Informing tobacco regulatory policy through laboratory assessment of appeal and demand for flavored tobacco products among young adults

项目总结 这是针对RFA-OD-15-004的重新提交。它响应优先领域#4(电子烟)、#6 (描述口味)，和#9(消费者感知)。监测数据显示， 香料烟草产品(FTP)在年轻人和年轻人中的使用(约18%)相对于任何其他年龄段1-4种香料 被认为是为了掩盖烟草的刺激性，使新的使用者更容易开始使用。果味浓郁， 巧克力味或薄荷味的FTP也有助于人们认为FTP更安全、危害更小和 比非自由贸易伙伴更容易上瘾，5，6所有这些都增强了他们的吸引力和吸引力，增加了好奇心，并促进了 烟草产品的实验。FTP的试验与普通烟草的进展有关 年轻人和年轻人(YAS-定义为18-24岁)的使用和尼古丁依赖。7-11尽管FDA 被禁止的调味香烟、薄荷醇香烟等产品，以及调味雪茄、小雪茄/雪茄、e- 香烟和水烟并不是被禁止的。需要及时研究以确定ftp特征的影响， 如呼吁、对好奇心、启蒙和使用行为等弱势群体，包括雅斯，以便监管 可以根据经验采取有针对性的行动，以最大限度地提高人口健康。电流的限制 烟草产品吸引力的衡量标准是，吸引力可能隐含地--在意识到的情况下--给出 这些产品的已知危害、围绕其使用的社会规范和吸引力之间的潜在不协调 产品营销和包装，包括口味。6借鉴成瘾的双重过程模型，这 研究使用多方法实验室和纵向设计来开发量化FTP吸引力和 解决这些限制的滥用责任，并将告知FDA对烟草产品的监管。我们将招募年轻的 成人(YA)当前吸烟者(n=60)和易感(从不)吸烟者(n=60)，并测量基线含蓄吸引力 对于FTP和非FTP，以及上诉对6个月内烟草使用行为和态度变化的影响 使用每月基于网络的评估。隐性吸引力将通过两项实验室任务进行评估：含蓄的 关联任务(IAT)，衡量参与者准确配对FTP和非FTP图片的速度 与“有吸引力的”或“没有吸引力的”相关的词语，以及一项旨在评估 在价格不断攀升的情况下，对自由贸易伙伴与非自由贸易伙伴的需求。如果隐式ftp请求高于非ftp请求 吸引力，特别是在易受影响的从不使用的人中，如果ftp上诉对烟草使用结果产生负面影响 和态度，这表明自由贸易协定是一个公共健康危害。结果可以为潜在的FDA监管部门提供信息 关于自由贸易协定的决定，包括对其他烟草产品实施加香卷烟禁令，限制销售 将烟草控制方案推广到成人专用场所，并开展反烟草公共卫生运动，以降低烟草控制方案的吸引力。发现 将帮助PI在烟草监管研究方面建立独立的职业生涯，并将为 烟草产品申诉R01将告知FDA对烟草产品的监管，以保护公众健康。

PROJECT SUMMARY This is a resubmission in response to RFA-OD-15-004. It responds to priority areas #4 (e-cigarettes), #6 (characterizing flavors), and #9 (consumer perceptions) in this RFA. Surveillance data document a high prevalence of flavored tobacco product (FTP) use among youth and young adults (~18%) relative to any other age group.1-4 Flavors have been hypothesized to mask the harshness of tobacco, making it easier for new users to initiate. The fruity, chocolatey, or minty flavors of FTPs also contribute to the perception that FTPs are safer and less harmful and addictive than non-FTPs,5,6 all of which enhance their appeal and attractiveness, increase curiosity, and facilitate experimentation with tobacco products. Experimentation with FTPs has been linked to progression to regular tobacco use and nicotine dependence in youth and young adults (YAs-defined as ages 18-24).7-11 Although the FDA has banned flavored cigarettes, products like menthol cigarettes, as well as flavored cigars, little cigars/cigarillos, e- cigarettes, and hookah are not banned. Timely research is needed to determine the impact of FTP characteristics, such as appeal, on curiosity, initiation, and use behavior in vulnerable groups, including YAs, so that regulatory actions can be empirically informed and appropriately targeted to maximize population health. The limitation of current measurements of tobacco product appeal is that appeal likely occurs implicitly - below conscious awareness - given potential dissonance between the known harms of these products, social norms surrounding their use, and the appeal of product marketing and packaging, including flavors.6 Drawing on the Dual Process Model of Addiction, this study uses a multi-method laboratory and longitudinal design to develop new methods for quantifying FTP appeal and abuse liability that address these limitations and will inform FDA regulation of tobacco products. We will recruit young adult (YA) current tobacco users (n = 60) and susceptible (never) users (n = 60) and measure baseline implicit appeal for FTPs and non-FTPs and the impact of appeal on changes in tobacco use behavior and attitudes over 6-months using monthly web-based assessments. Implicit appeal will be assessed via two laboratory tasks: an Implicit Association Task (IAT) that measures the speed with which participants accurately pair pictures of FTPs vs non-FTPs with words related to “attractive” or “unattractive”, and a behavioral economic purchase task designed to assess demand for FTPs vs non-FTPs under escalating price conditions. If implicit FTP appeal is higher than non-FTP appeal, especially among susceptible never users, and if FTP appeal negatively influences tobacco use outcomes and attitudes, this suggests that FTPs are a public health hazard. Results can inform potential FDA regulatory decisions about FTPs, including applying the flavored cigarette ban to other tobacco products, restricting the sale of FTPs to adult-only venues, and developing anti-tobacco public health campaigns to reduce appeal of FTPs. Findings will help the PI establish an independent career in tobacco regulatory research and will provide preliminary data for an R01 of tobacco product appeal that will inform FDA’s regulation of tobacco products to protect public health.