Nicotine Emissions, Toxicity, and Behavior by Electronic Cigarettes

描述（由申请人提供）：随着2009年《家庭预防和烟草控制法案》的通过，联邦政府获得了对烟草制品配方和营销的监管权力。尽管在传统烟草产品的开发和评估方面，有大量的科学资料可以向FDA提供信息，但在电子烟方面却几乎没有科学资料。由于缺乏描述这些产品实际使用情况和由此产生的健康影响（包括毒性和滥用责任）的数据，目前阻碍了对终端产品制定适当的监管政策。在此，我们的多学科研究建议在电子烟和香烟之间建立尼古丁排放量和剂量的比较，并评估这些剂量是否会在小鼠体内产生毒理学反应。在拟议的研究中，我们验证了这样一个假设：与传统香烟相比，电子烟使用者接触到的尼古丁含量较低，但这些接触水平会在体内诱发有毒的氧化和炎症反应，并导致与吸烟相当的成瘾。我们的具体目标是：(1)确定电子烟的成分、成分和设计特征在不同制造商之间的差异，以及消费者使用行为对排放的影响；(2)确定电子烟在小鼠模型中是否具有与传统香烟烟雾相似的体内毒性氧化损伤和促炎作用，以及长期接触电子烟后小鼠对电子烟的依赖性和成瘾性。这项研究的结果将影响消费者对电子烟的使用和尼古丁替代疗法的有效性的决定。目前，这种消费者观念是在没有独立科学数据支持的情况下形成的。此外，本研究对吸烟引起的呼吸系统和心血管疾病以及癌症的尼古丁相关疾病机制具有更广泛的意义。总体而言，该提案将确定电子烟中存在的有害成分的潜在毒性和健康影响，确定接触的毒性，了解电子烟的依赖性和成瘾性。该项目将为FDA提供相关发现和数据，为电子烟的生产、分销和营销监管提供信息，并最终为FDA提供信息

DESCRIPTION (provided by applicant): With the passage of the Family Prevention and Tobacco Control Act of 2009, the Federal Government has gained regulatory authority over the formulation and marketing of tobacco based products. Although a great deal of science is available to inform the FDA on the development and evaluation of conventional tobacco products, little science is available on electronic cigarettes. Appropriate regulatory policy for ENDS is currently hindered by the lack of data describing realistic use of these products and the resulting health impacts, including toxicity and abuse liability. Herein, our multidisciplinary tea proposes to establish comparative nicotine emissions and dosages between e-cigarettes and cigarettes, and to evaluate whether or not these doses result in toxicological responses in vivo in mice. In the proposed study, we test the hypothesis that electronic cigarette users are exposed to lower amounts of nicotine compared to conventional cigarettes, but that these exposure levels will induce toxic oxidative and inflammatory responses in vivo, and addiction comparable to that seen from smoking. Our specific aims are to (1) Determine how the constituents, components and design features of electronic cigarettes vary among different manufactures and how emissions are affected by consumer use behaviors, and (2) determine if e-cigarettes have toxic oxidative damage and pro inflammatory effects in vivo in mouse models similar to conventional cigarette smoke, and dependence potential and addictive properties of electronic cigarettes in mice after chronic e-cigarette exposures. Results of this study will impac consumer's decisions regarding the use and effectiveness of electronic cigarettes for nicotine replacement therapy. Currently, such consumer perceptions are being formed the without the benefit of independent scientific data. Furthermore, this study has broader implications on the nicotine-related disease mechanisms of smoking induced respiratory and cardiovascular diseases, and cancer. Overall, this proposal will determine the potential toxicity and health implications of harmful constituents present in electronic cigarettes, determine the toxicity of exposure, understand the dependence potential, and addictiveness of electronic cigarettes. This project will serve the FDA by generating relevant findings and data needed to inform the regulation of the manufacture, distribution, and marketing of electronic cigarettes, and ultimately provide the scientific data needed to determine if electronic cigarette use has a negative or positive impact on public health.