Scientific organizations and experts (such as the US Surgeons General) agree that although nicotine is addictive and not risk-free, the adverse health effects of smoking are not caused by nicotine, but are driven primarily by the toxic substances generated by the combustion in a cigarette.
You state there is reduced exposure of HPHCs and less HPHC inhalation, what does this mean for my health?
HPHCs are Harmful and Potentially Harmful constituents which are present in cigarette smoke. When tobacco is heated at 250-300 °C compared to being heated to temperatures above 800 °C in cigarettes, the number and levels of HPHCs found in the aerosol are significantly reduced. We have also shown that when current adult smoker switch to Platform 1, there is a reduction in the number and levels of HPHCs absorbed by the body. The HPHCs that we measure have been identified by public health organizations as likely to be associated with smoking-related disease. We have already shown that the numbers and levels of HPHCs are significantly reduced in Platform 1 aerosol compared to cigarette smoke, and we are currently determining that this results in a reduction in disease risk when adult smokers switch to the product.
It seems RRPs contain relatively high levels of nicotine. Are there plans to reduce the amount of nicotine in RRPs?
Our goal is to provide current adult smokers with acceptable alternatives that are reduced risk compared to continued cigarette smoking. As explained in the section on "The Case for RRPs" in order to have a positive impact on population health, not only does a product need to have a reduced risk profile, it must also be acceptable to current adult smokers so that they are more likely to switch. A reduced risk product will have little or no impact on population harm if not enough adult smokers switch to it. It is important to note that we do not add nicotine to our tobacco-containing products. The nicotine present in cigarette smoke and the aerosol from tobacco-containing RRPs is naturally present in tobacco. Although nicotine is addictive and is not risk-free, many experts agree that it is not responsible for smoking-related disease, and that the toxic substances generated by combustion are the drivers of disease.
Do you agree that RRPs should carry health warnings?
Yes. E-cigarettes contains nicotine which is addictive and not risk-free, therefore we support appropriate warnings on these products and on other potentially reduced-risk products such as heated tobacco products. We think that it is equally important that consumers receive objective and substantiated facts about the different profile of these products compared to cigarettes.
Do you think the fact that your RRPs still contain nicotine will be seen negatively?
Heating tobacco instead of burning it allows the release of a tasteful, nicotine-containing aerosol with significantly reduced levels of toxic substances compared to cigarette smoke. We believe that our Platform 1 has a high potential to be accepted by adult smokers. Ultimately, adult smokers will decide whether they prefer a tobacco or a nicotine containing product. It is important that adult smokers are able to choose from a range of different products.
Given the history of your industry, do you think people will trust the data you are generating?
Philip Morris International's Research and Development operations are based in Switzerland and include over 300 expert scientists covering a range of scientific and engineering disciplines including biology, chemistry, physics, electronics, computational coding, mathematics and statistics. We work with several external laboratories and qualified Clinical Research Organizations around the world. We use state of the art methodologies and our clinical studies are conducted in accordance with Good Clinical Practice, an international set of standards that is applied in pharmaceutical research. We regularly present our data at relevant scientific conferences and submit papers for publication in peer-reviewed journals. Since 2010 we have published more than 100 papers in peer-reviewed scientific journals, such as the American Journal of Physiology, Nature Biotechnology and Regulatory Toxicology and Pharmacology. We have a global program in place called sbv IMPROVER, which uses crowd sourcing to independently verify the data we are generating and the conclusions we make. Visit our Library to access our publications and our presentations. We understand the skepticism around our research and we welcome independent verification of our results. You can contact us on email@example.com if you would like to conduct such a study and require help with obtaining products or methodologies.
Do you expect RRPs to be used and sold indoors in territories where indoor smoking is banned?
No. We encourage consumers to comply with applicable regulations and to exercise common sense with respect to who they use these products around. The composition of the aerosol of these products is significantly different than cigarette smoke but, ultimately, a decision on their use in indoor public places will have to be made by public authorities. Several public health groups have supported exemptions from existing public place smoking restrictions for e-vapor products. We think that their use in places where smoking is not allowed should be considered in light of (1) the science which shows a clear distinction between cigarette smoke and e-vapor and (2) the objective to encourage switching.
Can you explain the health risk of 'heat-not-burn' products compared to that of e-cigarettes?
