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  1. FDA Import Process

Import Refusals

What is an import refusal?

A refusal is FDA’s final decision that a detained shipment is in violation of FDA laws and regulations.  A refused shipment must either be destroyed or exported under the supervision of Customs and Border Protection (CBP) and FDA within 90 days of the date of the Notice of FDA Action (Refusal Notice).

Examples of why your product may be refused:

  • You did not provide a response to the FDA Notice of Detention and Hearing within the specified ten business days and an extension of time for responding was not requested and/or granted.
  • You provided evidence to demonstrate the product is in compliance, but FDA determined the evidence provided did not overcome the appearance of a violation.

    Example: Your product is on import alert and requires a private laboratory analysis showing the product is not violative. You sent a private laboratory report, but FDA determined the laboratory did not follow scientific protocol and therefore the report is not valid.

  • You have submitted a proposal to recondition (FORM FDA 766) your product and the proposal was denied because it did not give FDA confidence that it would bring the product into compliance.

    Example: Your product was found to contain Salmonella.  You proposed to sanitize the product. FDA rejected your proposal due to inadequate sanitization steps.

  • You have submitted two separate proposals to recondition adulterated or misbranded product and neither attempt is sufficient to bring your product into compliance.  Requests for a third attempt at reconditioning will generally not be granted and a Notice of Refusal of Admission would be issued.

    Example:  Your product contained labeling violations and the second attempt at reconditioning the product was insufficient to bring the product into compliance, as labeling deficiencies were still found on the revised labeling. 

  • A portion of your detained shipment was reconditioned pursuant to an approved application (Form FDA-766).  FDA agreed to the exportation or destruction of the remaining rejected portion of the shipment.  A Notice of Refusal of Admission was issued covering the rejected portion.

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How will I be notified of a refusal?

FDA will always issue a Notice of Refusal of Admission to the importer of record (who is the same person or firm who was issued the Notice of Detention).  Local FDA practices may also include sending copies to the broker (entry filer) and consignee. FDA will also notify CBP of the refusal.

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What are the options if my product is refused?

When a refusal is issued, the importer has the following options:

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

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Who do I contact if I need to destroy or export my product?  

You will receive instructions from the local CBP office. You must export or destroy the product within 90 days of refusal. If FDA is going to witness the exportation or destruction, you should contact the FDA compliance officer identified on the Notice of FDA Action.  

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What happens if I do not export or destroy the product within 90 days?

When FDA issues a refusal, CBP is notified and will request that you redeliver the product to a CBP approved location at a port of entry. The notice gives you 90 days to return the product.  If you fail to do so, CBP may assess liquidated damages against the bond. 

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Can I request an extension beyond the 90 days to FDA?

No, FDA has no authority to grant such extensions. You can contact the local CBP office for questions related to extending the 90-day period.

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Can I appeal the refusal decision?

A refusal is a final decision. Unless the refusal was issued by FDA in error, consideration is not given to a request to rescind the refusal.

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Where can I find a list of FDA refusals?

The import refusals report (IRR) provides a list of refusals by country/area and by product based on the industry code. The IRR is updated on a monthly basis. FDA developed the IRR in an effort to provide the public with information on shipments that appear to violate FDA laws and regulations.

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