241, Silver Spring, MD 20993-0002, 301-796-2277, 
<a href="/cdn-cgi/l/email-protection#99d6d0d0e9f6f5f0fae0eaedf8ffffead9fffdf8b7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="337c7a7a435c5f5a504a404752555540735557521d5b5b401d545c45">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Questions and Answers Regarding Mandatory Cosmetics Recalls: 
Guidance for Industry.'' The purpose of this guidance document is to 
provide guidance to industry on the implementation of the mandatory 
cosmetics recall provisions of section 611 of the Federal Food, Drug, 
and Cosmetic Act, which was added by section 3502 of the Modernization 
of Cosmetics Regulation Act of 2022. The guidance is in the form of 
Questions and Answers and provides answers to common questions that 
might arise about these mandatory recall provisions and FDA's current 
thinking regarding their implementation.
    In the Federal Register of December 18, 2025 (90 FR 59129), FDA 
announced the availability of the draft guidance entitled ``Questions 
and Answers Regarding Mandatory Cosmetics Recalls; Draft Guidance for 
Industry.''
    FDA received seven comments on the draft guidance, which were 
broadly supportive of the guidance, and some of which asked for certain 
clarifications of issues discussed in the guidance. After considering 
the comments we received, we are publishing the guidance as drafted 
with no substantive changes. The guidance announced in this notice 
finalizes the draft guidance dated December 18, 2025.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on mandatory cosmetics recalls. 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

    This guidance contains no new collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21679 Filed 10-22-26; 8:45 am]
BILLING CODE 4164-01-P


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