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(Section 916)4 The PMI IQOS MRTP application In December 2016, PMI submitted a multimillion-page MRTPA to FDA seeking permission to market IQOS in the USA with two modified-risk claims (switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases and switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes) and one modified-exposure claim (switching completely from cigarettes to the IQOS system significantly reduces your bodys exposure to harmful and potentially harmful chemicals).7 In January 2018, PMI presented its IQOS MRTPA to TPSAC, and TPSAC found that PMIs MRTPA failed to provide sufficient scientific evidence supporting its modified risk claims.11 13 In March 2017, PMI submitted a PMTA28 seeking authorisation to market IQOS in the USA which is required whether or not IQOS is marketed with MRTP claims

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