Philip Morris International Urges U.S. Food and Drug Administration Advisory Committee to Recommend Continued Marketing of IQOS as Modified Risk Product

(BUSINESS WIRE)--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.

Notes to the editor

The IQOS 2.4 system was first authorized as “appropriate for the promotion of the public health” through the MRTP application process in 2020, following authorization through the premarket tobacco product application (PMTA) process in 2019.

The IQOS 3 system secured MRTP authorization in the 2022 application process, following a premarket authorization in 2020.

In issuing MRTP orders for IQOS, the FDA concluded that “the reasonably likely overall impact of use of the [IQOS system] remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users.”

The MRTPs for the IQOS system were granted for an initial four-year period.

Throughout the six-year surveillance period, PMI has not received any communication or concerns from the FDA regarding the APPH (“appropriate for the protection of the public health”) status of these products.

Across both the PMTA and MRTP review processes, PMI has submitted a total of nine applications, presented at two TPSAC meetings, including the Oct. 7 meeting, and submitted six years of additional post-market evidence to the FDA in comprehensive annual reports. PMI has also submitted PMTAs and MRTPAs for IQOS ILUMA, a later version of IQOS, which has shown even higher rates of legal-age adults fully switching from combustible cigarettes globally.

Under an initial agreement granting Altria exclusive rights to commercialize the IQOS system in the U.S., the FDA-authorized products were initially marketed by Altria affiliates in select U.S. locations starting in October 2019.

Due to a patent dispute with British American Tobacco before the International Trade Commission, the IQOS systems were removed from the U.S. market in November 2021.

In 2022, PMI reached an agreement with Altria Group, Inc. to end its commercial relationship in the U.S. covering IQOS as of April 30, 2024. PMI now holds the full rights to commercialize IQOS in the U.S.

The patent dispute was subsequently resolved, and marketing of the IQOS system solely by PMI U.S. has resumed in select U.S. locations, including Austin, TX, Jackson, MS, and on selected military bases.

References to “PMI” mean the Philip Morris International family of companies. “PMI U.S.,” “we,” “our,” and “us” refer to one or more PMI U.S. businesses.

Invested in America

Philip Morris International Inc.’s U.S. businesses are invested in America’s future and advancing a smoke-free nation. The businesses are committed to providing the approximately 30 million legal-age consumers who smoke cigarettes with better, smoke-free alternatives and to ensuring the products are marketed responsibly. From PMI’s global headquarters in Stamford, Connecticut, and other locations nationwide, PMI U.S. contributes leadership, jobs, investment, and innovation in the U.S. The U.S. businesses employ more than 3,000 people across America and operate product manufacturing facilities, including in Owensboro, Kentucky, and Wilson, North Carolina. For more information, please visit www.uspmi.com.

Philip Morris International: A Global Smoke-Free Champion

Philip Morris International is a leading international consumer goods company, actively delivering a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector. The company’s current product portfolio primarily consists of cigarettes and smoke-free products, including heat-not-burn, nicotine pouch and e-vapor products. As of June 30, 2025, our smoke-free products were available for sale in 97 markets, and PMI estimates they were used by over 41 million legal-age consumers around the world, many of whom have moved away from cigarettes or significantly reduced their consumption. The smoke-free business accounted for 41% of PMI’s first-half 2025 total net revenues. Since 2008, PMI has invested over $14 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of completely ending the sale of cigarettes. This includes the building of world-class scientific assessment capabilities, notably in the areas of pre-clinical systems toxicology, clinical and behavioral research, as well as post-market studies. Following a robust science-based review, the U.S. Food and Drug Administration has authorized the marketing of Swedish Match’s General snus and ZYN nicotine pouches and versions of PMI’s IQOS devices and consumables - the first-ever such authorizations in their respective categories. Versions of IQOS devices and consumables and General snus also obtained the first-ever Modified Risk Tobacco Product authorizations from the FDA. With a strong foundation and significant expertise in life sciences, PMI has a long-term ambition to expand into wellness and healthcare areas and aims to enhance life through the delivery of seamless health experiences. References to “PMI”, “we”, “our” and “us” mean Philip Morris International Inc., and its subsidiaries. For more information, please visit www.pmi.com and www.pmiscience.com.

Forward-Looking and Cautionary Statements

This press release contains projections of future results and goals and other forward-looking statements, including statements regarding business plans and strategies. Achievement of future results is subject to risks, uncertainties, and inaccurate assumptions. In the event that risks or uncertainties materialize, or underlying assumptions prove inaccurate, actual results could vary materially from those contained in such forward-looking statements. Pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, PMI is identifying important factors that, individually or in the aggregate, could cause actual results and outcomes to differ materially from those contained in any forward-looking statements made by PMI.

PMI’s business risks include: excise tax increases and discriminatory tax structures; increasing marketing and regulatory restrictions that could reduce our competitiveness, eliminate our ability to communicate with adult consumers, or ban certain of our products in certain markets or countries; health concerns relating to the use of tobacco and other nicotine-containing products and exposure to environmental tobacco smoke; litigation related to tobacco and/or nicotine use and intellectual property; intense competition; the effects of global and individual country economic, regulatory and political developments, natural disasters and conflicts; the impact and consequences of Russia’s invasion of Ukraine; changes in adult smoker behavior; the impact of natural disasters and pandemics on PMI’s business; lost revenues as a result of counterfeiting, contraband and cross-border purchases; governmental investigations; unfavorable currency exchange rates and currency devaluations, and limitations on the ability to repatriate funds; adverse changes in applicable corporate tax laws; adverse changes in the cost, availability, and quality of tobacco and other agricultural products and raw materials, as well as components and materials for our electronic devices; and the integrity of its information systems and effectiveness of its data privacy policies. PMI’s future profitability may also be adversely affected should it be unsuccessful in its attempts to introduce, commercialize, and grow smoke-free products or if regulation or taxation do not differentiate between such products and cigarettes; if it is unable to successfully introduce new products, promote brand equity, enter new markets or improve its margins through increased prices and productivity gains; if it is unable to expand its brand portfolio internally or through acquisitions and the development of strategic business relationships; if it is unable to attract and retain the best global talent; or if it is unable to successfully integrate and realize the expected benefits from recent transactions and acquisitions. Future results are also subject to the lower predictability of our smoke-free products’ performance.

PMI is further subject to other risks detailed from time to time in its publicly filed documents, including PMI’s Annual Report on Form 10-K for the fourth quarter and year ended December 31, 2024 and the Quarterly Report on Form 10-Q for the second quarter ended June 30, 2025. PMI cautions that the foregoing list of important factors is not a complete discussion of all potential risks and uncertainties. PMI does not undertake to update any forward-looking statement that it may make from time to time, except in the normal course of its public disclosure obligations.

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