February 10, 2010 - "Electronic cigarettes" that vaporize nicotine juice to inhale instead of smoke from burning tobacco do not deliver as promised, according to research at Virginia Commonwealth University. "They are as effective at nicotine delivery as puffing on an unlit cigarette," said Dr. Thomas Eissenberg, at the school's Institute for Drug and Alcohol Studies.
In a previous study, back in July 2009 Eissenberg and colleagues reported that the tobacco and drug industries' hottest contenders for a reduced harm product -- snus, a traditional Swedish oral tobacco, as well as powdered tobacco tablets and nicotine lozenges -- don't ease smokers' cravings for nicotine as well as cigarettes do. (Smokeless tobacco products may not curb smokers’ cravings..)
The latest clinical evidence suggests users of e-cigarettes are not getting the addictive substance they get from smoking tobacco. "These e-cigs do not deliver nicotine," Eissenberg said of the findings he expects to publish in an upcoming issue Tobacco Control, a product of the British Medical Journal Group.
This past summer, Eissenberg recruited smokers without prior experience using e-cigarettes to volunteer to use two popular brands of the devices for a set period. The 16 subjects were regularly measured in a clinical setting for the presence of nicotine in their bodies, their reported craving for conventional cigarettes, and certain physiological effects such as a change in heart rate.
"Ten puffs from either of these electronic cigarettes with a 16 mg nicotine cartridge delivered little to no nicotine," the study found.
But the units may deliver hazardous chemicals, according to preliminary checks by federal regulators. In a notice to importers, the FDA blocked continued shipments after finding diethylene glycol, a chemical used in antifreeze that is toxic to humans. (FDA: Electronic cigarettes contain toxic chemicals..
The government's statement noted there are no health warnings on the products, and that "the FDA analyses detected carcinogens, including nitrosamines."
The notice of the import ban says "the product appears to be a combination drug-device," that "requires pre-approval, registration and listing with the FDA" in order to be marketed in the United States.
A company challenging the import ban claims in federal court documents to have sold 600,000 of the devices in a year's time through a network of 120 distributors in the United States.
"We are on the verge of going out of business, which is why we are suing the FDA in U.S. District Court," said Washington, attorney Kip Schwartz, representing a company called "Smoking Everywhere," a U.S. wholesaler that was importing the devices from China.
The lawsuit questions the FDA's authority to block shipments of a non-tobacco product, and says the agency has violated its statutory process for product review. Liquid nicotine is available on the open market through pharmaceutical houses and vendors who sell e-cigarettes.
A judge January 14 ruled the FDA does not have such authority, but the agency has taken the matter to the U.S. Court of Appeals, which has yet to decide the case. The appeals panel issued a stay against the judge's ruling until it can rule on the agency's appeal. Meanwhile, based on the judge's ruling, lawyers for the importers have filed a request to compel the FDA to lift its import ban, saying the agency is not likely to win its appeal. The filing says "although e-cigarettes have been sold since 2007, FDA has not identified a single instance, either in this Court or below, of an adverse health effect from e-cigarettes."
A federal appeals court has put on hold a lower court ruling (paragraph above) allowing electronic cigarettes to be imported. The U.S. Court of Appeals for the District of Columbia Circuit stayed a lower court order banning the U.S. Food and Drug Administration (FDA) from seizing the devices when they enter the country. (U.S. - federal appeals court, import of e-cigarettes on hold again..)
Reference: Study: 'Electronic cigarettes' don't deliver by Paul Courson, CNN, 2/9/2010.
(e-cigarettes, e-cigs)
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