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On 25 January 2018, the Food and Drug Administration (FDA) Tobacco Scientific Advisory Committee unanimously voted (with one abstention) that Phillip Morris International (PMI) could not claim their heated tobacco product (HTP) IQOS (I-Quit-Ordinary-Smoking) would reduce the risk of tobacco-related diseases. Regardless, IQOS is already available in over 30 countries, and thus merits scrutiny from the scientific and medical communities. The preclinical and clinical data PMI submitted to FDA indicate that IQOS exposure may be associated with unexpected liver toxicity. We reviewed preclinical studies conducted by PMI scientists1 and clinical studies of 5 and 90 days of exposure to IQOS and IQOS menthol2–5 included in PMI’s Modified Risk Tobacco Product application submitted to the US FDA.
Wong and colleagues1 exposed 92 male and 92 female Sprague Dawley rats to up to 90 days of mainstream aerosol from IQOS, mainstream smoke from 3R4F research cigarettes, or room air (sham). After 90 days of exposure, liver weights and blood levels …
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