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.

抽象的 2014年外科医生总报告（SGR）得出的结论是，肺部意外有所增加 腺癌，现在是最常见的肺癌类型。 SGR识别出香烟的通风 过滤器，一种在1960年代引入的设计，也是降低机器测量香烟焦油产量的重要方法， 作为这些肺癌增加的潜在贡献者。在最近的评论中，我们发现了极大的暗示性 过滤通风的香烟的证据是腺癌肺发病率增加的原因 癌症并得出结论，有足够的证据使FDA考虑调节过滤通风， 包括禁令。独立于腺癌的风险，将有足够的理由 根据通风对有害成分产量，吸烟行为和吸烟者的影响的监管 误解健康风险。但是，在采取任何监管行动之前，这种禁令的后果 被研究。该P01描述了一组系统和全面的研究，该研究检查了毒性， 在市场背景下，与通风过滤器相比，未通风过滤器的上诉和滥用责任 有和没有替代性尼古丁输送系统（和）。四个集成项目和三个核心是 提议并参与了一组跨学科研究人员，他们共同努力开发 验证了测试烟草产品的模型和措施。这四个项目解决了1）如何无泄漏的VS。 抽烟通风的香烟，并在使用时导致的致癌水平和潜在的伤害 有或没有和没有（项目1）； 2）这些通风的相对滥用责任与未发泄的香烟 以及在多大程度上用来代替未发泄香烟的替代品（项目2和3）； 3） 通风和产品包装/消息传递对消费者对危害，反应和反应的看法的影响 吸收以及如何通过AND修改这些感知（项目4）。这项研究在许多方面都是新颖的， 包括第一个评估删除过滤通风并在复杂情况下进行此操作的影响的影响 烟草市场。我们建议的项目高度整合。这些研究都不能 解决禁令对通风的影响。这是这些互补研究的组合 这可以解决禁止毒性，摄取和产品强度来确定人口的影响 健康影响。这项研究的结果将为美国食品和药物提供关键信息 关于禁令是否会改善公共卫生的管理。