The MoCRA compliance checklist every cosmetics brand needs

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is, in the FDA's own words, "the most significant expansion of FDA's authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938." That's not marketing language — it's the framing on FDA's own MoCRA overview page. If you sell a cosmetic product in the United States, whether you formulate it yourself or a contract manufacturer makes it for you, MoCRA's obligations follow the product and the people responsible for it, not just the label artwork. Here's what to check before your next shipment.

1. Decide who your "responsible person" is

MoCRA defines the responsible person as "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label," per FDA's MoCRA overview. Every obligation below — product listing, safety substantiation, adverse event reporting — sits with this person or entity, not with whichever factory physically filled the bottle. If you work with a contract manufacturer or a private-label supplier, settle in writing, before your first shipment, who is going to be the responsible person on the US label.

2. Register every facility that touches your product, then renew every two years

"Manufacturers and processors must register their facilities with FDA and renew their registration every two years," per the same FDA overview page. FDA's registration and listing guidance adds the practical detail: renewal is biennial from your initial registration date, not a fixed calendar date — register in February 2024 and your renewal is due by February 2026. Registration is tied to an FDA Establishment Identifier (FEI); check the FEI Search Portal before you file so you don't create a duplicate record.

3. List every marketed product, then keep the listing current every year

Separately from facility registration, "a responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually," per FDA's registration and listing page. A facility registration and a product listing are two different filings — don't assume one covers the other, and don't assume a listing filed once stays accurate without an annual look.

4. Know your submission path before deadline week

FDA's Cosmetics Direct portal is the electronic system built specifically for MoCRA facility registration and product listing. The alternative, FDA's Electronic Submissions Gateway (ESG NextGen), requires a free account that "can take one to three weeks" to process, so FDA's own guidance urges registrants to apply well ahead of any submission deadline. Paper Forms FDA 5066 (facility) and 5067 (product listing) exist as a fallback, though FDA "strongly encourages electronic submissions."

5. Build a safety substantiation file — there's no fixed test list

"Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients," but the responsible person must still "ensure and maintain records supporting adequate safety substantiation of their cosmetic products," per FDA's MoCRA overview. In practice: gather whatever safety data you already have — raw-material documentation, existing irritation or stability data — and confirm it's "derived from scientifically robust methods." Animal testing is explicitly not a requirement.

6. Write your adverse event process before you need it

Serious adverse events must reach FDA "within 15 business days," with a copy of the product's label included, and if new medical information about the same event arrives within a year of the initial report, that update is due within another 15 business days (same source). Decide now who owns intake, how a report gets escalated internally, and how it gets filed — this is a bad thing to design for the first time under deadline pressure.

7. Check the small-business exemption carefully — the carve-outs matter more than the headline

MoCRA "exempts certain small businesses from GMP, registration, and product listing requirements" — but per the same FDA page, that exemption does not apply to facilities making products that regularly contact the mucous membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours where removal isn't part of customary use. If your line includes lash serums, injectable-adjacent products, or long-wear tinting, don't assume small-business status gets you out of registering.

Where this leaves you

FDA's own registration data makes the scale plain: since the program's December 2023 start, well over 16,000 unique facilities and more than 1.29 million products have been actively registered and listed under MoCRA, per FDA's published counts. This isn't a niche filing a handful of importers deal with — it's now standard operating procedure for anyone selling cosmetics into the US.

Tamats keeps a MoCRA workbench in the same workspace as your formulation work, so exemption status, facility registration, and adverse-event deadlines stay attached to the product they belong to — every status links back to the FDA source behind it. tamats.org