FDA Refusals

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. Under these circumstances, Customs will issue a Demand for Redelivery (in the case of an FDA refusal) requiring that the detained be exported or destroyed.  In either case, the article cannot be distributed in the US. Failing to comply with a Demand for Redelivery has serious implications, including liability to Customs for liquidated damages (fines up to three times the value of the goods), or forfeiture and destruction of the imported product, and/or civil monetary penalties. Once a shipment is refused, it is much more difficult to obtain its release. Even worse, FDA often uses prior refused shipments as a basis for placing the foreign manufacturer or shipper on import alert.  The import alert can be devastating to the foreign company because it prevents the subject of the import alert from entering the country.

If your company has articles subject to FDA Refusal, FDA Imports.com, LLC can assist you in cutting through the red tape quickly, to get your products released.  Importantly, our firm provides compliance consulting so that you comply with all relevant laws and regulations to avoid refusal in the first place. FDA Imports.com, LLC is a full-service regulatory consulting firm with consultants and affiliated attorneys with substantial experience in the field of FDA Refusals. We can help you understand what requirements you need to follow to protect yourself and your company from the business expense of an FDA refusal. Let us show you “the way through” and show you how well the process can work when you have the right people working to resolve your FDA-refused product.