Abstract SY01-03: Reducing harm by targeting the addictiveness of combusted tobacco products through regulated reductions in nicotine content

Nicotine is the primary addictive constituent in cigarettes, driving chronic dependent use in millions of Americans. Approximately half of those individuals will die as a result of smoking unless they quit. One strategy for greatly reducing the harm caused by smoking is to limit the nicotine content of cigarettes and other combusted tobacco products to levels that are less addictive. This approach differs from so-called “light” and “ultralight” cigarettes, which have nicotine content similar to full-flavored cigarettes; light cigarettes reduce machine-measured nicotine yield as a consequence of ventilation, a design feature that smokers can easily overcome (e.g., by inhaling larger volumes) to maintain high levels of nicotine exposure. True regulated reductions in nicotine content became possible in 2009 when the Family Smoking Prevention and Tobacco Control Act gave the U.S. Food and Drug Administration (FDA) the authority to reduce (but not eliminate) the nicotine in tobacco products. Consequently, the FDA and NIH are supporting a large portfolio of research aimed at evaluating the potential public health impact of product standards that would reduce the nicotine content of cigarettes. This presentation focuses primarily on recent randomized clinical trials in which participants are provided investigational cigarettes with varying levels of nicotine and followed over weeks to months to assess the potential benefits and risks of regulated reductions in nicotine. These studies indicate that reducing the nicotine content of cigarettes by approximately 85% or more leads to fewer cigarettes smoked per day, reduced nicotine exposure, and/or reduced nicotine dependence with little evidence of compensatory smoking or other unintended consequences. In addition, preclinical data from rat models of nicotine self-administration indicate that nicotine reduction would likely also decrease the initiation of use among nicotine-naive adolescent users. These data, if supported by other ongoing trials, raise critically important questions about whether and how a product standard that limits the nicotine content of all combusted tobacco products might be promulgated to reduce the harms associated with smoking. Further discussion of this approach and how it might interact with the rapidly changing landscape of tobacco products (e.g., e-cigarettes) should be a high priority for all those interested in the prevention of tobacco-related disease. Funding: Research reported in this presentation was supported by the National Institute on Drug Abuse and FDA Center for Tobacco Products (CTP) (U54 DA031659). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration. Citation Format: Eric Donny. Reducing harm by targeting the addictiveness of combusted tobacco products through regulated reductions in nicotine content [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr SY01-03. doi:10.1158/1538-7445.AM2017-SY01-03