Standardized service

Annual U.S. Agent Service (Food)

Foreign food facilities must designate a U.S.-based agent when registering with the FDA, serving as the point of contact between FDA and the facility. We provide an annual U.S. agent service covering registration support, renewals, and day-to-day FDA correspondence.

RegulatorU.S. FDA

Designation1-2 business days

TermAnnual

Linked dutyBiennial registration renewal

On this page

What this service is

A U.S. agent is the U.S.-based contact designated in a foreign food facility's FDA registration. The agent receives FDA's emergency and routine communications, relays inquiries, assists with inspection scheduling, and handles registration-related matters.

Under the Bioterrorism Act, every foreign facility exporting food to the United States must designate a U.S. agent at registration. The agent agreement is a commercial arrangement and is customarily signed on an annual basis — even though the registration itself is renewed only every two years.

FD&C Act §415Bioterrorism Act of 200221 CFR Part 1 Subpart H

Who needs it

Foreign food manufacturing, processing, packing, or holding facilities without a U.S. entity

Companies registering a food facility for the first time that need a U.S. agent in parallel

Registered facilities that wish to replace their current U.S. agent

Prerequisites and sequence

D-U-N-S Number→Food U.S. Agent

Facility name in Chinese and English, address, and D-U-N-S Number are confirmed
A signed U.S. agent authorization
If already registered, the existing registration number so the agent information can be updated in the FDA system

Who holds regulatory responsibility

The U.S. agent is a communications role: it does not represent FDA, and acting as agent does not transfer responsibility for food safety or labeling compliance, which always remains with the facility and the importer. FDA does not approve or recognize any U.S. agent organization, and a certificate issued by an agent does not represent FDA authorization.

Materials we need from you

Facility name in Chinese and English and full address

D-U-N-S Number

Existing FDA registration number, if already registered

Name, title, and contact details of the authorized signatory

Emergency contact information

Process

01
Sign the annual U.S. agent agreement
02
Verify facility and registration details
03
Register or update the U.S. agent information in the FDA system
04
Receive and relay FDA emergency and routine communications during the service term
05
Assist with the biennial registration renewal
06
Send a renewal reminder before the agreement expires

Deliverables

The annual U.S. agent agreement

Confirmation of the agent designation (reflected in the FDA registration)

A record of FDA correspondence relayed during the service term

Timeline

After the agreement is signed and details verified, the agent designation is typically registered within 1-2 business days. The service runs on an annual term and is renewable.

Scope

What we provide

Receipt and relay of FDA emergency and routine communications
Annual review of registration details
Assistance with the biennial registration renewal
Communication and coordination for FDA inspection scheduling

What is not included

Specialized services such as label review or GMP guidance (engaged separately)
Accompaniment and remediation for FDA on-site inspections (assessed separately)
Prior Notice filings
Compliance and safety responsibility for the product itself

What usually follows

FDA Food Facility Registration FDA Food Label Review

Common pitfalls

Assuming the U.S. agent is FDA-approvedFDA does not approve or recognize any agent organization, and a certificate issued by an agent is not FDA authorization. Treat 'FDA official agent' marketing with caution and verify the actual role before paying for it.

Expecting the agent to carry compliance liabilityThe agent is only a communications contact; responsibility for food safety, labeling, and manufacturing compliance always remains with the facility and the importer. When FDA inspects or sends a notice, the facility must still organize its own response.

Letting the agent agreement lapseAgent agreements are customarily annual. If the term expires without renewal and no new agent is designated, FDA's emergency notices may go unanswered and the registration's agent information becomes stale. Renew in time or update the designation in the FDA system.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Is the U.S. agent appointed or approved by FDA?

No. The facility appoints its own U.S. agent. FDA does not approve or recognize any agent organization, and a certificate issued by an agent does not represent FDA endorsement.

Registration renews every two years — why is the agent agreement annual?

The agent agreement is a commercial arrangement between the facility and the agent. The industry convention is an annual term to ensure the agent can respond to FDA at any time; multi-year terms are also available.

Can we change our U.S. agent?

Yes. After signing an authorization with the new agent, the agent information is updated in the FDA system; the existing registration number stays the same.

Does the U.S. agent assume FDA-related liability for us?

No. The agent's role is communication and relay of information. Responsibility for food safety, labeling, and manufacturing compliance always remains with the facility and the importer.

Related services

Food Facility RegistrationAny facility that manufactures, processes, packs, or holds food for the U.S. market must register with the FDA. We prepare the registration, arrange the U.S. agent appointment, and obtain the registration number; a D-U-N-S Number is required before registration.Food Label ReviewA line-by-line review of your label against FDA food labeling rules (21 CFR 101 and related requirements): mandatory declarations, Nutrition Facts, ingredients, and claims — with an action-points document and annotated correction suggestions so the label is compliant before it goes to market.FSVP Importer AgentWhen U.S.-bound food enters without a U.S. owner or consignee, a U.S.-based FSVP agent must be designated to carry the foreign supplier verification responsibility. We act as your FSVP importer agent and coordinate the fulfilment and recordkeeping of the verification obligations.

Disclaimer

This is a U.S. agent liaison service. It is not legal advice and does not transfer the facility's regulatory compliance responsibilities.