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. We serve as that U.S. Agent for foreign food, beverage, dietary supplement and animal-food facilities, together with Food Facility Registration, updates and biennial renewal. Trusted by 1,000+ clients in 135+ countries.
Need a U.S. Agent for your foreign food facility? Send the facility's legal name, physical address, UFI/DUNS and any existing registration details. We review the registration, establish the U.S. Agent relationship and prepare or update the filing, typically within 24–48 hours.
Appoint My Food U.S. AgentYour 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
Who Needs a U.S. Agent and 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 and 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.
1U.S. Agent
Only one person or entity is designated as the food facility's U.S. Agent at a time.
$0FDA Government Fee
FDA does not charge a government fee for Food Facility Registration or U.S. Agent designation.
60 daysMost Registration Changes
Most changes to required registration information must be submitted within 60 calendar days.
2 yearsRegistration Renewal Cycle
Food Facility Registration renews during October–December of even-numbered years.
Keep Your U.S. Agent Current at Every Renewal
This page covers food and dietary supplement facilities. For other FDA-regulated products, see our drug, medical device, and cosmetic U.S. Agent services. For renewal help, see food facility registration renewal.
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.
The Rules Behind the Food Facility U.S. Agent Requirement
The U.S. Agent requirement is part of FDA's Food Facility Registration framework for foreign facilities.
FD&C Act § 415
Section 415 establishes the Food Facility Registration framework. A foreign facility's registration includes its U.S. Agent information. FDA Food Facility Registration resources
21 CFR 1.227: U.S. Agent
FDA defines the U.S. Agent as a person residing or maintaining a place of business in the United States whom a foreign facility designates as its agent for purposes of the registration regulation. Read 21 CFR Part 1, Subpart H
U.S. Agent Voluntary Identification System (VIS)
FDA's optional VIS allows U.S. Agents to identify the foreign facilities they represent and can streamline FDA's U.S. Agent verification process. FDA VIS guidance
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.
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 and 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 or 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 and 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 |
FDA does not require a third-party registrar or paid U.S. Agent provider. A professional service is for facilities that want experienced registration maintenance and a dedicated FDA communications contact.
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 and 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 |
Do not choose a party for one role simply because it already performs another. The Food Facility U.S. Agent, importer of record, and FSVP importer should each be evaluated under the rules that apply to that specific role.
U.S. Agent and Food Facility Registration Terms
Important terms used in FDA's Food Facility Registration system and U.S. Agent guidance.
| Term | Definition |
|---|---|
| U.S. Agent | A person residing or maintaining a place of business in the United States whom a foreign facility designates for purposes of the Food Facility Registration regulation. |
| FFR | Food Facility Registration: FDA's registration framework for covered domestic and foreign food facilities under section 415 of the FD&C Act. |
| FFRM | Food Facility Registration Module: the FDA Industry Systems module used to register, update, renew, cancel, and manage food facility registrations. |
| VIS | U.S. Agent Voluntary Identification System: FDA's optional system designed to streamline and improve U.S. Agent verification. |
| UFI | Unique Facility Identifier: an FDA-recognized identifier required with Food Facility Registration submissions. |
| DUNS | The Dun & Bradstreet identifier FDA currently recognizes as an acceptable UFI for Food Facility Registration. |
| Emergency Contact | A contact phone FDA can call 24/7 in an emergency. For a foreign facility, the U.S. Agent is the emergency contact unless another emergency contact is designated. |
| Biennial Renewal | Food Facility Registration renewal during October 1–December 31 of every even-numbered year. |
| FSVP Importer | The person identified under FDA's FSVP regulation as responsible for applicable foreign-supplier verification requirements for covered imported food. |
| Importer of Record | A customs-entry role that is separate from FDA's food-facility U.S. Agent role and may be held by a different party. |
Common U.S. Agent and Registration Problems
These issues can cause verification, registration, communication, or import problems. They do not all trigger the same automatic FDA outcome.
- U.S. Agent information does not identify a real U.S. residence or place of business
- U.S. Agent is merely a mailbox or answering service with no physically present agent
- FDA cannot verify or reach the listed U.S. Agent
- U.S. Agent contact information changed but the registration was not timely updated
- Facility confuses its U.S. Agent with its importer of record or FSVP importer
- Facility misses the biennial Food Facility Registration renewal window
- Facility creates duplicate registration records instead of correcting the existing registration
- Facility shares FDA account credentials or registration information more broadly than necessary
Food Registration and Import Compliance Services
A foreign facility may need more than U.S. Agent representation depending on its products, facility activities, and import structure. Explore all food compliance services.
