BRADENTON, Fla.--(BUSINESS WIRE)--Totally Wicked, suppliers of electronic cigarettes and e-liquids pride themselves on uninterrupted availability of their products to customers within the United States. Recently this became disrupted when the United States Food and Drug Administration in the United States District Court for the District of Columbia detained a shipment of Totally Wicked’s products at Miami International Airport resulted in a lawsuit being filed.
The shipment was detained in October 2010 on grounds that the products constituted “unapproved new drugs” or “misbranded drugs or devices” in violation of the federal Food, Drug and Cosmetic Act. Another case filed a motion for temporary restraining order which requested expedited determination by the District Court that FDA lacks the statutory authority to regulate their products as “drugs” or “devices” under the above act and the Court order the immediate release of the shipment held at Miami.
FDA immediately entered into negotiations with Totally Wicked attorney’s from Thompson Hine LLP instead of filing an opposition. Marketing material and product labelling was submitted to FDA for FDA’s review throughout March and April 2010 and several measures related to Totally Wicked’s website forum were addressed following claims made by forum users about their products.
On April 25th 2011 near conclusion of the settlement negotiations, FDA released a “letter to stakeholders” regarding the regulation of electronic cigarettes wherein FDA announced that it would no longer seek to regulate electronic cigarettes as "drugs" or "devices" so long as such products are not marketed for "therapeutic purposes."
Totally Wicked’s products will no longer be detained or refused shipment under the “drug” or “device” provisions of the federal Food, Drug and Cosmetic Act which was stated in a letter sent direct to them. The FDA rescinded its "refusal" determination regarding Totally Wicked's shipment which was held in Miami since October 2010 and released the shipment from detention.
The FDA had provided substantially all of the relief that Totally Wicked sought when it filed the lawsuit and so they voluntarily dismissed their case against the FDA, their dismissal can be found here. Totally Wicked retain the right to immediately re-file the case in the event that the FDA fails to comply with its promised future course of action.
They will continue to monitor FDA's activities relating to the regulation of electronic cigarettes and e-liquids and fully intend to take all measures necessary, even up to the point of further litigation against the FDA, to ensure that our products remain available to our customers and that our ability to import products into the United States remains uninterrupted.
Totally Wicked USA, manufacturers of electronic cigarettes and e-liquids opened business in Florida on 5th December 2008 and is parent company to Totally Wicked UK. Totally Wicked USA is a premium supplier of electronic cigarettes and e-liquids who are fully committed to ensuring customers in the United States have unfettered access to our products. Totally Wicked has sales offices in the UK and the USA.