RESEARCH

      PMI’s research on smoke-free products

      At Philip Morris International (PMI), our scientific assessment program is built on a collaborative approach and expertise in the research fields of chemistry, biology, informatics, and medicine. Our practices are inspired by the pharmaceutical industry and are aligned to the draft guidance issued by U.S. Food and Drug Administration’s Center for Tobacco Products in 2012. Learn more about how we conduct our smoke-free product research and explore the results of our studies.

       

      We have more than 1,180 scientists, engineers, and support staff working on our smoke-free products, covering 30 different scientific and engineering disciplines. All this work has generated more than 500 scientific publications since 2008, most of which are open access. At each step of our assessment program, we apply rigorous standards according to internationally recognized research guidelines, principles, and practices.

       

      This program contains five “steps,” although each product progresses through the assessment program differently. Learn more about the steps of our smoke-free product assessment program and the results we have gathered on our products with this efficient yet thorough approach.

      Assessment approach

      Aerosol chemistry and physics research

      Aerosol research is a foundational part of our smoke-free product assessment. Our smoke-free products are developed to avoid burning tobacco. The aerosol chemistry and physics studies we conduct aim to confirm that burning does not take place and to confirm for each product that the resulting aerosol contains lower levels of harmful chemicals compared with cigarette smoke. Aerosol research also includes studies on the effects of smoke-free products on indoor air quality. This research is conducted according to Good Laboratory Practice (GLP) and national regulations, and follows several standards set by the International Organization for Standardization (ISO) and other authorities.

      platform assessment approach
      Scientist in a white coat holds a transparent tube, examining its content.
      Assessment approach

      Toxicology research

      Toxicological research helps to translate the aerosol assessment into an estimate of the risk-reduction potential for a smoke-free product. Some toxicology studies are necessary before clinical studies can begin. Toxicology answers the question of whether smoke-free product aerosols are toxic to cells and other model systems compared with cigarettes and allows scientists to understand the biological processes that lead from exposure to the onset of smoking-related diseases. Our toxicology research is conducted according to GLP and ISO standards, as well as guidelines published by the U.S. Food and Drug Administration (FDA), the Organisation for Economic Co-operation and Development (OECD), as well as other guidelines and national regulations.

      Assessment Approach

      Clinical research

      Clinical research is a cornerstone of our smoke-free product assessment. Clinical studies provide human data on the use and acceptance of our smoke-free products as well as their potential to reduce exposure to harmful chemicals, and the potential to reduce the risk of smoking-related diseases as compared with continued smoking. All of our clinical studies are conducted in partnership with Contract Research Organizations (CROs) and are conducted according to Good Clinical Practice (GCP) and other internationally recognized guidelines and national regulations. We also register all our studies on www.clinicaltrials.gov.

      clinical-assessment-blue.png
      People in a show room checking out smoke-free products.
      Assessment approach

      Perception and behavior research

      Perception and behavior research provides insights on how the introduction of a smoke-free product can impact population health. Earlier steps of smoke-free product assessment focus on the risks associated with the product, while perception and behavior studies measure whether current smokers who would otherwise continue to smoke are switching to a smoke-free product and that nonsmokers and former smokers recognize that the product is not for them. This research is conducted according to Good Epidemiologic Practice (GEP), guidance by the U.S. FDA, the Declaration of Helinski, and other guidelines and regulations. 

      Assessment Approach

      Long-term research

      Long-term research tracks the impacts that a smoke-free product is having on population health after it has been launched to market. This area of research includes post-market studies, safety surveillance, clinical studies, and epidemiological studies. Together over time, these efforts build up an increasingly clear picture of the role a smoke-free product has on public health. Our long-term research studies are aligned to GEP standards, GCP for the long-term clinical studies, and national regulations.

      long-term-assessment-blue.png

      How does PMI conduct its scientific assessments?

      At each step of the scientific assessment approach, scientific rigor is applied to generate data that may support a claim that smoke-free products reduce exposure to harmful and potentially harmful constituents and present less risk of harm than continued smoking. A risk-based Quality Management System has been conceived for smoke-free products to coordinate and guide activities with the aim of ensuring quality and integrity of the product during its complete lifecycle, from the conception through to commercialization. 

      1. Juran, J. M. (1992). Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. 
      2. OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring. 
      3. International Organization for Standardization. 
      4. ICH – Validation of Analytical Procedures: Text and Methodology. 
      5. European Committee for Standardization (2007). CEN European Standard EN 15251. Indoor Environmental Input Parameters for Design and Assessment of Energy Performance of Buildings Addressing Indoor Air Quality, Thermal Environment, Lighting and Acoustics. European Committee for Standardization, Brussels. 
      6. World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 
      7. ICH – Guideline for Good Clinical Practice. 
      8. Good Epidemiologic Practice (GEP) – German Society for Epidemiology (DGEpi). 
      9. Food and Drug Administration (2009). Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 
      10. IEA Guidelines for proper conduct in epidemiologic research (2007). 

      PMI openly shares our evidence on smoke-free products

      We are sharing the results of our research openly and transparently. The results of our smoke-free product research are published in peer-reviewed journals, presented at conferences, summarized in our literature review series, described in our Scientific Updates, and presented and discussed at our Open Science events. We have also created the PMI Science Booklet that is regularly updated with a more in-depth summary of our key results, facts and figures on our research, and other interesting information. Importantly, this is not an exhaustive list of the ways we share our research. In addition to sharing our own research, we also encourage independent research to understand the potential impacts of smoke-free products on public health. We support third-party research via our Investigator Initiated Studies (IIS) program, and we stay up to date on the independent research that has been conducted so far. Altogether, our own rigorous research and that of others builds an increasingly clear picture of the role that smoke-free products have in helping to reduce the harms of smoking on public health.