What is a US Agent?
A US Agent is a US-based person or company designated by a foreign food facility as a point of contact for FDA communications. The requirement is established under 21 CFR §1.227(b)(13) and applies to all foreign food facilities that are required to register with FDA.
The US Agent must be physically located in the United States and must be available to FDA during normal US business hours.
Key point: A US Agent is a communications intermediary — not a legal representative, not an Importer of Record, and not an FSVP importer. The US Agent receives FDA communications on behalf of the foreign facility but does not take on legal responsibility for the food or the import.
US Agent vs FSVP Agent — What Is the Difference?
These are two separate and distinct roles that are often confused:
- US Agent (21 CFR §1.227): Required for foreign food facility FDA registration. A communications intermediary. No compliance documentation obligations.
- FSVP Agent (21 CFR §1.500): Required for foreign importers without a US entity. Maintains the FSVP compliance program, conducts annual re-verification, and is FDA's point of contact for FSVP records. A regulatory documentation role.
A single company can serve as both your US Agent and your FSVP Agent — ClearPath offers both services.
US Agent Obligations
The US Agent is responsible for:
- Receiving and forwarding FDA communications to the foreign facility
- Being available to FDA during US business hours by phone, email, or in person
- Updating FDA registration when the US Agent changes
The US Agent is not responsible for the facility's compliance, cannot be penalised for the facility's violations, and does not guarantee the safety or legality of the food produced.
Need a US Agent or FSVP Agent?
ClearPath provides US Agent services and FSVP Agent services for foreign food importers and facilities. Start with a free intake assessment.
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