The Food and Drug Administration said that it had determined that electronic cigarettes marketed by two manufacturers contained carcinogens, varying amounts of nicotine, and impurities such as diethylene glycol.
Since July 2008, the agency has been seizing shipments of the so-called “e-cigarettes” at the United States border and analyzing them. It has determined that the e-cigarettes meet the legal definition of a drug and a device, and therefore, are being illegally sold. However, the FDA has not, as of yet, taken any additional action, agency officials said in a briefing with reporters. The agency is considering additional steps, said Michael Levy, division director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.
The FDA held the briefing to alert the public to its laboratory findings and express concern that the products may be used by children as a gateway to cigarettes, said Dr. Joshua Sharfstein, principal deputy commissioner.
Battery powered, electronic cigarettes vaporize chemicals contained in a cartridge; users inhale the vapor.
The FDA analyzed 19 cartridges made by Smoking Everywhere and NJOY. The agency found detectable levels of tobacco-specific nitrosamines—which are known human carcinogens—in half the samples. Most samples also contained impurities known to be toxic to humans, such as anabasine, myosmine, and beta-nicotyrine. One cartridge contained 1% diethylene glycol, a toxic component of antifreeze. In another instance, cartridges claiming to have no nicotine had low levels of the substance, and the amount of nicotine per puff varied widely.
Generally, the e-cigarettes are marketed as smoking cessation aids or smoke-free alternatives to cigarettes, said agency officials. The products can be purchased online and at retailers, including shopping malls, where children congregate, said Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics Tobacco Consortium, who participated in the briefing.
In addition, the cartridges come in flavors such as bubble gum, mint, chocolate, and chocolate chip, he noted. Such flavors are particularly appealing to children and novice smokers.
“Once you've smoked an e-cigarette and are nicotine dependent, the leap to a regular cigarette may not be as great,” said Dr. Winickoff.”
For now, the e-cigarettes will remain on the market. Sunrise, Fla.–based Smoking Everywhere has sued the FDA, claiming it does not have jurisdiction over its products. The agency has argued that it has the power to regulate the e-cigarettes in a manner similar to smoking cessation products.