The fledgling electronic-cigarette industry scored another victory against the Food and Drug Administration in federal court Monday, potentially setting the stage for the battery-powered devices to be regulated like conventional tobacco products.
The U.S. Court of Appeals for the District of Columbia Circuit rejected the FDA’s request to have the entire court review a December decision by a three-judge panel that went against the agency.
The FDA, which contends that the products should be regulated as drug devices, now has the option of asking the U.S. Supreme Court to take up the case. An FDA spokesman said Monday that the agency is evaluating the latest court ruling “and considering its legal and regulatory options.”
E-cigarettes are battery-powered tubes that turn nicotine-laced liquid into a vapor mist. The devices have caught on with thousands of smokers who want an alternative to their daily habit, leading to annual industry revenue of at least $100 million.
On Dec. 7, a three-judge D.C. appeals panel ruled that e-cigarettes, which are sold online and in malls, should be regulated as tobacco products by the FDA unless marketers make claims that the devices help smokers quit or provide other remedies.
The agency has argued that e-cigarettes are drug or medical devices that require pre-approval from the FDA, much like nicotine gums, patches or sprays. The agency began intercepting shipments of e-cigarettes from China in 2008, prompting a lawsuit from the industry.
Sottera Inc., an Arizona e-cigarette distributor that joined the suit as a plaintiff, and some other e-cigarette purveyors say their products are simply recreational alternatives to cigarettes and should not be subject to the onerous pre-approval process required of quit-smoking aids.
The agency has regulated nicotine-replacement products for years and gained authority to regulate the production and marketing of cigarettes and other tobacco prodcuts for the first time in 2009. If the government decided to regulate e-cigarettes as tobacco products, manufacturers would still face significant regulations, but it would be easier to bring the devices into the market.
“We are very pleased with the court’s decision not to rehear the case,” Gregory Garre, an attorney who represents Sottera, said in an email Monday. “The fact that the full court unanimously declined the government’s rehearing request underscores the force of the panel’s original decision.”
The appeals court Monday also refused to reinstate a stay of a preliminary injunction that was granted to the e-cigarette distributors by a U.S. district-court judge in January 2010. The injunction blocked the agency from intercepting their product shipments from China.
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