The million dollars and what the exemption covers

Brands that make or sell skin care in the United States have entered the first renewal period under the Modernization of Cosmetics Regulation Act, called MoCRA, and some smaller companies are finding the forms heavier than expected.

Congress passed MoCRA in December 2022, the first broad revision of federal cosmetics law since 1938. It directs sites that make or process cosmetics to register with the Food and Drug Administration, and it directs the responsible person for each product to list the product with its ingredients. Those registrations need renewal each two years, so 2026 brings the first renewal round. The FDA issues automatic email reminders before each renewal date, so an old contact address remains the most frequent reason for a missed filing.

For someone who orders from independent labels for the hour before bed, the change stays mostly out of sight. Online marketplaces and shops more often request proof of registration and listing, and many small labels rely on a contract maker to maintain its own current registration. A label that believed its maker had covered every filing may learn otherwise only when a shop requests confirmation.

The statute offers some relief to smaller firms. Companies with average gross yearly cosmetics sales under one million dollars across the prior three years are usually exempt from facility registration and product listing. The exemption leaves out products used around the eye area, products that are injected, products intended for internal use, and products meant to alter appearance for longer than 24 hours, and it leaves the duty to report serious adverse events in place. A tiny label selling lip balm plus face oil may qualify as exempt, while one selling lash products does not.

The wider unsettled issue concerns manufacturing practice. MoCRA instructed the FDA to complete good manufacturing practice rules for cosmetics by the end of 2025, yet that date passed with no final rule, and law firms following the matter expect a proposal first with later phased start dates, including longer periods for small firms. In the meantime, the agency expects sites to show reasonable controls even with no detailed rulebook in effect.

What to watch next involves whether the FDA releases the proposed manufacturing rule this year, and whether missed renewals bring the first public enforcement steps under its new authority, which covers mandatory recalls and suspension of a facility registration. Labels that have not reviewed their listings and their makers registrations would do well to check them soon.