The short version
- MoCRA was enacted on 29 December 2022 and is codified from 21 U.S.C. 364 onward.
- Facilities register; the responsible person lists each product.
- Businesses under $1 million in average annual sales are exempt from registration and listing, with four product exceptions.
- Sunscreens and other cosmetic-drugs follow the drug rules instead.
Who MoCRA puts the duties on
MoCRA defines the responsible person as the manufacturer, packer or distributor of a cosmetic whose name appears on its label (21 U.S.C. 364). For a K-beauty product that is often the Korean brand; where a US importer or distributor is named on the label, it can be the importer. Which one it is decides who lists the product and who handles adverse-event reports, so settle it before the first shipment.
Sources: 21 U.S.C. 364 (FD&C Act §604)
Facility registration and product listing
- Registration. Every facility that manufactures or processes cosmetic products for distribution in the United States registers with FDA — a factory in Korea included.
- Listing. The responsible person lists each cosmetic product with FDA, including its ingredients and the facility where it is made.
- Keeping them current. The same section sets how often registrations are renewed and listings updated. Read the dates in the section itself; this page does not restate them.
Sources: 21 U.S.C. 364c (FD&C Act §607)
The small-business exemption
Businesses whose average annual sales are under $1 million are exempt from registration and listing (21 U.S.C. 364h). The exemption does not reach four kinds of product:
- products that regularly come into contact with the mucus membrane of the eye under customary use;
- products that are injected;
- products intended for internal use;
- products intended to alter appearance for more than 24 hours.
Sources: 21 U.S.C. 364h (FD&C Act §612); Small Businesses & Homemade Cosmetics: Fact Sheet
Safety records, adverse events and the label
- Safety substantiation — the responsible person holds records showing each product's safety is adequately substantiated (21 U.S.C. 364d).
- Serious adverse events — the responsible person reports them to FDA, on the timeline the section sets (21 U.S.C. 364a).
- Label contact — since 29 December 2024, the label carries a US contact through which adverse events can be reported (21 U.S.C. 364e(a)).
Sources: 21 U.S.C. 364d (FD&C Act §608); 21 U.S.C. 364a (FD&C Act §605); 21 U.S.C. 364e (FD&C Act §609)
Sunscreens and other cosmetic-drugs
A product that is also a drug — a sunscreen, an acne treatment — is exempt from MoCRA's adverse-event, manufacturing-practice, registration and listing, safety-substantiation, label-contact, records and recall provisions, and follows the drug rules instead (21 U.S.C. 364i(a)). The exemption does not reach a facility's other products: a factory that also makes ordinary cosmetics still registers under MoCRA for them (21 U.S.C. 364i(b)). Establishments that make the drug register and list under 21 CFR part 207.
Sources: 21 U.S.C. 364i (FD&C Act §613); 21 U.S.C. 321(g)(1), 321(i); 21 CFR 207.17, 207.69
What happens at the border
Cosmetics are not approved by FDA before sale, but imports are subject to FDA review. Under section 801(a) of the Federal Food, Drug, and Cosmetic Act, FDA can refuse admission to a cosmetic that appears adulterated or misbranded — a label that does not meet the rules is misbranding.
Sources: 21 U.S.C. 381(a) (FD&C Act §801(a)); Cosmetic Overview for Imported Products; FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated