U.S. FDA Agent Services
Every foreign food facility importing to the United States is required by law to designate a U.S. FDA Agent. We handle every step — professionally and reliably.
A U.S. Agent is a person or entity physically located in the United States that every foreign food facility is legally required to designate when registering with the FDA under 21 CFR 1.227. The U.S. Agent serves as the FDA's official domestic point of contact for all communications, inspections, and emergencies — and must be available during normal business hours. Without a valid, responsive U.S. Agent, your FDA food facility registration is invalid and your products cannot legally enter the United States.
Your Required U.S. Representative for FDA Compliance
Under the FDA Food Safety Modernization Act (FSMA) and 21 CFR Part 1, every foreign food facility that manufactures, processes, packs, or holds food for consumption in the United States must designate a U.S. Agent. This agent serves as the official point of contact between your facility and the FDA.
Your U.S. Agent must be physically located in the United States and available during normal business hours to receive communications from the FDA on your behalf. Failing to designate an agent — or having an unreachable agent — can result in your registration being suspended or cancelled, which will prevent your products from entering the U.S. market.
- Required by law for all foreign food facilities exporting to the U.S.
- Must be physically located and reachable in the United States
- Acts as official FDA contact for inspections and correspondence
- Included in your FDA food facility registration
Requirements & Responsibilities
Any foreign food facility that exports food products to the United States must designate a U.S. FDA Agent. Here's what that means in practice.
Who Must Designate an Agent
Any foreign facility that manufactures, processes, packs, or holds food for U.S. consumption — including dietary supplements, infant formula, and beverages.
- Foreign food manufacturers
- Foreign food processors and packers
- Foreign food storage facilities
- Dietary supplement producers
Agent Responsibilities
Your U.S. Agent is responsible for receiving FDA communications and acting as liaison between your facility and the FDA during inspections or regulatory actions.
- Receive FDA inspection notices
- Forward FDA correspondence to your facility
- Be reachable during U.S. business hours
- Assist during FDA facility inspections
Trusted by Facilities Worldwide
We have helped thousands of foreign food facilities maintain full FDA compliance and uninterrupted U.S. market access.
Get Your U.S. Agent in 4 Simple Steps
Our streamlined process gets your U.S. Agent designation completed quickly and accurately.
Submit Your Information
Complete our simple online form with your facility details and contact information.
We Review Your File
Our FDA compliance experts review your submission and prepare the agent designation.
Agent Designated
We officially designate ourselves as your U.S. FDA Agent and update your FDA registration.
Ongoing Support
We handle all FDA correspondence and notifications on your behalf for the full year.
U.S. Agent Responsibilities
The U.S. Agent is not just a name on a form — they have specific, ongoing legal responsibilities under 21 CFR 1.227. Here is exactly what a compliant U.S. Agent must do for your foreign food facility.
Serve as the FDA's official domestic contact for the foreign facility.
Respond to FDA communications and inquiries promptly.
Coordinate and facilitate FDA inspections at the foreign facility.
Receive Prior Notice and import-related FDA correspondence.
Confirm U.S. Agent designation through the FURLS portal.
Be available during normal U.S. business hours.
Maintain a verifiable physical U.S. address (no P.O. boxes).
Update the FDA within 60 days of any change to facility or agent information.
U.S. Agent vs FSVP Agent
| Criteria | U.S. Agent | FSVP Agent |
|---|---|---|
| Who designates it | The foreign food facility | The U.S. importer (or their representative) |
| Who it represents | The foreign food facility | The U.S. importer |
| Required by | FDA Food Facility Registration | FDA Foreign Supplier Verification Program |
| Governing regulation | 21 CFR 1.227 | 21 CFR Part 1, Subpart L (FSVP) |
| Primary function | Domestic FDA point of contact for the foreign facility | Responsible party for foreign supplier verification activities |
| Required for | Every foreign food facility exporting to the U.S. | Every U.S. importer of human or animal food |
A U.S. Agent and an FSVP Agent are two completely separate roles, even though both involve FDA food compliance and both must be located in the United States. The U.S. Agent represents the foreign food facility and is the FDA's domestic point of contact for that facility's registration under 21 CFR 1.227. The FSVP Agent, by contrast, represents the U.S. importer and is the responsible party for verifying that the foreign supplier produces food in compliance with U.S. safety standards under the Foreign Supplier Verification Program. Because these roles serve different parties and different regulations, many businesses need both — one to keep the foreign facility's FDA registration valid, and a second to keep the U.S. importer's FSVP compliant.
