Notice2026-01159
FDA Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 22, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "FDA Records Access Authority for Cosmetics: Guidance for Industry." The draft guidance document provides answers to frequently asked questions about certain authorities for FDA to access records related to cosmetic products. It is intended to inform regulated industry about the Agency's current thinking regarding the criteria, process, and expectations for FDA's access to these records.
Full Text
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<title>Federal Register, Volume 91 Issue 14 (Thursday, January 22, 2026)</title>
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[Federal Register Volume 91, Number 14 (Thursday, January 22, 2026)]
[Notices]
[Pages 2779-2781]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01159]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-2243]
FDA Records Access Authority for Cosmetics; Draft Guidance for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, Agency, or we) is
announcing the availability of a draft document entitled ``FDA Records
Access Authority for Cosmetics: Guidance for Industry.'' The draft
guidance document provides answers to frequently asked questions about
certain authorities for FDA to access records related to cosmetic
products. It is intended to inform regulated industry about the
Agency's current thinking regarding the criteria, process, and
expectations for FDA's access to these records.
DATES: Submit either electronic or written comments on the draft
guidance by March 23, 2026 to ensure that the Agency considers your
comment on this
[[Page 2780]]
draft guidance before it begins work on the final version of the
guidance.
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 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 (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-2243 for ``FDA Records Access Authority for Cosmetics:
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 draft 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 one self-addressed adhesive
labels to assist the office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Nadine Dominique, Office of
Inspections and Investigations, Food and Drug Administration, Element
Building, 12420 Parklawn Dr., Rockville, MD 20857, 301-348-1868,
<a href="/cdn-cgi/l/email-protection#246a45404d4a410a604b494d4a4d555141644240450a4c4c570a434b52"><span class="__cf_email__" data-cfemail="d896b9bcb1b6bdf69cb7b5b1b6b1a9adbd98bebcb9f6b0b0abf6bfb7ae">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``FDA Records Access Authority for Cosmetics: Guidance for
Industry.'' 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 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.
On December 29, 2022, the Consolidated Appropriations Act, 2023
(Pub. L. 117-328), which included the Modernization of Cosmetics
Regulation Act of 2022 (MoCRA), was signed into law. Among other
provisions, MoCRA added sections 605 (21 U.S.C. 364a) and 610 (21
U.S.C. 364f) to, and amended section 704(a)(1) (21 U.S.C. 374(a)(1))
of, the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing
new authorities for FDA to access and copy records related to cosmetic
products for inspection. Section 605 specifies that the Secretary has
access to adverse event records during an inspection under section 704
(21 U.S.C. 374). Section 610 authorizes FDA to access and copy certain
records if FDA has a reasonable belief that a cosmetic product,
including an ingredient in the product, and any other cosmetic product
that FDA reasonably believes is likely to be affected in a similar
manner, is likely to be adulterated such that the use or exposure to
such product presents a threat of serious adverse health consequences
or death to humans (SAHCODH). Section 704(a)(1) of the FD&C Act, as
amended by section 3504 of MoCRA, extends FDA's inspectional authority
over all records and other information described in sections 605 and
610 from facilities that manufacture and process cosmetic products,
when the standard for those sections apply. This draft guidance focuses
on the authorities to access records described in sections 605 (adverse
event reports), 610 (SAHCODH), and 704 (inspections).
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
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
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information in sections 605 and 610 of the FD&C Act have been approved
under 0910-0599.
III. Electronic Access
Persons with access to the internet may obtain the draft 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>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-01159 Filed 1-21-26; 8:45 am]
BILLING CODE 4164-01-P
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