MoCRA Cosmetic Facility Registration with FDA
FDA facility registration under MoCRA for facilities that manufacture or process cosmetics for the US market.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
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Quick answer
Under MoCRA, every facility that manufactures or processes cosmetics for US distribution must register with the FDA and renew every two years. We prepare and submit your registration through FDA's Cosmetics Direct portal. There is no FDA fee. Foreign facilities also need a US agent. FDA issues no certificate. £795 per facility.
What's included in your facility registration
| Document | What it is |
|---|---|
| Eligibility check | Whether your site manufactures or processes cosmetics and must register |
| Registration preparation | Facility name, address, FEI number, contacts, product categories and brands |
| Cosmetics Direct submission | Submitted through FDA's portal on your behalf |
| US agent check | Confirms the US agent named for a foreign facility |
| Record of submission | The registration number once FDA issues it, and your renewal date |
Who this facility registration is for
- Owners or operators of cosmetic manufacturing or processing facilities outside the US
- UK and EU contract manufacturers supplying US brands
- Brands that own their own production site
- US facilities that have not yet registered
What this facility registration does not include
- A US agent. Foreign facilities must name one; Phoenix Safety Consultants LLC can act as your US agent as a separate service.
- Product listings. Each cosmetic product is listed separately by the responsible person.
- A registration certificate. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.
- A guaranteed date. FDA processing time varies and is outside our control, so we do not guarantee a date.
How it works
- Send your details Facility name and address, owner or operator, FEI or DUNS number if you have one, product categories, brands and US agent details.
- Check and prepare We check what is needed and prepare the registration.
- Submit We submit through Cosmetics Direct once your information is complete.
- Confirmed We send the registration number when FDA issues it and note your two-year renewal date.
What is MoCRA facility registration?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added section 607 to the US Federal Food, Drug, and Cosmetic Act. It requires each facility that manufactures or processes cosmetics for US distribution to register with the FDA through Cosmetics Direct and to renew the registration every two years. Facilities outside the US must name a US agent. There is no government fee. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.
What we submit to the FDA
Facility information:
- Identity: Facility name, physical address, owner or operator and contact details.
- Identifiers: FEI number, and DUNS where applicable.
- US agent: Required for foreign facilities.
Products made there:
- Categories: The cosmetic product categories manufactured or processed.
- Brands: The brand names sold in the US.
After registration:
- Renewal: Every two years.
- Changes: Updates within 60 days of a change to the registration information.
What you receive
- Submitted FDA facility registration
- The facility registration number once issued
- A summary of the information submitted
- Your two-year renewal date
Legal framework for MoCRA facility registration
- FD&C Act section 607(a) — facilities that manufacture or process cosmetics for US distribution must register
- Section 607(a)(3) — registrations are renewed every two years
- Section 607(b) — foreign facility registrations include a US agent
- Section 612 — some small businesses are exempt, but not for certain product types
- No FDA fee — no government fee applies to registration
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix for MoCRA registration
- Prepared and submitted for you — through FDA's Cosmetics Direct portal.
- US agent available — Phoenix Safety Consultants LLC can act as your US agent.
- Clear about what FDA issues — a registration number, not a certificate.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Register before you ship to the US. Order above, or message us on WhatsApp on +44 7346 009332 if you are unsure whether your facility must register.
Frequently asked questions
Do I need to register my cosmetic facility with the FDA?
Yes, if your facility manufactures or processes cosmetics for US distribution, unless a MoCRA small business exemption applies to you and your products.
Is there an FDA fee for cosmetic facility registration?
No. FDA charges no fee for MoCRA facility registration or product listing. Our fee covers preparation and submission.
Does FDA issue a registration certificate?
No. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.
How often must a cosmetic facility registration be renewed?
Every two years. Changes to the registration information must be updated within 60 days.
Do foreign facilities need a US agent?
Yes. A facility outside the US must name a US agent in its registration. Phoenix Safety Consultants LLC can act as your US agent as a separate service.
How much does MoCRA facility registration cost?
£795 per facility for preparation and submission. FDA processing time varies and is outside our control, so we do not guarantee a date.