DIY U.S. Agent vs Professional U.S. Agent Service
| Criteria | DIY / Individual Contact | Professional U.S. Agent Service |
|---|---|---|
| Cost | $0 (but high hidden risk) | $858 / year — fixed and transparent |
| Availability | Depends on individual schedule; gaps common | Reachable during full U.S. business hours, every business day |
| FDA inspection support | Usually none; inspector left without a U.S. contact | Full coordination and communication with FDA inspectors |
| Risk of registration cancellation | High — non-response leads to invalidation | Low — professionally monitored at all times |
| Confirmation handling | Often missed (the FDA confirmation email is overlooked) | Actively confirmed in FURLS as soon as it arrives |
| Renewal & 60-day update tracking | Manual, easy to forget | Tracked and filed on your behalf |
Most foreign facilities discover too late that a casual "DIY" U.S. Agent is the single biggest risk to their FDA registration. A dedicated professional U.S. Agent service exists for exactly one reason: to make sure your facility never loses U.S. market access because of a missed email or an unreachable contact. A professional service is monitored every business day, confirms the FDA designation immediately, supports inspections, files 60-day updates, and tracks your biennial renewal — none of which a friend, employee, or unrelated contact reliably does.
Free / Friend U.S. Agent vs FDA Registration Assistance U.S. Agent
| Criteria | Free / Friend U.S. Agent | FDA Registration Assistance U.S. Agent |
|---|---|---|
| FDA government fee | $0 — the FDA charges no fee for U.S. Agent designation | $0 — the FDA still charges no fee; our $858/year covers professional service |
| Pros | No upfront cost; uses someone you already know | FDA-compliant, monitored, inspection-ready, renewal-tracked |
| Cons | Often non-responsive; unaware of FDA obligations; missed confirmation emails; lost registration | Annual service fee of $858/year |
| Best for | No one with real U.S. import operations | Any foreign food facility that wants its FDA registration to stay valid |
The FDA charges no government fee for U.S. Agent designation, so it can be tempting to use a friend, relative, or unrelated third party. The risk is concrete: if that person fails to respond to the FDA — even once — the agency treats the registration as invalid and shipments stop. A professional U.S. Agent eliminates that single point of failure.
U.S. Agent & FDA Registration Terms
The U.S. Agent ecosystem uses very specific FDA terminology. Here are the key technical terms you'll see throughout the registration and compliance process.
Common U.S. Agent Failures
The FDA does not warn you multiple times. A single U.S. Agent failure can invalidate your food facility registration and stop your shipments at the U.S. border. These are the most common causes we see.
Complete FDA Compliance Solutions
We offer a full range of FDA registration and compliance services to help your facility succeed in the U.S. market.
Foreign Food Facility Registration
Register your foreign food facility with the FDA — required for all facilities exporting food to the U.S.
Domestic Food Facility Registration
Register your U.S.-based food facility with the FDA under the Food Safety Modernization Act (FSMA).
FSVP Compliance
Ensure your U.S. importer meets FDA's Foreign Supplier Verification Program requirements.
Annual Registration Renewal
FDA food facility registrations must be renewed every two years. We handle the biennial renewal process for you.
Shipment Compliance Consulting
Expert guidance on FDA import requirements, shipment monitoring, and avoiding costly import alerts.
HACCP Plan Development
Develop and review your HACCP food safety plan to meet FDA requirements and protect your facility's compliance status.
Label & Ingredient Review
Ensure your product labels and ingredient declarations meet all FDA labeling requirements before entering the U.S. market.
Import Alert Assistance
Get expert help resolving FDA import alerts and detentions to restore your products' ability to enter the U.S.
DUNS Request Assistance
We help you obtain your DUNS number, required for FDA food facility registration and federal business activities.
Prior Notice Filing
Submit FDA Prior Notice for food shipments entering the U.S. — required at least 2 hours before arrival at port.
FSVP for Amazon Sellers
Specialized FSVP compliance for Amazon sellers importing food products — meet FDA requirements and keep your listings active.
Food Canning Establishment (FCE-SID)
Register your acidified or thermally processed low-acid food facility with the FDA as required for canned and shelf-stable products.
Frequently Asked Questions
Everything you need to know about U.S. FDA Agent designation.
A U.S. FDA Agent is an individual or company physically located in the United States who acts as the official point of contact between a foreign food facility and the FDA. They receive and forward FDA communications on your behalf. Learn more about our U.S. Agent service.
Every foreign food facility that manufactures, processes, packs, or holds food intended for human or animal consumption in the United States must designate a U.S. FDA Agent. This is a legal requirement under 21 CFR Part 1. See our food facility registration service.
