US District Judge Says Harm to e-Cigarette Company Outweighs Harm to Patients PDF  | Print |  Email

Saying the harm done to the public by these new nicotine-delivering devices is outweighed by the economic harm done to the companies that import them, US District Judge Richard J. Leon ruled that the United States Food and Drug Administration overstepped its authority in having the electronic cigarettes impounded. Leon sits on the bench of the US District Court for Washington, DC.

In his ruling, Leon wrote that the FDA did not prove that these devices are a more immediate threat than already available products.

“[The] FDA cites no evidence that [e-cigarettes] ... are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available,” Leon wrote.

In blocking e-cigarettes entry into the United States, the FDA cited safety concerns over nicotine levels. The Agency contends they are unapproved and misbranded drug delivery devices.

Leon went on to write that electronic cigarettes should not be considered a drug-device combination.

“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,” he wrote.

Judge Leon’s decision bars federal restrictions on e-cigarette marketing while the case is being litigated. The FDA is expected to appeal the ruling.

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