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Federal Judge Rules FDA Cannot Regulate e-Cigarettes as Drug-Delivery System


Both the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO) have warned of health concerns of e-cigarettes. These safety concerns, unknown levels of nicotine and other chemicals, promoted the FDA to block the U.S. entry of e-cigarettes, labeling them as unapproved drug delivery devices.

In September 2008, Smoking Everywhere Inc. and NJOY sued the FDA, alleging that the agency overstepped its authority. Federal Judge Richard J. Leon, U.S. District Court for the District of Columbia, agreed in a Jan. 14 decision. The ruling means that the Food and Drug Administration cannot regulate electronic cigarettes as drug delivery devices.

"There is no basis for FDA to treat electronic cigarettes ... as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette," Judge Richard J. Leon wrote.

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The FDA is likely to appeal, but the ruling bars federal restrictions on e-cigarette marketing while the case is being litigated.

E-cigarettes consist of a battery-powered delivery system that generally contain cartridges filled with nicotine, flavor and other chemicals which are turned into a vapor the user inhales. Most e-cigarettes look like their conventional counterparts.

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AMA News
Smoking Everywhere Inc. and Sottera Inc. d/b/a NJOY v. U.S. Food and Drug Administration, U.S. District Court for the District of Columbia. Jan. 14. Reference is found here.