A Notice of FDA Action that says “refused” is one of the most expensive documents an importer can receive. The shipment cannot enter United States commerce, storage charges keep accruing, and a deadline starts running. What happens next is up to the importer, but only within the time allowed.

Food, dietary supplements, cosmetics, drugs, and medical devices are all subject to FDA admissibility review at the border. This guide covers what a refusal means, how the export-or-destroy decision works, and how destruction of refused cargo is actually handled.

Why FDA Refuses Shipments

FDA can refuse admission when an imported product appears to be adulterated, misbranded, or otherwise in violation of the Federal Food, Drug, and Cosmetic Act. Common reasons include:

• Labeling problems, including missing English labeling, undeclared allergens, or unapproved claims
• Filth, decomposition, or contamination found on examination or sampling
• Pesticide residues, heavy metals, or pathogens detected in laboratory testing
• Missing or invalid food facility registration or prior notice
• Drugs or devices without the required approval, clearance, or listing
• Products from a manufacturer on an import alert, subject to detention without physical examination

Many refusals begin as a detention. The importer has an opportunity to respond with evidence or to propose reconditioning before a final decision is made. Once the shipment is formally refused, the options narrow quickly.

The Export-or-Destroy Rule

Under the Federal Food, Drug, and Cosmetic Act, an article refused admission must be exported within 90 days of the notice of refusal, or within additional time that may be permitted. If it is not exported, it is destroyed. The importer pays for storage, cartage, and labor throughout.

Exporting is not always as simple as it sounds. The goods have to go somewhere that will accept them, the original supplier may not want them back, and the return freight can exceed the value of the product. For food that has been sitting in a warehouse for weeks, there may be nothing left worth shipping.

For certain refused drugs and devices valued at 2,500 dollars or less, FDA has the authority to destroy the product itself without offering the export option, after notice and an opportunity to be heard. Most commercial shipments are well above that value, so for most importers the decision is still theirs.

Redelivery and the Customs Bond

If refused merchandise has already been released to the importer under bond, CBP can demand that it be redelivered to customs custody. Failing to redeliver merchandise, or failing to export or destroy it as required, can lead to a claim for liquidated damages against the importer’s bond. These claims are often calculated as a multiple of the merchandise value, which can make them far more expensive than the goods.

This is why the destruction of refused cargo has to be arranged through the proper customs process and documented carefully. Work with your customs broker to confirm the procedure that applies to your shipment.

When Destruction Is the Better Choice

• The supplier will not accept a return, or the return freight costs more than the goods are worth
• Perishable product has deteriorated during detention and storage
• The product cannot lawfully be sold in any market you can reach
• Relabeling or reconditioning is not possible or not cost-effective
• The deadline is approaching and an export cannot be arranged in time

Destruction also has one advantage that export does not. It ends the matter permanently. Exported product sometimes returns to the United States through other channels, and the importer’s name can follow it.

How Destruction of Refused Cargo Is Handled

• Confirmation of the refusal status and any conditions set by FDA and CBP
• Coordination with the customs broker on the required notice and supervision
• Scheduled transfer from the port, the bonded warehouse, or the importer’s facility
• Destruction by a method appropriate to the product, such as depackaging for food and secure destruction for drugs and devices
• Attendance by CBP if the agency elects to supervise
• A Certificate of Destruction referencing the entry number, the FDA refusal, the product, and the quantity

Documentation That Closes the File

Keep the Notice of FDA Action, the entry documents, any CBP correspondence, and the Certificate of Destruction together. If a liquidated damages claim or a future import review raises questions about the shipment, that file is what answers them. A certificate that does not reference the entry and the refusal will not do the job.

Do Not Let the Deadline Decide for You

At importdestruction.com, we coordinate destruction of FDA-refused shipments with your customs broker, schedule the work before the deadline, and issue a Certificate of Destruction tied to the entry on every project.

Contact our team today to arrange compliant destruction of refused import cargo at ports across the United States.