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.