FDA U.S. Agent Services for Foreign Food Facilities
Foreign food facilities that are required to register with FDA must designate one U.S. Agent who resides or maintains a place of business in the United States and is physically present in the U.S.
A food facility U.S. Agent is the communications link between FDA and a foreign food facility for routine and emergency communications. FDA treats information or documents provided to the U.S. Agent as equivalent to providing them to the foreign facility. The U.S. Agent role is part of the foreign facility's Food Facility Registration — it is not the same as the importer of record or the FSVP importer.
Your FDA Communications Link in the United States
A foreign food facility that is required to register with FDA must include U.S. Agent information in its Food Facility Registration. The U.S. Agent is a person residing or maintaining a place of business in the United States whom the foreign facility designates for purposes of the registration regulation.
The U.S. Agent serves as the communications link between FDA and the foreign facility for routine and emergency communications. FDA may provide information or documents to the U.S. Agent, and the regulation treats that as equivalent to providing the information or documents to the foreign facility.
- Required for foreign food facilities that are required to register with FDA
- Must reside or maintain a place of business in the United States
- Only one food-facility U.S. Agent is designated at a time
- Acts as FDA's communications link with the foreign facility
- U.S. Agent information is part of the Food Facility Registration record
These roles can sometimes be performed by the same company, but FDA defines and regulates them differently. A Food Facility U.S. Agent represents the foreign facility for registration communications; an importer of record is a customs-entry role; and the FSVP importer is the U.S. party identified under FDA's FSVP regulation for covered imported food.
Who Needs a U.S. Agent & What Qualifies?
The requirement applies to foreign facilities that are required to register — not automatically to every foreign food business.
Foreign Facility Must Be Subject to Registration
The U.S. Agent requirement follows the Food Facility Registration requirement. If the foreign facility is exempt from registration, the food-facility U.S. Agent requirement does not independently create a registration obligation.
- Covered foreign food manufacturers and processors
- Covered foreign packers and co-packers
- Covered foreign holding/storage facilities
- Covered dietary supplement and animal-food facilities
U.S. Agent Must Have a Real U.S. Presence
The U.S. Agent must reside or maintain a place of business in the United States and be physically present in the United States for purposes of the registration regulation.
- U.S. residence or place of business
- Not merely a mailbox, answering machine, or place without a physically present agent
- Valid contact information included in the registration
- Available to function as FDA's communications link
Four Rules That Matter Most
The U.S. Agent relationship must stay accurate as part of the foreign facility's registration record.
Appoint Your FDA U.S. Agent in 4 Clear Steps
We review the facility, establish the U.S. Agent relationship, update or prepare the registration, and remain available for ongoing FDA communications.
Submit Facility Information
Provide the foreign facility's legal name, physical address, UFI/DUNS, existing registration information if available, and primary contacts.
Registration Review
We review the Food Facility Registration status and U.S. Agent information to identify required filing or update steps.
U.S. Agent Designation
We establish the representation and support the FDA registration or U.S. Agent update using the appropriate FDA process.
Ongoing Support
We remain the FDA communications link and support registration maintenance, required updates, and biennial renewal when due.
Food Facility U.S. Agent Responsibilities
The core regulatory role is communication. A professional service can also support the registration workflow and inspection coordination without changing who remains responsible for facility compliance.
Serve as the communications link between FDA and the foreign food facility.
Receive routine FDA communications and promptly relay relevant information to the foreign facility.
Receive emergency FDA communications when the U.S. Agent is identified as the facility's emergency contact.
Maintain accurate U.S. Agent contact information in the foreign facility's FDA registration.
Assist with FDA communication and scheduling when FDA seeks to interact with or inspect the foreign facility.
Support U.S. Agent verification, including FDA's optional VIS process when used.
Support required registration updates and ensure the U.S. Agent relationship remains reflected accurately.
Support the foreign facility through biennial Food Facility Registration renewal when due under the active service.
