Uptake and Patterns of Use of the IQOS Heated Tobacco System by US Smokers

项目摘要 2019年4月30日，美国食品药品监督管理局（FDA）发布了一项营销令，授权IQOS “烟草加热系统”（IQOS），由菲利普莫里斯国际制造，用于州际贸易， 美国IQOS由一个电子系统保持器和可充电电池组成，可加热烟草填充棒 （热棒）以产生含尼古丁的气雾剂。菲利普莫里斯美国公司选择了格鲁吉亚的亚特兰大作为其第一个 测试IQOS市场，并在多个零售接触点推出，包括IQOS旗舰店、移动的零售 2019年10月，在约400家零售贸易合作伙伴商店分销Heatstick。关键在于FDA的 IQOS的营销顺序是评估IQOS用户将主要是目前的香烟 吸烟者和相当大的比例将从吸烟转向专门的IQOS使用。更大 非吸烟者的预期使用或IQOS和燃烧烟草的双重使用可能会产生负面影响 人口健康。然而，在美国，IQOS对人群健康的实际影响仍然存在不确定性， 由于FDA的评估主要基于PMI提交的有限研究， 市场的在IQOS进入美国市场的关键时刻，该项目的目标是提供独特的 以及及时的美国上市后证据，评估IQOS的社会人口统计学和烟草使用模式 发起者，包括（1）成年吸烟者在多大程度上：（a）实现完全戒烟 产品，（B）转换为专门的IQOS使用，（c）继续吸烟沿着使用IQOS，或（d）产品 拒绝和继续吸烟;（2）社会人口学变量对IQOS的看法和使用 与烟草的差异有关。目标1将审查社会人口和烟草使用特点， 假定的决策过程，以及IQOS成人发起者的营销风险。目标2将检查 长期吸烟结果的纵向决定因素， 并开始使用IQOS。这些目标将通过顺序的混合方法设计来实现， 对1000名成年IQOS首次购买者进行消费者调查，并对600名当前吸烟者进行随访调查 在1个月、6个月和12个月时。随后的一项焦点小组研究对那些有以下情况之一的成年人进行了研究： 转换为单独使用IQOS或（B）双重使用IQOS和香烟，将进行更深入的研究 了解定量结果。本研究的成果是关于翻译的可译知识， 目前吸烟者的IQOS和烟草使用模式的接受情况以及长期结果和烟草差异 人口。预计拟议的研究将产生很大的影响，提供及时的发现，以提高 FDA评估PM USA是否符合FDA上市后要求的能力， IQOS引入对成人烟草使用行为的影响，并评估PMTA和ENDS政策， 烟草市场中的其他烟草产品可能会被IQOS改变。

Project Abstract On April 30, 2019, the U.S. Food and Drug Administration (FDA) issued a marketing order authorizing the IQOS “Tobacco Heating System” (IQOS), manufactured by Phillip Morris International, for interstate commerce in the U.S. The IQOS consists of an electronic system holder with rechargeable battery that heats tobacco-filled sticks (Heatsticks) to generate a nicotine-containing aerosol. Philip Morris USA selected Atlanta, Georgia as its first test market for IQOS and introduced it at multiple retail touchpoints, including IQOS flagship stores, mobile retail units, and Heatstick distribution in approximately 400 retail trade partner stores in October 2019. Crucial in FDA’s marketing order for IQOS were the assessments that IQOS users would be predominantly current cigarette smokers and that a substantial proportion would switch from cigarette smoking to exclusive IQOS use. Greater than anticipated use among nonsmokers or dual-use of IQOS and combusted tobacco could negatively impact population health. However, there remains uncertainty in the actual population health impact of IQOS in the U.S., as FDA’s assessments were based primarily on limited research submitted by PMI and mostly in international markets. At this critical time as IQOS is entering the U.S. market, the objective of this project is to provide unique and timely U.S. postmarket evidence evaluating the sociodemographic and tobacco use patterns of IQOS initiators, including (1) the extent to which adult smokers are: (a) attaining complete cessation of all tobacco products, (b) switching to exclusive IQOS use, (c) continued smoking along with use of IQOS, or (d) product rejection and continued smoking; and (2) the perceptions and use of IQOS by sociodemographic variables relevant to tobacco disparities. Aim 1 will examine the sociodemographic and tobacco use characteristics, putative decision-making processes, and marketing exposure among adult initiators of IQOS. Aim 2 will examine the longitudinal determinants of long-term tobacco use outcomes among adult cigarette smokers who purchased and initiated use of IQOS. These aims will be accomplished by a sequential, mixed-methods design with a consumer survey of 1000 adult IQOS initial purchasers with follow-up surveys of 600 current smokers conducted at 1 month, 6 months, and 12 months. A subsequent focus group study of those adults who had either (a) switched to exclusive IQOS use or (b) were dual using IQOS and cigarettes will be conducted to obtain a deeper understanding of the quantitative findings. The outcome of this research is translatable knowledge regarding the uptake of IQOS and tobacco use patterns and long-term outcomes among current smokers and tobacco disparity populations. The proposed research is expected to have high impact by providing timely findings to enhance FDA’s capacity to evaluate PM USA’s compliance with FDA’s postmarket requirements, assess the potential impact of IQOS’ introduction on adult tobacco use behaviors, and evaluate PMTA and policies for ENDS and other tobacco products in a tobacco market potentially transformed by IQOS.