Facility registrations must be renewed on schedule. If you are not yet covered, there is still time to bring your US compliance current. Read about the deadline →
What the law requires
What the US market requires.
MoCRA, the Modernization of Cosmetics Regulation Act, brought US cosmetics under a federal registration regime for the first time. To sell a cosmetic in the United States, your brand must meet a set of FDA obligations built around one central role: the Responsible Person.
Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026
Selling cosmetics in the US under MoCRA means facility registration with biennial renewals, a product listing per product, a US Agent for foreign facilities, safety substantiation and an adverse-event contact on the label. CIG acts as US Agent and files registrations and listings through Cosmetics Direct.
Legal basis: FDA: MoCRA, FDA Cosmetics Direct, FDA: Registration and Listing.
MoCRA is newer than the European regimes and is still unfamiliar to many brands, which makes missed registrations and renewals a real risk. The registration and listing deadlines have already passed, so a brand that has not yet acted is out of step with the law now rather than later.
Who holds the obligation
The Responsible Person and the US Agent are two different roles.
Under MoCRA the Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label, defined under FD&C Act section 609(a) and the Fair Packaging and Labeling Act. The Responsible Person lists each marketed cosmetic with the FDA, keeps the listing current, holds the safety substantiation, and reports serious adverse events. A brand cannot hand this accountability to its contract manufacturer. The manufacturer registers its own facility, but the brand named on the label still has to list its products and answer for them.
The Responsible Person can be located outside the United States. What must sit inside the country is the US Agent. Any foreign cosmetic facility that has to register with the FDA has to designate a US Agent who resides in, or keeps a place of business in, the US and is physically present there. A mailbox or an answering service does not qualify. The US Agent is the communication liaison between the FDA and the foreign facility. This is a separate matter from the label requirement that a US contact for adverse-event reporting appears on packaging, which took effect on 29 December 2024.
Small business, and what still applies
The small-business exemption is narrower than it sounds.
MoCRA defines a small business as one whose average gross annual US cosmetic sales over the previous three-year period are under $1,000,000, adjusted for inflation. A qualifying small business is exempt from Good Manufacturing Practice requirements, facility registration, and product listing. That is real relief, and many indie brands qualify.
The exemption is narrower than most makers assume. It does not apply to any product that regularly contacts the mucous membrane of the eye, is injected, is for internal use, or alters appearance for more than 24 hours where removal is not part of ordinary use. The exemption is all-or-nothing: a single eyeliner, mascara, or long-wear product in the range voids it for the whole business. And two obligations never lift for anyone. Every brand keeps safety substantiation on file for every product, and every brand reports serious adverse events. For many small brands the substantiation dossier is the single largest new task MoCRA introduced.
How it works, step by step
From your product list to a filed registration.
MoCRA submissions go through Cosmetics Direct, the FDA's free online tool, in Structured Product Labeling format. That format is XML-based and error-prone for brands new to FDA systems, which is where first-time attempts stall. The steps below are the same whether we file for you or you attempt it yourself. The difference is where the time goes.
Listing a product with the FDA does not mean it is FDA approved. The FDA does not approve cosmetics before they go on the market. Registration and listing put your product on the record and meet the law. They are not an endorsement, and no one should describe them as one.
Why products get pulled here
Where US launches go wrong.
Most US problems come from a handful of first-timer mistakes rather than anything exotic. Knowing them in advance is usually enough to avoid them.
How CIG covers it
Your MoCRA obligations, in one place.
CIG registers your facilities, submits and maintains your annual product listing, and acts as your US Agent for foreign facilities. We track your renewal dates and confirm every submission with you before it is filed. Your MoCRA obligations can also be folded into ongoing Compliance Care.
Why CIG
Why brands choose CIG for the US.
What you need in this market
The US requirements, each handled by a CIG service.
US questions, answered
Frequently asked questions.
In practice
Compliance, in the real world.
