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FDA: E-Cigarettes Bad, but Not Banned

FDA Issues Warning as Tests Find Electronic Cigarettes 'Illegal'
By
WebMD Health News
Reviewed by Louise Chang, MD

fda_warning_e_cigarettes_2.jpg

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. 

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