Use this hub to sequence US work. Listing and adverse-event processes are live duties. Several MoCRA rulemakings (GMP, fragrance allergens, talc/asbestos methods) remain on a delayed or re-proposed path — check FDA.gov, not social recaps.
US MoCRA for SME cosmetic brands
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the largest expansion of FDA cosmetics authority since the FD&C Act: listing, safety substantiation, adverse events, and further rules still being written.
Who should care
US and foreign brands selling cosmetics in the United States, contract manufacturers, and facility owners. Some small-business exemptions exist — verify on FDA pages, do not assume you are out of scope.
Official sources
SME: first 5 things
-
1
Confirm you are in scope
Most cosmetics in US commerce are; check FDA definitions and any small-business exemptions.
-
2
Keep facility listing current
Manufacturing/processing facilities must be listed and updated after material changes.
-
3
Keep product listing current
List marketed products and refresh when formula, brand, or facility data change.
-
4
Build a serious adverse event path
Designate a US contact and a clock for required reports.
-
5
Track rules vs reports
PFAS report (Dec 2025) is an assessment, not a ban. Asbestos method rule was withdrawn Nov 2025. State PFAS laws can still bind you.
Obligation map
Common pitfalls
- Assuming a small brand has no MoCRA duties
- Listing once and never updating
- Treating the FDA PFAS report as a federal ingredient ban
- Ignoring state PFAS/chemical laws (e.g. Illinois Cosmetic Products Act)
- Mixing drug claims into cosmetic positioning
More context
What this page covers
Federal MoCRA orientation plus pointers to state chemical laws. Confirm exemptions and current rule status on FDA.gov.
Recent regulatory updates
All news- Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products August 25, 2026
- FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products August 25, 2026
- FDA Issues Proposed Rule on Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products August 25, 2026
- FDA Issues Final Guidance on Tattoo Inks August 25, 2026
- FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products August 25, 2026
- Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing August 25, 2026
- Draft Guidance for Industry: Cosmetic Good Manufacturing Practices August 25, 2026
- FDA Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability August 25, 2026
Related Insights
Track updates in Workbench, or upgrade for full Regulatory Details and follow-up tools.
Always confirm requirements against official publications before decisions.