# FDA Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice of availability.
**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 The draft guidance document provides answers to frequently asked questions about certain authorities for FDA to access records related to cosmetic products.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Submit either electronic or written comments on the draft guidance by March 23, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:
• *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-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 *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 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 *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 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, *[email protected].*
**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 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 *https://www.fda.gov/regulatory-information/search-fda-guidance-documents* or *https://www.regulations.gov.*
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International Affairs.