Small brands face the first MoCRA renewal season

Brands that make or sell skin care in the United States are entering the first renewal season under the Modernization of Cosmetics Regulation Act, known as MoCRA, and the paperwork is catching some smaller companies off guard.

MoCRA, signed in December 2022, was the first major overhaul of federal cosmetics law since 1938. It requires facilities that manufacture or process cosmetics to register with the Food and Drug Administration, and it requires the responsible person for each product to list that product, including its ingredients. Those registrations must be renewed every two years, which makes 2026 the first renewal cycle. The FDA sends automated email reminders ahead of each renewal date, so an out-of-date contact address is the most common way to miss one.

For a reader who buys from independent brands, the practical effect shows up behind the scenes. Marketplaces and retailers increasingly ask brands to prove they are registered and listed, and many small labels depend on a contract manufacturer to keep its own registration current. A brand that assumed its manufacturer had handled everything may find out only when a retailer asks for confirmation.

The law does give smaller companies some relief. Businesses with average gross annual cosmetics sales below one million dollars over the previous three years are generally exempt from facility registration and product listing. That exemption does not apply to products that touch the eye area, are injected, are meant for internal use, or are designed to change appearance for more than 24 hours, and it does not remove the duty to report serious adverse events. A small brand selling a lip balm and a face oil may be exempt, while one selling lash products is not.

The larger open question is manufacturing practice. MoCRA told the FDA to finalize good manufacturing practice rules for cosmetics by the end of 2025, but that deadline passed without a final rule, and law firms tracking the issue expect the rule to be proposed first and phased in later, with longer timelines for small businesses. Until then, the agency expects facilities to show sensible controls even without a detailed rulebook.

What to watch next: whether the FDA publishes the proposed manufacturing rule this year, and whether renewal lapses lead to the first visible enforcement actions under its new powers, which include mandatory recalls and suspending a facility’s registration. Brands that have not checked their listings and their manufacturers’ registrations are better off doing so now.