If your cosmetic facility is outside the United States, MoCRA requires you to designate a U.S. agent – a person or company in America who serves as FDA’s official point of contact for your facility. But not just anyone qualifies. FDA sets specific requirements for who can serve in this role.

This guide explains the legal requirements, who can and cannot be your agent, the different types of agents, and how to choose the right one for your business.

The legal requirement

Under MoCRA, every foreign facility that manufactures or processes cosmetic products for the U.S. market must designate a U.S. agent. This is not optional – it is a condition of registration. FDA will not process a foreign facility’s registration without a designated agent.

FDA’s guidance specifies that the agent must be someone who resides or maintains a physical place of business in the United States. A foreign address, a P.O. box, or a virtual mailbox does not satisfy this requirement. The agent must have a real, physical U.S. presence where FDA can reach them.

Who can serve as your U.S. agent

FDA allows several types of persons or entities to serve as a U.S. agent, as long as they meet the physical-presence requirement:

An individual U.S. resident. A U.S. citizen or resident – for example, an employee of your U.S. subsidiary, a consultant, or a trusted business contact. They must reside in the United States.
A U.S.-registered business entity. A company incorporated or registered in the United States with a physical place of business here.
A third-party regulatory service. A professional firm that provides U.S. agent services to multiple foreign facilities. This is the most common choice, as these providers specialize in FDA communications, filings, and renewals.
Your U.S. importer or distributor. If you have a U.S. business partner, they can serve as your agent – provided they agree and meet the requirements.
A U.S. subsidiary. If your company has a registered U.S. entity, it can act as the agent for your foreign facilities.

What the agent actually does

The U.S. agent is FDA’s official contact for your facility. Their core responsibilities include:

Receiving FDA communications. Inspection notifications, information requests, and enforcement correspondence go to the agent.
Receiving renewal reminders. FDA’s automated renewal reminders are sent to the contact on file – for foreign facilities, that is the agent’s email.
Facilitating inspections. If FDA schedules a facility inspection, the agent is the contact point for coordination.
Responding on your behalf. The agent receives and forwards FDA communications promptly so you can respond within required timeframes.

Limits: what an agent is not

The U.S. agent role has boundaries worth understanding:

Not a legal representative. The agent is a communications contact, not your attorney. They receive and forward FDA correspondence; they do not provide legal advice unless separately qualified and engaged.
Not liable for your compliance. Designating an agent does not transfer your regulatory obligations. The facility owner remains responsible for compliance with MoCRA.
Not a substitute for registration. Having an agent does not mean you are registered. The facility registration itself must still be filed.

How to choose the right agent

Consider these factors:

Responsiveness. The agent’s core job is receiving and forwarding FDA communications quickly. Ask about response times and processes.
Regulatory knowledge. A specialist understands MoCRA filings, renewals, SPL formatting, and FDA expectations – not just mail forwarding.
Renewal tracking. Your agent should track your biennial renewal date and initiate the process in advance.
Transparency. Clear pricing, written authorization, and defined scope of services. Avoid providers who cannot explain exactly what is included.
Stability. Choose an established provider. If your agent disappears, you face an urgent transition – appointing a replacement while ensuring no gap in representation.

Key point: Your U.S. agent is the address FDA has on file for your facility. Choose someone who will actually be there – reading every message, tracking every deadline, and picking up the phone when it matters.

New to MoCRA? Start with our complete MoCRA Compliance Guide for Cosmetic Brands (2026).

Frequently asked questions

Can our U.S. distributor be our agent?

Yes, if they reside in or maintain a physical U.S. business location and agree to the role. Get the arrangement in writing, and confirm they understand the responsibilities – especially receiving and forwarding FDA communications promptly.

Can one agent represent multiple facilities?

Yes. Third-party agent services routinely represent many facilities. Each facility’s registration names the agent, and the agent manages communications for all of them.

Does the agent need to be available 24/7?

No, but they should be reliably reachable during business hours and have processes for urgent FDA communications. Ask potential agents how they handle time-sensitive correspondence.

What if we want to change agents?

You can change agents by filing an amended registration naming the new agent. Appoint the replacement before the old agent’s resignation takes effect to avoid any gap in representation.

US MoCRA Agent is a private service provider and is not affiliated with the FDA. Questions about U.S. agent requirements: usmocra@outlook.com – +1 909-997-0000 – pricing.

This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on FDA’s published guidance and are current as of September 2026; always verify requirements against FDA’s official sources before acting.

Related Guides

How to Change or Transfer Your MoCRA U.S. Agent — if your agent stops meeting requirements.
MoCRA U.S. Agent Pricing: What Agent Services Cost and Include — what compliant agent services cost.
Cosmetics Direct: How to Register Your Facility Step by Step — where the agent is designated.

Who Can Be Your MoCRA U.S. Agent? Requirements Explained