Guide
An FDA US agent will not save an Amazon listing or make a product “FDA certified”
The agent is a communications link. Assignment of a registration number does not convey FDA approval. Amazon taking a listing down over claims or ingredients is a different problem from whether someone in Tustin answers the phone.
Updated 2026-08-24
The short answer
21 CFR 1.242 says assignment of a registration number means the facility is registered with FDA. It does not in any way convey FDA’s approval or endorsement of a facility or its products.
The US agent’s job, in the food-facility definition, is to be the communications link. The agent does not review Amazon copy, does not approve a Supplement Facts panel, and does not issue a badge you can paste onto the main image.
What FDA has already said about private “certificates”
FDA does not issue a certificate of food-facility registration. It does not recognise one issued by a private business. It is not affiliated with firms that sell US-agent or renewal services, and those firms do not act on FDA’s behalf.
Using the FDA logo on private materials can suggest endorsement that FDA cannot give. That is a logo-policy problem, not proof that the agent relationship is in place.
Why the listing still comes down
Disease claims, unapproved ingredients, a missing structure/function notification, or a cosmetics listing that was never filed are listing problems. Naming an agent does not rewrite 21 CFR 101.93, and it does not complete a MoCRA product listing.
If Amazon asked for an agent name as a document check, send the real agent. If Amazon took the ASIN down over the word “treat,” sending an agent letter will not put the word back. See which words crossed the line.
What we will and will not write
We will serve as US agent for $299 a year and relay FDA correspondence. We will not draft “FDA certified,” “FDA approved formula,” or an FDA-logo badge for Seller Central.
If the listing already says those things, say so before checkout. Claim review is a different line on the pricing page.
Common questions
Can I say “FDA registered factory” once the agent is in place?
You can state a true fact without implying approval. “The manufacturing facility is registered with FDA as a food facility” is not the same sentence as “FDA certified.” The registration number itself is not public.
Will the agent talk to Amazon for me?
The statutory role is communication with FDA. Talking to Amazon is optional extra work, not the 21 CFR 1.227 function.
My supplier sent an “FDA US agent certificate.”
FDA does not issue that document. Ask for the facility’s registration status and the agent’s actual name and US address instead.
Does having an agent mean the product may be legally marketed?
No. Registration of an establishment does not mean a product may be legally marketed. FDA has said so on the “Is It Really FDA Approved?” page.
Is there a government fee for the agent?
No. FDA charges nothing to name a US agent. Private firms may charge for the service of being here.
Sources
- 21 CFR 1.242 — assignment of a registration number does not convey FDA approval or endorsement of a facility or its products — ecfr.gov
- 21 CFR 1.227 — US agent is a communications link — ecfr.gov
- FDA, food facility registration fees — no certificate of registration; FDA is not affiliated with private US-agent businesses — fda.gov
- FDA, “Is It Really ‘FDA Approved’?” — mere registration of an establishment does not denote approval or mean a product may be legally marketed — fda.gov
This guide is general information about what a US agent does not do for an Amazon listing, not legal advice, and it does not create a client relationship.
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