Abstract
Background: This was a pre-market, observational, actual use study with the Tobacco Heating System (THS),a candidate modified risk tobacco product. The main goal of the study was to describe THS adoption within current adult daily smokers by replicating the usage of THS in real-world conditions with participants being able to consume cigarettes, THS, and any other nicotine-containing products (e.g., e-cigarettes, cigars, etc.) ad libitum. Methods: This study assessed self-reported stick-by-stick consumption of THS compared with the use of commercial cigarettes over six weeks. The aim of the analysis was to identify potential predictors for adoption of THS using stepwise logistic regression analysis. Results: By the end of the observational period (in Week 6), 14.6% of participants (n=965) had adopted THS meaning that THS formed 70% or more of their total tobacco consumption. The main predictors of adoption were the liking of the smell, taste, aftertaste, and ease of use of THS. The proportion of adoption was higher in participants aged 44 years and older and in Hispanic or Latino adult smokers. Additionally, adoption of THS was more likely in participants who had never attempted to quit smoking and in participants who smoked up to 10 cigarettes per day. Finally, the adoption of THS was higher in participants who consumed both regular and menthol THS compared with those who consumed only one THS variant. Conclusions: The findings suggest that the introduction of THS in the U.S. has the potential to result in adoption by current adult smokers who would otherwise continue to smoke cigarettes, and that the adoption of THS is unlikely to result in an increase of tobacco consumption. Post-marketing studies will provide further insights on THS adoption and THS use patterns to allow assessment of the impact of the THS at the individual and the overall population level.
Highlights
Cigarette smoking causes pulmonary, cardiovascular, and other serious diseases and is responsible for the largest number of preventable deaths in the United States (U.S.)[1,2]
Limitations include the fact that due to the study having been conducted in a pre-market setting, the study participants did not pay for the Tobacco Heating System (THS) products, while they continued to pay for their cigarettes, which may have overestimated the level of THS adoption in this study
In view of the above limitations, post-market studies are needed to provide actual levels and drivers of THS adoption and use patterns once THS is commercially marketed in the U.S Consistent with several theoretical frameworks that have been used to understand the impact of intervention or prevention policies[74,75], research should look at factors intrinsic to the users or to the product to explain use behavior and take into consideration the influence of social and societal/environmental factors. This actual use study showed that after a six week period of ad libitum use of THS provided at no expense, almost 15% of U.S daily adult smokers in the sample replaced 70% or more of their tobacco consumption with THS
Summary
Cardiovascular, and other serious diseases and is responsible for the largest number of preventable deaths in the United States (U.S.)[1,2]. The Reviewers outlined that reference to actual use studies with a similar tobacco heating system (THS) would enhance the articles and provide basis for comparison in discussion. We updated in the Introduction the status of the PMI MRTP Applications for IQOS to indicate that, in July 2020, the FDA authorized the following claim “AVAILABLE EVIDENCE TO DATE: The IQOS system heats tobacco but does not burn it This significantly reduces the production of harmful and potentially harmful chemicals. We specified that “As of March 31, 2021 IQOS was available in 66 countries.” This was a pre-market, observational, actual use study with the Tobacco Heating System (THS), a candidate modified risk tobacco product. The reference to logistic regression reflects part of the study methods and should be moved
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