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.
What this does not cover
stated in the document's own scope- Covers cosmetic products; products that are drugs (including many sunscreens) or that are soap as defined by the Act fall outside or partly outside the cosmetics framework.
- Establishes statutory duties and directs rulemaking; the detailed cosmetic GMP requirements themselves await the FDA regulation MoCRA calls for.
- Some provisions provide exemptions or modified requirements for small businesses, as set out in the statute.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA authority over cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938. It requires facilities that manufacture or process cosmetics to register and to list their products, obliges responsible persons to substantiate the safety of their cosmetic products, establishes serious-adverse-event reporting and associated recordkeeping, and gives FDA mandatory-recall authority for cosmetics. It also directs FDA to establish good manufacturing practice regulations for cosmetics and to address fragrance-allergen labeling and the safety of certain ingredients, moving cosmetics toward a framework closer to other FDA-regulated products.
Scope & applicability
Cosmetic products and facilities marketed in the US — registration, listing, safety substantiation, adverse-event reporting, and forthcoming GMP.
Legal basis & how it acquires force
MoCRA was enacted as part of the Consolidated Appropriations Act, 2023, and amends the cosmetics provisions of the Federal Food, Drug, and Cosmetic Act (the Act’s cosmetics chapter). It is primary legislation, so its core duties — facility registration, product listing, safety substantiation, adverse-event reporting, and FDA recall authority — are statutory obligations, while several elements (notably the cosmetic GMP regulation and fragrance-allergen labeling) are delegated to FDA to implement through rulemaking. Specific section numbers should be confirmed against the enacted text, as MoCRA inserted a new set of cosmetics sections into the Act.
Document structure
| Part | Covers |
|---|---|
| Facility registration | Registration of establishments that manufacture or process cosmetic products |
| Product listing | Listing of cosmetic products and their ingredients with FDA |
| Safety substantiation | The responsible person’s duty to maintain records supporting product safety |
| Adverse event reporting | Reporting of serious adverse events and related recordkeeping |
| Recall authority | FDA authority to order a mandatory recall of a cosmetic product |
| Good manufacturing practice and labeling | Direction to FDA to set cosmetic GMP regulations and fragrance-allergen labeling |
Key requirements
- 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
Implementation tips
- Stand up serious-adverse-event intake now — the 15-business-day clock is unforgiving
- Build safety-substantiation dossiers per product; "generally recognized as safe" is not enough
- Adopt ISO 22716 GMP ahead of FDA’s cosmetic-GMP rulemaking
Revision notes
Signed into law December 2022; obligations phased in from 2023–2024, with FDA cosmetic GMP rulemaking to follow.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
MoCRA moves US cosmetics oversight toward the registration, listing, safety-substantiation, and adverse-event-reporting model already familiar from other FDA-regulated product areas. The cosmetic GMP regulation it directs FDA to write is expected to draw on the internationally used ISO 22716 cosmetics GMP standard. It works alongside the existing cosmetics regulations in 21 CFR Part 700 and the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act.
MoCRA (FD&C Act Ch. VI): frequently asked questions
Quick answers to common questions about MoCRA (FD&C Act Ch. VI).
What did MoCRA change for cosmetics?
It introduced facility registration and product listing, required responsible persons to substantiate product safety, established serious-adverse-event reporting and recordkeeping, and gave FDA mandatory-recall authority — the largest expansion of FDA cosmetics authority since 1938.
Does MoCRA create cosmetic GMP requirements directly?
It directs FDA to establish good manufacturing practice regulations for cosmetics through rulemaking, rather than setting the detailed GMP itself. That expected regulation is anticipated to draw on ISO 22716.
What law does MoCRA amend?
MoCRA amends the cosmetics provisions of the Federal Food, Drug, and Cosmetic Act and was enacted as part of the Consolidated Appropriations Act, 2023. Specific section numbers should be confirmed against the enacted text.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.