No Sisyphean Task: How the FDA Can Regulate Electronic Cigarettes
32 Pages Posted: 28 Jul 2012 Last revised: 17 Jul 2013
Date Written: October 16, 2012
The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers have tried everything from “low” or “light” cigarettes; nicotine-infused chewing gum, lozenges and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the internet, reaching a rapidly expanding international market. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, convenient, and easily accessible alternative to cigarettes.
The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), for their unknown effects on public health and an absent safety profile. Existing at a murky area among traditional cigarettes and other products deemed “tobacco products” under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation based on their novel technology, various components, and nearly nonexistent safety and efficacy data. Recent case law restricting FDA enforcement efforts against e-cigarettes further complicates the matter.
This article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act (TCA). It examines the tumultuous history of attempts at tobacco regulation by reflecting on the history of Congressional activity to regulate tobacco advertising and promotion; analyzes the legislative provisions and overarching authority imparted to the FDA over tobacco products contained in the TCA; provides an overview of the e-cigarette industry, promotional tactics, public perceptions, and FDA actions against e-cigarettes; compares judicial and regulatory outcomes with e-cigarettes to previous novel nicotine delivery products and discusses the importance of the scope of intent in marketing and advertising; and suggests a feasible approach to strengthening regulation of e-cigarettes under the TCA framework.
Keywords: electronic cigarettes, FDA, Family Smoking Prevention and Tobacco Control Act, marketing, promotion, safety
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