FDA Issues Draft Guidance for Industry: FDA Records Access Authority for Cosmetics Products

Cosmetics Constituent Update

January 21, 2026

Today the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled "FDA Records Access Authority for Cosmetics Products: Guidance for Industry." This draft guidance provides critical information about FDA's authorities to access records related to cosmetic products added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Background

On December 29, 2022, the Consolidated Appropriations Act, 2023, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), was signed into law. Among other provisions, MoCRA established new authorities for FDA to access and copy records related to cosmetic products by:

Adding Section 605 (21 U.S.C. 364a) - Granting FDA access to adverse event report records during inspections under section 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Adding Section 610 (21 U.S.C. 364f) - Authorizing FDA to access and copy certain records when there is reasonable belief that a cosmetic product is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death (SAHCOD) to humans
Amending Section 704(a)(1) (21 U.S.C. 374(a)(1)) - Extending FDA's inspectional authority over all records and information described in sections 605 and 610 from facilities that manufacture or process cosmetic products

These new authorities represent a significant expansion of FDA's oversight capabilities for cosmetic products, providing the agency with enhanced tools to protect public health and safety.

Key Provisions of the Draft Guidance

The draft guidance addresses frequently asked questions about FDA's record access authorities, specifically covering:

Adverse Event Records Access (Section 605) - Clarifies that FDA has access to adverse event records during inspections, including communications between responsible persons and those who provided adverse event information, assessments of events as serious or non-serious, and serious adverse event reports to FDA
Records Access for SAHCOD Situations (Section 610) - Details FDA's authority to access manufacturing records, raw materials receipt records, product distribution records, analytical results, recall records, customer distribution lists, complaint records, and safety substantiation records when products may present SAHCOD to humans
Enhanced Inspection Authority (Section 704(a)(1)) - Explains the extended inspectional authority over records from facilities that manufacture or process cosmetic products

What This Means for Industry

The guidance provides industry with clarity on:

Scope of Authority - Which entities are subject to these record access requirements (responsible persons and facilities)
Triggering Circumstances - When FDA may exercise these authorities, such as during product recalls, adverse event investigations, consumer complaints, or when inspections reveal potential SAHCOD to humans
Record Retention Requirements - How records should be maintained, such as records format, retention of adverse event records for 6 years (or 3 years for qualifying small businesses), and English translation of records
Confidentiality Protections - How FDA will protect trade secrets, confidential commercial information, and personal privacy information
Consequences of Refusal - Legal and regulatory actions FDA may take when firms refuse to provide access to required records

Comment Period and Next Steps

FDA is seeking public comments on this draft guidance. Comments must be submitted within 60 days of publication in the Federal Register to ensure consideration before FDA begins work on the final version.

How to Submit Comments

Electronic Submissions: Submit comments through the Federal eRulemaking Portal at https://www.regulations.gov using the docket number listed in the Federal Register notice

Written/Paper Submissions: Mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852

For More Information

Draft Guidance Document:

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents
Also available at https://www.regulations.gov

Related MoCRA Resources:

Contact Information

For questions about this draft guidance: Office of Inspections and Investigations (OII)
Office of Field Regulatory Operations (OFRO)
Email: OIIPolicyStaffs@fda.hhs.gov

For Cosmetics Direct technical assistance: Email: cosmeticsdirect@fda.hhs.gov

For questions on Cosmetics: Food and Cosmetic Information Center (FCIC) Office of Field
Email: https://www.fda.gov/food/resources-you-food/get-assistance-fda-human-foods-program-hfp