In a July 21, 2011 Perspective article published in the New England Journal of Medicine, the authors challenge the U.S. Food & Drug Administration’s decision to regulate electronic cigarettes as tobacco products and invite further regulation. The authors, Nathan K. Cobb, MD, a pulmonologist and assistant professor at Georgetown University Medical Center, and David B. Abrams, PhD, executive director of the Steven A. Schroeder National Institute for Tobacco Research and Policy Studies, question the regulatory scene for e-cigarettes and raise points for debate among healthcare participants, policy makers and e-cigarette users.
The authors begin by noting that the term e-cigarette itself is misleading, noting that the devices “have more in common with pipes, multi-dose inhalers, nebulizers, or other devices loaded with a drug, whether regulated (such as albuterol) or illicit (such as cocaine).” The article further comments that the lack of regulation, in terms of what constitutes an e-cigarette as well as appropriate dosage delivery levels among products, is problematic given variability among manufacturers studied. The article concludes that “[u]ltimately, Congress, the courts, and the FDA must find an effective regulatory approach for nicotine products that minimizes risk and maximizes the public welfare.”
The article is entitled E-Cigarette or Drug Delivery Device? Regulating Novel Nicotine Products and it is likely that this article will be increasingly referred to by state and local governments seeking to regulate the sale and use of e-cigarettes. The Troutman Sanders Tobacco practice will continue to monitor developments in this area.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco practice partner, at 804.697.1420 or by email.