Totally Wicked-ELiquid to Sue FDA
Just a few days ago, it was revealed via TweetDeck that the US subsidiary of Totally Wicked-ELiquid inc intends to sue the United States Food and Drug Association for improperly seizing some of their e-cigarette imports as well as unlawfully regulating e-cigarettes as drug devices. In their verified complaint, Totally Wicked Inc. asks that the court
- Enter a temporary restraining order, a preliminary injunction, and a permanent injunction that enjoins Defendants from enforcing any import ban on TWI’s electronic cigarettes arising out of their purported classification as a drug, device, or drug-device combination product under the FDCA, or from enforcing Import Alert 66-41 with respect to TWI’s electronic cigarettes and electronic cigarette accessories;
- Enter a declaratory judgment that Defendants are without statutory authority to regulate TWI’s electronic cigarettes and accessories as a drug, device, or drug-device combination product under the FDCA, and that the addition of electronic cigarettes to Import Alert 66-41 is invalid, unlawful, and ultra vires of Defendants’ authority; and
- Order the release of any of TWI’s electronic cigarettes and electronic cigarette accessories currently detained or seized by the United States pursuant to the FDA’s unlawful declaration that it has jurisdiction over electronic cigarettes and electronic cigarette accessories under the FDA’s authority to regulate drugs, devices, and drug-device combination products;
- Award TWI its costs and expenses, including reasonable attorneys’ fees; and Award such other and further relief as is necessary and appropriate.
In summary, totally Wicked is suing the FDA in order to ensure that it no longer attempts to seize importations of Totally Wicked’s electronic cigarettes, as well as to give back previously seized shipments of Totally Wicked e-cigarettes, and finally, pay for TWI’s legal expenses and “further relief” which I could imagine may be quite a hefty sum if Totally Wicked Wins the case.
From the looks of it, legal services are currently being provided by Thompson Hine LLC, one of the largest corporate law firms in the United States. I feel hopeful that Totally Wicked Inc may have a case, especially since it was recently ruled that electronic cigarettes cannot be regulated as drug delivery devices.
I will continue posting updates on the case as it develops!