FDA must stop blocking imported e-cigarettes
Judge rules that the devices should be regulated as tobacco products rather than as drug or medical devices.
Fri, Jan 15 2010 at 5:04 PM
Photo: ZUMA Press
The Food and Drug Administration will no longer be able to block the importation of electronic cigarettes from China, according to a recent New York Times story. The FDA’s drug division tried to ban the devices because it believes that e-cigarettes have not been proven safe for people to use.
Federal judge Richard J. Leon of Federal District Court in Washington ordered the FDA to regulate e-cigarettes, which are battery-powered tubes that heat liquid nicotine into an inhalable vapor that tastes like tobacco, as tobacco products rather than as drug or medical devices. The device works by using a heating element that vaporizes a refillable liquid nicotine mixture inside a plastic tube, and as the smoker inhales, the device creates a vapor with a taste and feel that's very similar to cigarette smoke.
“This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices,” wrote Judge Leon, issuing a preliminary injunction in a lawsuit brought by two e-cigarette distributors.
The judge explained that the devices should be regulated in the same way as other tobacco products because e-cigarettes were not marketed as medical devices to help smokers quit, as the Food and Drug Administration had argued, but rather as safer substitutes to give users “the nicotine hit that smokers crave," according to the Times report.
"The public health issues surrounding electronic cigarettes are of serious concern to the FDA. The agency is reviewing Judge Leon’s opinion and will decide the appropriate action to take," wrote the FDA in a statement.
Meanwhile, e-cigarette companies are pretty happy with the outcome of the ruling. Ray Story, vice president of Smoking Everywhere, which filed the suit, said the ruling would help provide smokers with a cigarette that's safe to use.
However, anti-smoking advocacy groups were not as pleased with the judge’s decision. Matthew L. Myers, president of anti-smoking advocacy group Campaign for Tobacco-Free Kids, told the Times that the judge’s decision “ignores the common-sense distinction” the FDA has long drawn between traditional tobacco products and “a host of non-tobacco products, ranging from toothpaste to lollipops to water, in which manufacturers have added nicotine, a highly addictive substance.”
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