The US Food and Drug Administration plans to oversee electronic cigarettes as tobacco products – and won’t try to regulate them under stricter rules for drugs or medical devices.
E-cigarettes mimic the act of smoking, but they don’t burn tobacco directly, and their users release only water vapor. This nicotine-delivery device has been marketed as an alternative to cigarettes for those trying to quit.
Yesterday, the FDA said it will propose subjecting e-cigarette companies to rules that currently cover makers of regular cigarettes, such as providing lists of ingredients.
The FDA wanted to regulate e-cigarettes as drug-delivery devices, just as nicotine gum and smoking cessation products are regulated. But the US Court of Appeals for the D.C. Circuit decided that e-cigarettes aren’t medical devices (except those specifically marketed for therapeutic ‘stop smoking’ purposes).
Regulation as drugs or devices would have required e-cigarettes to go through a pre-market approval process. So while the agency can review new e-cigarette products before they go on sale, it can’t require manufacturers to conduct the types of animal and human studies mandated for FDA approval of drugs or medical devices, Bloomberg explains.
Sottera Inc., which does business as NJOY, says that its products are tobacco alternatives for ‘smoking pleasure,’ not drugs for therapeutic uses.
The battery-powered cigarette consists of a heating element and a cartridge containing a liquid suspension with nicotine from tobacco plants. When a user inhales, the liquid is heated and a nicotine vapor is emitted. A light at the tip even glows like a real cigarette.
Users and distributors say e-cigarettes address both 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 more than 4,000 chemicals found in cigarettes, AP reports.
According to the Tobacco Vapor Electronic Cigarette Association, the e-cigarette is 14,000 times less harmful and doesn’t alter body functions.
But the FDA might beg to differ, the Los Angeles Times reports. Half of the 19 brands of e-cigarettes the FDA sampled contained a carcinogen found in real cigarettes and many contained a poisonous ingredient of antifreeze.
Image: electronic cigarette by ahancyrus via Flickr
