The short answer
If FDA detains your shipment, you or your importer receive a Notice of FDA Action marked “Detained”. It lists the charges — the rules FDA thinks the product breaks. You then have a short window to respond: FDA’s procedures allow 10 business days from the detention date, and the notice usually gives a “respond by” date about 20 calendar days out. If nobody responds, FDA can refuse the shipment. A refused shipment must be exported or destroyed within 90 days.
The most important rule: act on the first day. Most refusals that could have been avoided come from slow or missing responses.
What the notice means
FDA’s Notice of FDA Action shows the status of each line of an entry. The common statuses are:
| Status | What it means | What you do |
|---|---|---|
| May proceed / Released | FDA has no objection to the product entering. | Nothing — the goods move on. |
| Hold / Sampled | FDA is reviewing documents or has taken samples for testing. | Keep the goods intact and wait. Do not move or sell them. |
| Detained | FDA believes the product appears to violate the law and lists the charges. | Respond by the deadline with evidence, or ask to recondition. |
| Refused | FDA has refused admission. | Export or destroy under CBP and FDA supervision within 90 days. |
A product can also be detained without examination if it is on an FDA import alert. In that case FDA does not need to test anything — the shipment is held until you prove it complies.
Step by step: what to do when you are detained
- 1Read the charges carefullyThe notice names the problem — for example a label problem, a missing canning registration, filth, Salmonella or a pesticide. Each one needs a different answer. Ask your customs broker for the full notice, not just a summary.
- 2Note the deadlineFDA’s procedures allow 10 business days from the detention date; the notice’s “respond by” date is usually about 20 calendar days out to allow for weekends and mailing. If you need more time, ask for an extension before the deadline and give a reason.
- 3Decide who answersThe owner or consignee may respond, and FDA also recognizes the importer of record (which may be the broker). A consultant can respond only if authorized in writing.
- 4Choose your pathProve the product complies (testimony and evidence), ask to recondition it, or accept refusal and plan export or destruction.
- 5Submit through ITACSFDA’s preferred way to send documents is its online Import Trade Auxiliary Communication System (ITACS). Keep copies of everything you send.
Path 1: show the product complies
This is called giving testimony. It can be written or oral and can include:
- Entry and shipping documents that answer the charge (for example proof of FDA facility registration, or FCE and SID numbers for canned foods)
- Private laboratory results, where the violation allows — for example for Salmonella or pesticide charges. The sampling and lab method must be sound; FDA rejects reports with poor methods
- An explanation of why the charge does not apply
Path 2: recondition the product
If the problem can be fixed, the importer of record can ask permission on Form FDA 766. Common examples are relabeling to fix a misbranded label, or sorting out and destroying a bad part of a lot. The application should explain how the product will be brought into compliance and how long it will take, with the new label attached if relabeling.
- By applying, the importer agrees to pay FDA’s supervision costs.
- Reconditioning must be finished within the time FDA approves, and FDA checks the result.
- A second application is generally approved only with meaningful changes; a third attempt is generally not granted.
Path 3: refusal, export or destruction
If the problem can’t be overcome, FDA refuses admission. The shipment must then be destroyed or exported within 90 days, under the supervision of U.S. Customs and Border Protection (CBP) and FDA. FDA says it cannot extend this period, and refusals are final. If the goods are not exported or destroyed in time, CBP can claim liquidated damages against the importer’s bond.
A refusal is also recorded in FDA’s public Import Refusal Report, and repeated problems can lead to an import alert for your company — so fix the cause before the next shipment.
Example: a label detention
A biscuit exporter in Türkiye has a shipment detained because the label does not declare wheat and milk in the required way and the Nutrition Facts panel is in the wrong format. The importer files Form FDA 766 with a corrected English label, relabels under supervision, and the lot is released. The exporter then changes its U.S. label at the factory so the next shipment arrives compliant.
How to avoid detention next time
- Check your FDA food facility registration is current and your Prior Notice is filed correctly for every shipment.
- Have your label reviewed for U.S. format, allergens and color additives before printing.
- For canned or acidified foods, make sure FCE and SID filings are in place for each product.
- Test high-risk products before shipping (Salmonella for spices and nuts, pesticides for produce and tea).
- Make sure your U.S. importer has an FSVP — without it, shipments can be held under Import Alert 99-41.
Get your corrected label reviewed before you file Form FDA 766. FDA label review from $250.
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Frequently asked questions
How long do I have to respond to an FDA detention?
FDA’s procedures allow 10 business days from the detention date. The Notice of FDA Action usually sets a “respond by” date about 20 calendar days out to cover weekends, holidays and mailing. You can ask for an extension within that time if you have a good reason.
What is Form FDA 766?
It is the application to recondition or relabel a detained product to bring it into compliance. The importer of record submits it to the FDA compliance officer named on the notice and agrees to pay FDA’s supervision costs.
Can I sell a detained shipment to another country?
Once refused, the shipment must be exported or destroyed within 90 days under CBP and FDA supervision. Exporting it means it leaves the United States; it may not be sold in the U.S.
Will one detention put me on an import alert?
Not automatically, but refusals are recorded and repeated violations can lead FDA to place a company or product on an import alert. Fix the root cause before your next shipment.
Sources
- FDA — Detention & Hearing
- FDA — Reconditioning of Imported FDA-Regulated Products
- FDA — Import Refusals
Deadlines and procedures checked against FDA sources on November 11, 2026. This article is general information, not legal advice.