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

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A pioneer in smoke-free tobacco products, Philip Morris International is the only company that has received modified risk tobacco product authorizations for heated tobacco products.

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In their order, FDA concluded 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”

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STAMFORD, CT — 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.

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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.

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“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.”

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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.”

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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.

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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.

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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:

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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.

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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.

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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.

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Philip Morris International: A Global Smoke-Free Champion

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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.