ecigarettes_0709

Consumer Health Information
www.fda.gov/consumer
submitted to FDA, consumers currently have no way of knowing
· whether e-cigarettes are safe for their intended use
· about what types or concentrations of potentially harmful chemicals, or what dose of nicotine they are inhaling when they use these products
The potential health risks posed by the use of e-cigarettes were addressed in a July 22, 2009, phone conference between Joshua M. Sharfstein, M.D., principal deputy commissioner of food and drugs; Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium; Jonathan Samet, M.D., director of the University of Southern California’s Institute for Global Health; and Matthew T. McKenna, M.D., director of the Office on Smoking and Health at the national Centers for Disease Control and Prevention.
Conference participants stressed the importance of parents being aware of the health and marketing concerns associated with e-cigarettes. It was stated that parents may want to tell their children and teenagers that these products are not safe to use.
Of particular concern to parents is that e-cigarettes are sold without any legal age restrictions, and are available in different flavors (such as chocolate, strawberry and mint) which may appeal to young people.
In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.
During the phone conference, which was shared with the news media, FDA announced findings from a laboratory analysis that indicates that electronic cigarettes expose users to harmful chemical ingredients.
FDA’s Division of Pharmaceutical Analysis—part of the agency’s Center for Drug Evaluation and Research—analyzed the ingredients in a small sample of cartridges from two leading brands of e-cigarette samples.
One sample was found to contain diethylene glycol, a toxic chemical used in antifreeze. Several other samples were found to contain carcinogens, including nitrosamines.
Agency Actions
FDA has been examining and detaining shipments of e-cigarettes at the border and has found that the products it has examined thus far meet the definition of a combination drug device product under the Federal Food, Drug, and Cosmetic Act.
The agency has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court.
FDA is planning additional activities to address its concerns about electronic cigarettes.
Meanwhile, health care professionals and consumers may report serious adverse events or product quality problems with the use of e-cigarettes to FDA through the MedWatch program, either online at www.fda.gov/Safety/MedWatch/default.htm or by phone at 1-800-FDA-1088.
This article appears on FDA’s Consumer Updates page (www.fda.gov/ForConsumers/ConsumerUpdates/default.htm), which features the latest on all FDA-regulated products.
For More Information
FDA Press Release
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm
E-Cigarettes: FDA Web page
www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.