FDA Authorizes ZYN ULTRA Nicotine Pouches Following Scientific Review

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Authorizations add selection of ZYN ULTRA products to PMI U.S.’s growing portfolio of better alternatives for legal-age adults who smoke or use traditional oral tobacco products

STAMFORD, CT--(BUSINESS WIRE)-- Philip Morris International Inc. (NYSE: PM) today announces that the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders to PMI’s U.S. affiliate, Swedish Match USA, Inc., authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, including all 9mg variants and one 11mg variant. Additional 11mg variants remain under scientific review.

Today’s action further enhances PMI’s leadership role in the smoke-free category.

“We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.”

ZYN ULTRA positions the brand to further extend its category leadership among legal-age consumers of nicotine products. Like the flagship FDA-authorized ZYN pouches, ZYN ULTRA, with its higher moisture content, is free of tobacco-leaf.

Today’s decisions build on the FDA’s earlier authorizations of ZYN in multiple flavors and both 3mg and 6 mg variants. ZYN was the first nicotine pouch authorized for sale in the United States following rigorous scientific review. PMI leads the industry in securing FDA authorizations, reinforcing its commitment to transparency and science-based regulation.

These authorizations underscore PMI U.S.’s commitment to innovation and responsible marketing practices to adults aged 21+, as the company works to offer alternatives that are a much better choice than continuing to smoke.

The FDA authorized the following products in 9 mg nicotine concentrations:

ZYN ULTRA Smooth (commercialized as Signature Smooth)
ZYN ULTRA Cool Mint (commercialized as Arctic Mint)
ZYN ULTRA Spearmint (commercialized as Fresh Spearmint)
ZYN ULTRA Wintergreen (commercialized as Wintergreen Blast)
ZYN ULTRA Peppermint (commercialized as Peppermint Frost)
ZYN ULTRA Citrus (commercialized as Citrus Zest)
ZYN ULTRA Chill (commercialized as Chill Mist)
ZYN ULTRA Menthol (commercialized as Menthol Ice)
ZYN ULTRA Deep Freeze
ZYN ULTRA Wintergreen Chill

The FDA authorized the following product in 11mg nicotine concentration:

ZYN ULTRA Smooth (commercialized as Signature Smooth)

EDITOR’S NOTE

From the FDA Granted Order: “Based on our review of your PMTAs, we determined that permitting the marketing of the new tobacco products, as described in your applications and specified in Appendix A, are appropriate for the protection of public health.”
Pre-market applications for other ZYN ULTRA 11mg variants remain under scientific review at FDA.
Today’s news follows a series of recent FDA actions involving PMI’s smoke-free portfolio, including modified risk tobacco product orders for certain previously authorized ZYN nicotine pouches. PMI U.S. began commercialization of ZYN ULTRA in June 2026 under recent FDA guidance.

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 109 markets as of June 30, 2026. 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 approximately 42% of PMI’s second-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 or use other nicotine-containing consumer products, 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, General snus and 20 ZYN nicotine pouch variants 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.

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.

About 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 Aurora, Colorado, Owensboro, Kentucky, and Wilson, North Carolina. For more information, please visit www.uspmi.com.

Forward-Looking and Cautionary Statements

This release contains projections of future results and goals and other forward-looking statements, including statements regarding expected financial or operational performance; capital allocation plans; investment strategies; regulatory outcomes; market expectations; 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; the impact and consequences of Russia's invasion of Ukraine; changes in legal-age 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 its 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, and 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, and the Quarterly Report on Form 10-Q for the second quarter ended June 30, 2026. 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.