No. The FDA requires that the U.S. Agent must be physically located in the United States. The agent must be available during normal U.S. business hours to receive communications from the FDA.
If your facility does not have a valid U.S. Agent, the FDA can suspend or cancel your food facility registration. This will prevent your products from legally entering the U.S. market and could result in shipment refusals at the border.
Our U.S. Agent service is $858 per year and includes full designation through FURLS, FDA email confirmation, ongoing availability during U.S. business hours, inspection coordination, biennial renewal support, and 60-day update filings. The FDA itself charges no government fee for U.S. Agent designation — the $858 covers our complete professional service. If you also need us to file your Foreign Food Facility Registration, the combined total is $429 (Registration) + $429 (U.S. Agent) = $858. Get started today.
Once we receive your complete information, the agent designation is typically completed within 24–48 hours. You will receive a confirmation once your FDA registration has been updated with the new agent information. Start your designation now.
Yes. A U.S. Agent designation is part of your FDA food facility registration, but it is billed separately. Your facility must be registered with the FDA, and the U.S. Agent information must be included in and kept current in that registration. View our food facility registration service.
Yes, you can change your U.S. FDA Agent at any time by updating your FDA food facility registration. The change must be submitted to the FDA, and the new agent must consent to the designation before it takes effect. Contact us to update your agent.
The FDA requires the agent's full name, U.S. address, phone number, and email address. The agent must have given their consent to serve in this role. We provide all of this as part of our service.
There is no FDA requirement that the U.S. Agent speak the same language as the foreign facility. However, effective communication is important, and our team supports multiple languages to ensure smooth coordination with your facility.
No. The U.S. Agent is a communications intermediary and is not legally responsible for the foreign facility's compliance or any violations. Regulatory responsibility remains with the foreign food facility itself.
A U.S. Agent is the designated FDA contact for a foreign food facility's registration. An Importer of Record is responsible for a specific shipment when it enters the U.S. They are different roles and may or may not be the same person or company.
No. FDA regulations require each foreign food facility to designate exactly one U.S. Agent at any given time. However, different facilities within the same company may each designate their own separate U.S. Agent.
Yes. FDA regulations require that the U.S. Agent be reachable by the FDA at any time — including nights, weekends, and holidays. Our service provides round-the-clock availability to ensure FDA can always reach a U.S.-based contact for your facility.
Your food facility registration remains active when you change U.S. Agents — only the agent contact information is updated. You must update the U.S. Agent details in the FDA FURLS system within 60 days of any change. We handle this update process for you as part of our service. Change your U.S. Agent today.
No. A U.S. Agent is a regulatory compliance contact designated specifically for FDA communication purposes. A U.S. Distributor handles the commercial sale and distribution of your products, and an Importer of Record takes legal responsibility for a shipment at entry. These are three separate roles and can be different companies or individuals.
Technically yes — the FDA allows any U.S.-resident individual or entity to serve as a U.S. Agent. In practice, this is one of the most common reasons foreign food facility registrations get cancelled. A friend or family member who does not understand FDA obligations, ignores an FDA email, misses an inspection coordination request, or does not actively confirm the designation will cause your registration to be invalidated. The FDA requires the U.S. Agent to actively confirm the designation via email and remain reachable during U.S. business hours — a passive contact will not meet this standard.
A non-responsive U.S. Agent is treated by the FDA as if no agent is designated. The FDA may immediately consider your food facility registration invalid, which makes your facility ineligible to ship products into the United States. Shipments may be detained or refused entry at the port, and the registration can be cancelled outright. The FDA does not provide multiple warnings — a single missed confirmation email or unanswered inspection coordination request is enough to put your U.S. market access at risk.
Our U.S. Agent service is $858 per year and includes full designation through FURLS, FDA email confirmation, ongoing availability during U.S. business hours, inspection coordination, biennial renewal support, and 60-day update filings. The FDA itself charges no government fee for U.S. Agent designation — the $858 covers our complete professional service. If you also need us to file your Foreign Food Facility Registration, the combined total is $429 (Registration) + $429 (U.S. Agent) = $858. Get started today.
To change your U.S. Agent, you log into the FDA FURLS portal and update the U.S. Agent section of your food facility registration with the new agent's name, U.S. address, phone, and email. The new U.S. Agent must then confirm the designation by responding to the automated FDA confirmation email. Until that confirmation is completed, the FDA does not consider the change valid. FDA also requires that any change to U.S. Agent information be reported within 60 days. Our service handles the full FURLS update and confirmation process for you.
