Modernization of Cosmetics Regulation Act of 2022
The most significant expansion of FDA authority over cosmetics since 1938. MoCRA requires facility registration and product listing, safety substantiation for cosmetic products, serious adverse-event reporting and recordkeeping, and gives FDA mandatory-recall authority — and directs FDA to establish good manufacturing practice regulations for cosmetics.
Cosmetic products and facilities marketed in the US — registration, listing, safety substantiation, adverse-event reporting, and forthcoming GMP.
- 01Register facilities and list cosmetic products with FDA
- 02Maintain records substantiating product safety
- 03Report serious adverse events and keep adverse-event records
- 04Prepare for the forthcoming mandatory cosmetic GMP regulations
Signed into law December 2022; obligations phased in from 2023–2024, with FDA cosmetic GMP rulemaking to follow.
MoCRA (FD&C Act Ch. VI): frequently asked questions
Quick answers to common questions about MoCRA (FD&C Act Ch. VI).
What is MoCRA (FD&C Act Ch. VI)?
MoCRA (FD&C Act Ch. VI) — Modernization of Cosmetics Regulation Act of 2022 — is a regulation issued by the Food and Drug Administration (United States). The most significant expansion of FDA authority over cosmetics since 1938. MoCRA requires facility registration and product listing, safety substantiation for cosmetic products, serious adverse-event reporting and recordkeeping, and gives FDA mandatory-recall authority — and directs FDA to establish good manufacturing practice regulations for cosmetics.
Who does MoCRA (FD&C Act Ch. VI) apply to?
Cosmetic products and facilities marketed in the US — registration, listing, safety substantiation, adverse-event reporting, and forthcoming GMP.
What are the key requirements of MoCRA (FD&C Act Ch. VI)?
FDA MoCRA (FD&C Act Ch. VI) requires, among other things: Register facilities and list cosmetic products with FDA; Maintain records substantiating product safety; Report serious adverse events and keep adverse-event records; Prepare for the forthcoming mandatory cosmetic GMP regulations.
When was MoCRA (FD&C Act Ch. VI) last updated?
The current version of MoCRA (FD&C Act Ch. VI) dates from December 2022. Signed into law December 2022; obligations phased in from 2023–2024, with FDA cosmetic GMP rulemaking to follow.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When MoCRA (FD&C Act Ch. VI) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.