Survey: E-Cigarettes May Help Smokers Quit
Some E-Cig Smokers Say Devices Helped Them Quit Smoking Cigarettes
FDA Frustrated in Banning E-Cigarettes
E-cigarettes use a battery-driven heater to vaporize liquid nicotine and flavoring from a small cartridge. To make the vapor visible, the cartridges also dispense propylene glycol (PEG), commonly used for theatrical "smoke." Users puff or inhale the vapor from a mouthpiece.
To almost everybody, that sounds like a device for delivering nicotine. But because the nicotine is ultimately derived from tobacco plants, a federal court has ruled that e-cigarettes are -- legally speaking -- tobacco products and not nicotine-delivery devices.
Since they are tobacco products, the court ruled, the FDA lacks authority to regulate e-cigarettes as drugs or devices as long as they are marketed without claims of therapeutic effect.
This means that companies distributing e-cigarettes in the U.S. cannot sell their products as smoking-cessation devices, even though that is the only public health reason for their use.
"It is a bizarro world where the potential of e-cigarettes is not being realized for legal reasons," Eriksen says.
"This is a great public health opportunity," Siegel says. "You have companies willing to market the product as a smoking-cessation device. But they are wary of doing it because don't want to run afoul of the FDA."
In January, the U.S. Court of Appeals rejected the FDA's appeal.
"FDA is currently evaluating the D.C. Circuit's Jan. 24 ruling and considering its legal and regulatory options," FDA spokesman Jeff Ventura tells WebMD.
Are E-Cigarettes Safe for Smoking Cessation?
Are e-cigarettes safe? The FDA thinks not, for several reasons:
- E-cigarettes may get people, especially young people, addicted to nicotine, leading to cigarette use.
- The cartridge may contain toxic ingredients. One FDA study did find a small amount of an antifreeze-like chemical in at least one cartridge, but Siegel points to 16 other studies that find no such contamination. "Based on identified chemicals and quantities, there is basically not anything of alarm," he says.
- E-cigarettes have not been tested for efficacy and safety. Moreover, they are produced overseas with little oversight to ensure good manufacturing practices. "By being unregulated, there is no knowledge of the purity of what is being inhaled," Eriksen says. "It is a concern about the safety of this new behavior.
- E-cigarette cartridges contain varying amounts of nicotine, so users don't know what dosage they are getting.