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

项目摘要 2019年4月30日，美国食品和药物管理局(FDA)发布了一项营销命令，授权iQOS “烟草供暖系统”(IQOS)，由菲利普·莫里斯国际公司制造，用于美国州际商业。 美国的iQOS由一个电子系统支架和可充电电池组成，可加热装满烟草的棒子 (热粘)产生一种含有尼古丁的气雾剂。菲利普莫里斯美国公司选择佐治亚州亚特兰大作为第一个 测试iQOS市场，并在多个零售接触点推出，包括iQOS旗舰店、移动零售 2019年10月，HeatStick将在大约400家零售贸易合作伙伴门店进行分销。FDA的关键是 IQOS的营销订单是对iQOS用户将主要是当前香烟的评估 吸烟者和相当大比例的人将从吸烟转变为单独使用iQOS。更大 非吸烟者的使用量超过预期或同时使用iQOS和燃烧烟草可能会产生负面影响 人口健康。然而，在美国，iQOS对人口健康的实际影响仍然存在不确定性， 因为FDA的评估主要基于PMI提交的有限研究，而且大多是在国际上 市场。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的社会人口和烟草使用模式 发起者，包括(1)成年吸烟者的程度：(A)完全戒烟 (B)改用iQOS专用产品，(C)在使用iQOS的同时继续吸烟，或(D)产品 拒绝和持续吸烟；以及(2)社会人口统计变量对IQOS的认知和使用 与烟草差异有关的问题。目标1将审查社会人口学和烟草使用特征， 假定的决策过程，以及iQOS成人发起人的营销风险。Aim 2将检查 购买香烟的成年吸烟者长期烟草使用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、混合的方法设计来实现 对1000名成年iQOS首次购买者进行的消费者调查，以及对600名当前吸烟者的跟踪调查 分别为1个月、6个月和12个月。随后对患有以下两种疾病之一的成年人进行了焦点小组研究： 切换到独家使用iQOS或(B)分别使用iQOS和香烟将获得更深层次的 对量化结果的理解。这项研究的结果是关于 当前吸烟者对IQOS和烟草使用模式的接受以及长期结果和烟草差异 人口。预计拟议的研究将产生重大影响，及时提供研究结果，以增强 FDA评估PM USA遵守FDA上市后要求的能力，评估潜在的 引入iQOS对成人烟草使用行为的影响，并评估PMTA和政策的目的和 烟草市场上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.