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E-cigarettes are no drug delivery devices: Judge
by Arushi Chaudhary - February 15, 2010 - comments
As per the ruling, no restriction is to be imposed on the marketing of e-cigarettes while the case is still under litigation.
A federal judge has ruled that electronic cigarettes cannot be regulated as drug delivery devices by the Food and Drug Administration (FDA). This decision has left the public health community red-faced.
This means electronic cigarettes will stay in the market for now. The ruling could have far-reaching implication on federal regulation of tobacco products.
Those in favor of tobacco-control said that this ruling could give birth to a range of new nicotine-laced products that have been controlled by the FDA.
The case
In September 2008, the FDA confiscated imports of battery-operated devices that were used for turning a nicotine solution into vapors, for inhalation.
The FDA labeled these as drug delivery devices and banned their entry in the nation on the pretext that they these e-cigarettes were unapproved, misbranded products being used as a substitute to traditional cigarettes.
The agency had also expressed concerns over the indefinite intensity of nicotine and other chemicals in these.
FDA was sued by Smoking Everywhere Inc. and NJOY, whose e-cigarettes were seized. The companies alleged that the agency had overstepped its authority.
On Jan. 14, a U.S. District Court of the District of Columbia agreed to this argument. Judge Richard J Leon wrote, "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."
"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," the court observed, adding that FDA’s concerns did not in any way prevail over the economic harm sustained by the plaintiffs.
Concerns over e-cigarettes
As per the ruling, no restriction is to be imposed on the marketing of e-cigarettes while the case is still under litigation.
Reacting to the ruling, an FDA spokeswoman said, “The public health issues surrounding electronic cigarettes are of serious concern to the FDA."
Questions are being raised over e-cigarettes functioning as a smoking-cessation tool, however, the World Health Organization (WHO) has ruled out it being a valid therapy.
The issue has been taken up by the American Medical Association, which will reveal the outcome of a study currently underway at its House of Delegates Annual Meeting in June.
Thomas P Houston, MD, chair of the American Academy of Family Physicians' tobacco cessation advisory committee, said, "These devices may not be marketed for cessation, but anecdotally, that's what the public is using them for. We still don't know the quality control, so somebody needs to be able to set standards for safety for whatever ingredients might be added and to understand what these do for the smoker in the short and long term. Someone has to be accountable."
Jonathan P. Winickoff, MD, MPH, chair of the American Academy of Pediatrics Tobacco Consortium, has expressed concerns over the possibility of claims made by the companies being misleading. "This product delivers nicotine, and nicotine is a potent drug that fosters addiction," he said.
Dr. Winickoff, who helped the FDA in its study of e-cigarettes, said, "The primary claim that there is a net benefit for the public health is just unproven, and there's a very real risk that even people who have not used any tobacco products -- including children and young adults -- start with an e-cigarette thinking it's safe."