FDA detention and import refusal: how to respond and what happens next

When FDA thinks an imported food, cosmetic, drug or device shipment may break US rules, it issues a Notice of FDA Action marked "Detained", which is also the notice of detention and hearing. The importer then has a deadline to present evidence or ask to recondition the goods. If the violation is not overcome, FDA refuses admission, and the goods must be exported or destroyed within 90 days.

Checked against official sources: 2026-10

At a glance

Detention noticeNotice of FDA Action marked "Detained": the Notice of Detention and Hearing, listing the charges

Time to respond10 business days from detention under FDA's procedures; the notice generally allows 20 calendar days

TestimonyAny information to overcome the appearance of the violation, oral or written, preferably uploaded through ITACS

ReconditioningRequest to relabel or recondition with Form FDA 766

Third attemptAfter two insufficient reconditioning attempts, a third is generally not granted

RefusalFDA's final decision; the goods must be exported or destroyed under CBP and FDA supervision

Deadline after refusal90 days from the Notice of FDA Action date; FDA cannot extend it

Missed deadlineCBP may assess liquidated damages against the importer's bond

What happens when FDA detains a shipment

FDA reviews imports of regulated products when they are entered with CBP. If a product appears to violate FDA rules, FDA issues a Notice of FDA Action stating that the product is "Detained". This notice is considered the Notice of Detention and Hearing: it lists the laws and regulations that appear to be violated, called charges, and gives a "respond by" date for the importer, owner or consignee.

FDA's Regulatory Procedures Manual allows 10 business days from the date of detention; because weekends, holidays and mailing time are considered, the notice generally allows 20 calendar days. A request for more time, for example to wait for a private laboratory report on a product under detention without physical examination, must be sent to the compliance officer named on the notice within the original timeframe and with a reasonable basis.

Ways to respond to a detention

Submit testimony: any oral or written information that overcomes the appearance of the violation
Upload documents through ITACS, FDA's preferred method
Provide private laboratory results, where sampling is allowed
Request to relabel or recondition the product with Form FDA 766
Ask for a time extension within the original deadline, with a reasonable basis
If nothing works, arrange export or destruction with CBP and FDA

After a refusal

A refusal is FDA's final decision that a detained shipment violates FDA laws and regulations. The goods must then be destroyed or exported under the supervision of CBP and FDA within 90 days of the refusal, counted from the date of the Notice of FDA Action. FDA has no authority to extend that deadline, and if the goods are not moved in time, CBP may assess liquidated damages against the bond. A request to rescind a refusal is not considered unless FDA issued it in error.

Reconditioning that does not give FDA confidence it will bring the product into compliance can be denied, and after two insufficient attempts a third is generally not granted. Refusals appear in FDA's import refusal report, updated monthly by country or area and product, and repeated problems can lead to an import alert and detention without physical examination for future shipments.

Step by step

Read the Notice of FDA Action: note the charges and the respond-by date.
Collect evidence that answers each charge, such as labels, registrations, prior notice details or laboratory results.
Upload your testimony through ITACS before the deadline, or ask for an extension within it.
If the problem can be fixed, file Form FDA 766 to relabel or recondition the goods.
If the goods are refused, export or destroy them under CBP and FDA supervision within 90 days.

Documents you usually need

Notice of FDA Action (detention, release or refusal)
Testimony and supporting documents uploaded through ITACS
Private laboratory reports, where allowed
Form FDA 766 reconditioning or relabelling request
Proof of export or destruction after a refusal

Common problems and how to avoid them

The respond-by date passes without a reply.

What to do: A missed deadline can lead to refusal; respond or request an extension before the date on the notice.

The importer asks FDA for more than 90 days to export refused goods.

What to do: FDA cannot extend the 90 days; plan export or destruction immediately to avoid liquidated damages on the bond.

Two reconditioning attempts have failed.

What to do: A third attempt is generally not granted; export or destroy the goods instead.

Refused goods are moved away from the port without approval.

What to do: CBP may ask for them to be returned to a CBP-approved location; keep them under supervision until export or destruction.

Sources

Detention & Hearing Period for Imported Products U.S. Food and Drug Administration (FDA)
Import Refusals U.S. Food and Drug Administration (FDA)

Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.

Port codes by country

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Common questions

What does "Detained" mean on an FDA notice?

FDA believes the product appears to violate its rules. The notice is the Notice of Detention and Hearing and gives a deadline to present evidence.

How long do I have to respond to an FDA detention?

FDA's procedures allow 10 business days from detention, and the notice generally allows 20 calendar days; the exact date is on the notice.

Can a detained product be fixed?

Sometimes. You can ask to relabel or recondition it using Form FDA 766; after two insufficient attempts a third is generally not granted.

What happens after an FDA import refusal?

The goods must be exported or destroyed under CBP and FDA supervision within 90 days of the refusal, and FDA cannot extend that period.

Is an FDA refusal public?

Refusals appear in FDA's import refusal report, which is updated monthly by country or area and product.

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