On January 21, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled "FDA Records Access Authority for Cosmetics Products: Guidance for Industry." This draft guidance provides critical information about FDA's authorities to access records related to cosmetic products added by the Modernization of Cosmetics Regulation Act of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). FDA is seeking public comments on this draft guidance.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.
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Key Provisions of the Draft Guidance
The draft guidance addresses frequently asked questions about FDA's record access authorities, specifically covering: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.
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Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
Further Information：
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