Five electronic cigarette makers that promise consumers their products can help them quit smoking, lose weight and improve sexual vigor must drop their claims or show that the unapproved drugs they also sell as refills for e-cigarette cartridges are safe and effective.
In warning letters sent to the manufacturers, the Food and Drug Administration says the companies' unsubstantiated claims and poor manufacturing practices violate federal law. The alleged violations include advertisements claiming that e-cigarettes can mitigate, treat or prevent nicotine addiction and, in the case of E-Cig Technology, that they can be used to inhale liquid forms of erectile dysfunction and weight loss drugs. The federal agency sees a problem with such marketing because although e-cigarettes are currently classified as drug delivery devices and not subject to the same review process as drugs, an increasing number of "smokeless" components are chemical in nature and potentially present a health risk.
The E-Cig drugs, E-Cialis, E-Rimonabant, and Electronic Smoking Liquid Vitamins have never been reviewed and are not approved for use in the U.S. But on its web site, the Las Vegas company markets E-Cialis, an insoluble white powder, as "more effective and longer lasting than Viagra" and claims it can help men treat pulmonary arterial hypertension and "improve sexual capacity by smoking."
E-Cig officials could not be reached for comment and the phone number associated with the company appears to be disconnected. The company is the latest in a string of Internet purveyors of "performance enhancers" laced with undisclosed prescription drugs that have come under scrutiny by the FDA.
Also named in the warning letters are Ruyan America Inc, Gamucci America, E-CigaretteDirect LLC, and Johnson Creek Enterprises. States have also started to act against e-cigarettes.
Electronic cigarettes are battery-powered devices that provide inhaled doses of nicotine or other vaporized substances without the smoke of traditional tobacco products. In most models, air flow activates an atomizer that turns the liquid solution into vapor, which is then inhaled by the user. When the liquid in the cartridge has been depleted, it can be refilled or replaced with another cartridge.
Ruyan, whose simulated cigarettes were named one of the best 10 business ideas of 2007 by Business 2.0 Magazine, is credited with inventing the e-cigarette and introducing it to Asia and Europe in 2003 and 2006, respectively. The company is pushing some of its products as aids to bars and restaurants to remain popular with smokers despite the spread of smoking bans. But it is also careful to point out that although its products contain nicotine, they are neither tobacco nor drug products, and should be regarded as dietary supplements.
"E-cigarette companies have no problem being regulated by the FDA, but they want to be regulated under the Tobacco Act rather than the Food, Drug and Cosmetic Act, because under the latter they would have to do costly clinical trials," Michael Siegel, a professor at Boston University's School of Public Health told Consumer Ally in an interview. "A lot of these companies are very small and they don't have the [financial] capabilities."
The Tobacco Act essentially gives cigarette makers the freedom to sell nicotine products without scrubbing their advertising claims. In view of this, Siegel said the FDA's action is misguided as it misses the larger point of stressing the relative safety of smokeless, low-nicotine alternatives. If the agency successfully argues that e-cigarettes should be regulated as drugs, a requirement many manufacturers may fail to satisfy, it can ultimately pull them off the market.
"What they're not telling the public is that the trace levels of carcinogens in e-cigarettes is the same as the level of carcinogens in nicotine gum and other nicotine replacement products. Consider this in light of the fact that the FDA is already officially approving the sale and marketing of a deadly product -- cigarettes," Siegel said.
In a separate letter to the Electronic Cigarette Association, a self-regulatory industry group, the FDA declared its intent to begin monitoring electronic cigarettes and components so that they do not endanger public health. It says its actions are not meant to ban the sale of battery-powered electronic cigarettes.
"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter to the association read. The companies have two weeks to respond to the FDA.
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