Beirut, Lebanon – 28 July 2026: Philip Morris International (PMI) announced that the U.S. Food and Drug Administration (FDA) has authorized the commercialization of its ZYN smoke-free nicotine pouches as modified risk tobacco products (MRTPs).
The authorization marks a significant milestone, making ZYN the first and only nicotine pouch brand to receive this designation from the FDA. The agency’s decision recognizes that, based on the available scientific evidence, switching completely from cigarettes to ZYN significantly reduces exposure to harmful chemicals. This reduction is expected to lower the risk of developing several smoking-related diseases, including oral and lung cancer, heart disease, stroke, emphysema, and chronic bronchitis.
The authorization represents another step forward in PMI’s commitment to advancing smoke-free alternatives. The company continues to invest in the research, development, and commercialization of scientifically substantiated products within regulatory frameworks that prioritize rigorous scientific evaluation and transparent risk assessment.
Earlier this year, PMI presented its scientific evidence to the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) as part of its application to market ZYN as a modified risk tobacco product. The application was intended to ensure that adult smokers have access to accurate, science-based information about the benefits of switching completely from cigarettes to these products. This follows the FDA’s authorization in January 2025 allowing ZYN products to be marketed in the United States.
ZYN nicotine pouches contain nicotine derived from the tobacco plant. While nicotine is addictive, it is not the primary cause of smoking-related diseases. The pouches are made from plant-based fibers and are placed between the gum and upper lip, where nicotine is absorbed through the oral mucosa.
As part of its vision for a smoke-free future, PMI continues to invest in developing better alternatives for adults who would otherwise continue smoking cigarettes. Its smoke-free portfolio includes heated tobacco products, nicotine pouches, and e-vapor products, which are now available in markets around the world.
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. 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 43% of PMI’s first-quarter 2026 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 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 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.