FDA Refusals

When an FDA Import Detention is issued for an imported product, FDA must provide the importer, owner or consignee with sufficient notice explaining the specific violation of law FDA believes exists and providing an opportunity for the importer, owner or consignee to respond to (and correct) the problem. If the importer, owner, or consignee fails to respond to the FDA Import Detention notice, or if the response is inadequate, FDA will issue an FDA Import Refusal Notice. Once refused, the product must be destroyed or exported within 90 days of the date of the FDA Import Refusal notice.

When an imported shipment is subject to an FDA Import Refusal, U.S. Customs and Border Patrol (Customs) authority is engaged. Customs will then demand the imported and FDA refused shipment be redelivered to Customs custody. The Customs demand for redelivery is usually issued on a Customs Form 4647, although not always. In some ports of entry, Customs stamps the redelivery language directly onto the FDA Import Refusal notice and counter-signs the FDA refusal notice. In these cases, the FDA Import Refusal notice becomes the Customs demand for redelivery. The Customs demand for redelivery is issued primarily to the importer of record, who has posted the Customs importation bond covering the imported shipment. The importer ordinarily can comply with the Customs demand for redelivery by exporting the FDA refused merchandise (under Customs' supervision) or destroying the refused merchandise (under FDA's supervision). Failure to either export or destroy the FDA refused goods within the time allotted will ordinarily result in Customs issuing a claim for liquidated damages, requiring the importer to pay Customs an amount equal to three times the invoice value of the FDA refused merchandise, up to the monetary limit of the importation bond covering that shipment.

Rescinding an FDA Import Refusal notice is difficult and usually a very rare event. Rescinding an FDA Import Refusal depends upon the facts related to the shipment and the product, the way FDA handled the entry (including how and when FDA issued its notices to the importer), whether the importer or customs broker supplied any information to FDA to try to resolve the detention, and whether FDA is correct in its application or interpretation of the law.

Although it is a difficult process, and every case is very unique and fact specific, Environmental Testing Laboratory Inc. (ETL), has maintained approximately a 50% success rate in obtaining rescissions of FDA Import Refusals. ETL success in this area is partly based upon the fact that we are careful to only take cases and to try to obtain rescissions of FDA refusals where there is a valid legal argument given the specific facts. ETL will never attempt to seek rescission of an FDA Import Refusal if there is no basis to do so.

There are other options available to importers even if their products are refused admission. For instance, the Bioterrorism Act of 2002 (BTA) expressly permits the re-importation of foods that were previously refused admission by FDA. An importer wishing to re-import previously refused food must establish that the food complies with the relevant provisions of the law and regulations when the product is re-imported. ETL regularly assists companies in exporting and reimporting foods that were incorrectly refused admission, helping the importers identify and document compliance with the FDCA and FDA regulations.

 

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