Do I Need a U.S. FDA Agent? A Guide for Foreign Food Companies
Short answer: If your facility is located outside the United States and you manufacture, process, pack, or hold food, beverages, or dietary supplements intended for U.S. consumption, then yes — FDA requires you to appoint a U.S. Agent when you register your facility. Domestic (U.S.-based) facilities do not need one. The U.S. Agent is a person or business physically located in the United States who acts as your representative for all communication with FDA.
Who is required to have a U.S. Agent?
You need a U.S. Agent if both of these are true:
1. Your facility manufactures, processes, packs, or stores food, beverage, or dietary supplements intended for consumption in the United States, and
2. Your facility is physically located outside the United States.
Every such foreign facility must register with the FDA, and as part of that registration must designate a U.S. Agent. Domestic facilities register directly and do not appoint an agent.
What does a U.S. FDA Agent actually do?
The U.S. Agent is your domestic representative — the channel through which FDA reaches you. Specifically, the agent:
• Serves as FDA’s point of contact for your foreign facility
• Receives communications from FDA on your behalf
• Assists FDA with scheduling inspections of your facility if needed
• Responds to questions about your products during an emergency or routine matter
The U.S. Agent must be physically located in the United States (a U.S. mailing address alone is not enough — they must be reachable and able to act).
U.S. Agent vs. FSVP Agent — don’t confuse them
These are two different roles that foreign companies often need at the same time:
| U.S. Agent (facility registration) | FSVP Agent | |
|---|---|---|
| Tied to | FDA facility registration | The Foreign Supplier Verification Program |
| Who needs it | Foreign facilities (manufacturers, packers, storage) | U.S. importers without a qualified individual on staff |
| Core job | Be FDA’s contact for the facility | Perform supplier-verification activities and keep records in the U.S. |
A foreign manufacturer that also imports its own product into the U.S. can need both a U.S. Agent (for its facility registration) and an FSVP Agent (for the import side).
What happens if you don’t have one?
Without a designated U.S. Agent, a foreign facility cannot complete FDA registration — and without registration, your products can be detained or refused entry at U.S. ports. An unresponsive or invalid agent can also stall an FDA inspection request, which creates compliance risk of its own.
How to choose a U.S. FDA Agent
Look for:
• A real, reachable U.S. presence — not just a forwarding address
• Experience with your product category (food, beverage, or dietary supplements specifically)
• Responsiveness — the agent must act quickly if FDA makes contact
• Transparent, flat-fee pricing so renewals don’t surprise you
• Help with the full registration, not just the agent designation (DUNS number, account setup, biennial renewal)
Key facts to remember
• FDA food facility registration must be renewed every even-numbered year (October–December window).
• Registration itself is free through FDA, but foreign facilities must maintain a valid U.S. Agent to stay compliant.
• Appointing an agent does not make that company responsible for your food safety — it makes them your line of communication with FDA.
How US Imports helps
US Imports handles FDA food facility registration and serves as your U.S. Agent for foreign facilities — including the registration submission, your official FDA registration number and certificate, and ongoing U.S. Agent representation for FDA communications. Pricing is a flat $689/year, and every service is delivered by experienced consultants rather than templated or outsourced.
• Register my facility & appoint a U.S. Agent →
Not sure whether you’re a “facility” or an “importer” under FDA’s rules? Email info@usimports.us or call +1.202.417.8885 and we’ll tell you exactly what you need.
