US: FDA Faces Important Decisions on Regulation of E-cigarettes

Source from:  The Clinical Advisor  08/23/2013

The FDA faces a dilemma as electronic cigarettes, or 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.

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 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.

Although e-cigarette vapor is likely less toxic than cigarette smoke, calling it safe is a stretch. Preliminary testings shows the vapor conatins number of toxins, including carcinogenic tobacco-specific nitrosamines (TSNAs) and diethyline glycol, a substance commonly found in antifreeze.

More research on e-cigarette vapor — including its second-hand effects — is required to definitively determine exactly how dangerous it is. The authors proposed several questions around which to base future research:
1.Do low levels of contaminants in e-cigarette vapor pose a health risk?
2.What are the thresholds for toxicity of contaminants in vapor?
3.What should be the basis for product standards for e-cigarettes?
4.Could the risks be ameliorated by changes in engineering?

Regulatory concerns go beyond the chemical background of the product. Even if e-cigarettes are shown to be less toxic than cigarettes, there are social implications to consider, the authors pointed out.

The acceptance and prevalence of smoking a hand-held device may promote and renormalize the use of cigarettes, electronic or not. Nonsmokers may start smoking e-cigarettes before moving on to real ones, and the simultaneous use of both products could postpone or entirely hinder a smoker's quitting efforts.

Furthermore, the FDA must decide how marketing should be regulated in the context of potential benefits and population risks. "This includes deciding the legal age at which minors can purchase the products and other possible access restrictions, as well as evaluating the appeal of the marketing to youth," the authors wrote.

Currently, there are more than 250 e-cigarette brands, each of which uses different liquid nicotine solutions, additives and flavorings.

"A comprehensive regulatory approach to nicotine-containing products is needed," Benowitz and Goniewicz concluded. "Regulation needs to include the full spectrum of products, from the most hazardous to the least hazardous, with consideration of the potential of less harmful products to reduce exposure to the most harmful combustion products from smoked tobacco, while simultaneously evaluating the total public health effects of the policies." Enditem