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NAQC Newsroom: Research

The FDA, E-cigarettes, and the Demise of Combusted Tobacco.

Friday, December 12, 2014  
Posted by: Natalia Gromov
Cobb NK, Abrams DB.
The FDA, E-cigarettes, and the Demise of Combusted Tobacco. 
N Engl J Med. 2014 Oct 16;371(16):1469-71.
In this paper, the authors describe the potential for e-cigarettes to drive smoking cessation in a manner similar to the success, safety and efficacy of FDA approved Nicotine Replacement Therapeutics (NRTs). E-cigarettes can be made safe and effective, provided the FDA regulates them prudently and coordinates the comprehensive regulation of nicotine across its two Centers (CDER and CTP). CTP regulation should require manufacturers of e-cigarettes to register their products, disclose their ingredients, and prohibit sales to young people. With the appropriate product standards, e-cigarettes can be safe alternatives to more lethal cigarettes or any form of combustible tobacco products. FDA and the tobacco control community must ensure that tobacco companies do not avoid disruption of their business models to sell as much lethal combustible products as they can, by marketing innovations designed to sustain high levels of addiction and poly-use of all their existing products. Regulation for cessation could also ensure rapid but rigorous premarket approval for both reduced harm claims and cessation claims with aggressive post market surveillance to drive a wedge between regulated clean-nicotine products and combustible products. The goal is two-pronged: to speed the demise of the combusted cigarette while minimizing any unintended consequences of cleaner nicotine delivery systems, especially to non-users, youth and young adults. It would also include making combusted products less appealing, toxic and addictive (e.g. by mandating a reduction in nicotine levels to below those of e-cigarettes and NRT, eliminating flavorings such as menthol and other flavors found in lethal little cigars and hookah tobacco, and by creating greater price differentials through much higher cigarette/combusted product taxes than for clean nicotine delivery taxes like FDA-regulated e-cigarettes).

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