The FDA is also expected to make some headway on Philip Morris International’s modified risk tobacco product (MRTP) application—although the timing is less clear than with the PMTA, because there is no guidance on how long the agency has to make the decision. The application was submitted in December 2016 and accepted for review in May 2017. Knakmuhs of Philip Morris USA told the industry the company is “hopeful that the FDA will host a Tobacco Products Scientific Advisory Committee (TPSAC) meeting in 2018.”
But a TPSAC meeting is only the next step in the process: When Swedish Match filed its MRTP to market General Snus as less harmful than cigarettes, it took the FDA more than a year to rule after its 2015 TPSAC meeting.
While the FDA ultimately rejected Swedish Match’s MRTP, Philip Morris and Altria are confident iQOS will see a different outcome, largely due to the scientific data it has provided the FDA.
“PMI’s extensive regulatory filings for iQOS present a compelling case for the product’s harm-reduction potential,” Knakmuhs said. “For example, the research demonstrates that iQOS reduces levels of 18 harmful and potentially harmful constituents identified by the FDA by over 90%, and reduces levels of 15 known carcinogens by more than 95% vs. conventional cigarettes.”