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.

Project Narrative This project will generate U.S. data on adult smokers’ uptake and longitudinal use patterns of Philip Morris International’s IQOS Tobacco Heating System, the first electronic tobacco product granted market authorization by the Food and Drug Administration (FDA). These data are needed to evaluate whether adult smokers are using the IQOS to successfully quit smoking or to complement their smoking (dual use). The findings of this project will provide the FDA with independent, post-market evidence of smokers’ uptake and use of IQOS that could guide evaluations of future premarket tobacco product applications and tobacco regulatory and policy decisions based upon population health impact models.