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  • FDA Posts New Materials in Zyn MRTP Applications

    FDA Posts New Materials in Zyn MRTP Applications

    The FDA posted new materials today (Feb. 2) related to the modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The documents are available on the Swedish Match USA, Inc. MRTP application webpage. This is the final set of application materials.

    Accordingly, FDA is establishing the closing date for the public comment period on these MRTP applications. Public comments must be submitted to Docket Number FDA-2025-N-0835-0001 by 11:59 p.m. ET on March 4 to be considered. 

    Read the application materials here.

  • PMI Positive After FDA’s Zyn Hearing

    PMI Positive After FDA’s Zyn Hearing

    Philip Morris International (PMI) believes it moved a step closer to securing permission to market its Zyn nicotine pouches as a reduced-risk alternative to cigarettes in the United States, following a full-day public hearing convened by the U.S. Food and Drug Administration (FDA) yesterday (January 22). At the meeting, PMI scientists presented evidence to the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) in support of a Modified Risk Tobacco Product (MRTP) application that would allow the company to tell adult smokers that switching completely to Zyn lowers the risk of major smoking-related diseases. FDA briefing materials and staff presentations suggested regulators are leaning toward approving the proposed claim, with the agency stating that “the evidence suggests the proposed modified risk claim is scientifically accurate.”

    “The FDA’s Center for Tobacco Product’s 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 proposed language would allow PMI to say that using Zyn instead of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. FDA scientists said the “totality of the evidence” shows Zyn contains substantially lower levels of harmful chemicals than cigarettes, and that consumer research suggests the claim increases awareness of reduced risks without misleading users into believing the product is risk-free. The agency also noted that youth nicotine pouch use remains relatively low, at 2.4% of U.S. high school students in 2024, and that exposure to the proposed claim did not increase young adults’ intentions to use Zyn. PMI executives argued that clearer communication of relative risk could help smokers move away from combustible products, drawing comparisons to Swedish snus, which received an MRTP designation in 2019 and has been linked to Sweden’s low smoking rates.

    However, members of the independent TPSAC panel raised concerns about gaps in long-term data and whether reduced-risk marketing would meaningfully accelerate smoking cessation in the U.S. Public health advocates also warned about the potential appeal of flavored pouches, discreet use, and social-media promotion to underage users. While panelists generally agreed that Zyn is far less harmful than cigarettes, they questioned whether the evidence shows that marketing claims will drive widespread switching. The FDA is not bound by the panel’s non-binding recommendations and has not set a deadline for its final decision, which will determine whether PMI can formally promote Zyn as a reduced-risk product to adult smokers.

    “While the relatively expedited timeline for this MRTP review is encouraging, the fact that the TPSAC did not vote on a recommendation makes me question the reason for these meetings moving forward,” said Laura Leigh Oyler, VP of Regulatory Affairs for Haypp Group, whose subsidiaries sell nicotine pouches online. “The science, and the many public speakers who supported the authorization were clear: Americans deserve honest messaging around these products and their impacts on harm reduction.”

  • FDA Releases Meeting Materials for Zyn’s MRTP Application  

    FDA Releases Meeting Materials for Zyn’s MRTP Application  

    Today (January 20), the U.S. Food and Drug Administration released meeting materials ahead of a virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The materials include a draft agenda, background documents from both the applicant and the FDA, and draft questions for committee consideration, and are available on the FDA’s 2026 TPSAC Meeting Materials and Information page.

    The virtual TPSAC meeting is scheduled for January 22. FDA opened Docket No. FDA-2025-N-0835-0020  for public comments related to the meeting, with submissions due by 11:59 p.m. ET on January 21. Comments specific to the ZYN MRTP applications may also be submitted under a separate docket, Docket No. FDA-2025-N-0835-0001, which was established on June 18, 2025.

