Guide
A US Amazon account does not replace an FDA US agent
FDA looks at where the facility sits, not which marketplace account you log into. A US LLC or a North America Amazon store does not turn a China plant into a domestic facility.
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 is outside the United States, that foreign facility must register with FDA and designate a US agent. Opening a US Amazon account, forming a Delaware or California company, or having a US billing address does not change that.
The obligation sits on the facility. 21 CFR 1.227 draws a hard line: a domestic facility is one located in a US state or territory, the District of Columbia or Puerto Rico. Everything else that makes, packs or holds food for US consumption is a foreign facility.
What a US company actually changes
A US company can be the importer of record, can hold inventory in a US warehouse, and can be the seller of record on Amazon. None of those roles is the FDA US agent on a foreign plant’s registration.
If you later manufacture, pack or hold the same food only inside the United States, that US site is a domestic facility. Domestic facilities register too, but they do not name a US agent. The overseas contract manufacturer still does, for as long as it ships food into the US.
Where Amazon sellers mix this up
Seller Central lives in the US. The factory often does not. FDA’s communications link is for the factory, not for the storefront.
Amazon can still ask you for a US-agent name as a marketplace condition. That request does not create a new FDA duty, and it does not cancel the one the foreign plant already has. See whether an Amazon seller needs a US agent.
What it costs
FDA charges nothing to name a US agent and nothing to register a food facility. Agents may charge for the work of being here and relaying mail; that fee is between you and the person who agrees to serve.
Our current fee for a year of US agent service is $299, posted on the pricing page before it changes.
Common questions
I sell only on Amazon US. Isn’t that enough?
No. Marketplace presence is not facility location. If a foreign plant makes, packs or holds the food, that plant registers and names a US agent.
I formed a US LLC last month. Does the China factory still need an agent?
Yes. The LLC did not move the factory. Foreign versus domestic is about the physical site.
The product is already in a California warehouse. Do I still need an agent?
The California warehouse is a domestic site. The overseas plant that manufactured the lot still needs its own registration and, if it is foreign, its own US agent.
Can the LLC be listed as the US agent?
A US company can serve as the agent if it resides or maintains a place of business in the United States and a person is physically present. A paper company with a mailbox does not qualify.
Does the agent have to be the Amazon seller?
No. Commercial business in the United States need not run through the registration agent.
Sources
- 21 CFR 1.227 — definitions of domestic facility, foreign facility, and U.S. agent; commercial business need not be conducted through the registration agent — ecfr.gov
- FDA, Small Entity Compliance Guide: Registration of Food Facilities — foreign facilities must designate a US agent who lives or maintains a place of business in the US and is physically present — fda.gov
- FDA, Questions and Answers Regarding Food Facility Registration (Seventh Edition) — a foreign facility’s US agent may, but is not required to, register the facility — fda.gov
- FDA, food facility registration fees — there is no fee to register with FDA (21 CFR 1.231(c)); US agents may charge for their services — fda.gov
This guide is general information about FDA US-agent requirements for Amazon sellers, not legal advice, and it does not create a client relationship. Confirm the position for your own facilities before you rely on it.
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