FDA ruling seen as e-smoke win
RICHMOND, Va. - The Food and Drug Administration said Monday that it planned to regulate smokeless electronic cigarettes as tobacco products and would not try to regulate them under stricter rules for drug-delivery devices.
The news is considered a victory for makers and distributors of the devices.
E-cigarettes are plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the "smoker" inhales. A tiny light on the tip even glows like a real cigarette.
Users and distributors say e-cigarettes address the nicotine addiction and the behavioral aspects of smoking - the holding of the cigarette, the puffing, seeing the smoke come out, and the hand motion - without the 4,000-plus chemicals in cigarettes.
First marketed overseas in 2002, e-cigarettes did not become easily available in this country until late 2006. Now, the industry has grown from the thousands of users in 2006 to several million worldwide, with tens of thousands of new e-smokers every week.
No timeline has been set on the proposed rule changes.
The FDA said e-cigarettes could still be regulated as drugs or drug-delivery devices if they were "marketed for therapeutic purposes" - say, as a stop-smoking aid.
Craig Weiss, president of Sottera Inc., the Arizona-based company involved in the lawsuit that led to the FDA's decision Monday, said he was "very happy" with the decision. The company markets NJOY brand e-cigarettes.
Jason Healy, president of the e-cigarette maker Blu Cigs, also praised the decision. Once the FDA's rules covering e-cigarettes are in place, he said, they will help in "weeding out the shady companies." Right now, "you can potentially sell snake oil," Healy said.
Some e-cigarette makers have said the products will help smokers quit using traditional cigarettes, while other makers have tried to steer clear of the issue.
The FDA lost a court case last year after trying to treat e-cigarettes as drug-delivery devices, rather than tobacco products. A federal appeals court ruled electronic cigarettes should be regulated as tobacco products rather than as drug-delivery devices, which must satisfy more stringent requirements such as expensive clinical trials to prove they're safe and effective.
The FDA had until Monday to appeal to the U.S. Supreme Court.
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