MoCRA Essentials Annual Package
A 12-month MoCRA package for non-US cosmetic brands: registration, US agent, listings, a label review and regulatory alerts.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
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Service details
Everything included, explained
Quick answer
MoCRA Essentials is a 12-month package for non-US cosmetic brands. It covers FDA facility registration and renewal management, Phoenix Safety Consultants LLC as US agent, up to 10 product listings with annual updates, one US label and claims review and regulatory alerts, with a 5-business-day response time. FDA issues no certificate. £2,950 a year.
What's included in your MoCRA bundle
| Document | What it is |
|---|---|
| Facility registration | Prepared, submitted and renewal managed |
| US agent | Phoenix Safety Consultants LLC named in your registration for 12 months |
| Product listings | Up to 10 products listed, with annual updates |
| Label and claims review | One US label reviewed against FDA, FPLA and MoCRA |
| Regulatory alerts | Updates on MoCRA rules that affect your products |
| Response time | Replies within 5 business days |
Who this bundle is for
- Non-US cosmetic brands with up to 10 US products
- Amazon US sellers needing MoCRA compliance
- Brands that want one annual fee
What this bundle does not include
- Responsible person service. Included in the Professional package.
- Adverse event reporting. Included in Professional, or available separately.
- Safety substantiation files. Available separately.
- More than 10 listings or 1 label review. Charged separately.
- A guaranteed FDA date or certificate. FDA processing time varies and is outside our control, so we do not guarantee a date. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.
How it works
- Onboarding Send your facility, product and label details.
- Agreement You sign the 12-month package and US agent agreement.
- Submit We register your facility and list your products.
- Through the year Label review, alerts, listing updates and renewal tracking.
What does MoCRA require of a non-US cosmetic brand?
MoCRA requires facility registration (FD&C Act section 607(a)), a US agent for foreign facilities (607(b)) and product listing with annual updates (607(c)). MoCRA Essentials handles these for 12 months through Phoenix Safety Consultants LLC, plus a US label review and regulatory alerts, with work reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead. There is no FDA fee for cosmetic registration or listing.
What the package covers over 12 months
Core filings:
- Registration: Submitted, with the two-year renewal managed.
- Listings: Up to 10 products, updated annually.
Support:
- US agent: Phoenix Safety Consultants LLC.
- Label review: One label.
- Alerts and response: Regulatory alerts and replies within 5 business days.
What you receive
- Facility registration number once issued
- Product listing numbers once issued
- Signed US agent agreement
- Label review report
- Regulatory alerts through the year
Legal framework
- FD&C Act section 607 — registration, US agent and product listing
- Section 604 and 609 — responsible person and label contact
- Section 605 and 608 — adverse events and safety substantiation
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix
- One annual fee for the MoCRA basics.
- Phoenix Safety Consultants LLC (USA), our sister company as US agent.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Need more? See the Professional package, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What does MoCRA Essentials include?
Facility registration and renewal management, Phoenix Safety Consultants LLC as US agent, up to 10 product listings with annual updates, one label and claims review and regulatory alerts for 12 months.
Does Essentials include a responsible person?
No. The responsible person service and adverse event reporting are in the Professional package.
What response time does Essentials have?
We reply within 5 business days. FDA processing time varies and is outside our control.
Are there FDA fees?
No. FDA charges no fee for cosmetic registration or listing.
Can I add more products?
Yes. Extra listings and label reviews are charged separately, or you can move to Professional.
How much does Essentials cost?
£2,950 a year, with a 12-month minimum.