Philip Morris International Urges FDA Advisory Committee to Recommend Authorizing ZYN as a Modified Risk Tobacco Product

(BUSINESS WIRE)--Experts from Philip Morris International (PMI) (NYSE: PM) yesterday presented scientific evidence to the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) as part of the FDA’s process for a Modified Risk Tobacco Product (MRTP) designation for their ZYN nicotine pouch products. This designation would allow PMI’s U.S. family of businesses to communicate to U.S. legal-aged, 21+ adult cigarette smokers that switching completely to ZYN reduces their risk of many smoking-related diseases and we look forward to a decision by FDA.

"The FDA’s Center for Tobacco Product’s (CTP) mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, Chief External Affairs Officer for PMI U.S. “Smoke-free products, like ZYN, play a critical role in helping CTP achieve this mission and provide adults who smoke with important information to guide their choices and a real opportunity to change.

The full-day meeting on January 22 was part of the FDA’s scientific review of PMI-affiliate Swedish Match USA Inc.’s application to use the following proposed reduced risk claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” In their presentation to the committee, The FDA stated: "The evidence suggests the proposed modified risk claim is scientifically accurate." Additionally, the FDA noted: “Youth nicotine pouch use prevalence is currently relatively low” and “among young adults, viewing the proposed claim did not increase intentions to use ZYN.”

During the meeting, data were presented showing that exposure to the claim raised awareness that switching from cigarettes to ZYN lowers the risks of developing the six critical health conditions in the claim (i.e., mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis). The data presented also demonstrated that consumers understood ZYN products are not entirely risk-free, and the risk of developing the health conditions in the claim after switching to ZYN is significantly lower compared to continuing cigarettes.

The TPSAC, an independent panel of scientific experts that provides nonbinding recommendations to CTP, reviewed evidence showing that ZYN contains substantially lower levels of harmful chemicals than cigarettes. The evidence also demonstrated that ZYN promotes complete switching to help smokers transition away from combustible products while maintaining low levels of use by unintended populations, including youth. The committee also heard testimony that ZYN nicotine pouches represent the next evolution of Swedish Snus—an oral tobacco product that was the first to receive an MRTP designation from the FDA in 2019 and has been linked to Sweden’s low smoking prevalence and reduced rates of tobacco-related disease.

In January 2025, ZYN became the first nicotine pouch product to receive marketing authorization from FDA through the Premarket Tobacco Product Authorization (PMTA) pathway. With an MRTP designation, the FDA would recognize and acknowledge the scientific evidence showing that ZYN has a reduced‑risk profile compared to cigarettes. They would also permit this information to be communicated to adult consumers. The ZYN nicotine pouch products submitted for the MRTP designation are the same products that received PMTA authorization in January 2025, which include:

ZYN Cool Mint 3 mg and 6 mg
ZYN Peppermint 3 mg and 6 mg
ZYN Spearmint 3 mg and 6 mg
ZYN Wintergreen 3 mg and 6 mg
ZYN Citrus 3 mg and 6 mg
ZYN Coffee 3 mg and 6 mg
ZYN Cinnamon 3 mg and 6 mg
ZYN Smooth 3 mg and 6 mg
ZYN Chill 3 mg and 6 mg
ZYN Menthol 3 mg and 6 mg

References to “PMI” mean the Philip Morris International family of companies. “PMI U.S.,” refers to one or more PMI U.S. businesses.

EDITOR’S NOTE

• Nicotine pouches, like ZYN, deliver nicotine through oral absorption and do not require the burning or inhaling of smoke or aerosol of any kind. As they do not involve the burning of tobacco, this significantly reduces the production of harmful and potentially harmful chemicals (HPHCs) compared to combustible tobacco, such as cigarettes.
   
• In authorizing ZYN through the PMTA pathway in January 2025, the FDA noted: “the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products [ZYN] pose lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.”
   
• When reviewing the ZYN applications, 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 that 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%.

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 100 markets, and as of June 30, 2025, PMI estimates they were used by over 41 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% of PMI’s first-nine months 2025 total net revenues. Since 2008, PMI has invested over $14 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 and healthcare areas and aims to enhance life through the delivery of seamless health experiences. 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 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. 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 financial or operational performance, 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; 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 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.

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