Navigating FDA Compliance? Your Trusted US Agent is Your Gateway to the US Market.
U.S. Agent Services Cosmetics
Under the Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic manufacturers must designate a U.S. Agent. We serve as your official U.S. Agent and FDA contact, ensuring your cosmetic facility and products meet all MoCRA requirements.
Your MoCRA support can stay connected across U.S. Agent coverage, cosmetic facility registration, product listing, label and INCI review, Responsible Person compliance support, and renewal management through one accountable team.
U.S. Agent Services Cosmetics
Official Communication Hub
As your designated U.S. Agent, all official FDA MoCRA correspondence, regulatory notices, and inquiries are directed to us ensuring nothing is missed.
- Primary FDA MoCRA point of contact
- All official notices received & forwarded
- No missed communications due to time zones
- Regulatory inquiry handling
Inspection Coordination
We facilitate FDA inspections of your cosmetic facility under MoCRA coordinating logistics and ensuring your team is fully prepared for every regulatory visit.
- MoCRA inspection scheduling support
- Pre-inspection readiness guidance
- Liaison between FDA and your facility
- Documentation review support
Emergency Contact
For cosmetic safety alerts or product recalls under MoCRA, the FDA contacts us immediately to ensure rapid notification and response on your behalf.
- Product recall response coordination
- Serious adverse event communication
- Rapid escalation to your team
MoCRA Registration Support
We assist with cosmetic facility registration, product listing, Responsible Person designation, and renewal management on each program’s own schedule, keeping your MoCRA compliance current.
- Cosmetic facility registration (MoCRA)
- Product listing submissions
- Responsible Person designation
- Renewal management
Are You Cosmetics Compliant?
The Modernization of Cosmetics Regulation Act of 2022 brought sweeping new requirements for cosmetic manufacturers. Our team specializes in MoCRA compliance from initial facility registration to ongoing product listing and U.S. Agent representation.
Getting FDA compliant has never been easier
Step 1: Register & Designate
Complete our short form and designate FDA Entry Point as your U.S. Agent.
Step 2: We Confirm
We confirm and submit your FDA registration update within 1 business day.
Step 3: Active Coverage
We receive all FDA communications on your behalf immediately.
Step 4: Ongoing Renewal
We track and file your registration renewal on schedule, so there’s never a lapse in coverage.
becoming
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Cosmetics Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before facility registration; renew each year | $295/yr |
| Cosmetic Facility Registration | Domestic & foreign | Biennial | Initial registration required; renewal every 2 years | $449 |
| Cosmetic Product Listing | All cosmetic brands | Annual + per product | Within 120 days of marketing; updated every year | $299/product |
| Cosmetic Label Review | All manufacturers | Per product/change | Before market entry or reformulation | $449/product |
| Responsible Person Designation | Foreign brands | Ongoing | Required before marketing in the U.S. | $295/yr |
How to Change Your U.S. Agent
Already working with an agent? Here is how to switch to a new one without a gap in coverage.
Step 1: Select Your New U.S. Agent
Confirm the new agent agrees to the designation and provides a signed acceptance letter listing their U.S. address, phone number, and email address.
Step 2: Update Your Registration on Cosmetics Direct
Log in to Cosmetics Direct and update the U.S. Agent fields on your facility registration with your new agent’s contact information.
Step 3: Submit the Update
The change takes effect immediately upon successful submission. The FDA does not charge a fee for this update.
Step 4: Confirm With Your New Agent
Verify that your new U.S. Agent has received the registration confirmation and is ready to act on your behalf.
Step 5: Notify Your Former Agent
Let your outgoing agent know the change is complete so there is no confusion if the FDA reaches out to them during the transition.
Important Timing Note
Federal regulations require you to update your U.S. Agent information within 60 days of any change. Do not leave a gap in U.S. Agent coverage: if the FDA attempts to contact your facility through an outdated or non-functional agent, it can trigger enforcement action, including import refusal and registration cancellation.
Cosmetic US Agent FAQs
Any foreign facility that manufactures or processes cosmetic products for the U.S. market must designate a U.S. Agent. This is a mandatory requirement under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and applies regardless of company size or product volume. Domestic U.S. facilities are exempt.
Your U.S. Agent is the FDA’s official point of contact for your facility. We receive all regulatory correspondence and notices, coordinate and prepare you for FDA inspections, and serve as the emergency contact for recalls or serious adverse event communications. Without a responsive U.S. Agent, the FDA has no reliable way to reach your facility, which puts your registration at risk.
No. They’re separate, legally distinct roles under MoCRA. The U.S. Agent handles FDA communications and inspection coordination for your facility. The Responsible Person is accountable for product safety substantiation, product listing, and adverse event reporting, the name on your label. A foreign Responsible Person still needs a U.S. Agent. We can serve as your U.S. Agent and support your Responsible Person obligations, but it’s worth knowing these aren’t interchangeable.
The FDA can suspend your facility’s registration, which makes it illegal to distribute your cosmetic products in the U.S. until the registration is reinstated. A lapse in coverage, even briefly, creates real exposure: missed FDA notices, delayed inspection coordination, and risk to your ability to stay on the market.
Those are two different clocks. Your FDA Entry U.S. Agent service renews annually, that’s our service term, so your coverage and support never lapse. The FDA itself only formally reconfirms your U.S. Agent designation when your facility registration renews, every two years. We keep your agent information accurate with FDA in between regardless, so there’s no gap either way.