If you make or pack food outside the United States and want to sell there, the FDA requires you to have a US agent. It is a short line on the registration form and it is easy to treat it as a formality, but the choice of agent affects how quickly you can register, how well the FDA can reach you and how smoothly your shipments move.
This guide explains what a US agent is, what the role does and does not include, how it differs from other US roles such as the importer and the customs broker, what to look for when you choose one, and how to appoint one.
This is a practical overview and not legal advice. The rules are in FDA regulations and guidance and can change, so confirm the details with the FDA or an adviser.
What is an FDA US agent?
Every foreign facility that must register with the FDA to manufacture, process, pack or hold food for US consumption has to name a US agent as part of its registration. The US agent acts as the communications link between the FDA and the foreign facility. In practice, the FDA can use the agent for routine communications and for certain regulatory matters, such as contacting the facility about its registration, and the agent can help the FDA reach the facility when it needs to.
The agent must be a person or company with a real place of business in the United States, where someone is physically present. A mailbox, an answering service or an address where nobody can act for the facility does not meet the requirement. The agent can be an individual or a business, and it can be unrelated to the facility, such as a consultant, or connected to it, such as a US subsidiary or sales office.
The US agent is a requirement for foreign facilities only. A facility located in the US does not need one.
What does a US agent actually do?
The role is narrower than many producers assume.
Receives and passes on FDA communications. If the FDA needs to contact the facility, it can go through the agent. The agent should pass the message on quickly. The FDA can treat information or documents given to the agent as if they had been given to the facility, so a message sitting unread has consequences.
Confirms the role during registration. The FDA verifies the US agent before it issues a registration number to a foreign facility, so the agent has to be reachable and willing to confirm.
Can help the FDA with inspections. The agent can help the FDA arrange inspection times.
Is named on the registration. The details are part of your registration, and they must be updated if the agent changes.
What a US agent does not do
Many producers mix up the US agent with other US roles. This comparison shows the difference.
US agent: What it is: The FDA's communication link to a foreign facility, named in the facility's registration; Who usually fills it: An agent company, consultant, or the facility's own US office
FSVP importer: What it is: The US owner or consignee of the food at entry, responsible for verifying the foreign supplier under FSVP; Who usually fills it: Distributor, retailer, brand owner or importer
Importer of record: What it is: The party responsible to US Customs for entry and duties; Who usually fills it: The importer, or a customs broker acting for them
Customs broker: What it is: A licensed professional who files entry paperwork and Prior Notice; Who usually fills it: A customs brokerage firm
Registered facility: What it is: The place that manufactures, processes, packs or holds the food; Who usually fills it: You or your contract manufacturer
A US agent does not take title to your goods, does not file your Prior Notice by default, does not carry your FSVP obligations, and does not guarantee that your product meets US rules. If you also need help with those, you need to arrange them separately. The same company can fill more than one role, but each role has its own responsibilities.
Why the choice matters
A weak US agent causes problems that are easy to avoid.
Slow verification means a delayed registration number. If the agent does not confirm quickly, your registration waits, and so does your first shipment.
Missed FDA messages. If the agent is not monitoring email and phone, you may not hear about a request until it is urgent.
Registration problems at renewal. If your agent has stopped trading or changed address and nobody told you, your renewal can be delayed. Renewal runs from 1 October to 31 December every two years, and the current window closes on 31 December 2026.
Importers lose confidence. US importers check that your facility is properly registered, and a questionable agent raises doubts.
How to choose a US agent
Ask these questions before you appoint one.
Is the address real and staffed? The agent must have a physical place of business in the US where someone acts for you. Ask for the address and who works there.
Do they respond fast? The FDA works in US time. Ask how quickly they pass on communications, by which channel, and who covers holidays and absences.
Do they understand food regulation? An agent who knows the FDA's food rules can tell you when a message matters, and can recognise scam emails and requests for payment that do not come from the FDA.
Will they pass messages on in full? You want the original message and any attachments, not a summary.
Do they use the FDA's voluntary identification system? The FDA has a voluntary US agent identification system. An agent can get an identification number for each facility it represents, and you can enter that number during registration. If the facility name matches the details the agent supplied, the FDA treats it as verification without extra steps, which can speed up your registration number. Ask whether your agent uses it.
What is in the contract? Check the length of the term, the fee, what is and is not included, how to end the arrangement, and what happens to your registration details if the agent leaves.
Are there extras you do not need? Some agents bundle other services. Compare what you are paying for.
Can you speak to a person? Reaching a named contact matters when something urgent comes in.
Red flags
A claim that the agent is "FDA approved" or "FDA certified". The FDA does not approve or certify US agents. The identification system is a way to identify agents, not an endorsement.
A suggestion that the FDA charges a fee for registration or that you must pay a particular company to register. Registration and renewal are free.
Pressure to prepay several years with no refund.
No physical address, or an address that is only a mailbox.
No clear process for what happens if the agent stops trading.
How to appoint a US agent
Agree the arrangement in writing, including who the contact is and how messages are passed on.
Give the agent your facility details exactly as they will appear on the registration, so the agent can match them in the FDA's system.
Enter the agent's details in the registration form, with the agent's identification number if one is used.
Make sure the agent confirms the role when the FDA asks, because the FDA will not complete the registration until it has verified the agent.
Save the details in your compliance file, with the registration number and the agent's contact information.
Review the arrangement at each renewal, and update the registration if you change agent. If any facility information changes, update the registration promptly.
For the full registration process, including the DUNS number, the FDA Industry Systems account and the renewal window, see our guide to FDA food facility registration for foreign producers.
Can I be my own US agent?
Only if you have a place of business in the United States with someone physically present who can act as your agent. A foreign producer with a US sales office or subsidiary can use it. A producer with no US presence needs an outside agent.
If you sell private label
If a contract manufacturer makes your product, it is that facility that registers and needs the US agent, not you, unless you hold or pack food yourself. Check with your manufacturer who the agent is and that the registration is current. Our guide to private label food manufacturing covers how the roles are usually divided.
Frequently asked questions
Do foreign food facilities need a US agent?
Yes. A foreign facility that must register with the FDA must also name a US agent.
What does an FDA US agent do?
The agent acts as the FDA's communication link to the foreign facility, receives FDA messages and passes them on, confirms the role during registration and can help the FDA schedule inspections.
Is the US agent the same as the importer?
No. The importer is the US owner or consignee of the food, with FSVP and customs responsibilities. The agent is the FDA's communication contact. One company can do both, but they are separate roles.
Does the US agent file Prior Notice for me?
Not as part of the role. Prior Notice is usually filed by the importer, a customs broker or another party you designate. Our guide to FDA Prior Notice explains who can file.
Can my customs broker or importer act as my US agent?
Possibly, if they have a US place of business, agree to the role and meet the requirements. Make sure the arrangement is in writing and that they understand what the role involves.
How much does a US agent cost?
Fees vary by provider and by what is included. Ask for a written quote and check the term and exit conditions.
Can I change my US agent?
Yes. Update the registration with the new agent's details promptly, and confirm the new agent has accepted the role.
Is a US agent the same as an FSVP qualified individual?
No. A qualified individual is a person with the training and experience to carry out certain FSVP activities. It is a different concept. See our FSVP guide.
Where we can help
At VC Agriculinary Consulting we help foreign food producers handle US registration and compliance, including FDA coordination, registration and renewal, Prior Notice, FSVP support and labelling. If you need help appointing a US agent, or want a registration checked before the 31 December deadline, contact us and tell us about your facility. You can also read our practical checklist for food export compliance or see our services.