Does an Amazon seller need an FDA US agent? It depends on where the facility sits

Updated 2026-08-24

The short answer

If the plant that manufactures, processes, packs or holds your food or dietary supplement for the US market sits outside the United States, that foreign facility must name a US agent when it registers with FDA. If every facility in that chain is domestic, there is no US-agent requirement.

The agent is a communications link. FDA will treat what the agent says as coming from the facility, and will treat documents given to the agent as given to the facility. It is not a licence, an approval, or a person who can make FDA accept your listing.

Who actually has to name one

The obligation sits on the facility, not on the Amazon store. The owner, operator or agent in charge of a foreign facility that manufactures, processes, packs or holds food for consumption in the United States must register that facility and designate a US agent.

A brand owner who never operates a plant still needs the overseas contract manufacturer to be registered and to have an agent. A US seller packing and holding product only in a US warehouse names no US agent for that warehouse. Amazon FBA buildings are Amazon’s facilities; they do not replace the manufacturer’s registration.

Cosmetics follow a parallel rule under MoCRA: a foreign cosmetic facility registering with FDA must name a US agent. The agent must reside in the United States or maintain a US place of business and be physically present here. A mailbox, an answering machine or an answering service does not qualify.

What the agent is, and is not

For food facility registration, each foreign facility names one US agent. The agent may be an individual, a partnership, a corporation or an association. A US importer can serve as the agent if that importer actually meets the physical-presence test.

The agent does not have to know the product formula. At a minimum the agent has to know whom to call at the facility when FDA needs someone, including in an emergency, unless the registration lists a different emergency contact.

The agent may be authorised to register the facility. The agent is not required to. FDA still emails the listed agent an activation notice. If nobody opens that mail, the designation sits unfinished.

Where Amazon sellers mix this up

Amazon can ask a seller for a US-agent name as a condition of keeping a listing. That is Amazon’s commercial rule. It does not create an FDA obligation that was not already there.

Sellers who only dropship a US-made product into FBA usually do not need an agent of their own. Sellers who import from a Chinese plant do: the plant does. Putting a virtual-office address on the registration as the agent is the mistake FDA has already written down as not acceptable.

What it costs to have someone do it

FDA does not charge for naming a US agent. What you pay a firm for is the California address, a person who is actually here, and the relay of FDA mail.

Our current fee for a year of US agent service is $299, activated in one business day. Food or supplement facility registration bundled with a year of US agent is $499. These are service fees. They are posted on our pricing page before they change.

Common questions

I sell from a US Amazon account. Do I still need a US agent?

Not because of the Amazon account. You need a US agent if a foreign facility that makes, packs or holds your food, supplement or, under MoCRA, cosmetics is registering with FDA. A purely domestic facility does not name one.

Can I use a mailbox or a virtual office as the US agent?

No. FDA requires the agent to live in the United States or maintain a US place of business and be physically present here. A mailbox, answering machine or answering service does not satisfy that.

Does one agent cover every factory I use?

Each foreign food facility names one US agent for registration purposes. Two factories are two facilities. They can name the same person, but each registration has to list the agent.

Is the US agent the same as the importer of record?

No. The importer of record is a Customs role for a shipment. The US agent is the FDA communications contact on a facility registration. One person can hold both roles, but they are not the same job.

Will having a US agent stop Amazon taking the listing down?

No. An agent does not review claims, labels or Amazon copy. Listing problems are usually about disease claims, unapproved ingredients or missing paperwork, not about whether an agent exists.

Sources

• FDA, Guidance for Industry: Registration of Food Facilities — foreign facilities must designate a US agent who lives or maintains a place of business in the United States and is physically present — fda.gov
• FDA, Questions and Answers Regarding Food Facility Registration (Seventh Edition) — 21 CFR 1.227 definition of US agent; one agent per foreign facility; mailbox not addressed as a qualifying presence — fda.gov
• FDA, Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products — US agent required for a foreign cosmetic facility; mailbox, answering machine or service does not qualify — fda.gov

This guide is general information about FDA US-agent requirements, not legal advice, and it does not create a client relationship. Naming a US agent is not FDA approval. Confirm the position for your own facility before you rely on it.