Device Importers Sue FDA for Release of Shipments
Two medical device importers are suing the Food and Drug Administration in District of Columbia U.S. District Court in an effort to secure the release of over 260,000 knee braces that are currently being held at Dallas-Fort Worth Airport. Plymouth Direct and Natures Pillows say their supplier obtained, before they started to import the product, written confirmation from FDA headquarters that the braces do not need premarket approval or notification as packaged and labeled. Nonetheless, FDA officials in Dallas took issue with the labeling and placed the braces on detention without physical examination. Plymouth and Natures Pillows say FDA has not responded to their subsequent attempts to address the agency’s concerns.
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According to the Nov. 3 complaint, the braces are meant to relieve stress on the sciatic nerve, and are labeled as providing relief for back pain. Plymouth sells the braces by television advertising, while Natures Pillow sells them through retail and mail order. Since the two companies began importing the braces in April, following the written confirmation from FDA, they brought in over 200,000 of the braces from China without a problem, they said. But in early October, FDA officials at Dallas-Fort Worth detained a shipment and told Plymouth and Natures Pillows that the labeling claims on the braces required premarket approval. Over the next two weeks, FDA would detain six more shipments of braces, they said. Eventually, the agency would release the seven shipments, totaling 243,360 braces. Three of the releases were “with comment,” meaning the agency was letting the shipments in despite minor violations.
Two more shipments came in on Oct. 28, and FDA again detained them. This time, they notified the customs broker associated with the shipments that said the braces were being placed on detention without physical examination (DWPE), and were in the process of being posted to Import Alert 89-08. Several more shipments arrived subsequently and were put on DWPE, totaling over 260,000 braces. As a result, Plymouth and Natures Pillow are unable to ship the braces to the customers who ordered them. FDA has yet to respond to the importers’ offers to change the labeling or request premarket approval, says the complaint. Plymouth and Natures Pillow argue the agency can't detain their shipments absent a finding that the braces are adulterated or misbranded. They are requesting the D.C. District Court order the release of the shipments, as well as a declaration that the agency’s actions were unlawful. They are also asking for a court order preventing FDA from detaining any future shipments of the braces.
Email ITTNews@warren-news.com for a copy of the complaint.
(Plymouth Direct, Inc. and Natures Pillows, Inc. v. FDA, D.D.C. 14-01848)