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
"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
All but one cartridge marked as having no nicotine actually contained the
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
The devices emitted "tobacco-specific nitrosamines which are human
The devices emitted "tobacco-specific impurities suspected of being harmful
The FDA news conference also featured experts who issued strong warnings
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
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
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
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.