Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetic manufacturers and processors must register their facilities with the FDA for the first time. This is a major regulatory change, and we help you navigate it from start to finish.
New Facility Registration (MoCRA)
Cosmetic manufacturers, processors, and packers must register with the FDA under MoCRA. We manage the full registration submission on your behalf.
- MoCRA-compliant facility registration
- Domestic & foreign facility support
- Responsible Person designation
- All cosmetic categories covered
Biennial Renewal
MoCRA cosmetic facility registrations must be renewed every two years. We track your deadline and manage the renewal process for you.
- Biennial renewal management
- Updated facility information
- Timely FDA submission
- Confirmation documentation
Responsible Person Designation
MoCRA requires every cosmetic product to have a Responsible Person, the manufacturer, packer, or distributor whose name appears on the product label, who is accountable for the product meeting FDA requirements. A Responsible Person based outside the U.S. must also designate a U.S. Agent.
- Responsible Person support alongside your U.S. Agent service
- Serious Adverse Event reporting
- Safety records maintenance
Registration Amendments
Changes to your cosmetic facility new locations, ownership, or contact information require FDA updates under MoCRA. We file amendments promptly.
- Facility address amendments
- Ownership change updates
- Contact information revisions
- Facility category updates
Ready to get started? Register now:
Cosmetic Facility Registration FAQs
Maybe not, but check the exceptions carefully. MoCRA exempts businesses with average annual revenue under $1 million (over the past three years) from facility registration, product listing, and GMP requirements. However, this exemption does not apply if you manufacture certain higher-risk products: anything that contacts the eye area, is injected, is intended for internal use, or alters appearance for more than 24 hours without consumer removal. If even one of your products falls into those categories, you lose the exemption entirely and must register, regardless of your revenue.
Per facility. Registration covers the physical location where manufacturing or processing happens, not individual products. Product listing is the separate, per-product requirement, where you disclose each product’s ingredients and formulation details to the FDA.
A facility must register within 60 days of first engaging in cosmetic manufacturing or processing for the U.S. market. If you’re updating an existing registration, changes such as a new address, ownership, or contact information must also be filed within 60 days of the change.
The FDA can refuse or suspend your facility’s registration, which makes it illegal to distribute cosmetic products from that site in the U.S. This also disrupts your product listings, since those are tied to an active facility registration. Operating without a current registration creates real exposure to enforcement action and market disruption.