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 and 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.
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. The annual $858 service includes Food Facility Registration support, U.S. Agent representation and ongoing registration compliance support.
- Review of your registration status, UFI/DUNS and current U.S. Agent details.
- U.S. Agent designation with registration filing or update, typically within 24–48 hours.
- FDA communications, required updates and biennial renewal managed while the service is active.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Foreign food facility registration · FSVP · Registration pricing.
Appoint My Food U.S. AgentFDA Registration Assistance is a private consulting firm, not FDA or any government agency. Food Facility Registration and U.S. Agent designation are not FDA approval, certification or endorsement.
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.
What is a U.S. Agent for a foreign food facility?
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.
Is an “FDA registration agent” the same as a food facility U.S. Agent?
Usually, yes. “FDA registration agent” and “FDA agent” are informal terms. For food, FDA’s rule defines the U.S. Agent: a person residing or maintaining a place of business in the United States whom a foreign facility designates in its Food Facility Registration (21 CFR 1.227). A registration service may also prepare and submit the filing; our $858/year service covers both.
Does food facility registration renewal require current U.S. Agent information?
Yes. Food facilities renew between October 1 and December 31 of each even-numbered year, and a renewal must contain the information required under 21 CFR 1.232, which includes U.S. Agent details for a foreign facility. FDA considers a registration expired if it is not renewed by December 31 of the renewal year (FDA).
Does a food U.S. Agent also cover drugs, medical devices, or cosmetics?
No. Each FDA registration system records its own U.S. Agent, so a food facility U.S. Agent designation does not carry over to drug, device, or cosmetic registrations. See our drug, medical device, and cosmetic U.S. Agent services.
Who is required to designate a food facility U.S. Agent?
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.
Can the U.S. Agent be located outside the United States?
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.
Can a P.O. box or answering service be the U.S. Agent?
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.
How many U.S. Agents can a foreign food facility designate?
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.
What does the U.S. Agent do?
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.
Does the U.S. Agent have to be available 24 hours a day?
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.
Does FDA verify the U.S. Agent?
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.
Does the U.S. Agent need to submit the Food Facility Registration?
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.
How much does FDA charge for U.S. Agent designation?
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.
How much is FDA Registration Assistance's food U.S. Agent service?
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.
Is the $858 fee an FDA government fee?
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.
Is U.S. Agent representation billed annually even though Food Facility Registration renews biennially?
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.
Can a foreign food facility change its U.S. Agent?
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.
What information is required for the U.S. Agent?
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.
What is FDA's U.S. Agent Voluntary Identification System (VIS)?
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.
Is a Food Facility U.S. Agent the same as an importer of record?
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.
Is a Food Facility U.S. Agent the same as the FSVP importer?
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.
Is there a separate FDA registration called an 'FSVP Agent'?
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.
Can the same company be U.S. Agent, importer of record, and FSVP importer?
Sometimes, depending on the facts and each role's eligibility requirements. Even when one company performs multiple functions, the legal responsibilities remain separate.
Does Amazon act as the U.S. Agent for a foreign food facility?
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.
Do dietary supplement facilities need a food facility U.S. Agent?
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.
Do foreign pet food or animal food facilities need a U.S. Agent?
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.
Does a foreign warehouse need a U.S. Agent?
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.
Does a U.S. Agent make the foreign facility FDA compliant?
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.
Does Food Facility Registration or U.S. Agent designation mean FDA approved the facility?
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.
What happens if a foreign facility that is required to register is not registered?
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.
Can a non-responsive U.S. Agent create registration problems?
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.
Do I need a new U.S. Agent every time Food Facility Registration renews?
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.
When does Food Facility Registration renew?
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.
Can FDA Registration Assistance manage both Food Facility Registration and U.S. Agent representation?
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 Food Facility U.S. Agent
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
Submitting this inquiry does not purchase a service or authorize paid work. Our team can discuss the scope and required materials before you commission assistance. Fields marked with an asterisk are required.