The FDA must review the science behind a product before granting its marketing order. Here is an excerpt from the PMI application to the FDA for IQOS as a MRTP.
The chemical analysis of the aerosol generated by IQOS, which confirmed that IQOS aerosol contains substantially reduced levels of HPHCs (on average, >90% reduction in the levels of HPHCs compared with 3R4F7 cigarette smoke).
Six in vitro and two in vivo studies using standard methods in toxicology, conducted to compare the effects of IQOS aerosol with those of cigarette smoke. These studies showed a consistent and substantial reduction in cytotoxicity, genotoxicity, inflammation, respiratory organ toxicity and systemic toxicity of IQOS aerosol compared with cigarette smoke.
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Furthermore, lung inflammation, emphysema, and lung function measurements assessed in a chronic toxicity study in A/J mice showed significantly lower effects in IQOS aerosol-exposed mice than in smoke-exposed animals. The pulmonary outcomes in IQOS aerosol exposed mice were not different from those obtained in air-exposed animals.
Advanced nonclinical systems toxicology studies that enabled the detailed comparison of the effects of cigarette smoke and IQOS aerosol on biological mechanisms related to the causation of smoking-related diseases. These studies employed computational methods to analyze a broad array of comprehensive molecular measurements (transcriptomics, proteomics, lipidomics), in addition to the standard measurements used in toxicity studies and the evaluation of disease endpoints in animal models of disease (emphysema, lung function and atherosclerotic plaque size).
Smokers who completely switched to IQOS showed a reduction in 15 measured biomarkers of exposure (BoExp) to HPHCs and improvements in the six measured clinically relevant risk markers linked to mechanistic pathways involved in smoking-related diseases. For instance, the exposure reduction achieved by switching to IQOS preserved on average >90% of the exposure reduction observed in smokers who abstained from smoking for the duration of the studies. These results confirm that the reduced formation of HPHCs by IQOS leads to a reduced exposure in adult smokers, which in turn leads to an improvement of clinical risk markers.