What is MoCRA and who does it apply to?

MoCRA is the Modernization of Cosmetics Regulation Act, which expands FDA oversight of cosmetics. Requirements can apply to cosmetic manufacturers, processors, packers, and certain responsible persons depending on the business role and products sold in the U.S. market.

Do cosmetic companies need to register with the FDA?

Cosmetic facility registration and product listing may be required under MoCRA for certain businesses and products. Requirements depend on the facility role and the products being marketed in the United States.

Do foreign cosmetic companies need a U.S. Agent?

Many foreign cosmetic companies benefit from a U.S. Agent to support FDA communications and compliance workflows. FDA Registration Assistance provides U.S. Agent services for cosmetic and personal care companies worldwide.

Can you help with cosmetic product listing and ingredient documentation?

Yes. We assist with cosmetic product listing workflows and compliance documentation, including organizing required product and ingredient information based on your product category and role.

Do you provide cosmetic label review?

Yes. We review cosmetic labels for compliance considerations such as identity statement, net quantity, ingredient declaration, warnings, and company information to reduce misbranding risk.

Do you support adverse event and recordkeeping requirements?

Yes. We can help set up practical compliance workflows for recordkeeping and adverse event processes, depending on your role, product types, and distribution model.