FDA cosmetic GMP rule under MoCRA: proposal projected for November 2027
Key facts
- Type / category
- Standard / Rule
- Status
- Planned
- Agency
- FDA
- Source date
- Sectors
- Cosmetics
- Standards
- MoCRA
- ISO 22716
- Reference
- RIN 0910-AJ00
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires FDA to issue good manufacturing practice (GMP) regulations for facilities that manufacture cosmetic products. The statute set December 29, 2024 as the deadline for a proposed rule, and that date has passed without one.
In the most recent Unified Agenda entry available on Reginfo.gov (Fall 2025), the rule, titled Good Manufacturing Practice for Cosmetic Product Facilities (RIN 0910-AJ00, 21 CFR 711), is listed as a long-term action with a notice of proposed rulemaking projected for November 2027. Projected agenda dates are estimates and often move. Once FDA publishes a proposed rule, there will be a public comment period before any final rule.
Until then, FDA's 2013 draft guidance on cosmetic GMPs and its GMP inspection checklist remain the agency's published reference points. FDA said in May 2023 that it intends to withdraw or revise the draft guidance based on the MoCRA rulemaking. ISO 22716 is the international cosmetic GMP standard many manufacturers already follow.
What it means for labs
If your lab tests cosmetics or supports cosmetic manufacturers, there is no FDA cosmetic GMP regulation to comply with yet. Programs aligned with ISO 22716 and FDA's draft guidance may be a reasonable basis, and it helps to watch for the proposed rule and its comment period.
Sources
- FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (opens in new tab)Official source · FDA
- FDA: Draft Guidance for Industry, Cosmetic Good Manufacturing Practices (June 2013) (opens in new tab)Official source · FDA
- Reginfo.gov Unified Agenda (Fall 2025): RIN 0910-AJ00 (opens in new tab)Secondary source · OMB/OIRA
This summary is for general information and may not reflect later changes. Always check the official source linked above. It isn't legal or regulatory advice, and Micro-Core Consulting isn't affiliated with the agencies or standards bodies named.