Global Import Agent
Food & Beverage

FDA US Agent Service

A U.S. agent is the person in the United States that a foreign food facility names on its FDA registration as its link with FDA, for routine and emergency communications. The agent must live or have a place of business in the US, and can't be a mailbox or answering service (21 CFR 1.227). Global Import Agent can act as your U.S. agent.

Every foreign facility that manufactures, processes, packs or holds food for consumption in the US must register with FDA and give the name, address, phone and email of its U.S. agent (21 CFR 1.232(c)).

· By the Global Import Agent team
Overview

What does an FDA US Agent do?

Source: 21 CFR 1.227.

  • FDA's point of contact. The U.S. agent is the communications link between FDA and your facility, and the person FDA calls in an emergency unless you name another emergency contact.
  • Speaks for your facility. FDA treats what the U.S. agent says as coming from your facility, and treats documents sent to the agent as sent to you.
  • Sees your registration. The agent can view the information in your facility's registration.
  • What we add: we forward FDA notices and correspondence to you promptly, help coordinate inspection scheduling, support your Prior Notice filings, and remind you before each renewal window.
Cargo containers moving through an international port

Who needs a US Agent?

  • Food and drink manufacturers outside the US making packaged foods, drinks, sauces or snacks for US sale.
  • Dietary supplement makers shipping to the US.
  • Packers and warehouses outside the US that pack or hold food bound for the US.
  • Medical device establishments have their own U.S. agent rule (21 CFR 807.40). See our medical device registration service.

What happens if you don't have one?

FDA won't confirm a foreign facility's registration or issue a registration number until the named U.S. agent confirms they've agreed to serve (21 CFR 1.231(a)(5)). Food from a foreign facility that isn't registered as required is subject to being held at the port (21 CFR 1.285).

Product documentation being reviewed for compliance
Food & Beverage

FDA US Agent Service

What you'll need

  • Facility name, full address and contact details
  • Your DUNS number (FDA's accepted unique facility identifier), with the same address as the registration
  • Food product categories and the activities carried out at the facility
  • Owner, operator or agent-in-charge details and an emergency contact
  • If you're already registered: your FURLS account and registration number

How it works

  1. 1

    Tell us about your facility. Products, sites and where you ship.

  2. 2

    We agree to act as your U.S. agent and complete or update your registration with our details.

  3. 3

    FDA checks with us. FDA verifies that we've agreed to serve before it confirms your registration.

  4. 4

    We stay on record. We forward FDA messages and remind you before each renewal window: 1 October to 31 December of every even-numbered year (21 CFR 1.230(b)).

US Agent, FSVP agent or importer of record?

They're different roles. The U.S. agent is your facility's contact with FDA for registration. An FSVP importer verifies foreign suppliers for the food it imports. The importer of record handles customs entry.

Free tool

Official sources

Related services: FSVP agent services · US importer of record for food · FSVP agent vs FDA agent: what’s the difference?

Frequently asked questions

FDA US Agent Service

Requirements vary by product and destination. These answers outline the starting point for the questions we receive most often.

Ask our team

Who can be my FDA US Agent?

A person or business that lives in, or has a place of business in, the United States and is physically present there. A mailbox, answering machine or answering service can't act as your U.S. agent (21 CFR 1.227). They also need to agree to it: FDA checks with them before confirming your registration.

Does FDA charge a fee for registration or a US Agent?

FDA charges no fee to register or renew a food facility (21 CFR 1.231(c)). U.S. agents, including us, charge for their own services.

Can my US distributor act as my US Agent?

Yes, if they meet the definition. Remember that FDA will send them your communications and they can see your registration information, so choose someone you trust to pass things on quickly.

Do I need a new US Agent when I renew?

No. You confirm or update your details, including your U.S. agent, when you renew in the October to December window of each even-numbered year.

Is a US Agent the same as an FSVP agent?

No. The U.S. agent is the FDA contact on your facility registration. FSVP is about the importer verifying foreign suppliers. We offer both, but they're separate roles.

Do you act as US Agent for device or cosmetic facilities too?

We support food, supplement, cosmetic and device businesses. Device establishments follow separate rules under 21 CFR Part 807. See our medical device registration service.

Read more

Further reading

En español: Agente de EE. UU. ante la FDA

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Consultation

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