STAMFORD, CT -- Experts from Philip Morris International Inc. (NYSE: PM) presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC). The committee, comprised of independent scientific researchers, provides nonbinding recommendations to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP).

The full-day meeting on October 7 was part of the FDA’s customary review of PMI’s request to continue marketing versions of its IQOS heated tobacco products in the U.S. as modified risk tobacco products (MRTPs), a necessary step while FDA completes its review of pending applications for IQOS ILUMA (a later version of the IQOS models that are currently authorized by the FDA) to reach and transition even more legal-age adults away from combustible cigarettes.

“The evidence presented at this meeting, as also noted by the FDA, further supports the agency’s original conclusions that led the FDA to authorize the IQOS system as a modified risk tobacco product,” said Stacey Kennedy, PMI U.S. CEO. “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 and has globally shown even higher rates of legal-age adults fully switching from combustible cigarettes—that are a better choice for legal-age adults who would otherwise use traditional tobacco products, including combustible cigarettes.”

The IQOS system heats tobacco instead of burning it, which significantly reduces the production of and users’ exposure to harmful chemicals while still providing real tobacco taste and the ritual of smoking to maximize complete switching away from cigarettes. As of June 30, 2025, PMI estimates there are approximately 34 million legal-age IQOS consumers globally—many of whom have moved away from cigarettes or significantly reduced their consumption. The modified risk tobacco products submitted for renewal include two versions of the IQOS device and three variants of the tobacco consumables, called HEETS, including:

· IQOS 2.4 System Holder and Charger
· IQOS 3.0 System Holder and Charger
· Amber HEETS
· Green Menthol HEETS
· Blue Menthol HEETS

Initially granted by the FDA in 2020, the MRTP designation for the IQOS system authorizes PMI to communicate to legal-age consumers that: “AVAILABLE EVIDENCE TO DATE:

· The IQOS system heats tobacco but does not burn it.
· This significantly reduces the production of harmful and potentially harmful chemicals.
· Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly
reduces your body’s exposure to harmful or potentially harmful chemicals.”

During the meeting, representatives from PMI and committee members discussed a range of scientific, technical, and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented additional evidence and research demonstrating high levels of complete switching among current legal-age smokers while maintaining low levels of use by unintended populations.

Addressing committee members, Keagan Lenihan, VP and Chief External Affairs Officer for PMI U.S., said: “CTP’s mission is to make tobacco-related disease and death a part of America’s past. Smoke-free products, like PMI’s IQOS system, play a critical role in helping CTP achieve this mission and provide adults who smoke with a real opportunity to change. The IQOS system, when marketed with the reduced-exposure claim, promotes complete switching from combustible cigarettes.”

PMI in the U.S is focused on providing better options than traditional tobacco products to America’s 45 million legal-age nicotine users—around 30 million of whom still smoke cigarettes, the most harmful form of nicotine consumption.

Since 2008, PMI has invested over $14 billion globally to develop, scientifically substantiate, and commercialize innovative smoke-free products for adults who would otherwise smoke, with the goal of completely ending the sale of cigarettes.

PMI first entered the U.S. market in 2022, following its acquisition of Swedish Match—a leader in oral nicotine delivery—creating a global smoke-free champion. Globally, our ambition is that all those who would otherwise continue smoking abandon cigarettes and switch completely to scientifically substantiated smoke-free products as soon as possible. Regulatory policies and decisions can substantially accelerate the speed and magnitude of this historic change.