Cosmetics imported into the United States are subject to FDA review at entry and must comply with applicable U.S. cosmetic laws and regulations.
Cosmetics are regulated, not generally “FDA approved”
Do not treat a statement such as “FDA approved cosmetic” as proof of compliance. FDA does not operate a general pre-approval program for cosmetic products, although specific requirements such as color-additive approvals can apply.
MoCRA registration and listing
The Modernization of Cosmetics Regulation Act (MoCRA) introduced facility registration and cosmetic product listing requirements, subject to statutory exemptions. FDA's current registration/listing page states that certain small businesses can be exempt, with exceptions for specified higher-risk cosmetic product types.
FDA intends to use the FDA Establishment Identifier (FEI) as the cosmetic facility registration number. Product listings are submitted by the responsible person and require periodic updates.
Shipment data
For entry, obtain the correct FDA Product Code, intended use and party data. Do not assume a cosmetic's regulatory status solely from the commercial description.