Stanton Glantz, a professor of medicine at the University of California, San Francisco, has urged the U.S. Food and Drug Administration (FDA) to reject Philip Morris International’s (PMI) application to market iQOS as a modified-risk product.
In his submission to the FDA’s public consultation on PMI’s modified-risk tobacco product application, Glantz argues that PMI has failed to demonstrate that the heat-not-burn product, as it is actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual users.
According to Glantz, PMI presented data on 24 biomarkers of potential harm in humans derived from studies in Japan and the U.S., which show that there is no statistically detectable difference between iQOS and conventional cigarettes for 23 of these 24 biomarkers in Americans, although the results from Japan are “slightly more positive,” as three of 13 biomarkers showed differences.
He said PMI’s own data supports the conclusion that IQOS is no different from conventional cigarettes in terms of effects on these biomarkers of potential harm in American people.