Controversy surrounds electronic cigarettes. Critics say that the unregulated products deliver harmful toxins and can lead children and young people to use other tobacco products. Proponents claim that the devices can help people gradually quit smoking, especially if they have been unsuccessful with other cessation methods. Electronic cigarettes, or e-cigarettes, are battery-powered devices that deliver nicotine in vapor form without tobacco or smoke. Most resemble conventional cigarettes, cigars, or pipes, although some look more like pens or even USB flash drives. Users insert replaceable cartridges into the device; the cartridges contain nicotine, usually dissolved in a clear, colorless liquid called propylene glycol. Inhalation activates a heating device that turns the liquid into a vapor. For several years, FDA has expressed concern about the safety of e-cigarettes and how they are marketed. In 2009, the agency conducted a preliminary analysis of the ingredients in some samples of e-cigarettes and their components. According to the study, potentially harmful tobacco-specific impurities such as anabasine, myosmine, and betanicotyrine were found in a majority of the samples tested. Half the samples also tested positive for the presence of certain tobacco-specific nitrosoamines that are known human carcinogens. In one sample, researchers detected diethylene glycol, a toxic chemical used in antifreeze. In addition to safety concerns, FDA has warned that bubble gum– and chocolate-flavored versions of e-cigarettes could appeal to young people and encourage them to move on to smoking tobacco. The agency also expressed concern over the lack of quality control and labeling accuracy of e-cigarettes. According to a 2011 study by Anna Trtchounian and Prue Talbot, PhD, published in Tobacco Control, most e-cigarette liquid and cartridge labels do not specify whether the stated amount of nicotine is per cartridge or per milliliter. The authors said that regulation of manufacturing, quality control, sales, and advertising of e-cigarettes are needed. FDA has expressed a desire to regulate electronic cigarettes, but because the products aren’t marketed as therapeutic devices, the agency’s jurisdiction over them has been challenged in court. The agency announced in April 2011 that it will not attempt to regulate the products as drugs or devices but will develop a strategy to regulate them as tobacco products. Some researchers, such as Jonathan Foulds, PhD, Professor of Public Health Sciences and Psychiatry at Penn State University College of Medicine, believe that while more research on e-cigarettes is needed, they may hold promise for reducing tobacco use. In a 2011 study, Foulds and colleagues surveyed 104 long-term e-cigarette users and found that 78% no longer used tobacco. Foulds stressed that his study was not designed to be a representative sample of all consumers who had tried e-cigarettes; the sample was drawn from a self-selected group of e-cigarette users who had used the products for, on average, more than a year. While he believes smokers should be “strongly directed towards evidence-based treatments [such as] counseling and approved medicines like nicotine replacement, bupropion, or varenicline [Chantix—Pfizer] rather than to e-cigarettes,” Foulds said that he wouldn’t counsel a patient who has stopped smoking by using e-cigarettes to stop using them. “We shouldn’t be scaring patients away from these products if they’ve had success quitting smoking with e-cigarettes because it’s very, very unlikely that e-cigarettes are as harmful as the 4,000-plus chemicals that smokers are inhaling with tobacco cigarettes,” Foulds said. “The focus should be on staying smoke free rather than e-cigarette free.” Michael Siegel, MD, MPH, Professor of Community Health Sciences at Boston University School of Public Health, agreed that while e-cigarettes need to be regulated to ensure quality control, they could help smokers trying to quit. “Most smokers who try to quit using traditional methods are unsuccessful. Only 3% actually completely quit in any given year, which is a dismal rate even with all the existing smoking cessation products on the market,” he said. “In this context, we need some alternatives.” Seigel and Foulds recommended allowing e-cigarettes to remain on the market in the hope that a manufacturer would be willing to conduct randomized controlled trials and put quality controls into place. Foulds said he sees the potential in e-cigarettes for a powerful smoking cessation tool. “I’m optimistic about the potential of e-cigarettes, but we don’t have the data yet to prove it,” he said. For these researchers, the e-cigarette question comes down to weighing the lesser of two evils. Siegel said he worries that former cigarette smokers may return to tobacco if e-cigarettes are no longer available. “My hope is that FDA doesn’t take e-cigarettes completely off the market while leaving [tobacco] cigarettes on,” said Foulds.
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Mar 7, 2014
Aaron Levin 
Open Access