FDA faces important decisions on regulation of EGO CE4 e-cigarettes-Priceangels.com

The FDA faces a dilemma as electronic cigarettes, or CE4 e-cigarettes, grow in popularity, according to researchers.The agency initially tried to block the sale of e-cigarettes, claiming that they were unapproved “drug/device combinations.” Manufacturers successfully challenged the FDA's position, but in a 2010 ruling, a federal appeals court held that e-cigarettes could be regulated by the agency as tobacco products.

In 2010, 11.4% of U.S. smokers report ever using an e-cigarette, and 4.1% report using one within the last 30 days, the most recent data from two surveys that involved more than 6,000 people indicate. In the city of Boston, 28 permits to sell e-cigarettes were given out in June 2013, compared with only three in June 2012.

Yet many of the alleged benefits of e-cigarettes are unproven and tighter regulations to ensure the quality of the product are needed to protect public safety.At the same time more regulation could slow down innovation and production -- delaying the potential benefits a shift away from traditional cigarettes may yield, Neal L. Benowitz, MD, of the University of California San Francisco and Maciej L. Goniewicz, PhD, of Roswell Park Cancer Institute, Buffalo, New York, suggested in the Journal of the American Medical Association.fg342GFD

They explained the unknowns, weighed the agency's options and made several recommendations for how to proceed in a Viewpoint published online.First introduced in 2007, e-cigarettes are the latest form of nicotine replacement therapy (NRT). The mechanism of action is a battery-powered device that heats a nicotine solution, creating an inhalable vapor without burning tobacco products or other toxins usually found in cigarettes.

Other NRT methods include nicotine patches and nicotine gum, but EGO CE4 e-cigarettes have surpassed these methods in popularity as they mimic a real cigarette in appearance and absorption method. E-cigarettes also enable those who want to quit for health reasons to retain smoking culture.

E-cigarette proponents say the product facilitates smoking fewer cigarettes and may help users quit entirely, but a longitudinal analysis using population-level data show no difference in quit rates among e-cigarette users and regular smokers.

"Controlled clinical trials and population-level observational cohort studies are needed to establish the utility of these cigarettes to facilitate smoking cessation. Research is also needed regarding the role of e-cigarettes in harm reduction, including reduced cigarette smoking and associated reduction of tobacco toxicant exposure," Benowitz and Goniewicz recommended.