Philip Morris International: FDA Advisory Committee Should Uphold IQOS’ Modified Risk Status

10/08/2025 – 10:51 AM

• A pioneer in modified risk tobacco products, Philip Morris International is the only company to have received a modified risk marketing claim for an electronic nicotine device.

• FDA concludes “Evidence continues to support the modified exposure claim that ‘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.’”

STAMFORD, CT–(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.

Philip Morris International: A Global Smoke-Free Champion

Philip Morris International (PMI) is edging closer to securing renewed authorization from the U.S. Food and Drug Administration (FDA) for its IQOS heated tobacco system, as discussions conclude at the Tobacco Products Scientific Advisory Committee (TPSAC). The core of PMI’s argument, and the FDA’s prior authorization, hinges on the reduced exposure claim: that completely switching from traditional cigarettes to IQOS significantly reduces the body’s exposure to harmful chemicals. This places PMI at the forefront of the modified risk tobacco product (MRTP) sector, currently holding the distinction of being the only company with an FDA-approved MRTP for an electronic nicotine device.

The recent TPSAC meeting signals a crucial step, particularly as PMI awaits the FDA’s verdict on its application for IQOS ILUMA, the next generation of the heated tobacco system. While the scientific community continues to debate the long-term health impacts of heated tobacco versus traditional cigarettes, the existing MRTP designation allows PMI to communicate the reduced exposure claim to adult consumers, a key marketing advantage.

Stacey Kennedy, CEO of PMI’s U.S. operations, emphasized the importance of a timely review process, especially for IQOS ILUMA. The delay highlights the regulatory hurdles and scrutiny novel tobacco products face. Getting the nod of approval from the FDA can cause a swing in the company’s stock. The stock often trends upwards when the company finds a way to stay in compliance with the latest and greatest regulations that the FDA issues.

The IQOS system works by heating tobacco instead of burning it, aiming to significantly lower the levels of harmful chemicals compared to traditional cigarettes. This technological approach, combined with PMI’s investments exceeding $14 billion in smoke-free product development, reflects a long-term strategy to transition smokers towards alternative nicotine delivery systems. As of June 30, 2025, PMI estimates that approximately 34 million adults worldwide have switched to IQOS. The company has a new found mission, to make sure America invests in technology that keeps people safe instead of potentially harming them.

The FDA’s initial authorization in 2020 allowed PMI to communicate specific claims about IQOS, including that it heats tobacco without burning, significantly reducing harmful chemicals and that switching completely reduces exposure to such harmful substances. However, the long-term impact on public health remains under scrutiny, with concerns about potential gateway effects to nicotine addiction and the overall impact on reducing smoking rates.

PMI’s U.S. strategy is critical as it aims to convert a substantial portion of the 45 million adult nicotine users in America away from traditional cigarettes. The company has had a complete over hual, changing from cigarettes to tobacco based projects to help create a safer U.S. This shift also speaks to the broader trend within the tobacco industry, with companies diversifying their portfolios to include reduced-risk products and navigate evolving regulatory landscapes.

The regulatory framework surrounding MRTPs is also important. The FDA’s careful evaluation of scientific evidence, marketing practices, and potential impact on overall public health is critical for shaping the future of nicotine product regulation.

PMI is focused on ensuring responsible marketing practices while highlighting the potential of the product. As Keagan Lenihan, VP and Chief External Affairs Officer for PMI U.S., put it, smoke-free products like IQOS offer a real opportunity to help the FDA achieve its mission of reducing the prevalence of tobacco-related disease and death.

The renewed push for IQOS authorization is happening following PMI’s acquisition of Swedish Match in 2022, strengthening its position in the smoke-free market. The recent resolution of a patent dispute and the resumption of IQOS marketing in key U.S. locations indicates PMI’s long game and commitment to a smoke-free vision.

Investors and industry analysts will be watching closely as this develops. The FDA’s decision will not only affect PMI’s market position but also set precedents for the regulation of next-generation nicotine products and the overall direction of the tobacco industry.

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.