PMI's own in vivo clinical data on biomarkers of potential harm in Americans show that IQOS is not detectably different from conventional cigarettes

Tob Control. 2018 Nov;27(Suppl 1):s9-s12. doi: 10.1136/tobaccocontrol-2018-054413. Epub 2018 Aug 21.


Introduction: New 'heated tobacco products' are being marketed in several countries with claims that they expose users to lower levels of toxins than conventional cigarettes which could be read as being less likely to cause health problems than conventional cigarettes. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration for permission to market its heated tobacco product, IQOS, with reduced exposure and reduced risk claims.

Methods: Analysis of detailed results on 24 biomarkers of potential harm in PMI studies of humans using IQOS compared with humans using conventional cigarettes.

Results: Among American adults, there is no statistically detectable difference between IQOS and conventional cigarette users for 23 of the 24 biomarkers of potential harm in PMI's studies. In Japan, there were no significant differences between people using IQOS and conventional cigarettes in 10 of 13 biomarkers of potential harm. It is likely that some of the significant differences are false positives.

Conclusion: Despite delivering lower levels of some toxins than conventional cigarettes, PMI's own data fail to show consistently lower risks of harm in humans using its heated tobacco product, IQOS, than conventional cigarettes.

Keywords: non-cigarette tobacco products; public policy; smoking-caused disease; tobacco industry.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Biomarkers*
  • Clinical Trials as Topic / statistics & numerical data*
  • Humans
  • Tobacco Industry*
  • Tobacco Products / adverse effects*
  • United States


  • Biomarkers