FDA: E-Cigarettes Bad, but Not Banned

FDA Issues Warning as Tests Find Electronic Cigarettes 'Illegal'

By Daniel J. DeNoon
WebMD Health News

Reviewed By Louise Chang, MD

July 22, 2009 -- The FDA today warned Americans not to use electronic cigarettes -- but did not ban the sale of the smoke-free devices.

E-cigarettes and similar products are sold online and in scores of mall kiosks across the U.S. They deliver nicotine in a puff of hot gas that feels like smoke; nicotine-free versions are also sold.

Now the FDA has tested two of the devices: the Smoking Everywhere and Njoy products.

"The products we reviewed so far we found to be illegal," attorney Michael Levy, director of the FDA's office of compliance in the division of drug evaluation and research, said today during an FDA news conference. But the FDA has not banned them because "There is pending litigation on the issue of FDA's jurisdiction over e-cigarettes," Levy said.

Why call a news conference?

"We felt it important that while there is litigation and we are considering options, there is no reason to be confused about FDA's position on this issue," Joshua Sharfstein, MD, FDA principal deputy commissioner, said.

At the news conference, FDA analyst Benjamin Westenberger described testing 19 cartridges from the two e-cigarettes at the FDA's St. Louis facility. Among the findings:

• All but one cartridge marked as having no nicotine actually contained the addictive substance.
• Cartridges marked as having low, medium, or high amounts of nicotine actually had varying amounts of nicotine.
• One of the cartridges contained a toxic antifreeze ingredient, diethylene glycol.
• The devices emitted "tobacco-specific nitrosamines which are human carcinogens."
• The devices emitted "tobacco-specific impurities suspected of being harmful to humans."

The FDA news conference also featured experts who issued strong warnings against e-cigarettes.

Jonathan Winickoff, MD, chairman of the American Academy of Pediatrics Tobacco Consortium, warned that the products seem "tailor-made to appeal to kids." He said the devices could addict kids to nicotine and turn them into smokers.

Matthew McKenna, MD, director, of the CDC's Office of Smoking and Health, noted that e-cigarettes can be used in smoke-free environments and thus weaken the health benefits of antismoking efforts.

Jonathan Samet, MD, director of the Institute for Global Health at the University of Southern California, warned that e-cigarettes are nothing like FDA-approved nicotine-delivery devices shown to help people quit smoking. He noted that e-cigarettes have no proven benefits but very clear risks.

Since 2008, the FDA has been trying to prevent e-cigarettes from entering the country. To date, 50 shipments have been refused, but this has not stopped distribution and sale of e-cigarettes. Canada fully banned the devices in March 2009.

E-cigarette makers and distributors have argued that their devices are safer than real cigarettes, thereby mitigating the harm of smoking. Some have implied that their products help people quit smoking tobacco products.

The FDA rejects both claims. Because the devices can deliver a dose of synthetic nicotine, the agency sees them as unapproved drug-delivery devices with unknown safety. And whether they can safely help people quit smoking is also unknown, while they have a clear potential to entice new smokers with their fruit and candy flavors.

How E-Cigarettes Work

The e-cigarette comes in many shapes and sizes. Many look more or less like long cigarettes; others look like cigars or pipes. They all work the same basic way:

• The user inhales through a mouthpiece.
• Air flow triggers a sensor that switches on a small, battery-powered heater.
• The heater vaporizes liquid nicotine in a small cartridge (it also activates a light at the "lit" end of the e-cigarette). Users can opt for a cartridge without nicotine.
• The heater also vaporizes propylene glycol (PEG) in the cartridge. PEG is the stuff of which theatrical smoke is made.
• The user gets a puff of hot gas that feels a lot like tobacco smoke.
• When the user exhales, there's a cloud of PEG vapor that looks like smoke. The vapor quickly dissipates.
• E-cigarettes contain no tobacco products; even the nicotine is synthetic.

The devices retail for $100 to $200. Refill cartridge packs vary in price depending on nicotine content, and liquid for do-it-yourself refills are sold, too. Each cartridge is good for several uses.

Device makers say they make no health claims for their products. Craig Youngblood, president of the InLife e-cigarette company, says that since regular tobacco is very bad for you, something that assuages your nicotine habit without smoke must be less bad.

"In our product you have nicotine or no nicotine, PEG, and some flavoring. In cigarettes you have nicotine, PEG, and 4,000 chemicals and 43 carcinogens," Youngblood last April told WebMD. "I am a proponent of harm reduction. People have rights and choices and should be allowed to make them."

Others see the devices as a sneaky way to get people hooked on nicotine. One is Michael Eriksen, ScD, director of the institute of public health at Atlanta's Georgia State University and former director of CDC's office of smoking and health.

"I have seen no evidence that people switch from tobacco cigarettes to e-cigarettes or other smokeless tobacco products," Eriksen recently told WebMD. "If you look at how smokeless products are marketed, they are sold as something to use at times you can't smoke. The implication is you will increase nicotine exposure, not reduce smoking."

SOURCES: Joshua Sharfstein, MD, principal deputy commissioner, FDA. Jonathan Winickoff, MD, chairman, American Academy of Pediatrics Tobacco Consortium. Jonathan Samet, MD, director, Institute for Global Health, University of Southern California. Matthew McKenna, MD, director, Office of Smoking and Health, CDC. Benjamin Westenberger, deputy director, division of pharmaceutical analysis, FDA. Michael Levy, division director, Office of Compliance, Center for Drug Evaluation and Research, FDA. WebMD Health News: "E-Cigarettes Under Fire." FDA news releases, July 22, 2009.

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