Your FBA shipment is on FDA hold: the first three things to do

Updated 2026-08-24

What “FDA hold” actually is

When a product offered for import appears to violate FDA law, FDA may detain it and issue a Notice of FDA Action marked “Detained.” That notice is the Notice of Detention and Hearing. Typical grounds are adulteration, misbranding, an unapproved new drug, insanitary manufacturing, or a product forbidden in the country it came from.

If the foreign facility that produced a food shipment is not registered, or its registration has been suspended, the article is held at the port and may not be delivered to the importer, owner or consignee until the facility is registered. That is a statutory hold, not Amazon’s warehouse being slow.

The first three things

One. Get the notice. FDA sends the Notice of Detention and Hearing to the responsible parties. It lists the charges, the “respond by” date, and the compliance officer. FDA’s Regulatory Procedures Manual allows 10 business days from detention; the notice commonly writes 20 calendar days to cover weekends, holidays and mail. If nobody answers by that date, the officer can refuse admission.

Two. Name who is allowed to answer. The owner, the consignee and the importer of record may respond. A broker or a consultant may respond only with written authorisation. Amazon as the fulfilment destination is often not the party FDA will take an unauthorised letter from.

Three. Put the file in ITACS. FDA’s preferred route for documents is the Import Trade Auxiliary Communication System. Testimony is whatever you have that overcomes the appearance of the violation: the facility registration, the label, a prior-notice confirmation, a private-laboratory package where DWPE is the issue, or a Form FDA 766 request to recondition.

What not to do

Do not book another FBA inbound against the same lot. Do not move the goods out of the port of entry area if FDA may still examine or sample them; FDA can ask CBP for a demand for redelivery. Do not ignore the notice because the goods are “already sold on Amazon.” They have not been admitted.

If you cannot overcome the appearance of a violation, the goods are refused. You then work with CBP and FDA to export or destroy them, generally within 90 days of refusal. That clock is not Amazon’s return window.

Why FBA shipments get detained in the first place

The usual file we see is missing or expired food-facility registration, missing prior notice, a label that does not match what the entry said, or a product that has become a drug because of its claims or its undeclared ingredients. Detention without physical examination (DWPE) under an import alert is a separate track: the appearance of a violation is already on the books, and a private laboratory report may be how you try to get this one shipment in.

A US agent can receive FDA’s mail and hand it to you the same day. The agent cannot talk FDA into releasing the container. Release turns on the evidence.

Where we come in

If the hold is a missing foreign-facility registration, the registration itself is $299, or $499 with a year of US agent. If the hold is the words on the label or the listing, label review is $349 per SKU. We do not promise FDA will admit the goods. We assemble the file the notice asked for.

Common questions

Can Amazon clear an FDA detention for me?

Amazon can be a consignee on paper. FDA still expects the owner, consignee or importer of record, or a person they have authorised in writing, to answer the notice.

How long do I have to respond?

The notice carries a “respond by” date. The procedures manual allows 10 business days from detention; the face of the notice is often 20 calendar days. Ask for an extension before that date if you need one, and give a reason.

Can I move the goods to an Amazon warehouse while they are detained?

FDA expects the entry to stay in the declared port of entry area. If the goods leave and FDA then wants to examine or sample them, CBP can demand redelivery.

What if I do nothing?

The compliance officer can issue a refusal of admission. Refused goods are exported or destroyed, not delivered to FBA.

Is a US agent enough to get a detained shipment released?

No. The agent is the communications link on a facility registration. Release depends on overcoming the charges on the notice.

Sources

• FDA, Detention and Hearing — notice, respond-by timing, who may answer, ITACS, refusal and export or destruction — fda.gov
• FDA, Compliance Policy Guide Sec. 100.250 — food from an unregistered or suspended foreign facility is held at the port under section 801(l) — fda.gov
• FDA, Importing Human Foods — prior notice and facility registration at entry — fda.gov

This guide is general information about FDA import detention, not legal advice, and it does not create a client relationship. We cannot promise FDA will admit a shipment. Read the notice you actually received before you act.