by Brendon Nafziger
, DOTmed News Associate Editor | April 26, 2011
The Food and Drug Administration said Monday it would treat e-cigarettes as tobacco products rather than medical devices in obedience to a federal court ruling.
Since 2008, the agency had been fighting to treat e-cigarettes as an unapproved drug-device combination, meaning the smokeless devices would have to pass agency tests before they could be sold to consumers.
But in a letter to stakeholders Monday, the agency said it would accept a D.C. district court's December ruling that the devices were tobacco products under the Federal Food, Drug, and Cosmetic Act, which was amended in 2009 to give the FDA the power to regulate tobacco products.
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"The court held that e-cigarettes and other products made or derived from tobacco can be regulated as 'tobacco products' under the Act and are not drugs/devices unless they are marketed for therapeutic purposes," Dr. Lawrence R. Deyton, director of the Center for Tobacco Products, and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, wrote in the letter.
E-cigarette maker Sottera Inc., doing business as NJOY, sued the FDA in 2009 after the agency blocked a shipment of its products.
Electronic cigarettes are battery-powered devices that vaporize a liquid suspension containing nicotine, producing an inhalable gas without smoke.
The FDA said it would soon release rules that would subject the devices to the same general controls that apply to other tobacco products, such as "registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions."