Response | Clinical | Feb 12, 2019

      Summary Response to UCSF on Reduced Exposure

      Response to the article entitled “IQOS: examination of Philip Morris International claim of reduced exposure”

      by Gideon St. Helen1,2, Peyton Jacob III1,2, Natalie Nardone1, Neal L. Benowitz1,2,3

      1 Division of Clinical Pharmacology, Department of Medicine, University of California San Francisco, San Francisco, California, USA; 2 Center for Tobacco Control Research and Education, University of California, San Francisco, California, USA; 3 Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, California, USA

       

      by Gizelle Baker, Cédric Gubelmann, Serge Maeder, Patrick Picavet, Maurice Smith, and Manuel C. Peitsch1

      1 PMI Research and Development, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland. Authors are listed in alphabetical order.

      TIME TO READ: 1.5 MIN

      The Division of Clinical Pharmacology, Department of Medicine, University of California San Francisco, California, USA, has recently published a research paper in Tobacco Control (St Helen, 2018) claiming that “PMI’s data […] show significantly higher levels of several substances that are not recognised as HPHCs by the FDA in IQOS emissions compared with combustible cigarette smoke. The impact of these substances on the overall toxicity or harm of IQOS is not known. We examined PMI’s MRTP application, specifically sections on aerosol chemistry and human exposure assessment, to assess the validity of PMI’s claims of reduced exposure and risk.”

      In summary, we have assessed these claims based on a careful review of our scientific data (PMI’s Modified Risk Tobacco Product Application (MRTPA) for IQOS) submitted to the U.S. Food and Drug Administration (FDA). The scientific data is in the FDA submission and requires knowledge of the design and conduct of aerosol chemistry and clinical studies, together with a careful and detailed review of the resulting data, to reach accurate, science-based conclusions. While we welcome scientific review and discussion of our results, the authors of this paper failed to consider the totality of the available evidence and therefore led to conclusions that are incorrect and misleading.

      We have prepared a point-by-point assessment of the claims made by the authors, and this detailed analysis can be found here.

      In conclusion, based on an analysis of our aerosol chemistry and human exposure studies performed according to international standards of good practice, the totality of evidence supports the claim of Philip Morris International (PMI) that the Tobacco Heating System (THS) emits significantly lower levels of harmful and potentially harmful constituents (HPHC) that are emitted in cigarette smoke and, consequently, leads to significant reduction in exposure to HPHCs in smokers who completely switch to THS.

      Although THS is not risk-free, the totality of evidence available for THS clearly demonstrates that switching completely to THS significantly reduces the exposure to harmful compounds contained in cigarette smoke and presents less risk of harm compared with continuing to smoke.

      PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site 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 advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
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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.