Food Facility U.S. Agent vs FSVP Importer
| Criteria | Food Facility U.S. Agent | FSVP Importer |
|---|---|---|
| Who the Role Serves | Foreign food facility | U.S. food-import transaction / importer compliance |
| Primary FDA Framework | Food Facility Registration — 21 CFR Part 1, Subpart H | Foreign Supplier Verification Program — 21 CFR Part 1, Subpart L |
| Primary Function | Communications link between FDA and the foreign facility | Responsible for meeting applicable FSVP requirements for covered imported food |
| Who Must Be in the U.S. | U.S. Agent must reside or maintain a place of business in the U.S. and be physically present in the U.S. | FSVP importer is generally the U.S. owner or consignee; when there is none, the U.S. agent or representative of the foreign owner/consignee can serve if the regulatory conditions are met |
| Separate FDA “FSVP Agent” Registration? | Not applicable | No. “FSVP Agent” is a commercial description; FDA's regulation defines the FSVP importer |
Self-Managed U.S. Agent vs Professional U.S. Agent Service
| Criteria | Self-Managed / Existing U.S. Contact | FDA Registration Assistance |
|---|---|---|
| FDA Government Fee | $0 | $0 FDA fee; $858/year professional Food Facility Registration & U.S. Agent service |
| Registration Review | Facility manages the FDA registration record and U.S. Agent information | Professional review of registration status, UFI/DUNS information, and U.S. Agent details |
| FDA Communications | Depends on the designated contact's monitoring and response process | Monitored professional contact for FDA registration communications |
| Required Updates | Facility tracks and submits applicable registration changes | Registration-update support during the active service |
| Biennial Renewal | Facility tracks the even-year October–December renewal window | Renewal management when due under the active service |
| Inspection Communications | Depends on the individual's familiarity and availability | Professional support relaying and coordinating FDA communications with the foreign facility |
U.S. Agent vs Importer of Record vs FSVP Importer
| Role | Who It Represents / Covers | Main Function |
|---|---|---|
| Food Facility U.S. Agent | Foreign food facility | FDA communications link for the foreign facility's Food Facility Registration |
| Importer of Record | Customs entry / imported merchandise | Customs-entry role responsible for entry-related obligations; not the same FDA role as the food-facility U.S. Agent |
| FSVP Importer | Covered imported food under FSVP | Responsible for applicable foreign-supplier verification requirements |
| Can One Company Hold Multiple Roles? | Sometimes, depending on the facts and eligibility requirements | The roles remain legally distinct even when the same company performs more than one |
U.S. Agent & Food Facility Registration Terms
Important terms used in FDA's Food Facility Registration system and U.S. Agent guidance.
Common U.S. Agent & Registration Problems
These issues can cause verification, registration, communication, or import problems. They do not all trigger the same automatic FDA outcome.
Food Registration & Import Compliance Services
A foreign facility may need more than U.S. Agent representation depending on its products, facility activities, and import structure.
Foreign Food Facility Registration
Registration and U.S. Agent support for covered foreign food facilities.
Biennial Registration Renewal
Food Facility Registration renewal support during October–December of even-numbered years.
DUNS / UFI Assistance
Help obtaining or correcting facility identifier information used for Food Facility Registration.
FSVP Compliance
FSVP program development and management for covered U.S. food importers.
FDA Prior Notice
Preparation and filing of Prior Notice for imported food shipments when required.
Food Label & Ingredient Review
Review food labels, Nutrition Facts, allergens, ingredients, and claims for FDA compliance risks.
FCE / SID Assistance
Registration and scheduled-process support for covered acidified and low-acid canned foods.
Shipment Compliance Consulting
FDA import and shipment compliance support for registration and entry issues.
Import Alert Assistance
Review Import Alert issues and support an appropriate corrective or removal strategy when available.
Food Compliance Services
Explore Food Facility Registration, U.S. Agent, FSVP, Prior Notice, labeling, FCE/SID, and related services.
FDA U.S. Agent Services — Frequently Asked Questions
Direct answers about eligibility, U.S. presence, FDA communications, verification, fees, Food Facility Registration, FSVP, and related U.S. Agent questions.
A food facility U.S. Agent is a person residing or maintaining a place of business in the United States whom a foreign facility designates as its agent for purposes of FDA's Food Facility Registration regulation. The U.S. Agent acts as the communications link between FDA and the foreign facility for routine and emergency communications.
A foreign food facility that is required to register with FDA under section 415 of the FD&C Act must include U.S. Agent information in its registration. The requirement is tied to the facility's registration obligation, so facilities that qualify for a registration exemption do not become subject solely because they are foreign.
No. FDA defines the U.S. Agent as a person residing or maintaining a place of business in the United States, and FDA's guidance states the agent must be physically present in the United States for purposes of Food Facility Registration.
No. FDA states that a U.S. Agent cannot be merely a mailbox, answering machine, service, or other place where an individual acting as the foreign facility's agent is not physically present.
FDA states that only one person may be designated as the food facility's U.S. Agent at a time. A facility may have other agents for other business purposes, but only one is designated as the U.S. Agent for Food Facility Registration.
The U.S. Agent acts as the communications link between FDA and the foreign facility for routine and emergency communications. FDA may provide information or documents to the U.S. Agent, and the regulation treats that as equivalent to providing the information or documents to the foreign facility.
FDA requires an emergency contact phone that can be called 24 hours a day, 7 days a week. For a foreign facility, FDA will use the U.S. Agent as the emergency contact unless the registration specifies another emergency contact. Routine U.S. Agent communications are separate from that emergency-contact requirement.
