Amazon FBA is not your FDA US agent

Updated 2026-08-24

The short answer

A US agent is the person a foreign facility designates so FDA has someone in the United States to call. 21 CFR 1.227 says that person must reside or maintain a place of business here, must be physically present, and may not be a mailbox, an answering machine or a service where nobody is actually there.

Amazon Fulfillment is none of those things for your plant. FBA stores and ships your units. It does not agree, in FDA’s system, to be the communications link for a factory in another country.

Two different buildings, two different jobs

The foreign plant that manufactured, processed, packed or held the food is a foreign facility. It registers itself and names a US agent.

An Amazon fulfilment centre that later holds the same food in the United States is Amazon’s building. It is not a substitute for the manufacturer’s registration, and stocking there does not appoint Amazon as the plant’s US agent.

The same regulation is explicit on another point: having a US agent for registration does not mean your commercial business has to run through that agent. FBA can move the boxes. The agent still answers FDA.

What happens if you type Amazon into the agent field

FDA will try to verify that the person named as US agent agreed to serve. The agency will not confirm the registration or issue a registration number until that person confirms. Amazon has not agreed to be your plant’s agent, so that confirmation never arrives.

Sellers who treat the FBA warehouse address as a US-agent address are filling the field with a location where the individual acting as agent is not present for that factory. That is the fact pattern the definition already rules out.

What to put instead

Name a person or firm that actually agreed, lives or keeps a place of business in the United States, and can take FDA’s call. Our current fee for that service is $299 a year.

If the shipment is already sitting on an FDA hold, the first moves are in the FBA hold guide, not in renaming the warehouse as an agent.

Common questions

Amazon holds my inventory. Isn’t that “physically present”?

Amazon is physically present for Amazon. The US agent has to be the person the foreign facility designated, and that person has to have agreed.

Can I list Amazon as the emergency contact?

You may list a different emergency contact on the registration. That still is not the same as Amazon serving as US agent. Do not name a party that has not agreed.

Does FBA registration cover my factory?

No. Each facility that manufactures, processes, packs or holds food for US consumption registers for itself, unless an exemption applies.

If I use Seller Fulfilled Prime instead, do I need an agent?

The fulfilment method does not decide it. The foreign facility does.

Can my US 3PL be the US agent?

A 3PL can serve if it agrees, is physically present, and is not just a mailbox. Most fulfilment contracts do not include that FDA role. Ask in writing before you type the name.

Sources

• 21 CFR 1.227 — US agent definition; mailbox, answering machine or service disqualified; commercial business need not run through the registration agent — ecfr.gov
• 21 CFR 1.231 — for a foreign facility, FDA will not confirm the registration or provide a registration number until the named US agent confirms agreement to serve — ecfr.gov
• FDA Food Facility Registration User Guide — every foreign facility must have a US agent as the domestic communications representative; domestic facilities do not — fda.gov

This guide is general information about the FDA US-agent role versus Amazon fulfilment, not legal advice, and it does not create a client relationship.