- Every facility registered under MoCRA must re-register on a two-year schedule, and this year is the first time that clock runs out.
- The FDA missed its own end-of-2025 target for a final cosmetics manufacturing rule, so facilities work without a detailed standard.
- Brands under the sales threshold can skip some filings, but not for eye-area products, and never for serious adverse event reports.
Before a formula reaches a shelf, a surprising amount of regulation happens on paper, and for the first time that paperwork is coming due again for skincare makers across the United States.
The law at the centre is the Modernization of Cosmetics Regulation Act, or MoCRA, which was signed in December 2022. It replaced a regime that had barely changed since 1938. Under it, any facility that makes or processes cosmetics has to be registered with the Food and Drug Administration, and the responsible person behind each product has to list it, ingredients included. Registration lasts two years. That means 2026 is the first year anyone has to renew. The agency sends reminders by email, so the usual failure is mundane: the address on file is no longer read by anyone.
This matters to a reader of ingredient lists because the checking has moved downstream. Retailers and marketplaces now ask labels for proof of registration and listing. Many small brands do not run their own plant. They rely on a contract manufacturer to keep its registration in order, and some find out whether that happened only when a buyer asks for the number.
There is a carve-out. A business whose cosmetics sales averaged under one million dollars a year across the previous three years is generally excused from registering facilities and listing products. The limits are specific, and they are where small brands trip. The exemption does not reach products used around the eyes, injected products, products intended for internal use, or those meant to alter appearance for longer than 24 hours. It also leaves the adverse event duty in place. So a brand with a lip balm and a face oil may qualify, while a brand with a lash serum does not.
The harder gap is on the factory floor. The statute asked the FDA to finalize good manufacturing practice requirements for cosmetics by the end of 2025. No final rule appeared. Lawyers who follow the topic expect a proposal first, followed by a phase-in with more time for smaller companies. In the meantime, the agency still expects facilities to show reasonable controls, even with no detailed checklist to measure them against.
Two things are worth watching. One is whether the FDA proposes the manufacturing rule this year. The other is whether missed renewals produce the first public enforcement under the agency’s newer tools, which include ordering a recall and suspending a facility’s registration. Nothing here requires a lawyer to act on. A brand can check its own listing, then ask its manufacturer for a copy of the current registration, and do both before a retailer asks.
Madeline Hawkins
Madeline runs the news desk and the evidence guides at Face Value. She reads the methods section before the abstract and keeps a tally of every study a press release cites, next to the number she could actually find.
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