FDA may verify U.S. Agent information. FDA also offers the optional U.S. Agent Voluntary Identification System (VIS), which allows U.S. Agents to identify the foreign facilities they represent and can streamline FDA's verification process.
No. FDA states that a foreign facility's U.S. Agent may, but is not required to, register the facility. The owner, operator, or agent in charge may authorize another individual to submit the registration.
FDA charges no government fee for initial Food Facility Registration, updates, renewal, or cancellation. Private U.S. Agent and compliance-service providers may charge professional service fees.
FDA Registration Assistance's annual professional Food Facility Registration service is $858 per year and includes Food Facility Registration service, U.S. Agent representation for a foreign facility, and ongoing registration compliance support. FDA itself charges no government fee for Food Facility Registration.
No. The $858 is the professional service fee charged by FDA Registration Assistance. FDA does not charge a government fee for Food Facility Registration or U.S. Agent designation.
Yes. The professional representation and compliance service is annual because the U.S. Agent relationship and FDA communications role continue throughout the year. FDA Food Facility Registration itself renews every two years during October through December of even-numbered years.
Yes. U.S. Agent information is part of the Food Facility Registration record and can be updated. Most changes to required registration information must be submitted within 60 calendar days.
The Food Facility Registration includes U.S. Agent identifying and contact information such as the agent's name, U.S. address, phone number, and email address. The registration also includes emergency-contact information unless a different emergency contact is designated.
VIS is an optional FDA system intended to improve the accuracy of U.S. Agent information and streamline the U.S. Agent verification process. A U.S. Agent can use VIS to identify the facilities it has agreed to represent and receive a U.S. Agent identification number for those facilities.
No. The U.S. Agent is the foreign facility's FDA communications contact for Food Facility Registration. The importer of record is a customs-entry role. The same company may sometimes perform both, but the roles are legally distinct.
No. Food Facility Registration and FSVP are separate FDA frameworks. The U.S. Agent represents the foreign food facility for registration communications, while the FSVP importer is the person identified under the FSVP regulation as responsible for applicable foreign-supplier verification requirements.
No. 'FSVP Agent' is commonly used as a commercial description, but FDA's FSVP regulation defines the FSVP importer. When there is no U.S. owner or consignee at the time of entry, a U.S. agent or representative of the foreign owner or consignee may serve as the FSVP importer if the regulatory conditions are met.
Sometimes, depending on the facts and each role's eligibility requirements. Even when one company performs multiple functions, the legal responsibilities remain separate.
Using Amazon, a marketplace, warehouse, or fulfillment provider does not by itself satisfy the foreign facility's Food Facility Registration U.S. Agent requirement. The foreign facility should identify a qualifying U.S. Agent in its FDA registration when required.
Dietary supplements are regulated as food for Food Facility Registration purposes. A foreign dietary supplement facility that is required to register must include U.S. Agent information in the registration.
A foreign animal-food facility that is required to register under the Food Facility Registration requirements must include U.S. Agent information in its foreign facility registration.
A foreign warehouse or holding facility that is required to register must include U.S. Agent information. Whether a particular warehouse must register depends on its activities and any applicable exemption.
No. The U.S. Agent is a communications role within Food Facility Registration. The foreign facility remains responsible for complying with the FDA requirements that apply to its operations and products.
No. Food Facility Registration and U.S. Agent designation are regulatory requirements; they are not FDA approval, certification, clearance, or endorsement of the facility or its food products.
FDA states that failure to register, update required elements, or cancel a registration as required is a prohibited act. Food from a foreign facility that is required to register but fails to do so is subject to refusal when offered for import into the United States.
Yes. The U.S. Agent is the FDA communications link for the foreign facility, and FDA may verify the agent's information. A facility should keep its U.S. Agent information accurate and use an agent that can reliably perform the role. The specific FDA consequence depends on the facts rather than an automatic one-size-fits-all cancellation rule.
No. A foreign facility can continue using the same U.S. Agent as long as the relationship remains valid and the registration information is accurate. The U.S. Agent information should be reviewed as part of each biennial renewal.
Food Facility Registration renews every two years during October 1 through December 31 of each even-numbered year. The annual professional U.S. Agent service is separate from FDA's biennial registration-renewal cycle.
Yes. The annual $858 Food Facility Registration service includes foreign Food Facility Registration support, U.S. Agent representation, and ongoing registration compliance support. Separate services such as DUNS acquisition assistance, FSVP, Prior Notice, labeling, or FCE/SID may require separate scope and fees.
Appoint Your FDA U.S. Agent
Tell us about your foreign food facility and current registration status. Our food compliance team will review the information and contact you about the U.S. Agent appointment.