Consortium on Methods Evaluating Tobacco (COMET): FilterVentilation and Product Standards

烟草评估方法联盟 (COMET)：过滤器通风和产品标准

• 批准号: 10246918
• 负责人: DOROTHY K HATSUKAMI
• 金额: $ 248.85万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10246918
• 关键词: Address; Adenocarcinoma; Adopted; Affect; Alternative Nicotine Delivery Systems; Animal Experimentation; Animals; Applications Grants; Belief; Biological Markers; Biometry; Blood; Burn injury; Carcinogen exposure; Carcinogens; Cigarette; Clinical Trials; Complex; Dangerousness; Decision Making; Economic Models; Elasticity; Electronic cigarette; Epidemiology; Etiology; Evaluation; Excision; Exposure to; Goals; Health; Human; Incidence; Inhalation; Lead; Literature; Lung; Lung Adenocarcinoma; Malignant neoplasm of lung; Marketing; Measurement; Measures; Methods; Modeling; Mutagens; Nicotine; Perception; Peripheral; Population; Product Packaging; Public Health; Publishing; Randomized Clinical Trials; Regulation; Reporting; Research; Research Personnel; Risk; Self Administration; Self Stimulation; Series; Services; Smoke; Smoker; Smoking; Smoking Behavior; Suggestion; Surgeon; Tars; Testing; Tobacco; Tobacco Industry; Toxic effect; Toxicant exposure; United States Food and Drug Administration; Urine; Variant; Work; base; behavioral economics; cigarette smoke; combustible cigarette; design; exposed human population; improved; innovation; interest; laboratory experiment; multidisciplinary; novel; novel marker; population health; response; smoking prevalence; tobacco products; tobacco tar; uptake; ventilation

ABSTRACT The 2014 Surgeon General Report (SGR) concluded that there has been an unanticipated increase in lung adenocarcinomas, now the most common type of lung cancer. The SGR identified ventilation in cigarette filters, a design introduced in the 1960s and an important way to lower machine measured cigarette tar yields, as a potential contributor to the increase in these lung cancers. In a recent review, we found highly suggestive evidence that filter ventilated cigarettes was the cause of the increased incidence of adenocarcinoma lung cancer and concluded that there was enough evidence for the FDA to consider regulating filter ventilation, including a ban. Independent of the risk for adenocarcinoma, there would be sufficient justification for regulation based on the impact of ventilation on harmful constituent yields, smoking behavior and smokers' misperception of health risks. However, prior to any regulatory action, the consequences of such a ban needs to be studied. This P01 describes a set of systematic and comprehensive studies that examines the toxicity, appeal and abuse liability of unventilated filters as compared to ventilated filters in the context of a marketplace with and without alternative nicotine delivery systems (ANDS). Four integrated projects and three cores are proposed and involve a team of multi-disciplinary investigators who have worked together in developing validated models and measures to test tobacco products. The four projects address 1) how unventilated vs. ventilated cigarettes are smoked and the resulting carcinogen exposure levels and potential harm when used with and without ANDS (Project 1); 2) the relative abuse liability of these ventilated vs. unventilated cigarettes and the extent to which ANDS serves as a substitute for unventilated cigarettes (Projects 2 and 3); and 3) the effects of ventilation and product packaging/messaging on consumer perceptions of harm, response and uptake and how these perceptions can be modified by ANDS (Project 4). This research is novel in many ways, including the first to assess the impact of removing filter ventilation and doing this in the context of a complex tobacco marketplace. The projects that we propose are highly integrated. None of these studies alone can address the population impact of a ban on ventilation. It is the combination of these complementary studies that can address the impact of a ban on toxicity, uptake and intensity of product use to determine population health impact. The results of this study would provide critical information to the U.S. Food and Drug Administration on whether or not a ban would lead to improved public health.

摘要 2014年外科医生总报告（SGR）得出结论， 腺癌，现在是最常见的肺癌类型。SGR确定了香烟中的通风 过滤嘴是20世纪60年代推出的一种设计，是降低卷烟焦油量的重要方法， 是导致这些肺癌增加的潜在因素。在最近的一次调查中，我们发现 有证据表明过滤嘴通风香烟是肺腺癌发病率增加的原因 并得出结论，有足够的证据让FDA考虑调节过滤器通气， 包括禁令。与腺癌风险无关，有充分的理由 基于通风对有害成分产量、吸烟行为和吸烟者的健康的影响的法规 对健康风险的误解。然而，在采取任何监管行动之前，这种禁令的后果需要 有待研究。本P01描述了一系列系统和全面的研究，检查了毒性， 在市场环境中，与通风过滤器相比，不通风过滤器的上诉和滥用责任 有和没有替代尼古丁输送系统（ANDS）。四个一体化项目和三个核心是 建议并涉及一个多学科调查人员小组，他们共同努力， 经验证的模型和措施，以测试烟草产品。这四个项目解决1）如何不通风与 吸通风香烟，使用时产生的致癌物暴露水平和潜在危害 有和没有ANDS（项目1）; 2）这些通风与不通风香烟的相对滥用倾向 以及ANDS作为不通风香烟的替代品的程度（项目2和3）;以及3） 通风和产品包装/信息对消费者对伤害、反应和 吸收和如何通过阿富汗国家发展战略改变这些看法（项目4）。这项研究在很多方面都是新颖的， 包括第一次评估去除过滤器通风的影响，并在一个复杂的环境中这样做， 烟草市场我们提出的项目是高度一体化的。单靠这些研究， 解决通风禁令对人口的影响。正是这些互补研究的结合 这可以解决禁止使用产品的毒性、摄入量和强度的影响， 健康影响。这项研究的结果将为美国食品和药物管理局提供关键信息。 政府对禁令是否会改善公众健康表示怀疑。