21 CFR § 1.227 · Bioterrorism Act 2002
U.S. Agent for FDA Food Facility
Any foreign food facility registered with the FDA must designate a U.S. Agent. The U.S. Agent is your official point of contact with the FDA and must be physically located in the United States. Here is what you need to know.
What Is a U.S. Agent?
A U.S. Agent is a person or company located in the United States who acts as the FDA's primary contact for a foreign food facility. The requirement is established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and codified in 21 CFR § 1.227.
The U.S. Agent must be available during U.S. business hours to receive communications from the FDA. This includes notifications of facility inspections, requests for records, and regulatory correspondence.
Common Questions
Who needs a U.S. Agent?
Every foreign food facility that is required to register with the FDA must have a U.S. Agent. If your facility manufactures, processes, packs, or holds food for consumption in the United States, you almost certainly need one.
Can my U.S. distributor be my U.S. Agent?
Yes — your U.S. importer, distributor, or any other U.S.-based business can serve as your U.S. Agent, as long as they agree to the role and are available during U.S. business hours. The agent must be a person or company residing or maintaining a place of business in the U.S.
Can a foreign national living in the U.S. be the U.S. Agent?
Yes. The requirement is that the person physically resides or has a place of business in the United States — citizenship is not required. However, the agent cannot be the foreign facility itself.
What does the U.S. Agent actually do?
The U.S. Agent receives FDA communications on behalf of the foreign facility — including inspection notices, warning letters, requests for records, and import alerts. They act as a relay, not a legal representative. The FDA communicates through the U.S. Agent, not directly to the foreign manufacturer.
How do I designate a U.S. Agent?
You designate your U.S. Agent during the FDA food facility registration process through the FDA's FURLS system. You will need to provide the agent's name, address, phone number, and email. The agent must consent to the designation.
Can I change my U.S. Agent?
Yes. You can update your U.S. Agent at any time by updating your facility registration in FURLS. You should update it promptly if your agent changes, as the FDA will attempt to contact your listed agent if needed.
What Happens If You Don't Have a U.S. Agent
Failure to designate a U.S. Agent — or designating an agent who does not maintain a U.S. physical presence — can result in your facility registration being considered incomplete or invalid. An invalid registration can lead to your shipments being detained or refused at the U.S. border.
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Listing a foreign address as your U.S. Agent — the agent must physically be in the United States✕
Using a P.O. box as the U.S. Agent address — a physical U.S. address is required✕
Failing to update your U.S. Agent when the person or company changes✕
Designating a U.S. Agent without their knowledge or consent