FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products

Key Terms

modified risk tobacco product regulatory

A modified risk tobacco product is a tobacco or nicotine product that is marketed with claims it reduces health risks or exposure to harmful substances compared with other tobacco products; such claims are typically subject to regulatory review and approval. For investors, this matters because approved modified-risk status can change consumer demand, legal exposure, labeling requirements and market access—similar to how a government-backed “low-risk” label can alter a product’s sales and liability profile.

mrtp regulatory

An MRTP (Modified Risk Tobacco Product) is an official U.S. regulatory designation for a tobacco or nicotine product that a regulator has reviewed and allowed to be marketed as posing lower health risks or reduced exposure to harmful substances. Think of it like an official “lower-risk” label: investors watch MRTP decisions closely because they can open or restrict market access, change legal and marketing rights, and materially affect a product’s sales and a company’s valuation.

premarket tobacco product application regulatory

A premarket tobacco product application is the formal submission a company must file with regulators to get permission to market a new or significantly changed tobacco product. Think of it as a permit showing evidence that the product is acceptable for public health—companies must provide scientific data on ingredients, emissions and likely impact on users and non-users. Investors care because approval determines whether a product can be sold, affects revenue potential, regulatory risk and a company’s valuation.

pmta regulatory

A Premarket Tobacco Product Application (PMTA) is a formal submission to a regulatory agency seeking permission to legally sell a new or changed tobacco or nicotine product. It lays out safety data, product design, and evidence that the product is appropriate for public health; approval is like a green light to enter the market. For investors, PMTA outcomes can make or break a company’s ability to sell products, affecting revenue forecasts and stock value, much like a building permit determines whether a construction project can proceed.

heat-not-burn technical

A heat-not-burn product is a consumer device that warms processed tobacco or nicotine material to generate an inhalable aerosol without burning it, similar to how a hot plate steams food instead of frying it. Investors watch these products because they can change demand for traditional cigarettes, face distinct regulatory and legal risks, and influence long-term revenue and public perception in tobacco and nicotine markets.

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FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes

STAMFORD, CT--(BUSINESS WIRE)-- Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing 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.”

“FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” said Stacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer,” she added. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the continuum of risk and communicating those findings transparently.”

The FDA’s action highlights a stark contrast: in the U.S., nicotine products undergo detailed scientific review before being authorized, while in many countries policymakers opt for bans rather than careful evaluation.

Products covered by the FDA’s MRTP orders include:

ZYN Cool Mint 3 mg

ZYN Cool Mint 6 mg

ZYN Peppermint 3 mg

ZYN Peppermint 6 mg

ZYN Spearmint 3 mg

ZYN Spearmint 6 mg

ZYN Wintergreen 3 mg

ZYN Wintergreen 6 mg

ZYN Citrus 3 mg

ZYN Citrus 6 mg

ZYN Coffee 3 mg

ZYN Coffee 6 mg

ZYN Cinnamon 3 mg

ZYN Cinnamon 6 mg

ZYN Smooth 3 mg

ZYN Smooth 6 mg

ZYN Chill 3 mg

ZYN Chill 6 mg

ZYN Menthol 3 mg

ZYN Menthol 6 mg

In January 2025, ZYN was the first nicotine pouch authorized for sale in the United States following rigorous scientific review. With today’s decision, PMI holds MRTP authorizations for ZYN, the first nicotine pouch authorized by the FDA, versions of IQOS devices and consumables and eight General snus products, underscoring the company’s position as an industry leader and innovator.

EDITOR’S NOTE

• FDA has authorized the ZYN MRTP claim, effective immediately.

• 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.’”

• Nicotine pouches, like ZYN, deliver nicotine through oral absorption and do not require the burning of tobacco, or inhaling of smoke. This significantly reduces exposure to harmful and potentially harmful chemicals compared to the use of combustible tobacco, such as cigarettes.
• In authorizing ZYN through the premarket tobacco product application (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 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%.

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, General snus and ZYN also obtained the first-ever Modified Risk Tobacco Product authorizations in their respective categories 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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260630053034/en/

Corey Henry
Philip Morris International
T. +1 (202) 679 7296
E. corey.henry@pmi.com

Source: Philip Morris International