FDA holds · Notice of FDA Action
FDA is holding your shipment. What happens now?
FDA reviews each entry of food, drugs, devices, cosmetics and other FDA-regulated goods. When FDA does not let a line proceed, the Notice of FDA Action says why and by what date to respond. Allied files the entry and answers the notice with you.
- Respond by
- The date on the notice
- FDA allows 10 business days. Notices usually give 20 calendar days.
- Fix the goods
- Form FDA 766
- Relabel or recondition (21 CFR 1.95)
- After a refusal
- Export or destroy in 90 days
- Under CBP and FDA supervision
- Our fee
- Quote on request
What does "May proceed" mean, and what is a hold?
| FDA status | What it means | What you do |
|---|---|---|
| May proceed | FDA does not need to examine the line now. The goods can go into U.S. commerce. FDA can still act later if it finds a problem. | Nothing more for this line. Keep the entry records. |
| Documents requested | An FDA reviewer needs papers to decide: for example the invoice, the bill of lading, labels, certificates or ingredient lists. | Send the papers at once. We upload them in ITACS, the FDA system for entry documents. |
| Hold for examination or sampling | FDA will inspect the goods, check the labels or take a sample for its laboratory. | Keep the goods intact. Tell FDA where they are. Do not sell, move or open them. |
| Detained | FDA sees the appearance of a violation. This notice is the Notice of Detention and Hearing, with a respond-by date. | Answer by the respond-by date with evidence, or apply to recondition on Form FDA 766. |
| Released | After the review, exam or hearing, FDA found no apparent violation. | The goods can go into U.S. commerce. |
| Refused | The final FDA decision. The goods cannot enter U.S. commerce. | Export or destroy the goods under CBP and FDA supervision within 90 days. |
CBP release of FDA-regulated goods is conditional
CBP can release the goods before FDA decides. The release stays conditional until FDA lets the goods proceed, FDA refuses them, or 30 days pass with no FDA notice (19 CFR 141.113(c)).
If FDA refuses goods that you already sold, CBP demands their return. If you cannot return them, CBP can claim liquidated damages equal to three times their value.
What is on the Notice of FDA Action?
Entry and lines
The entry number and the lines that the action covers. Lines that the notice does not name can be released.Status
For example, hold for examination, detained, released or refused. Each change of status brings a new notice.Charges
The sections of law that the goods appear to violate. For example, adulterated, misbranded, or an unapproved new drug.Respond-by date
The last day to give FDA your evidence, or to ask for more time.Compliance officer
The FDA contact who runs the hearing. The name is usually at the bottom of the last page.Who received it
FDA sends notices to the importer of record, the consignee and the filer. Send us your copy the day it arrives.
How long do I have to respond?
The Notice of Detention and Hearing gives a respond-by date. The FDA Regulatory Procedures Manual allows 10 business days from the date of detention. To allow for weekends, holidays and mail, the notice generally gives 20 calendar days.
You can ask for more time. Ask the compliance officer before the date passes, and give a reason, for example a laboratory analysis that is not finished. If FDA agrees, it issues a new notice with the new date.
If FDA receives no response by the date, the compliance officer can refuse the goods. The owner, the consignee or the importer of record can respond. A representative, such as your customs broker, can respond for you with your written authorization.
Send us the notice the day it arrives
Evidence and laboratory work take time. The respond-by date does not move unless FDA agrees in writing.
What are DWPE and import alerts?
FDA puts a firm, a product or a country on an import alert after it finds a violation. Each alert names the problem, the firms and products, and the charges. Its Guidance section says what evidence releases a shipment and how to ask for removal. An import alert can have three lists.
- Red list
Subject to DWPE
The firm, product or country met the criteria for DWPE. FDA detains each shipment until you overcome the appearance of the violation. - Yellow list
Intensified surveillance
The firm, product or country gets intensified surveillance: more field exams or more analyses of each entry. - Green list
Exempt from DWPE
The firm, product or country met the criteria for exemption from DWPE under that alert.
Check the import alerts before you order
Search the FDA import alerts by manufacturer, product and country before you buy. A red-list product can need a laboratory analysis of each shipment, or it can be refused. Search FDA import alerts.
