MoCRA U.S. Agent Requirements — Who Needs One?
Under the Modernization of Cosmetics Regulation Act (MoCRA), enacted December 29, 2022, all foreign cosmetic facilities selling into the U.S. must designate a U.S. Agent as part of their FDA facility registration.
This applies to:
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Foreign cosmetics manufacturers exporting to the United States
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Foreign contract manufacturers producing cosmetics for U.S. brands
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Foreign OEM/ODM cosmetic facilities
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Foreign private-label cosmetic producers
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Foreign cosmetic ingredient suppliers with finished product operations
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Repackers / relabelers of cosmetic products outside the U.S.
Without a designated MoCRA U.S. Agent, your facility faces:
❌ Facility registration rejection in FDA's FURLS system
❌ FDA refusal of your cosmetic imports at U.S. ports
❌ Product listing delays and compliance holds
❌ Inability to report adverse events as required under MoCRA Section 605
❌ Compliance enforcement actions
We provide all required MoCRA U.S. Agent services — during U.S. business hours and for adverse event reporting.
Verified U.S. Address
For FDA cosmetic facility registration and all MoCRA-related correspondence. A real physical address — not a P.O. Box.
U.S. Phone Number
We receive compliance calls, FDA inquiries, and adverse event notifications on your behalf during U.S. business hours.
Official Correspondence Handling
All FDA notices, inspection requests, adverse event follow-ups, and enforcement letters received and forwarded same day.
12-mo coverage
Full one-year MoCRA U.S. Agent service with no additional fees, no hidden charges. Renew annually.
What Our MoCRA U.S. Agent Service Includes
How it works
Step 1 — Select the MoCRA U.S. Agent plan and complete checkout. You'll receive an onboarding form immediately.
Step 2 — Provide your facility name, FDA Establishment Identifier (FEI) if available, and designated contact information. Takes less than 5 minutes.
Step 3 — We assign your verified U.S. mailing address and phone number. You receive your official U.S. Agent designation letter to use for FDA facility registration in FURLS.
Step 4 — We receive and forward inspection notices, adverse event inquiries, verification messages, and enforcement letters — same day.
Step 5 — Your MoCRA U.S. Agent remains available at any time throughout the year — no additional fees, no hidden charges.
Why Foreign Cosmetics Companies Need a U.S. Agent Under MoCRA
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MoCRA is the most significant update to U.S. cosmetics regulation since 1938. For the first time, the FDA has authority to require facility registration, product listing, Good Manufacturing Practices (GMP), and adverse event reporting for all cosmetics sold in the United States.
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If your facility is located outside the U.S., MoCRA requires you to designate a U.S. Agent before you can register your facility in FDA's electronic system (FURLS). Without a U.S. Agent, your registration will not be accepted and your products may be refused entry at U.S. ports.
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Your U.S. Agent serves as the official link between your company and the FDA. We receive all regulatory communications on your behalf and forward them to you immediately — ensuring you never miss a deadline, inspection notice, or adverse event inquiry.
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Unlike full-service regulatory consultants who charge $1,000+ for bundled compliance packages, US Compliance Agent provides a focused, affordable U.S. Agent designation service. We handle the communications — you handle the compliance.
Frequently Asked Questions
Q: Is this legal under MoCRA regulations?
Yes. MoCRA requires all foreign cosmetic facilities to designate a U.S. Agent for FDA facility registration. We fulfill all MoCRA U.S. Agent requirements as defined under the Modernization of Cosmetics Regulation Act of 2022.
Q: How fast do I get my U.S. Agent information?
Immediately after payment. You'll receive your U.S. Agent designation letter and contact details within minutes of completing onboarding.
Q: Does this include FDA submissions or consulting?
No. This is a compliance-only U.S. Agent service. We do not provide MoCRA registration submissions, product listing assistance, GMP consulting, label review, or safety substantiation services.
Q: What happens if FDA requests an inspection?
We forward the notice instantly and confirm receipt. You remain responsible for arranging and cooperating with the inspection.
Q: What about adverse event reporting?
Under MoCRA Section 605, serious adverse events must be reported to FDA within 15 business days. As your U.S. Agent, we receive and relay any adverse event inquiries from FDA. You remain responsible for submitting the actual adverse event reports.
Q: Do I need a separate U.S. Agent for each facility?
Yes. Each registered foreign cosmetic facility must have its own U.S. Agent designation. If you operate multiple facilities, contact us for multi-facility pricing.
Q: What's the difference between a U.S. Agent and a Responsible Person?
A U.S. Agent is the FDA's official point of contact for a foreign facility. A Responsible Person is the individual or company responsible for product labeling and adverse event reporting — this is typically the U.S. importer, brand owner, or manufacturer. These are two different roles under MoCRA, and both are required. We serve as U.S. Agent only.
Q: How does this compare to Registrar Corp or Biorius?
Those companies offer full regulatory consulting packages that typically cost $500–$1,500+ and include registration assistance, label review, and compliance consulting. We provide a focused U.S. Agent designation service at $249/year — ideal for companies that only need the agent requirement fulfilled and can handle their own compliance.
Legal Notice:
US Compliance Agent LLC provides U.S. Agent services for compliance and verification purposes only.
We do not provide FDA consulting, regulatory submissions, auditing, or product testing services.