Electronic cigarettes, or e-cigarettes, as they're commonly called, have been giving the FDA the shakes for almost a year now.
But as the regulatory debate over the tobaccoless nicotine delivery systems rages on, a new issue has come to light: How much nicotine, if any, are these e-cigarettes actually sending into users' brains? When the FDA did their lab analysis, they found e-cigarettes contained much higher concentrations of nicotine per puff compared to previously approved nicotine inhalers. But yesterday, CNN reported on a new academic study from Virginia Commonwealth University that found electronic cigarettes deliver little to no nicotine when users' inhale. So, which is it? Do e-cigarettes deliver more nicotine or none at all?
The plastic cigarette-looking devices first appeared in China about 7 years ago, but American distributors only recently started importing them and selling them online and at mall kiosks. Electronic cigarettes don't contain tobacco, but they do contain nicotine-infused water, which is heated via a lithium battery to create an odorless vapor.
The idea is to simulate the smoking experience while delivering the addictive nicotine smokers crave. The FDA considers e-cigarettes nicotine delivery systems, much like nicotine inhalers, and therefore subject to government regulation as smoking cessation devices. But the e-cig distributors, which have names like Smoking Everywhere, claim the devices are merely cigarette alternatives for smokers who need a nicotine fix but can't get outside, not tools to help them quit. They also argue that since their products don't contain tobacco, they're protected from the FDA's new-found power to regulate cigarettes and other tobacco products.
The FDA thought they'd found a loophole last spring. After analyzing a few e-cigarettes in the lab, they found traces of harmful chemicals, such as diethylene glycol, an ingredient in antifreeze, which they declared was grounds for banning importation of the devices. The distributors appealed the ban, and last month a federal judge ruled in their favor, saying: "This case appears to be yet another example of the F.D.A.'s aggressive efforts to regulate recreational tobacco products as drugs or devices." Now the FDA has appealed, and a few weeks ago an appeals court reinstituted the import ban until a new court date is decided.
Researchers probably won't have a concrete answer about nicotine levels for some time. In the meantime, the real question becomes whether the FDA should have the authority to regulate all products that contain nicotine. This has come up before. Remember the NicoWater and nicotine lollipops cases of 2002?