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PMIs own data fail to show consistently lower risks of harm in humans using IQOS compared with conventional cigarettes,30 31 that IQOS is associated with pulmonary and immunomodulatory harms not significantly different from conventional cigarettes,32 33 that IQOS use may be associated with hepatotoxicity and unexpected organ toxicity that has not been associated with conventional cigarettes34 35 and that IQOS use does not necessarily avoid the adverse cardiovascular effects of conventional cigarette smoking.36 37 In addition, data collected independently of PMI revealed IQOS does not consistently reduce exposure to harmful or potentially harmful chemicals.29 3842 Moreover, Reuters published a report in December 2017 identifying irregularities in PMIs IQOS research.43 44 At its January 2018 meeting, TPSAC voted that PMIs MRTPA failed to provide scientific evidence supporting its modified risk claims.13 The evidence presented in PMIs MRTPA also failed to demonstrate a net public health benefit as required for both a PMTA order (Section 910(c)(4))4 and a MRTP order