PMI presses FDA to uphold IQOS ‘modified risk’ status
October 9, 2025
Philip Morris International (PMI) has urged a U.S. Food and Drug Administration (FDA) advisory committee to recommend that its IQOS heated tobacco system retain its status as a “modified risk tobacco product” (MRTP), highlighting fresh evidence of reduced harm and complete switching among adult smokers.
The appeal came during a full-day meeting on 7 October of the Tobacco Products Scientific Advisory Committee (TPSAC), which provides scientific recommendations to the FDA’s Center for Tobacco Products (CTP). The review is part of PMI’s request to continue marketing its IQOS devices in the U.S. with reduced-risk claims while the agency evaluates its pending application for the next-generation IQOS ILUMA.
PMI U.S. CEO Stacey Kennedy said the company’s latest data reinforce the FDA’s 2020 conclusion authorising IQOS as a modified risk product. “The evidence presented at this meeting, as also noted by the FDA, further supports the agency’s original conclusions,” she said. “We encourage the FDA to continue efforts to establish a timely scientific review process for smoke-free products – including for IQOS ILUMA, which has been pending FDA review for nearly two years.”
The IQOS system heats tobacco rather than burning it, substantially reducing the production of harmful and potentially harmful chemicals. PMI said its global consumer base had reached approximately 34 million legal-age users by mid-2025, many of whom had either quit or significantly reduced cigarette consumption.
The MRTP renewal covers two IQOS devices (2.4 and 3.0 systems) and three HEETS variants – Amber, Green Menthol, and Blue Menthol. The FDA’s original authorisation allows PMI to inform consumers that switching completely from cigarettes to IQOS reduces exposure to harmful chemicals.
PMI executives also presented data on switching rates and responsible marketing, claiming high levels of conversion among adult smokers and low uptake among unintended populations.
“CTP’s mission is to make tobacco-related disease and death a part of America’s past,” said Keagan Lenihan, PMI U.S. VP and Chief External Affairs Officer. “Smoke-free products like PMI’s IQOS system play a critical role in achieving this mission and provide adults who smoke with a real opportunity to change.”
Since 2008, PMI has invested more than $14 billion in developing and commercialising scientifically substantiated smoke-free products, as part of its goal to end cigarette sales entirely. The company entered the U.S. market in 2022 following its acquisition of Swedish Match, expanding its smoke-free portfolio to include heated tobacco and oral nicotine products.
PMI said continued regulatory support for risk-proportionate innovation will be key to accelerating the decline of combustible cigarette use.
