FDA MoCRA for Perfume Brands: Factory Support vs Brand Responsibility

For perfume brands entering the United States, MoCRA creates responsibilities that should be assigned before launch. FDA facility registration or cosmetic product listing must not be presented as FDA approval of a perfume.

The responsible person named on the label has obligations relating to product listing and serious adverse event reporting, while applicable manufacturing or processing facilities address registration and renewal requirements. Exemptions and details depend on the business and product.

Coordinate the legal entity, US contact information, ingredient data, label and manufacturing information. The factory can support with available records, but the US responsible person should obtain qualified regulatory advice for the actual product.

FDA: MoCRA information