Foreign food facility US agent: what a Chinese factory must provide to FDA

Updated 2026-09-22

First, check whether the facility has to register

FDA registration applies to a domestic or foreign facility that manufactures, processes, packs, or holds food for consumption in the United States, unless an exemption applies. The question is about the facility's activity, not whether it sells through Amazon, a distributor, or its own website.

Some operations are exempt. FDA lists examples including farms, retail food establishments, restaurants, and private residences where FDA-regulated food is made. If your facts are close to an exemption, confirm the classification before filing instead of assuming a factory registration is required.

What the US agent is—and is not

For a foreign food facility's registration, the US agent is a person who resides in the United States or maintains a place of business there and is physically present in the United States. A mailbox, answering machine, answering service, or other place without a physically present individual cannot be the agent.

The role is FDA communication. FDA may treat information given to the US agent as if it were given to the foreign facility, and the agent is the routine and emergency contact link. It does not turn the agent into your importer of record, FSVP importer, customs broker, or Amazon account holder. Those are separate roles with separate responsibilities.

Prepare these items before the registration starts

Have the facility's legal name, physical address, all trade names, food product categories, and the owner, operator, or agent in charge ready. FDA's registration guidance also requires contact information and a certification that the submission is true, accurate, and authorized.

For a foreign facility, prepare the US agent's name and contact information, including emergency contact information unless another emergency contact is named. The facility should also obtain its unique facility identifier before filing; FDA directs food facilities to obtain a D-U-N-S number from Dun & Bradstreet.

Use the same real facility identity across records. An old D-U-N-S address, a trading-company address in place of the manufacturing site, or an unreachable agent makes the registration information harder to rely on when FDA needs to contact the facility.

Registration is not FDA approval

FDA registration is a facility requirement; it is not a product approval, clearance, certificate, or an endorsement by FDA. Do not describe a registered food facility or product as "FDA approved" solely because a registration number exists.

FDA does not charge a fee to register, update, renew, or cancel a food-facility registration, and FDA does not require a facility to hire a third-party registrar. A service provider may charge for its own work or US-agent service, but that private fee is not an FDA fee.

A practical next step for a China-based factory

Make a one-page facility record before you start: legal entity, manufacturing address, product categories, D-U-N-S number, authorized signatory, and US-agent contact. Then confirm whether the actual manufacturing, processing, packing, or holding activity fits FDA's registration rule and whether an exemption applies.

If you are using a service provider, ask them to state in writing which role they are filling. A legitimate US-agent arrangement should not be presented as FDA approval or as a replacement for the people who remain responsible for the facility, importing, and food-safety obligations.

Common questions

Does every Chinese food factory need an FDA US agent?

A foreign facility that is required to register with FDA must include a US agent in its registration. Whether a particular factory has to register depends on its activity and any applicable exemption; FDA lists farms, retail food establishments, restaurants, and certain private residences among examples that are exempt.

Can a mailbox be the FDA US agent?

No. FDA says the US agent must reside in the United States or maintain a US place of business and be physically present there. A mailbox, answering machine, or answering service does not qualify.

Is an FDA US agent the same as an importer or customs broker?

No. The US agent is the FDA communication link for the foreign facility's registration. Importer-of-record, FSVP-importer, customs-broker, and marketplace roles are distinct and should be assigned separately.

Does FDA charge a food-facility registration fee?

No. FDA says there is no FDA fee for the initial registration, update, renewal, or cancellation of a food-facility registration. A third party may charge for its own services, but FDA does not require use of one.

Does FDA registration mean my food product is FDA approved?

No. A food-facility registration is not FDA approval, clearance, certification, or endorsement of a facility or product.

Sources

• FDA, How to Start a Food Business
• FDA, Food Facility Registration User Guide: Summary of Fields
• FDA, Foreign Food Facility Inspection Program Questions & Answers
• FDA, Questions Regarding Registration Fees and Private Businesses

This guide provides general information about FDA food-facility registration. It is not legal advice, does not establish a client relationship, and does not determine whether a particular facility is exempt. FDA registration is not FDA approval or clearance.