Refusal in favor of the state - customs procedure

What is Import Refusal?

An import refusal occurs when the FDA determines that a detained shipment violates FDA laws and regulations. Once a refusal notice is issued, the rejected shipment must be destroyed or exported under the supervision of Customs and Border Protection (CBP) and the FDA within 90 days.

Reasons for Merchandise Rejection

Your merchandise might be rejected for several reasons:

• Failure to Respond: If you did not respond to the FDA's Notice of Detention and Hearing within the allotted ten working days, and no extension was requested or granted.
• Insufficient Proof: If you provided evidence of compliance, but the FDA deemed it insufficient to dispel concerns of a violation.
• Invalid Laboratory Analysis: If you submitted a report from a private laboratory, but the FDA found the lab did not follow proper scientific procedures, rendering the report invalid.
• Rejected Reconditioning Proposal: If you proposed to recondition the product (using FORM FDA 766), but the FDA rejected it due to doubts about the proposal's ability to bring the product into compliance.
• Example: Salmonella was found in your product, and your proposed sterilization process was deemed inadequate by the FDA.
• Repeated Insufficient Reconditioning Attempts: If two reconditioning attempts were insufficient to bring your product into compliance.
• Example: Even after reconditioning for labeling violations, errors remained on the new labels.
• Repair and Final Refusal: If a part of your detained shipment was repaired under an authorized application, and the FDA approved the exportation or destruction of the final refused portion.

Notification of Refusal

The FDA will send a Notice of Refusal of Admission to the shipper of record, who is the same entity that received the Notice of Detention. Copies may also be sent to the broker (entry filer) and consignee, depending on local FDA practices. CBP will be notified of the refusal as well.

Options if Your Merchandise is Rejected

If your merchandise is refused, you have two options:

• Destroy the product under FDA and CBP supervision.
• Export the product under the guidance of CBP and FDA.

Contact Information for Shipping or Destroying the Product

You will receive instructions from the local CBP office. The product must be exported or destroyed within 90 days of the refusal. Contact the FDA compliance manager listed on the Notice of FDA Action if FDA presence is required during exportation or destruction.

Consequences of Not Exporting or Destroying Merchandise

If the merchandise is not exported or destroyed within 90 days, CBP will require you to redeliver the item to a CBP-approved location at a port of entry. Failure to do so may result in CBP charging the bond for liquidated damages.

Extension Requests

The FDA cannot grant extensions beyond the 90-day period. For extension inquiries, contact your local CBP office.

Challenging the Refusal Decision

A refusal is a final decision. Requests to rescind the refusal are not considered unless the FDA made an error.

Record of FDA Refusals

The Import Refusals Report (IRR) lists refusals by industry code, broken down by country/region and product. The IRR is updated monthly and aims to inform the public about shipments that violate FDA regulations.