Long-Term studies

      Long-term studies on smoke-free products

      Even after our smoke-free products are placed on the market, we continue to assess them over the long term. This area of research includes post-market studies, safety surveillance, clinical studies, and epidemiological studies to continually refine our understanding of the risk-reduction potential of our products.

      Long-term studies are an ongoing part of smoke-free product assessment

      Our Tobacco Heating System (THS) is a heated tobacco product that has been on the market in several countries long enough to begin to see some potential early impacts. Epidemiological and other post-market clinical studies on the impact of smoke-free products on population and individual health are underway, but long-term results are not yet available.

      In addition to these studies, we can also take the currently available data about a product’s risk profile, combined with information about product use patterns, and develop models to estimate how the introduction of smoke-free products, as well as other interventions, can influence the population health in a country. We’ve developed our own Population Health Impact Model, and several independent groups have also developed their own as well.

      THS is the first of our smoke-free products which has reached the long-term research stage of our assessment program, after going through aerosol, toxicology, and clinical assessments, as well as our studies on product use patterns. We look forward to sharing more updates in the future about the impact that THS and of other products in our smoke-free product portfolio are having in the countries where they are available.

      You can find a summary of our entire product assessment program in the PMI Science Booklet, and our publications, most of which are open-access, can be found via the publications library.

      Take a closer look at information about our long-term studies and observations:

      • Safety surveillance studies

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      • Population Health Impact Model (PHIM)

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      • Japan: declining cigarette sales

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      We conduct safety surveillance studies to monitor and identify any potential safety concerns

      We have set up a post-market safety surveillance program for consumers to report any health-related adverse events associated with the use of our smoke-free products. We constantly monitor this information to identify potential safety concerns and to report them to the regulatory authorities when required.

      The proactive monitoring of the safety profile of our smoke-free products enables continuous evaluation and prompt response to any emerging safety concerns. Compliance with regulatory standards is critically important, and adverse events meeting regulatory criteria for seriousness are promptly reported to regulatory authorities. We actively collect and analyze data from various channels, including:

      • Call centers
      • Poison centers
      • Social media
      • Clinical studies
      • Literature screenings

      Importantly, an adverse event is any health-related event associated with the use of a tobacco product in humans that is adverse or unfavorable, whether or not it is considered tobacco product related.

      We have developed a model to estimate the impact of smoke-free products' use on population health

      Our Population Health Impact Model (PHIM) was developed to estimate the potential population-level health impact of smoke-free products. This epidemiological model is a mathematical simulation that is based on publicly available data from different countries, such as the U.S., Germany, the U.K., and Japan.

      The development of the PHIM relies on data-driven simulations that incorporate epidemiological data, business and behavioral data, and clinical data. The PHIM is based on a hypothetical population of individuals, and it creates a tobacco use history for each individual simulated in the model. It then estimates the relative and absolute risks of dying from certain smoking-related diseases. By linking tobacco use to an individual’s risk profile, the model enables researchers to assess how the relative and absolute risks of dying from smoking-related disease could vary between individuals who have never smoked, those who currently smoke, those who have quit smoking, and those who switch to smoke-free products.

      These simulations build scenarios to estimate the long-term impact of introducing a new product into a market. Such models are both a regulatory requirement and a complementary tool for the assessment of the potential for smoke-free products to impact public health.

      Despite its strengths, the PHIM and other similar models also face challenges, including limitations in available data, uncertainties in transition probabilities, assumptions about the relative risks associated with smoke-free products, and disease prevalence and mortality. As more data become available and researchers refine their models, some of these limitations can be addressed, leading to more accurate estimates of the possible population health impact of smoke-free products on various smoking-related diseases. These models, however, can provide policymakers and public health officials with valuable insights to inform future decisions about the regulation and acceptance of smoke-free products as part of their harm reduction strategies.

      Read some of the results below, or find more publications on our PHIM in the publications library:

      A novel approach to assess the population health impact of introducing a Modified Risk Tobacco Product
      A novel approach to assess the population health impact of introducing a Modified Risk Tobacco Product
      Modeling the impact of changes in tobacco use on individual disease risks
      Modeling the impact of changes in tobacco use on individual disease risks
      Modeling the population health impact of introducing a Modified Risk Tobacco Product into the U.S. market
      Modeling the population health impact of introducing a Modified Risk Tobacco Product into the U.S. market
      Estimating the population health impact of introducing a reduced-risk tobacco product into Japan. The effect of differing assumptions, and some comparisons with the U.S.
      Estimating the population health impact of introducing a reduced-risk tobacco product into Japan. The effect of differing assumptions, and some comparisons with the U.S.
      Using data on snus use in Sweden to compare different modelling approaches to estimate the population health impact of introducing a smoke-free tobacco product
      Using data on snus use in Sweden to compare different modelling approaches to estimate the population health impact of introducing a smoke-free tobacco product

      Introducing THS to the Japanese market likely led to a reduction in cigarette sales in the country

      Independent research has been published, showing a marked decline in cigarette sales in Japan during the period after the introduction of THS to Japan. At least two independent publications observed a correlation between the introduction of THS, the most common heated tobacco product in the Japanese market, with the decline of cigarette sales. 

      The cigarette sales data from Japan show that the downward trend of overall tobacco sales has continued, while the sales of cigarettes and cigarillos dropped even more sharply in the years following the launch of THS. As the sales of heated tobacco units increased, the sales of cigarettes dropped, without an observed increase in overall tobacco sales. This observation indicates that the launch of THS has not led to a population-level increase in overall tobacco sales, meaning that heated tobacco product sales have replaced a portion of cigarette sales.

      Related Articles
      Why did cigarette sales decline in Japan?
      Discover how the introduction of heated tobacco products and our THS in Japan contributed to the decline of cigarette sales.
      Assessing lung cancer risk reduction potential of smoke-free alternatives
      PMI has introduced a new approach to assessing the lung cancer risk reduction potential of smoke-free products, based on systems toxicology principles. Learn more here.
      Illustrated overview of the principle of models estimating the impact of MRTP introduction on population health
      Estimating the impact of introducing modified risk tobacco products (MRTPs) on overall population health
      Explore different modelling approaches and expert reviews on the effects of introducing modified risk tobacco products (MRTPs) on population health.

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      Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.