Research Project 2: Modeling the Impact of Nicotine Regulation on Smoking and Smoking-Related Mortality

项目2 -摘要 长期以来，尼古丁一直被认为是烟草中的主要成瘾物质。食品药品 美国食品和药物管理局（FDA）有权监管所有烟草的尼古丁水平（而不是消除它） 产品，必须解决这个问题。在实施任何政策之前，FDA必须制定一项 彻底评估该政策对公众健康可能造成的影响。同时降低尼古丁含量 虽然可能会导致吸烟率下降，但这些政策可能会产生意想不到的后果。 这将削弱其效力。我们提出的分析将研究尼古丁监管如何可能 影响公众健康，包括赔偿行为可能产生的意外后果， 黑市的出现。该项目的结果将告知FDA，因为它考虑设计， 评估和论证旨在将烟草制品中的尼古丁减少到非成瘾水平的政策。 该项目的目的是：（1）修改美国现有的两个基于人口的动态吸烟流行率， 死亡率模型，以解释将尼古丁降低到非成瘾水平的政策的影响， 燃烧的烟草制品;（2）模拟新吸烟者的数量，吸烟流行轨迹，以及 在没有尼古丁监管的情况下，2018-2100年美国人口吸烟相关死亡率;以及（3） 就尼古丁法规对吸烟流行率的影响进行政策模拟演习， 相关死亡率。我们将重点关注吸烟流行率和总体吸烟率的潜在政策相关变化， 死亡率;然而，其他健康结果可能会被纳入，因为它们可以从项目一获得。 虽然这项研究的重点将是尼古丁的减少，但模型将具有足够的灵活性，可以检查 其他FDA法规的影响，以改变香烟的内容，如对特定有毒成分的限制。这 项目将侧重于影响分析（目标3）和健康影响（目标2和3），其次侧重于 成瘾（目标1和2），如RFA-OD-17-006所述。

PROJECT 2 - Abstract Nicotine has long been known to be the primary addictive substance in tobacco. The Food and Drug Administration (FDA) has the authority to regulate the nicotine levels (without eliminating it) on all tobacco products and is required to address this issue. Before implementing any policy, the FDA must make a thorough assessment of the likely impacts of the policy on the public’s health. While lowering nicotine levels might be expected to lead to declining smoking rates, such policies could generate unintended consequences that would undermine their effectiveness. Our proposed analysis will examine how nicotine regulation may impact the public’s health, including possible unintended consequences from compensation behaviors and the emergence of a black market. The results of this project will inform the FDA as it contemplates designing, evaluating and justifying a policy aimed at reducing nicotine in tobacco products to non-addictive levels. The Aims of the Project are: (1) to modify two existing US population-based dynamic smoking prevalence and mortality models to account for the effects of policies that reduce nicotine to non-addictive levels in all combusted tobacco products; (2) to model the number of new smokers, smoking prevalence trajectory, and smoking-related mortality in the US population from 2018-2100 in the absence of nicotine regulation; and (3) to conduct policy simulation exercises on the impact of nicotine regulations on smoking prevalence and associated mortality. We will focus on potential policy-related changes to smoking prevalence and overall mortality; however, other health outcomes may be incorporated as they become available from Project One. While the focus of the study will be on nicotine reduction, the models will be flexible enough to examine the effect of other FDA regulations to alter cigarette content, such as limits on particular toxic ingredients. This Project will focus on Impact Analysis (Aim 3) and Health Effects (Aims 2 and 3), with a secondary focus on Addiction (Aims 1 and 2), as described in RFA-OD-17-006.