FDA plans to regulate devices as “tobacco products.”
Electronic cigarettes, or e-cigarettes, provide a water vapor-powered alternative to traditional smoking that may help users drop the unhealthy habit. But, in light of the recent finding that use among middle and high school students is rapidly increasing, the Food and Drug Administration (FDA) has indicated that a new regulatory regime to manage these novel products more effectively is on the horizon.
E-cigarettes are battery-powered products that deliver nicotine to the user through an aerosol. The e-cigarette applies heat to a solution containing nicotine and other additives, producing a water vapor that the user inhales. As e-cigarettes may contain fewer chemicals than traditional cigarettes and rely on water-based delivery method, tobacco companies have successfully marketed them as a safer alternative that can help users quit smoking altogether. While the FDA emphasizes that the products have not be sufficiently studied to support such health claims, a recent independent research study found that the products may be effective in facilitating smoking cessation.
Fueled by star-studded advertising campaigns and the successful marketing message that “it’s O.K. to smoke again,” the e-cigarette industry has boomed in recent years. However, following the announcement of recent findings by the Centers for Disease Control and Prevention (CDC), regulators are now concerned that the industry is profiting from a surge in middle and high school-aged users.
Observers have expressed concern that the marketing tactics employed by e-cigarette producers effectively “re-glamorize” smoking in a way that particularly attracts young users. Matthew L. Mayers, president of the Campaign for Tobacco-Free Kids, explains, “[i]t is beyond troubling that e-cigarettes are using the exact same marketing tactics we saw the tobacco industry use in the ’50s, ’60s and ’70s, which made it so effective for tobacco products to reach youth.”
According to the CDC study, e-cigarette use among middle and high school students has doubled in recent years. Based on student surveys, the percentage of high school students who had tried e-cigarettes increased from 4.7 percent in 2011 to 10.0 percent in 2012. Middle school students reported a similar trend, as their usage increased from 3.3 percent in 2011 to 6.8 percent in 2012. The results of the 2013 Florida Youth Tobacco Survey reflect a similar upswing in usage. Further, while most high school students indicate that they have experimented with both traditional and e-cigarettes, an increasing number of middle school students reported trying e-cigarettes only.
These data have created concern among regulators that, instead of helping users quit smoking, e-cigarettes are serving as a gateway to smoking for young users. As 90 percent of smokers pick up the habit during their teenage years, CDC Director Tom Frieden worries that “[m]any teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.” Director of the CDC Office on Smoking and Health Tim McAfee agrees, stating “[w]e must keep our youth from experimenting or using any tobacco product. These dramatic increases suggest that developing strategies to prevent marketing, sales, and use of e-cigarettes among youth is critical.”
Despite the product’s popularity among both adults and minors, e-cigarettes are currently subject to minimal regulation. Besides e-cigarettes specifically marketed for therapeutic purposes, e-cigarettes currently remain unregulated by federal agencies. While the FDA has the power to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, its regulatory authority presently does not extend to e-cigarette products.
Similarly, in addition to escaping regulation by the FDA, e-cigarettes are also not subject to comprehensive state-level regulation. For example, most states do not currently prevent minors from purchasing e-cigarettes, resulting in increased access to the product for many young Americans. However, in response to recent reports on the spike in youth users, an increasing number of states has begun to pass bills blocking sales to minors in the past several months.
Producers of e-cigarettes emphasize that they do not market their products to minors. Rather, industry representatives argue that their advertising campaigns are directed at adults seeking help defeating the habit of smoking traditional cigarettes. Further, at least one industry group—the Tobacco Vapor Electronic Cigarette Association—has announced its support of “responsible regulation,” including a ban on sales of e-cigarettes to minors.
To gain the authority to regulate e-cigarettes, the FDA plans to issue a proposed rule that would “extend FDA’s tobacco product authorities to products that meet the statutory definition of ‘tobacco product.’” While the FDA delayed e-cigarette regulation earlier this year, citing the need for further research, the agency has indicated that observers may expect a notice of proposed rulemaking by October of this year.