We are conducting extensive studies to develop and assess Reduced-Risk Products (RRPs). We believe that the quality, breadth and depth of our product development and assessment position us to remain the industry leader as this new product category evolves.
Rigorous step-by-step scientific assessment
Although these products are consumer goods, intended as substitutes for combustible tobacco products, any claim that a particular product is less harmful than smoking should be backed up by robust science. Our scientific assessment program follows a step-by-step approach inspired by standards and practices long adopted by the pharmaceutical industry and by guidance issued by the US FDA’s Center for Tobacco Products.
Developing and assessing an RRP is a long and rigorous process that starts with the initial design of the product platform, a fundamental step to ensure quality and consistency. Laboratory and clinical studies are then used to assess the exposure and risk-reduction potential of an RRP. In addition to these studies, we also conduct real-world research on how people understand communications about a product’s risk profile and on how our products are actually used. Finally, we monitor the long-term use of our products once they are in the marketplace. At each step, we apply rigorous scientific standards to generate data that will be part of a comprehensive evidence package to support product claims.
- Platform development: Assessment of an RRP’s risk reduction potential relies on the quality of the initial product design and on strict manufacturing controls to ensure that the product delivers a consistent aerosol. In this initial phase of designing a product we verify that the product’s design does not pose any additional risks to those already known for combustible cigarettes. Only then can we begin to conduct further research.
- Laboratory research: Our next step is to verify an RRP’s potential to reduce risk by measuring the reductions in levels of toxic compounds as well as the reduction in toxicity when compared to cigarette smoke.
- Clinical studies: Once we have completed our laboratory research, we conduct clinical studies with adult smokers to understand whether switching to the RRP reduces their exposure to toxic compounds. We also determine whether this leads to a reduction in the risk of developing a smoking-related disease. The effects measured in smokers who switch to an RRP are compared with those in smokers who continue to smoke cigarettes and smokers who quit for the duration of the study. Clinical studies are at the core of our ability to substantiate claims.
- Real-life research: We also conduct several types of perception and behavioral studies to better understand an RRP’s potential to benefit public health. These studies include research into how smokers perceive a product’s risk and how they adopt and use an RRP under real-life conditions. We also verify that never smokers and former smokers understand that RRPs are not intended for them.
- Long-term assessment: We monitor and research the use of our RRPs once they are on the market in order to assess the product’s contribution to harm reduction.
Expert external advice
In addition to the expertise provided by PMI’s team of more than 430 scientists experts and staff, our research is guided by a Scientific Advisory Board comprised of leading scientists from outside the company. We also conduct our research in accordance with international standards and practices, such as the internationally accepted Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs).
Sharing our science
Gathering feedback from a wide range of external experts is central to our assessment program. For us, that means engaging in an ongoing dialogue with regulators and experts in the scientific and public health communities and regularly sharing our scientific methods and data. It also means inviting comment on our science through peer review of our publications and participation in scientific conferences around the world. Since 2010, we have published more than 150 RRP-related studies in peer-reviewed scientific journals , such as the American Journal of Physiology, Nature Biotechnology and Regulatory Toxicology and Pharmacology.
We also make information about PMI’s RRP scientific assessment program publicly available on PMIScience.com .
Results to date are encouraging and show that we are headed in the right direction
Our studies on one of our heated-tobacco products, Platform 1, are well advanced. We have already determined that the aerosol generated by Platform 1 produces 90 to 95% less harmful and potentially harmful compounds compared to a reference cigarette and that the aerosol is 90 to 95% less toxic than smoke from a reference cigarette. In a three-month clinical study recently carried out in Japan and the US, the average reduction in 15 biomarkers of exposure to 15 harmful and potentially harmful compounds measured in smokers who switched to Platform 1 approached the effect observed in smokers who quit smoking for the duration of the study.
While conclusions on the risk reduction profile of Platform 1 will be based on the totality of the evidence, such results give us confidence that we are on course with our plans to demonstrate that Platform 1 is not only a reduced-exposure product but also a less harmful alternative for smokers.
|Reduced Risk Products (RRPs) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking cigarettes. PMI’s RRPs are in various stages of development and commercialization, and we are conducting extensive and rigorous scientific studies to determine whether we can support claims for such products of reduced exposure to harmful and potentially harmful constituents in smoke, and ultimately claims of reduced disease risk, when compared to smoking cigarettes. Before making any such claims, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate reduced exposure or risk. Any such claims may also be subject to government review and authorization, as is the case in the USA today. - See more at: https://www.pmiscience.com/#sthash.1wc7NKXp.dpuf
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