Shipping to FBA from an unregistered foreign plant: what FDA can hold at the port

Updated 2026-08-24

The short answer

If an article of food from a foreign facility that is not registered as required is imported or offered for import, the food is subject to being held under section 801(l) of the FD&C Act. That is 21 CFR 1.285.

Foreign food facilities that must register must also designate a US agent. FDA will not confirm the registration or issue the number until that agent agrees. A plant that never finished that step is, for import purposes, an unregistered plant.

What “held” means in practice

Unless CBP agrees to immediate export, food placed under that hold must be held within the port of entry unless CBP or FDA directs otherwise. 21 CFR 1.285 then gives a short clock to get a valid registration number in: 30 calendar days from the notice of hold, or from FDA’s response to a request for review.

If no registration number is submitted and the goods are not exported, they are handled under CBP general-order rules. If arrangements cannot be made, the article may be destroyed.

Failure to register is also a prohibited act

Separate from the hold, 21 CFR 1.241(a) makes failure to register, renew or update required elements a prohibited act under section 301(dd). The United States can seek an injunction or a criminal case.

FDA’s small-entity guide says the same thing in one paragraph: food from a foreign facility that was required to register and did not is subject to being held at the port or a secure facility until the facility is registered.

What to do before the container leaves China

Confirm the manufacturing and packing sites are registered, the US agent has confirmed, and Prior Notice can carry a real registration number. Prior Notice is a separate filing that rides with every food shipment, including supplements. See Prior Notice and the first three things to do on an FBA hold.

A year of US-agent service is $299. It is cheaper than a hold. It is not a substitute for registering the plant.

Common questions

The goods are already at Amazon. Can FDA still hold them?

Section 801(l) and 21 CFR 1.285 speak to food imported or offered for import. Once the lot is in the fulfilment network the facts get messier. Do not use that as a plan for the next container.

Is a US agent enough, without a registration number?

No. The hold in 21 CFR 1.285 is about an unregistered foreign facility. The agent is how a foreign facility finishes registration. You need the confirmed number.

Does this apply to cosmetics?

The 801(l) hold described here is the food-facility / Prior Notice scheme. Cosmetics have their own import and MoCRA rules. Do not copy this paragraph onto a lipstick shipment.

Traders told me they do not need to register.

FDA says traders and brokers are not required to register under section 415. The facility that manufactured, processed, packed or held the food still is, unless an exemption applies.

How fast can a hold be lifted?

The regulation gives 30 calendar days to submit a valid registration number. How fast FDA and CBP move after that is their side, not a service promise.

Sources

• 21 CFR 1.285 — food imported from a foreign facility that is not registered as required is subject to hold under section 801(l); 30 calendar days to submit a valid registration number — ecfr.gov
• 21 CFR 1.241 — failure to register, renew or update is a prohibited act under section 301(dd) — ecfr.gov
• 21 CFR 1.231 — FDA will not confirm a foreign registration or issue a number until the US agent agrees to serve — ecfr.gov
• FDA, Small Entity Compliance Guide: Registration of Food Facilities — food from an unregistered foreign facility is subject to being held at the port of entry until the facility is registered — fda.gov

This guide is general information about import holds tied to unregistered foreign food facilities, not legal advice, and it does not create a client relationship. A live hold is fact-specific.