How do I get detained goods released?
Documents
Labels, ingredient lists, specifications, certificates, process records or supplier documents. FDA prefers to receive them in ITACS.Private laboratory analysis
A private laboratory samples the goods and sends FDA an analytical package. FDA reviews the method and the results before it decides.A request to recondition
If the goods do not comply as they are, propose how to bring them into compliance on Form FDA 766.
Laboratory accreditation for food. Under the FDA Laboratory Accreditation for Analyses of Foods (LAAF) rule, some import-related food tests must be done by a LAAF-accredited laboratory. This includes tests to support the admission of detained food and removal from an import alert. The rule applies to one analyte group at a time. For mycotoxins, it has applied since December 1, 2024.
Can I relabel or fix the goods?
- The application gives a detailed plan, the place of the work and the time to finish it. New labels go with the application (21 CFR 1.95).
- FDA grants or denies the application in writing. An approval sets the procedure, the time limit and the supervision (21 CFR 1.96).
- You do the work, then tell FDA that the goods are ready. FDA verifies the result at your cost.
- FDA charges for supervision by the hour: the officer, any analyst, travel and per diem. The minimum charge is 1 hour (21 CFR 1.99).
- The goods stay under a bond that includes a condition to redeliver them on CBP demand (21 CFR 1.97).
- A second application needs real changes to the plan. FDA generally does not grant a third attempt.
- FDA can release the part of a shipment that you fixed and refuse the rest.
Some violations cannot be fixed
FDA policy does not allow some reconditioning. For example, FDA does not allow it for a product detained as an unapproved new drug.
What happens if FDA refuses the goods?
A refusal is the final FDA decision. You must export or destroy the goods under CBP and FDA supervision within 90 days of the refusal notice. FDA cannot extend the 90 days. Ask the local CBP office about more time.
CBP asks you to redeliver the goods to a CBP-approved place at the port. If you do not, CBP can claim liquidated damages against your bond. FDA rescinds a refusal only when it issued the refusal in error.
FDA publishes refusals by country and product in its monthly Import Refusal Report.
How do I get off an import alert?
Investigation
How did the problem happen in your product?Corrective actions
What did you change to fix it?Preventive measures
What stops the problem from happening again?Evidence
Proof that the measures work. FDA gives examples: 5 clean commercial shipments, or a third-party audit.
Most petitions go to ImportAlerts2@fda.hhs.gov. Some alerts name another contact in their Guidance section. For example, FSVP cases under import alert 99-41 go to the compliance officer. Shipments that you use as evidence must follow your normal shipping pattern. A request for the green list works the same way: you show that the problem does not exist in your product.
Is a prior notice or registration hold different?
No prior notice, or an inaccurate one
Food that arrives without adequate prior notice is refused under section 801(m) and held at the port. It becomes general order merchandise and moves only under a custodial bond. If you do not export it, submit the prior notice within 10 calendar days of the refusal (21 CFR 1.283).
FDA prior notice explainedForeign facility not registered
Food from a foreign facility that must register with FDA and did not, or whose registration expired, can be held under section 801(l) (21 CFR 1.285). The same custody rules apply.
FDA food facility registration
For these holds, FDA and CBP are not liable for transportation, storage or other costs (21 CFR 1.283(a)(4), 1.285(e)).
Can FSVP stop my entry?
Yes. The Foreign Supplier Verification Programs rule (21 CFR Part 1, Subpart L) makes the FSVP importer verify that each foreign supplier produces safe food. The FSVP importer is the U.S. owner or consignee at entry. If there is none, the foreign owner names a U.S. agent or representative.
Each food line in the entry must show the name, email address and DUNS number of the FSVP importer (21 CFR 1.509). Since July 24, 2022, entries that show "UNK" in place of the DUNS number are rejected.
FDA can refuse food when the importer does not comply with FSVP (21 CFR 1.514). FDA can put importers with FSVP violations on the red list of import alert 99-41.
Get your DUNS number before the first shipment
Dun & Bradstreet issues DUNS numbers. FDA says a new number can take up to 45 days or more.
