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

研究项目 2：模拟尼古丁监管对吸烟和吸烟相关死亡率的影响

• 批准号: 10251104
• 负责人: David Mendez Emilien
• 金额: $ 43.5万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10251104
• 关键词: Accounting; Address; Adoption; Affect; Age; Attenuated; Behavior; Cancer Intervention and Surveillance Modeling Network; Cigarette; Consumption; Data Analyses; Development; Devices; Dose; Effectiveness; Electronic cigarette; Exercise; Financial compensation; Future; Gender; Growth; Health; Individual; Lead; Modeling; Nicotine; Outcome; Pattern; Policies; Population; Prevalence; Public Health; Regulation; Research; Research Project Grants; Smoker; Smoking; Smoking History; Structure; Tobacco; Toxin; United States Food and Drug Administration; addiction; authority; cigarette smoke; data dissemination; design; flexibility; models and simulation; mortality; population based; simulation; smoking prevalence; tobacco products; tobacco regulation; trend

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.

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。食品与药品 美国食品药品监督管理局(Fda)有权对所有烟草中的尼古丁水平进行管制(而不是消除它)。 产品，并需要解决这一问题。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产生的影响。同时降低尼古丁水平 可能会导致吸烟率下降，但这样的政策可能会产生意想不到的后果 这将削弱它们的有效性。我们建议的分析将研究尼古丁监管如何 影响公众健康，包括赔偿行为可能产生的意外后果以及 黑市的出现。该项目的结果将在FDA考虑设计时通知FDA， 评估和证明一项旨在将烟草产品中的尼古丁降低到不会使人上瘾的水平的政策的合理性。 该项目的目标是：(1)修改美国现有的两个基于人口的动态吸烟流行率和 考虑将尼古丁降至非成瘾性水平的政策效果的死亡率模型 焚烧烟草制品；(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年美国人口中与吸烟有关的死亡率；以及(3) 就尼古丁法规对吸烟流行率的影响和 相关死亡率。我们将重点关注吸烟流行率和总体上与政策相关的潜在变化 死亡率；然而，当其他健康成果从项目一中获得时，它们可能被纳入其中。 虽然研究的重点将是尼古丁的减少，但这些模型将足够灵活，可以检查 改变卷烟成分的FDA其他法规的影响，例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)，次要重点是 上瘾(目标1和2)，如RFA-OD-17-006所述。