The FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) earlier this year voted on several descriptive claims regarding Philip Morris International’s (PMI’s) heat-not-burn product iQOS. Specifically, the claims were noted in PMI’s application for modified-risk tobacco product (MRTP) status for iQOS and Marlboro HeatSticks (the nicotine sticks that users insert into the iQOS device).
According to NATO, Lakeville, Minn., a modified-risk product reduces harm or the risk of tobacco-related disease. To obtain MRTP status, a manufacturer needs to file an MRTP application with the FDA for review and action. As a part of the MRTP process, TPSAC reviews the claims and makes nonbinding recommendations to the FDA.
After reviewing PMI’s application for the iQOS product and Marlboro Heatsticks, the nine-member TSPAC panel voted during a January public hearing as follows:
— On a vote of eight in favor and one against, TPSAC supported the claim that the iQOS product “significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
Declined to support:
— On a vote of five against and three in favor, with one member abstaining, the TPSAC panel said that PMI had not proved that reducing harmful exposure would “translate to a measurable and substantial reduction in morbidity and mortality.”
— On a vote of eight against and zero in favor, with one member abstaining, TPSAC did not support the claim that the iQOS product would reduce the risk for tobacco-related diseases.
— On a vote of five against and four in favor, a simple majority of TPSAC panel members did not support the claim that “switching completely to iQOS presents less risk of harm than continuing to smoke cigarettes.”
PMI officials said they looked forward to working with the FDA as the agency moves to make its final decisions on PMI’s MRTP application. Because TPSAC is an advisory panel, the FDA may or may not accept its recommendations on an MRTP application, NATO officials said. The FDA will now finalize its review of the application and issue a final decision on the iQOS product and Marlboro Heatsticks.
While the MRTP application focuses only on whether PMI will be allowed to make a claim of reduced-health risk, the company has also filed a premarket tobacco application (PMTA) with the FDA requesting an order to allow the sale of the iQOS product and Marlboro HeatSticks in the United States. The company is awaiting word from the FDA on the PMTA decision.