IQOS is PMI’s mostadvanced non-combustible product. In December 2016, PMI submitted applications to the FDA to market IQOS as a “Modified Risk Tobacco Product” (MRTP). The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) requires that such “modified risk tobacco products” reduce harm and the risk of tobacco-related disease to individual users and benefit the health of the population as a whole. The FDA is still in the process of reviewing PMI’s applications and has not yet concluded on them. The results our scientific assessment to date show that:
Excluding nicotine, the levels of the harmful and potentially harmful constituents (HPHCs) that are required to be reported to FDA are more than 90% lower on average in the IQOS aerosol compared to smoke from a standard research cigarette. FDA’s independent testing also found lower levels of selected HPHCs in the aerosol delivered by the IQOS system compared to cigarette smoke.
In toxicity studies, adverse effects were fewer and less severe than what was observed with reference cigarette smoke and occurred at much higher concentrations.
In clinical studies, switching from combusted cigarette smoking to IQOS resulted in a substantial, and statistically significant, reduction in selected biomarkers of exposure to harmful chemicals that approached the levels observed in smokers who quit smoking for the duration of clinical trials, while nicotine delivery appeared sufficient to provide user satisfaction.
All IQOS user groups experienced a reduction in combusted cigarette consumption, including among smokers who were unable to switch to IQOS completely.
PMI’s premarket studies conducted in the U.S. found that few adult never and former smokers intended to try and use IQOS. While some level of trial and experimentation with IQOS among non-smokers, including youth, may be expected, comparisons with e-cigarette use are limited – nonsmokers may perceive and use IQOS differently, and some aspects of IQOS may dissuade trial and initiation among nonsmokers (e.g., its tobacco associations, restricted marketing, availability of tobacco and menthol flavors only, price etc.).
Premarket data from the U.S. is corroborated by the real-life results from countries where IQOS is already available. In countries where IQOS is available large numbers of cigarette smokers have been able to switch to IQOS and abandon cigarettes completely. PMI estimates that over 5 million adult smokers have quit smoking and use IQOS exclusively.