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.
- non-cigarette tobacco products
- public policy
- smoking-caused disease
- tobacco industry
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Contributors SAG is the sole author of this article.
Funding This work was supported by the US National Cancer Institute and Food and Drug Administration Center for Tobacco Products (P50 CA180890).
Disclaimer The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health or the FDA. The funding agencies played no role in design and conduct of the study; collection, management, analysis and interpretation of data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data are available in the PMI MRTP application on the FDA website.
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