Thursday, February 4, 2010

FDA: E-cigarettes Are Harmful

In a dramatic turn of events, the FDA convinced a federal appeals court to temporarily suspend federal judge Richard J. Leon’s ruling that the agency must regulate e-cigarettes as tobacco products rather than drug-delivery devices. The lower court ruling was discussed in a previous post, here.

If e-cigarettes are regulated as drug-delivery devices, the FDA would effectively ban them until manufacturers conduct clinical trials costing millions of dollars, delaying availability for 5 to 10 years. If the FDA prevails, all those e-cigarette users who are former smokers will have to quit nicotine, smoke regular cigarettes, or buy e-cigarette replacement units and cartridges on a black market that is sure to arise.

According to the media, Judge Leon based his decision on a 2000 case (FDA v. Brown & Williamson) in which the Supreme Court ruled that cigarettes and smokeless tobacco products could not be regulated as drugs or devices. But that is only part of the story. Judge Leon demonstrated that e-cigarettes are appropriately regulated under the 2009 Tobacco Act, which was written by tobacco prohibitionists. Leon ruled that they are “‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use.”

The news report quoted the FDA as saying that Judge Leon was “quite wrong to believe that no injury would result from the use of these harmful and addictive products.” This statement is wholly unfounded. Tobacco harm reduction experts have been monitoring use of e-cigarettes -- there have been no reports of adverse health effects. This is in stark contrast to a mountain of evidence that cigarette smoking is associated with diseases killing 400,000 Americans every year.

FDA officials apparently believe that banning e-cigarettes is much more important than saving the lives of American smokers. The federal appeals court should put a stop to this travesty by affirming Judge Leon’s decision.

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