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Alerts

Electronic Cigarette - A Potential Health Hazard

07/28/2009

The FDA is warning patients and health care professionals about the potential health hazards associated with use of electronic cigarettes (e-cigarettes). These products are intended for use as an alternative to regular cigarettes. E-cigarettes are battery operated devices which resemble a cigarette. These devices contain cartridges filled with nicotine, flavoring, and other chemicals, which are all vaporized by the e-cigarette. The vapors are inhaled by the user. These products have not been shown by the FDA to be safe and efficacious.

The FDA recently analyzed the contents of 2 brands of e-cigarettes. A chemical found in antifreeze, diethylene glycol, was found in one of the e-cigarette samples. Carcinogens, such as nitrosamines, and other tobacco-specific impurities were detected in many samples. Low levels of nicotine were detected in cartridges which were labeled as not containing any nicotine. The e-cigarettes were also inconsistent with the amount of nicotine delivered with each puff. One product contained twice the amount of nicotine as an FDA-approved nicotine inhalation product for smoking cessation.

The safety and efficacy of e-cigarettes is unknown. They pose a danger to young people, who may easily obtain products online or at malls. These products are not regulated by the FDA but by definition, could be classified as a drug-device combination product. A federal district court case is pending regarding whether these products fall within the FDA’s jurisdiction. Additional details can be found at the following links.

• MedWatch Alert:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173327.htm
• Press Release:
  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm
• Public Health Expert Concerns:
  http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173175.htm
• Summary of FDA Analyses:
  http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm

Updated
July 28, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.