Philip Morris International Announces U.S. FDA Reauthorization of IQOS as a Modified Risk Tobacco Product

(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) announced that it has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to PMI for two versions of the IQOS device and three variants of the tobacco consumables, commercialized under the HEETS brand. This renewal allows PMI to continue sharing reduced-exposure information with U.S. adults 21+ who use traditional tobacco products, such as combustible cigarettes.

The agency concluded that renewing the IQOS and HEETS MRTP authorizations is appropriate to promote public health and is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

“As the only company to have successfully secured and maintained MRTP authorizations for heated tobacco products in the U.S., we are confident that our science-based alternatives can help adult smokers transition away from combustible cigarettes,” said Stacey Kennedy, CEO, PMI U.S. “This decision from the FDA reflects both the rigorous scientific foundation supporting IQOS and our ongoing commitment to responsibly deliver smoke-free choices to adult consumers.”

In issuing the MRTP renewal orders for IQOS, the FDA reaffirmed that “the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely.”

The IQOS 2.4 system was the first heated tobacco product authorized via the FDA’s MRTP process in 2020 as “appropriate for the promotion of public health,” following its authorization through the premarket tobacco product application (PMTA) process in 2019. The IQOS 3 system secured MRTP authorization in 2022, following premarket authorization in 2020. The FDA continues to review PMTAs for IQOS ILUMA and given its strong application and demonstrated track record converting legal age smokers to a better alternative, PMI believes the application warrants expeditious FDA action.

PMI’s MRTP submission included an extensive body of scientific evidence indicating that the IQOS system produces aerosol with substantially lower levels of harmful and potentially harmful constituents compared with cigarette smoke. While no tobacco product is risk-free, a growing body of real-world data—including from markets such as Japan—indicates that the availability of heated tobacco products has been associated with notable reductions in combustible cigarette consumption.

Heated tobacco products, such as IQOS, heat tobacco without burning it, significantly reducing the formation of the harmful chemicals created by combustion while delivering real tobacco taste and nicotine satisfaction. The renewed authorization covers the following products:

• IQOS 2.4 System Holder and Charger
• IQOS 3.0 System Holder and Charger
• HEETS: Amber, Green Menthol, Blue Menthol

PMI U.S. is focused on providing better options than traditional tobacco products to America’s 45 million legal-age nicotine consumers—approximately 25 million of whom still smoke cigarettes, by far the most harmful way to consume nicotine.

Since 2008, PMI has invested over $16 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. PMI’s ambition is that all adults who would otherwise continue to smoke leave cigarettes behind for good by either quitting altogether or switching 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.

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 smokefree products, including heat-not-burn, nicotine pouch and e-vapor products. Our smoke-free products are available for sale in over 105 markets, and as of December 31, 2025 PMI estimates they were used by over 43 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 41.5% of PMI’s full year 2025 total net revenues. Since 2008, PMI has invested over $16 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 worldclass 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 as appropriate for the protection of public health - 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 areas. 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.

PMI U.S.: 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 25 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.

Forward-Looking and Cautionary Statements

This press release contains projections of future results and goals and other forward-looking statements, including statements regarding expected performance, regulatory outcomes, 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: marketing and regulatory restrictions that could reduce our competitiveness, disrupt our SFP commercialization efforts, eliminate our ability to communicate with adult consumers, or ban certain of our products in certain markets or countries; excise tax increases and discriminatory tax structures; health concerns relating to the use of tobacco and other nicotine-containing products; litigation related to tobacco and/or nicotine products and intellectual property rights; intense competition; inability to anticipate changes in adult consumer preferences; use and reliance on third-parties; the adverse effects of global and individual country economic, regulatory and political developments, natural disasters and conflicts; geopolitical instability affecting international trade; the impact and consequences of Russia's invasion of Ukraine; changes in adult smoker behavior; continued decline of tax-paid cigarettes; lost revenues as a result of counterfeiting, contraband and cross-border purchases; governmental investigations; unfavorable currency exchange rates and currency devaluations, sustained periods of elevated inflation, and limitations on the ability to repatriate funds; adverse changes in applicable corporate tax laws; disruptions in the credit markets or changes to its credit ratings; recent and potential future tariffs imposed by the U.S. and other countries; adverse changes in the cost, availability, and quality of tobacco and other agricultural products and raw materials, as well as product components 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 key markets or systemically, in its efforts 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; if there are prolonged disruptions of facilities used to produce its products; if it is unable to enter new markets or improve its margins through increased prices and productivity gains; if other market participants are more successful in their SFP commercialization efforts; 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, 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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