What cosmetic manufacturers and processors should understand about FDA’s records access authority under MoCRA
The U.S. Food and Drug Administration has issued new draft guidance clarifying its authority to access and copy records related to cosmetic products. The guidance explains when and how FDA may request records during inspections or when there is a reasonable belief that a cosmetic product could pose a serious health risk.
This guidance reflects FDA’s current thinking following expanded authorities established under the Modernization of Cosmetics Regulation Act (MoCRA) and is intended to help cosmetic companies prepare for inspections and safety-related inquiries.
Compliance Snapshot: FDA Records Access for Cosmetics
- Purpose: Clarifies FDA’s criteria, process, and expectations for accessing cosmetic-related records
- Legal Authority: Sections 605, 610, and 704 of the FD&C Act, as amended by MoCRA
- Who Is Affected: Facilities that manufacture or process cosmetic products
- When Records May Be Requested:
- During FDA inspections
- When FDA has a reasonable belief a product could cause serious adverse health consequences or death
- Status: Draft guidance (not legally binding)
What Records FDA May Access
Under the draft guidance, FDA may access and copy records related to cosmetic products, including:
- Adverse event records (Section 605)
Documentation related to reported adverse events associated with cosmetic products. - Health risk–related records (Section 610)
Records FDA believes are relevant when there is a reasonable probability that a cosmetic product could cause serious health consequences or death. - Inspection-related records (Section 704)
Certain records reviewed as part of FDA inspections of cosmetic manufacturing or processing facilities.
FDA notes that these authorities are intended to support timely oversight and protect public health, particularly when safety concerns arise.
Why This Matters for the Cosmetics Industry
While the draft guidance does not introduce new legal requirements, it signals increased FDA scrutiny and expectations around documentation, transparency, and record availability. Cosmetic companies should ensure that relevant records are organized, accessible, and ready to be provided during inspections or safety investigations.
FDA also emphasizes that companies may take alternative approaches, provided they meet applicable statutory requirements.
Comment Period Open
FDA is accepting public comments on the draft guidance through March 23, 2026.
How to submit comments:
- Online: https://www.regulations.gov
- Written submissions: FDA Dockets Management Staff, Rockville, MD
(Confidential information must be submitted via paper following FDA instructions.)
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