What does an FDA hold cost?
| Cost | Who charges it | Notes |
|---|---|---|
| Storage and demurrage | Terminal, warehouse or carrier | Runs each day the goods wait. For prior notice and registration holds, FDA and CBP do not pay storage or transport (21 CFR 1.283, 1.285). |
| Moving the goods for the exam | Trucker and warehouse | Drayage, unloading and labor, so that FDA can examine or sample the goods. |
| Samples that FDA takes | No cost if the goods comply | FDA pays for samples of goods that it finds in compliance. It does not pay if it first found the goods in violation (21 CFR 1.91). |
| Private laboratory analysis | The laboratory | Depends on the tests. Some food tests need a LAAF-accredited laboratory. |
| Reconditioning supervision | FDA, with payment instructions from CBP | Hourly charges for the supervising officer and the analyst, plus travel and per diem (21 CFR 1.99). |
| Export or destruction | Carrier, warehouse or destruction facility | Required within 90 days after a refusal, under CBP and FDA supervision. |
| Liquidated damages | CBP, against your customs bond | If you do not redeliver goods when CBP demands them. The claim can equal three times the value of the goods (19 CFR 141.113(c)). |
| Allied's fee | Allied | Quote on request. We give you the quote before we start. |
Storage and demurrage often cost the most. Demurrage and detention explained.
What does Allied do?
- Allied
File the entry with complete FDA data
We send FDA the data for each line: product code, manufacturer, FSVP importer, registration and prior notice details. FDA says complete, accurate data can lower the risk score of a line.
- Allied
Watch the FDA status
We check the FDA status of each line. We send you each Notice of FDA Action the day we receive it, with the respond-by date.
- You
Send the evidence and authorize us
Send labels, specifications, certificates of analysis and supplier records. Authorize Allied in writing to respond to FDA for you.
- Allied
Answer the notice with you
We prepare the testimony with you, upload it in ITACS and write to the compliance officer. If the evidence needs more time, we ask for an extension before the date.
- Allied
Arrange sampling and reconditioning
We arrange sampling by a private laboratory, with LAAF accreditation when the test requires it. We prepare the Form FDA 766 with your plan and new labels.
- Allied
Close the entry
After a release, we close the file. After a refusal, we arrange the export or the destruction with CBP within the 90 days.
Request: Help with an FDA hold or detention
Quote on request
FDA holds: common questions
Does "May proceed" mean that FDA approved my product?
No. It means that FDA does not need to examine the line at this time. FDA can still act later if it finds a problem. It is not an approval of the product or the firm.
Can I sell the goods while FDA holds them?
No. Keep them intact at the place that you gave FDA. CBP release of FDA-regulated goods is conditional until FDA decides (19 CFR 141.113(c)).
If goods are distributed before FDA decides, FDA can ask CBP to demand their return. If you cannot return them, CBP can claim liquidated damages against your bond.
Who can respond to the Notice of FDA Action?
The owner, the consignee or the importer of record. A representative, such as your customs broker, can respond for you if you authorize it in writing.
How long does an FDA exam take?
No law or regulation sets a time limit for FDA exams or sampling. FDA says it tries to act quickly. Plan for storage costs while you wait, and give FDA the location of the goods at once.
Can I appeal a refusal?
FDA treats a refusal as final. It rescinds a refusal only if FDA issued it in error. That is why the answer to the detention notice matters so much.
Will FDA pay for the samples it took?
Yes, if FDA finds the goods in compliance (21 CFR 1.91). FDA does not pay if it first found the goods in violation, even if they are later released. The billing contact is on the release notice.
My product is on the red list of an import alert. Can I still import it?
Often yes, shipment by shipment. The Guidance section of the alert says what evidence secures a release, for example a private laboratory analysis of each shipment. For some alerts, only removal from the alert allows a release.
Does an FDA hold affect my customs bond?
It can. The bond covers the duty to redeliver goods when CBP demands them. If FDA refuses goods that you already moved and you cannot return them, CBP can claim liquidated damages of up to three times their value.
Got a Notice of FDA Action?
Call (908) 291-8001 or email info@alliedchb.com
Last reviewed September 26, 2026. This page explains customs rules in general terms. It is not legal advice. Duty rates and CBP procedures change often, and we confirm the figures for your shipment in writing before you commit.