15 days and what adverse-event reporting requires

Two is the number in beauty right now, as in every two years. Facilities that make or process cosmetics in the United States reached their first renewal round under the Modernization of Cosmetics Regulation Act, called MoCRA, during 2026, and some indie labels were surprised by the admin.

Congress passed MoCRA in December 2022, the first broad rewrite of federal cosmetics law since 1938. It obliges plants that manufacture or process cosmetics to register with the Food and Drug Administration, and it obliges the responsible person behind each formula to list that formula with its ingredients. Renewal comes due on a two-year cycle, so 2026 became the first repeat round. FDA sends automatic email prompts before each due date, which means a stale inbox is the easiest way to fall out of status.

Shoppers may not see the forms, yet the effect lands on the shelf. Retailers and marketplaces now routinely request proof of registration and listing, and plenty of small lines rely on a contract manufacturer to maintain its own active registration. A founder who believed the factory covered every filing can learn otherwise when a buyer requests documentation.

Smaller operations receive partial relief under the statute. Companies averaging under one million dollars in yearly cosmetics sales across the prior three years are usually excused from facility registration and product listing. The carve-out falls away for products used around the eye area, injected, intended for internal use, or made to alter appearance for longer than 24 hours, and it never lifts the obligation to report serious adverse events. A tiny label with only lip balm and face oil might qualify, while one with lash formulas does not.

The bigger unresolved item concerns production standards. MoCRA directed FDA to complete good manufacturing practice rules for cosmetics by the end of 2025, yet that date went by with no final rule, and monitoring firms anticipate a proposal first followed by staged compliance, with extended schedules for small firms. In the meantime, the agency looks for reasonable controls even absent a full rulebook.

What to track next is whether FDA issues the draft manufacturing rule this year, plus whether missed renewals trigger the first public enforcement under its expanded authority, which covers mandatory recalls and suspension of a facility registration. Labels that have not reviewed their listings and their makers registrations should do it now.