CBP releases goods, but for food, cosmetics, medical devices, children’s products, plants, chemicals and electronics, another federal agency often has to agree first. When that agency has a concern, the shipment stops. Here is what importers ask us most, starting with FDA, which issues the most holds.
Which agencies can stop my shipment?
- FDA — food and supplements, cosmetics, drugs, medical devices, and electronic products that emit radiation.
- CPSC — consumer products, especially children’s products, which need a certificate of compliance based on third-party testing.
- USDA — plants, wood packaging, animal products, meat and poultry.
- EPA — chemicals under TSCA, pesticides and pesticide devices, and engines.
- FCC — radio-frequency devices, which need equipment authorization.
Most of them act through CBP’s systems, so the first sign may be a hold message from your broker. Ask the broker which agency and which line of the entry.
FDA sent a “Notice of FDA Action.” What does it mean?
The notice lists each line of the entry and what FDA is doing with it: may proceed, released, sampling, detained or refused. “Detained” is the Notice of Detention and Hearing. It states the charge — for example, unregistered facility, missing prior notice, labeling, or that the product appears adulterated — and a “respond by” date.
How long do I have to respond?
FDA’s procedures allow 10 business days from the date of detention. To account for weekends and mail, the notice usually gives about 20 calendar days. You can ask the compliance officer named on the notice for more time, but ask before the date passes. If FDA hears nothing, it can refuse the goods.
What does a response look like?
It is your chance to introduce testimony that the product complies (21 U.S.C. §381(a); 21 C.F.R. §1.94). Depending on the charge, that can be a corrected label, facility registration and FDA product codes, a certificate of analysis from an accredited lab, ingredient and process information, or proof that the product is not FDA-regulated at all. Answer each charge specifically. A general letter rarely works.
Can I fix the product instead?
Often, yes. If the problem can be corrected — relabeling is the most common — you can apply to recondition under FDA supervision using Form FDA 766. FDA must approve the plan before you start, and you usually post a bond.
What if FDA refuses the goods?
A refused shipment must be exported or destroyed under FDA and CBP supervision within 90 days of the refusal notice. If it is not, CBP will demand redelivery and can assess liquidated damages against your customs bond. Do not move or sell detained or refused goods. Distributing them can lead to redelivery demands, damages claims and future shipments being stopped without examination.
What is an import alert, and how do I get off one?
When FDA sees repeated problems with a product, manufacturer or shipper, it can place them on an import alert. Shipments are then detained without physical examination (DWPE), and the importer must prove compliance shipment by shipment. Removal requires a petition showing the problem has been fixed, usually including several consecutive clean shipments supported by lab results. It takes planning, so start as soon as you see the alert.
How are CPSC holds different?
CPSC staff at the port can sample or detain consumer products. For children’s products, you need a Children’s Product Certificate based on testing by a CPSC-accepted lab; for many other regulated products, a General Certificate of Conformity (16 C.F.R. part 1110). A missing or deficient certificate is a common reason for a hold. If CPSC finds a violation, the goods may be refused admission and must be exported or destroyed, and serious hazards can lead to recalls and penalties.
Who should do what?
- Importer of record: owns the response, the bond and the consequences.
- Customs broker: transmits filings and relays notices, but usually cannot argue the merits for you.
- Supplier: must provide test reports, registrations and process details quickly. Put that duty in your purchase contract.
How can I avoid the next hold?
- Confirm before the first order which agencies regulate the product and what each requires.
- Check the foreign facility’s FDA registration, product codes and labels in advance.
- Keep certificates and test reports ready for each shipment.
- Check FDA import alerts for your supplier and product type.
What is FDA prior notice, and why does it cause holds?
Food imported into the United States, including supplements and many ingredients, requires prior notice to FDA before arrival (21 C.F.R. part 1, subpart I). Missing or inaccurate prior notice can lead to the shipment being held at the port. Your broker usually files it, but the information comes from you and your supplier: the manufacturer’s registration number, the product description and the shipper.
Our supplier says its factory is “FDA approved.” Is that enough?
Usually not. FDA does not “approve” most food or cosmetic facilities. Registration is a listing, not an endorsement. Medical devices and drugs have their own requirements: device establishments register and list devices, and many devices need 510(k) clearance or other premarket authorization. Ask for the specific registration or clearance numbers and check them in FDA’s databases before you order.
How long does a typical hold last?
It depends on the problem. A missing document can be fixed in days. A sampling decision means waiting for lab results, often a few weeks. A labeling issue that requires reconditioning can take longer, because FDA must approve the plan and then verify the work. Storage and demurrage costs keep running, so it pays to respond quickly and completely the first time.
Can CBP seize goods that another agency is holding?
Yes. If the goods violate the law, for example counterfeit trademarks or prohibited items, CBP can seize them under its own authority, and the process then follows CBP’s seizure and forfeiture procedures, including the 30-day window to petition for relief or ask for court action. That is a different track from an FDA refusal and needs a different response.
Should we use a different port or broker after a hold?
Switching ports to avoid an agency that has stopped your goods does not help and can look like “port shopping,” which CBP and the Justice Department treat as a red flag. Fix the underlying problem instead: the label, the registration, the test report or the supplier. A broker who knows the agency’s requirements for your product can help, but the compliance file has to be yours.
What does it cost to respond to a hold?
It depends on what is needed: a simple document submission costs little, while testing, relabeling under supervision, or a petition to remove a product from an import alert takes more time and money. Storage and demurrage are often the largest costs, which is another reason to move quickly.
Sources: 21 U.S.C. §381; 21 C.F.R. §§1.94, 1.95; FDA, Detention & Hearing and Import Refusals guidance; 16 C.F.R. part 1110. As of November 2026.
