Dubai, UAE – August 27, 2026: Philip Morris International Inc. (PMI) (NYSE: PM) announced that the U.S. Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of its ZYN nicotine pouch products.
The FDA authorization represents a significant milestone, as these are the first Modified Risk Tobacco Product (MRTP) orders granted for nicotine pouches. The authorization recognizes the role that smoke-free alternatives can play in tobacco harm reduction, supported by scientific evidence demonstrating that they expose users to substantially lower levels of harmful chemicals than cigarettes. In the United States, the orders allow PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
This authorization marks another important step in PMI’s transformation toward a smoke-free future, as it continues to innovate, develop and scientifically substantiate smoke-free alternatives built on rigorous scientific assessment and transparent risk evaluation for adults who would otherwise smoke.
From the FDA Modified Risk Granted Order: “Based on our review of your MRTPAs, we determined that the proposed modified risk tobacco products, as described in your applications and specified in Appendix A, have satisfied the requirements of section 911(g)(1)(A) and (B), including that they, as actually used by consumers, would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and 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. Therefore, we authorize marketing of the tobacco products as modified risk tobacco products with the following modified risk information: ‘Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.’”
When reviewing the ZYN applications, the U.S. FDA considered extensive data showing that some adults who smoke and have started using ZYN products have reduced their cigarette use over time, with over half of those surveyed reporting no cigarette consumption in the past 30 days. Of those who continue to smoke cigarettes after starting to use ZYN products, the majority (80.7%) reduced their cigarette consumption, and over half (57.2%) reduced their cigarettes per day by more than 50%.
ZYN nicotine pouches, deliver nicotine through the oral absorption from the mucosa, unlike cigarettes where tobacco is burnt and smoke is inhaled. This significantly reduces exposure to harmful and potentially harmful chemicals compared to smoking cigarettes.
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 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 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.