Yes. The U.S. Agent requirement is not limited to food facilities. Foreign manufacturers of FDA-regulated drugs, medical devices, and cosmetics (under the Modernization of Cosmetics Regulation Act, or MoCRA) are also required to designate a U.S. Agent. The role and obligations are similar — domestic point of contact, U.S. address, business-hours availability — but each FDA product category has its own specific regulation governing the U.S. Agent designation.
The FDA confirmation email is an automated message the FDA sends to the designated U.S. Agent immediately after a foreign food facility submits or updates its registration. The U.S. Agent must actively click the confirmation link or respond to verify that they consent to serve in the role. Without this confirmation, the FDA considers the U.S. Agent designation invalid — which makes the entire food facility registration invalid.
Yes, the same company or individual can legally serve as both the U.S. Agent and the U.S. importer for a foreign facility. However, the two roles have different legal responsibilities: the U.S. Agent is the FDA's compliance contact, and the importer is legally responsible for the shipment. Many businesses prefer to keep these roles with separate parties so that a single point of failure does not jeopardize both compliance and operations.
Yes. Selling through Amazon FBA does not exempt you from FDA U.S. Agent requirements. If your foreign facility manufactures, processes, packs, or holds food, supplements, beverages, or pet food destined for the U.S. market, you must register with the FDA and designate a U.S. Agent — regardless of whether you sell on Amazon, Shopify, your own website, or to wholesale customers. Amazon itself does not act as your U.S. Agent. See our FSVP for Amazon Sellers service.
During an FDA inspection of a foreign food facility, the U.S. Agent acts as the primary communication channel between the FDA inspector and the foreign facility. The U.S. Agent receives inspection notices, helps coordinate scheduling, relays inspector questions in real time, and ensures the foreign facility's responses reach the FDA. An unreachable U.S. Agent during an inspection can result in the facility being placed on Import Alert or having its registration suspended.
The FDA verifies the U.S. Agent in three ways: (1) the U.S. Agent must respond to the automated confirmation email sent during registration, (2) the FDA may attempt to contact the agent at the listed phone number and U.S. address, and (3) during inspections or regulatory actions, the FDA expects the U.S. Agent to respond within a reasonable business window. Failure at any of these verification points can invalidate the registration.
The FDA requires the U.S. Agent to have a verifiable physical U.S. address — not a P.O. box. Virtual offices and coworking spaces with a physical street address are generally acceptable, but the U.S. Agent must be reachable at that location during normal U.S. business hours. If the address cannot accept mail, take phone calls, or receive an FDA inspector if needed, the FDA may reject the designation. A dedicated professional U.S. Agent service avoids this risk entirely.
"Consent of the U.S. Agent" is a required FDA field confirming that the designated U.S. Agent has knowingly agreed to serve in this role. Consent is given electronically through the FDA's FURLS confirmation email — the agent must actively confirm. A foreign facility cannot legally designate a U.S. Agent without that person or company first consenting. Submitting a registration with an unconsented U.S. Agent is a violation that the FDA flags during validation.
The FDA's FURLS system sends the U.S. Agent confirmation email automatically within minutes of submitting or updating a food facility registration. The U.S. Agent should respond and confirm within a few business days. If the confirmation is not completed promptly, the FDA may treat the registration as incomplete. As your professional U.S. Agent, we confirm immediately upon receipt — so your registration never sits in an unconfirmed state.
No. You do not need to change your U.S. Agent at every biennial renewal — the same agent can continue serving across multiple renewal cycles. However, you must re-confirm and re-verify the U.S. Agent's information during each biennial renewal (October–December of every even-numbered year). If your current U.S. Agent is still active and compliant, the renewal simply re-validates the existing designation. We handle this as part of our renewal service.
Yes. FDA Warning Letters, Untitled Letters, Import Alerts, and other regulatory correspondence addressed to a foreign food facility are typically routed through the designated U.S. Agent. The U.S. Agent must promptly forward these communications to the foreign facility and help coordinate any required response. Missing or delayed handling of a Warning Letter can dramatically worsen the regulatory outcome — which is why a professional, monitored U.S. Agent service is critical.
Yes. The FDA can and does reject U.S. Agent designations that fail to meet 21 CFR 1.227 requirements. Common rejection reasons include: the agent does not respond to the FDA confirmation email, the listed address is a P.O. box, the address cannot be physically verified, the phone number is invalid or unreachable, or the agent withdraws consent. When a designation is rejected, the underlying food facility registration is treated as invalid until a valid U.S. Agent is named and confirmed.
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