What is IQOS?

IQOS is a novel cigarette alternative that heats, but does not burn tobacco. Decades of scientific research show that the primary cause of smoking-related disease are the harmful and potentially harmful constituents (HPHCs) largely formed by the combustion of tobacco. While cigarettes burn at temperatures that can exceed 1600°F, IQOS heats tobacco to less than 570°F. The heating process releases a tobacco taste to provide current adult smokers who would otherwise continue smoking with a familiar experience and ritual without smoke. The IQOS heat-not-burn system consists of three components: a pocket charger, a holder, and a heated tobacco unit. This animation shows how IQOS works:

Since 2008, Philip Morris International (PMI) has invested over $6 billion and assembled a team of more than 400 world-class scientists and engineers seeking to develop non-combustible cigarette alternatives that replicate the attributes of smoking, while delivering an aerosol that is significantly less harmful. This scientific asessment starts with product development and includes toxicological assessments, clinical studies, a range of premarket perception and behavior studies, as well as postmarket studies and surveillance. We apply rigorous scientific standards to each step of our assessment to ensure the quality and integrity of the product during its complete lifecycle, from concept to commercialization.

IQOS is PMI’s most advanced 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.

More Information about PMI’s MRTP application is available at FDA’s website and any interested party can submit their comment on the application on a designated FDA docket.

 

An FDA order permitting marketing of an MRTP is not permanent; it is for a fixed period of time that will be specified in the order. PMI will conduct thorough population health impact monitoring if IQOS is authorized as a modified risk tobacco product to ensure that it continues to benefit the population as a whole, including both smokers and nonsmokers.