US Agent and MoCRA compliance for cosmetic products
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced FDA facility registration and product listing for cosmetics. Foreign facilities must name a US Agent. Our US company, EVIDORO DOO LAB LIAISON SERVICES LLC in Sheridan, Wyoming, can take on this role.
Legal basis: Federal Food, Drug, and Cosmetic Act, Chapter VI, as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
What we do
- US Agent for your foreign facility
- FDA facility registration
- Cosmetic product listing
- Label review, including the domestic contact for adverse event reports
- Support with safety substantiation records
- Check whether a small-business exemption may apply
Who it is for
Manufacturers and brands outside the United States that export cosmetics to the US.
Get a quoteHow it works
- ReviewWe check your facility, products and labels against MoCRA.
- AppointmentWe confirm the US Agent appointment.
- Registration and listingWe prepare the FDA facility registration and product listing.
- OngoingWe act as the FDA contact and help keep records up to date.
Questions
Is the US Agent the same as the Responsible Person?
No. Under MoCRA the 'responsible person' is the manufacturer, packer or distributor whose name is on the label. The US Agent is the FDA contact for a foreign facility.
Does every company have to register?
Most must, but MoCRA has exemptions for certain small businesses. We check whether an exemption may apply to you.
What must the label include under MoCRA?
Among other things, a domestic address, domestic phone number or electronic contact through which adverse event reports can be received.
Questions about this service
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Send us your product list and target markets. We reply with the next steps and a quote.
Our offices
EU Responsible Person
Honvéd utca 8. 1. em. 2., 1054 Budapest, Hungary
UK Responsible Person
4 Raven Road, Unit 1c3-627, London E18 1HB, England
Türkiye office
Dünya Ticaret Merkezi, EGS Business Park, B2 Blok 8/106, Yeşilköy, İstanbul
US Agent
30 N Gould St, Ste R, Sheridan, WY 82801, USA