FDA US Agent
US Agent designation for foreign establishments, receiving and relaying FDA correspondence.
Review scopeResources
Reference pages for teams preparing US market entry.
Guides answer the practical questions international brands ask before a shipment, registration, or Amazon launch. Each page links to its primary FDA source.
Food and supplement facility registration
FDA registration and biennial renewal for foreign food and supplement facilities. The 2026 renewal window runs 1 October to 31 December.
Review scopeMoCRA cosmetics
Cosmetic facility registration and product listing, filed through FDA Cosmetics Direct.
Review scope · How to comply with MoCRA regulationsAmazon claim risk flags
We flag the marketplace claims, images and product language that carry FDA-related risk, and cite the rule.
Review scopeLatest practical guides
Foreign food facility US agent: China factory checklist
What a foreign food or supplement plant needs before FDA registration, and what a US agent does.
2026 food-facility registration renewal
The October–December renewal window, D-U-N-S number, and common filing blockers.
MoCRA for Amazon cosmetics sellers
Separate the facility, product listing, responsible-person, and foreign-agent questions.
Amazon seller and FBA guides
Does an Amazon seller need an FDA US agent?
What depends on the facility, not the store account.
Amazon asks for an FDA registration number
How to identify the record Amazon may be requesting.
FDA registration for supplements on Amazon
Three cases sellers should separate before they act.
Amazon removed a listing over an FDA claim
The distinction between product claims and compliance records.
MoCRA for Amazon cosmetics sellers
Facility registration and product listing are separate steps.
An FBA shipment is on FDA hold
The first records to check before a shipment sits longer.
Prior Notice for food entering FBA
The filing that travels with an imported food shipment.
FDA US agent guides
A US Amazon account does not replace an FDA US agent
Why account location and facility location are different facts.
Amazon FBA is not your FDA US agent
What an agent must be able to do that a warehouse cannot.
A mailbox or virtual office cannot be your FDA US agent
FDA’s physical-presence requirement in plain language.
US agent, importer, and FSVP importer
Three roles that can overlap but are never the same job.
Registration is not finished until the US agent confirms
What the confirmation message means for a foreign facility.
Changing an FDA US agent: the 60-day clock
What to do after an agent relationship ends.
One US agent and several factories
How one contact can appear on more than one registration.
MoCRA’s US agent is not the food-facility agent
Do not transfer food-facility assumptions to cosmetics.
Registration, labels, and import records
2026 food facility renewal
The renewal window, D-U-N-S number, and common blockers.
Registration is not FDA approval
Why “FDA certified” is a misleading shortcut for food and cosmetics.
A US agent is not Amazon listing approval
What a US agent can and cannot solve for a seller.
Unregistered foreign plant shipping into FBA
What FDA can hold at the port and why.
Structure/function versus disease claims
One sentence can put product language in a different regulatory category.
Six Supplement Facts mistakes
Label details sellers should resolve before a listing goes live.