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MoCRA U.S. Agent Service for Foreign Cosmetics Facilities
A U.S. Agent for your FDA cosmetic facility registration. You get a U.S. address and phone number, and we forward FDA correspondence the same business day. Flat $249 per year.
If you need an agent to complete your registration, see our MoCRA U.S. Agent service blog.
MoCRA U.S. Agent Requirements — Who Needs One?
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), facilities that manufacture or process cosmetic products for sale in the U.S. must register with FDA. If the facility is outside the U.S., its registration must include the name and phone number of a U.S. agent. The agent must be physically present in the U.S. FDA says a mailbox, answering machine or answering service doesn’t qualify.
This usually applies to:
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Cosmetics manufacturers and processors outside the U.S.
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Contract manufacturers and OEM/ODM factories
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Private-label producers
Failing to register is a prohibited act under the FD&C Act. Facility registration also has to be renewed every two years.
Foreign facilities need a MoCRA U.S. Agent in place before entering the U.S. Agent details in Cosmetics Direct.
Chinese OEM and ODM factories can name a dedicated U.S. Agent for cosmetics facilities to handle FDA communications.
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-months 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 — this service covers FDA correspondence only, not product label addresses or Responsible Person services.
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 U.S. Agent details to enter in your Cosmetics Direct facility registration.
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.
Scope of Service
Our MoCRA U.S. Agent service covers FDA correspondence only. Our address is registered with the FDA as your U.S. Agent and cannot be used for any other purpose.
Our address may not be used as:
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The "Distributed by" or "Manufactured for" address on your product labels (21 CFR 701.12)
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Your MoCRA Responsible Person address under Sec. 609(a)
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A U.S. Distributor, Importer, or shipping address
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A business mailing address for purposes unrelated to FDA regulatory correspondence
What to do instead
For product label addresses, Responsible Person designation, or U.S. distribution, please engage a U.S.-based importer, distributor, 3PL partner, or regulatory consultant separately from your U.S. Agent designation.
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 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.
Q: Can I use your U.S. address on my product labels as "Distributed by" or as my Responsible Person?
No. Our address is registered with the FDA only as the U.S. Agent for your facility. Under FDA cosmetic labeling regulations (21 CFR 701.12), the address on a product label must identify the manufacturer, packer, or actual distributor — the party that physically handles or takes commercial responsibility for the product in U.S. commerce. We do not hold, distribute, or take commercial responsibility for any product. Using our address on your labels would create misbranding risk for your brand. For your Responsible Person and label address, appoint a U.S. importer, distributor, or 3PL partner.
Q: What U.S. Agent information goes into my registration?
For a foreign facility, the registration lists the U.S. agent's name and phone number, plus email if available.
Q: Who submits the facility registration?
The facility, or for contract manufacturing, the contract manufacturer or any Responsible Person whose products are made there.
Q: How often must I renew?
Every two years. Changes to registration information, including a new U.S. agent, must be updated within 60 days.
Q: Can I register on paper?
Yes, with Form FDA 5066, but FDA strongly encourages electronic submission through Cosmetics Direct.
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.
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