Washington — FDA Details New Cosmetics Safety Rules Under MoCRA

Washington — The Food and Drug Administration has published a detailed overview of the Modernization of Cosmetics Regulation Act of 2022, the law that expands federal oversight of the cosmetics and personal-care industry, according to the agency's MoCRA page.

What does MoCRA require of cosmetics manufacturers?

Under the statute, the FDA outlines new industry obligations that include facility registration, product listing, adverse event reporting, and safety substantiation requirements, according to the agency's summary. Facility registration means makers of cosmetic products must formally identify their manufacturing sites to the FDA. Product listing requires companies to submit information about individual products they place on the market. Adverse event reporting obligates firms to notify the agency when serious health complaints tied to a product surface. Safety substantiation requires companies to hold evidence supporting the safety of a finished cosmetic product and its ingredients.

How does this differ from previous U.S. cosmetics law?

The FDA describes MoCRA as the most significant expansion of its authority to regulate cosmetics since 1938, according to the agency's overview of the statute.

For nearly nine decades, the FDA's cosmetics authority rested largely on the original Federal Food, Drug, and Cosmetic Act, which did not include mandatory registration, listing, or safety-documentation duties comparable to those now outlined on the agency's MoCRA page. The new obligations move cosmetics regulation closer to the compliance architecture long applied to food and drug products.

Who has to comply, and where can companies check the requirements?

The FDA's MoCRA page is presented as the authoritative reference for manufacturers, packers, and distributors of cosmetic products sold in the United States, laying out the registration, listing, reporting, and substantiation duties described above. The agency's page functions as the primary document industry compliance teams are expected to consult as they build out registration and reporting systems.

What does this mean for consumers and beauty brands?

For shoppers, the practical effect is a system in which cosmetic products entering the U.S. market are tied to registered facilities and documented safety files, rather than the more informal oversight structure the FDA operated under previously. For brands, the listed obligations — registration, listing, adverse event reporting, and safety substantiation — represent new administrative and compliance work layered onto existing formulation and labeling practices. Readers researching how ingredient safety translates into everyday routines can see related coverage on science-backed skin care tips and on retinol versus retinal formulations, two areas where ingredient documentation and safety claims are already a point of consumer interest.

The FDA's page does not, in the material reviewed, specify compliance deadlines or enforcement penalties beyond the four obligations named — facility registration, product listing, adverse event reporting, and safety substantiation. Companies seeking dates, exemptions for small businesses, or enforcement mechanics are directed to consult the full FDA MoCRA page directly, as those specifics were not detailed in the summary reviewed for this report.

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