MoCRA — Modernization of Cosmetics Regulation Act
The biggest overhaul to US cosmetic law since 1938 — facility registration, product listing, safety records, and what applies to small makers
At a Glance
- MoCRA was signed December 29, 2022 — the first major update to US cosmetic law since the FD&C Act of 1938.
- It applies to cosmetics sold in the US, including products made by small home-based businesses.
- "True soap" (alkali + fatty acids, no cosmetic claims) is exempt from facility registration and product listing.
- Key requirements: register your facility, list each product, maintain safety records, and report serious adverse events.
- FDA now has mandatory recall authority over cosmetics — previously all recalls were voluntary.
What Is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022, as part of the Consolidated Appropriations Act. It represents the most significant expansion of FDA authority over cosmetics since the Food, Drug, and Cosmetic Act of 1938.
Before MoCRA, cosmetic companies did not need to register with the FDA, disclose their ingredients to the agency, report injuries, or maintain safety records in any standardized way. Companies could bring a cosmetic product to market with essentially no government oversight. MoCRA changed all of that.
The law creates new obligations for facility registration, product listing, safety substantiation, adverse event reporting, and labeling. It also gives FDA the power to order mandatory recalls — authority it did not previously have for cosmetics.
Key Deadlines
MoCRA signed into law
Facility registration deadline — businesses with >$1M annual cosmetic sales
Facility registration deadline — small businesses (≤$1M annual cosmetic sales)
Product listing deadline — all existing cosmetic products
New products must be listed within 120 days of first marketing
Fragrance allergen disclosure rules — proposed rulemaking in progress
GMP regulations — being finalized by FDA
Registration and listing deadlines have passed
If you sell cosmetics and have not yet registered your facility or listed your products, you are out of compliance. FDA has tools available at cosmetics.report.fda.gov to submit registrations and listings at no cost.