While the anti-tobacco movement has made major legislative strides over the years in the fight against death and disease caused by cigarette smoking and other tobacco products, a new tobacco substitute may interfere with this progress: the electronic cigarette or e-cigarette. The e-cigarette is a battery-powered device that is “designed to mimic cigarettes by vaporizing a nicotine-laced liquid that is inhaled by the user.” It often looks like a traditional cigarette or a thin metal tube. The supposed benefit is that e-cigarettes emit a scentless vapor, unlike the bothersome smoke of traditional cigarettes. Some even claim that e-cigarettes are a healthier alternative to other tobacco products. While the e-cigarette may be less of a nuisance than traditional cigarettes, there is no consensus that the e-cigarette is safer for the user or others who may be exposed to second-hand vapor exhaled by users. Due to the e-cigarette’s recent appearance on the market, the potential risks of inhaling chemicals contained in the vapors have not been well studied. Along with nicotine, chemicals found in e-cigarettes include formaldehyde, propylene glycol, glycerol, and other carcinogens and toxic chemicals.
The e-cigarette is now a growing trend among cigarette smokers who are hard-pressed to find places that permit cigarette smoking due to strict anti-smoking laws. More alarmingly, e-cigarettes may become a growing trend among youth. And considering e-cigarettes often come in a variety of attractive flavors such as bubblegum, chocolate, and cherry, use of e-cigarettes among children and teens is especially worrisome. Moreover, there is currently insufficient information to determine whether e-cigarettes serve as a gateway product for youth to become addicted to traditional cigarettes or other tobacco products already known to lead to disease and/or death.
The U.S. Food and Drug Administration (FDA) has recently begun to address the regulation of e-cigarettes. The Family Smoking Prevention and Tobacco Control Act of 2009 (“Tobacco Act”) authorized the FDA to regulate tobacco products, including cigarettes, roll-your-own tobacco and smokeless tobacco. However, the Tobacco Act does not currently extend the FDA’s authority to e-cigarettes, although the FDA’s Center for Drug Evaluation and Research (CDER) regulates e-cigarettes “marketed for therapeutic purposes.” In Sottera, Inc. v. FDA, the FDA attempted to regulate e-cigarettes under the drug/device provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). 627 F.3d 891 (D.C. Cir. 2010). Regulating e-cigarettes as a drug or device under the FDCA would have required e-cigarette manufacturers to demonstrate that the e-cigarette was “safe and effective for its intended use” and ensure adequate manufacturing methods, thus imposing standards applicable to drugs and devices. The D.C. Circuit Court disagreed that e-cigarettes were drugs or devices and concluded that the FDA already possessed the authority to regulate tobacco products under the Tobacco Act. Therefore, according to the court, the FDA may extend that authority to include e-cigarettes (although the court acknowledged that e-cigarettes specifically marketed for therapeutic purposes do fall under the purview of the FDCA). Id at 899.
To that end, the FDA recently issued a proposed rule on April 25, 2014 that would extend the definition of “tobacco product” to cover e-cigarettes and other new tobacco products. If the proposed rule is finalized, the FDA could impose age restrictions on the sale of e-cigarettes, require e-cigarette manufacturers to display health warnings, and mandate thorough scientific review regarding the health effects of e-cigarettes. The FDA will hold a final public workshop on June 1-2, 2015 and accept public comments on e-cigarettes and public health through July 2, 2015.
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