Recent independent reports by Public Health England indicate that e-cigarettes are 95% less toxic than cigarettes. Our data so far has shown that there is a 90-95% reduction in the toxicity of Platform 1 aerosol compared to cigarettes. Therefore we expect that the risk profile of e-cigarettes and Platform 1 to be similar. However, there has not been a direct comparison between e-cigarettes and heated tobacco products. We are conducting several clinical studies to assess the risk profile of Platform 1 compared to cigarettes, and we plan to conduct clinical studies on e-cigarettes in the future.
The data on nicotine (PK study) presented by PMI seem encouraging. Do you think this will be seen as negative to regulators?
Products that closely mimic the behavioral and pharmacological profile of cigarettes will be more likely to be accepted by adult smokers. In order to have a positive impact on population health, not only does a product need to have a reduced risk profile, it must also be acceptable to current adult smokers so that they are more likely to switch. A reduced risk product will have little or no impact on population harm if not enough adult smoker switch to it. This view is shared by many in the public health community.
What is the purpose of the clinical studies you are running?
Clinical trials are studies with adult smokers. The most recent studies we are conducting are designed to compare smokers who switch to HeatSticks for iQOS, smokers who continue smoking and smokers who quit for the duration of the study. These studies allow us to determine whether smokers who switch to iQOS significantly reduce their exposure to HPHCs and/or have biological effects that are similar to those seen in smokers who quit smoking. Clinical studies are fundamental to determine whether our RRPs reduce risk, and we will be conducting similar studies with all of our RRP Platforms.
What is your position on the inclusion of nictoine in your RRPs? Would you expect regulators to look negatively upon this?
Tobacco harm reduction depends on smoker acceptance of alternative products. Along with many public health experts, we believe that products that closely mimic the behavioral and pharmacological profile of cigarettes are likely to be accepted by adult smokers. We are therefore, encouraged by the findings from consumer research and clinical studies, which indicate that adult smokers find our Platform 1 product acceptable. Our perception and behavior research, and post-market surveillance and studies, are designed to address concerns about dual use and initiation.
What type of research are you conducting to substantiate the risk profile of your new products?
We have conducted numerous non-clinical (laboratory) and clinical studies to assess the risk profile of these products. We are also conducting perception and behavior research to ensure that product information is accurately understood and that we can assess use of the product in close to real life conditions.
Can you give us concrete examples of what claims you would make and how you would communicate them?
We are continuing to generate and evaluate data, and we are assessing a range of hypothetical claims in our research with adult smokers to assess their understanding and perception of risk. Any claim we will be making will be determined by our scientific conclusions and by the relevant local regulations and laws. We advocate for appropriate regulatory standards and rules for the communications of any such claims to consumers.
You categorize e-cigarettes as Reduced Risk products - do you believe they reduce the risk of disease?
We believe e-vapor products have the potential to reduce the risk of smoking related disease compared to cigarettes. As with other potentially reduced risk products, such as heated tobacco products, specific data are needed to validate whether a particular e-cigarette reduces risk compared to smoking.
Given PMI's previous focus was on 'heat-not-burn' why are they now entering the e-cigarette category?
We believe that both heated tobacco products and e-cigarettes have the potential to represent a less risky alternative to continued smoking. We entered the e-vapor category because we believe there is sufficient demand for it to make sense for us to participate in the category. We purchased a UK-based e-vapor company in 2014, commercialized an e-vapor product in Spain in 2015 and entered into an agreement to develop the next generation of e-vapor products with Altria in 2015. We continue to believe that our tobacco-containing potentially reduced-risk products have a high potential for full adoption by adult smokers, and also that there is sufficient space in the market for both product types.
What is different about RRPs; why does PMI believe they will reduce the risks associated with smoking?
The vast majority of the toxic constituents found in cigarette smoke are generated by the burning of tobacco. All of the tobacco-containing RRPs that we are developing eliminate combustion, and therefore significantly reduce or eliminate the toxic compounds present in the aerosol compared to cigarette smoke. We are also developing some products that deliver nicotine, but do not contain tobacco. The results of the research we have carried out to date are promising, and we continue to conduct further research and to evaluate the resulting data. Before making any conclusions about whether each of our product reduces risk in adult smokers who switch, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate such claim.
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PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts to develop and assess products that have the potential to reduce individual risk and population harm associated with tobacco use. This site is for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not for advertising or marketing. It is not intended for use by consumers.
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. Our RRPs are smoke-free products that produce an aerosol that contains far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.