Rescinding FDA Refusals
Rescinding Import Refusals of Admission
If an importer, owner or consignee fails to respond to a notice of detention, or fails to convince FDA or USDA that a detained shipment is not in violation of FDA or USDA law or regulation, FDA will issue a Notice of Refusal will be issued or Customs will reject the entry. Under these circumstances, Customs will issue a demand for redelivery (in the case of an FDA refusal) requiring exportation or destruction. In any case, the refused or rejected article ordinarily cannot be distributed in the US. Failing to comply with a refusal or rejection can have serious implications, including claims for liquidated damages up to three times the value of the goods, forfeiture and destruction of the imported product, and/or civil monetary penalties. Once a shipment is refused or rejected, it is much more difficult to obtain its release. FDA may use prior refused shipments to place the foreign manufacturer or shipper on import alert. This could be devastating to the foreign company, who may not even know that the importer has obtained the product from a third country or from a shipper who was not authorized to ship the product to the U.S.
Rescinding an FDA refusal is very difficult and very rare. FDA does not like to rescind a refusal of admission because the agency does not like to admit it was wrong and it does not like to rethink application of the law to a specific entry a second time.
FDAImports.com consultants and attorneys have had success in these actions, but every case is unique. Rescinding an FDA refusal depends upon the facts, how FDA handled the entry (including how and when FDA issued its notices to the importer), whether the importer or customs broker supplied information to FDA to try to resolve the detention, and whether FDA is correct in its application or interpretation of the law. Ordinarily, when we are successful at such appeals to the FDA, the product is released into domestic commerce for free sale within the US. It is necessary to act quickly in cases where FDA has already refused the shipment. It is important to resolve the issue prior to the exportation deadline. Therefore, these cases are handled in an expedited fashion.
FDAImports.com consultants and attorneys have been able to obtain rescission of FDA refusals and rejections for clients by quickly addressing the underlying reasons and authorities for the agency action.
