Does a Chinese food or supplement factory need an FDA US agent?

A foreign food facility that is required to register with FDA must include a US agent in its registration. Whether a facility must register depends on its activities and any applicable exemption.

Can a mailbox or virtual office be the FDA US agent?

No. FDA says the US agent must reside in the United States or maintain a US place of business and be physically present in the United States. A mailbox, answering machine, or answering service does not qualify.

Is an FDA US agent the same as an importer or customs broker?

No. The US agent is the FDA communication link for a foreign facility's registration. Importer-of-record, FSVP-importer, customs-broker, and marketplace roles are distinct.

Does FDA registration mean a food product is FDA approved?

No. Food-facility registration is not FDA approval, clearance, certification, or endorsement of a facility or product.

US FDA market-entry compliance

FDA cosmetic compliance services for international brands.

A practical compliance desk for MoCRA cosmetic facility registration and product listings, FDA US Agent coordination, food and supplement facility registration, and marketplace claim risk.

Request a compliance assessment Review cosmetic compliance scope

US-based coordinationWritten deliverablesFixed-scope pricingEnglish / Chinese workflow

Positioning

The service is FDA compliance clarity, not brand theater.

KECC provides defined FDA cosmetic compliance services for brands preparing US market entry: MoCRA facility registration, product-listing preparation, and source-linked scope review. The operating company is KECC LLC; final regulatory determinations remain with FDA.

Core services

Market-entry support by product and risk area.

FDA US Agent

US Agent designation for foreign establishments, receiving and relaying FDA correspondence.

Review scope

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 scope

MoCRA cosmetic compliance services

Cosmetic facility registration and product-listing preparation through FDA Cosmetics Direct; see the source-linked MoCRA compliance guide.

Review scope

Amazon claim risk flags

We flag the marketplace claims, images and product language that carry FDA-related risk, and cite the rule.

Review scope

Service matrix

What the compliance desk can handle.

Service	Best for	Typical deliverable	Timeline	Bought separately	Fee
FDA US Agent (1 year)	Foreign facilities	Agent designation, FDA correspondence relayed	1 business day	—	$299
Food / supplement facility registration or renewal	Foreign food and supplement plants	FDA registration number or renewal confirmation	3 business days	—	$299
Registration + US Agent bundle	Plants entering the US for the first time	Registration number plus a full year of US Agent	3 business days	$598	$499
US Market Entry Pack	First-time entrants with no DUNS number yet	D-U-N-S number, facility registration, a full year of US Agent	3 business days after the number is issued	$747	$649
MoCRA cosmetic facility registration	Cosmetic manufacturers	Facility registration plus one product listing	3 business days	—	$549
MoCRA package	Cosmetic brands	Facility registration and five product listings	5 business days	$1,029	$899
Additional cosmetic product listing	Brands with more products than the package covers	Listing number for that product	Filed with the same submission	—	$120
Amazon / ecommerce claim risk flags	Marketplace sellers	Each risky claim flagged, with the rule behind it	3 business days	—	$249/listing
D-U-N-S number filing	Foreign plants without a DUNS number	A DUNS number, which FDA registration requires	Tracked until issued	—	$149
EIN filing	Clients importing in their own name or forming a US entity	EIN issued by the IRS	Same call by phone, about 4 business days by fax, about 4 weeks by mail	—	$199
US company formation (you choose the state)	Foreign clients setting up a US entity	Filing in the state you choose, plus the EIN	Per state processing	—	$599
Company formation + US Agent bundle	Clients who need both a US entity and a US Agent	Formation, EIN, and a full year of US Agent	Per state processing	$898	$699
CBP importer number (Form 5106)	Foreign companies acting as importer without a US entity	CBP-assigned importer number	Per CBP processing	—	$299

Foreign-facility answers

FDA US agent questions, answered plainly.

A foreign food facility that must register with FDA needs a US agent in the registration. The exact requirement depends on the facility's activity and any exemption; it is not determined by whether the brand sells through Amazon or a distributor.

A qualifying US agent is an FDA communication contact, not the importer of record, an FSVP importer, a customs broker, or an FDA approval. A mailbox or answering service cannot fill that role.

Read the source-linked guide for Chinese food and supplement factories, including the information to prepare before registration.

Need clarity?

Send product details and we will identify the likely FDA compliance workstream.

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