    Visit the event webpage to learn more about attending the meeting online

  • Swedish Match Discontinues Four Zyn Products for 2026

    Swedish Match Discontinues Four Zyn Products for 2026

    Swedish Match announced the retirement of four Zyn products for 2026: Apple Mint Mini Extra Strong, Original Mini Normal, Original Mini Extra Strong, and Cucumber Lime Slim Normal. On the company’s website, it suggested alternative products with similar flavors and strengths. The brand’s remaining portfolio, including about 15 mint and apple-based flavors, will continue to be available on the swedishmatch.se platform.

  • Federal Judge Allows Deceptive Claim in Zyn Case

    Federal Judge Allows Deceptive Claim in Zyn Case

    A federal judge in Florida has allowed deceptive practices claims against Philip Morris International (PMI) and its subsidiaries to move forward, according to Law360. On December 12, U.S. District Judge William P. Dimitrouleas of the Southern District of Florida denied the companies’ motion to dismiss claims brought by plaintiff Kovadis Palmer under the Florida Deceptive and Unfair Trade Practices Act (FDUTPA).

    Palmer alleges that PMI and Swedish Match North America LLC misleadingly marketed Zyn nicotine pouches as “tobacco-free,” suggesting a lower addiction risk even though the nicotine is derived from tobacco. He claims he developed nicotine dependence as a result. While the court previously dismissed Palmer’s common-law fraud claims for failing to meet heightened pleading standards, it found that the amended FDUTPA claims advance a distinct legal theory.

    The judge ruled that FDUTPA claims do not require proof of intent to deceive and are not subject to the stricter fraud pleading rules. As a result, the court held that the claims are not merely a repackaging of dismissed fraud allegations and may proceed.

  • CTFK Accuses PMI of Targeting Youth with F1 Sponsorship

    CTFK Accuses PMI of Targeting Youth with F1 Sponsorship

    The Campaign for Tobacco-Free Kids criticized Philip Morris International (PMI) for its partnership with Ferrari to market Zyn nicotine pouches on Formula 1 race cars, calling it a tactic that exposes youth to tobacco marketing. Yolonda C. Richardson, president and CEO, said PMI’s claim that the sponsorship targets adults is “laughable.” Formula 1 previously said that Gen Z (those born between 1997 and 2012) “is helping shape the rhythm of modern fandom,” but Richardson argued that F1’s audience now includes more than 4 million children aged 8 to 12, evidenced by collaborations with youth-oriented brands like Disney, Lego, and Hot Wheels.

    Richardson said that plastering Zyn logos on F1 cars associates the product with excitement and glamour, has the potential to attract millions of young people, and urged Formula 1 and its partners to end the sponsorship, calling on policymakers to prevent tobacco companies from targeting a new generation of consumers.

    When asked for comment, a spokesperson for PMI U.S. clearly disagreed.

    “Adult consumers of nicotine products do not live in a vacuum,” the spokesperson said. “They have hobbies, interests, and attend social gatherings and events—it’s vital to reach them where they are. Scuderia Ferrari HP at Formula 1 is a global platform where we can engage adult consumers worldwide with a message of choice and innovative alternatives to smoking.

    “CTFK’s allegation is nothing more than a tired, lazy, and erroneous characterization—absent of any facts. Formula 1’s and Scuderi Ferrari HP’s audience is overwhelmingly adult, and our brand presence is carefully assessed to ensure responsible marketing practices.”

  • Zyn Launches 1.5 Mg Option in UK

    Zyn Launches 1.5 Mg Option in UK

    Zyn launched Zyn X-Low, its lowest-strength nicotine pouch at 1.5mg, positioning it as an entry-level option for adult users new to the category, according to Talking Retail. The product expands Zyn’s UK and Ireland portfolio and is available in spearmint, black cherry, and cool mint via grocery, convenience, and wholesale channels, including Philip Morris’ Open retailer platform.

    “Expanding the range in this way allows us to meet a broader spectrum of adult nicotine preferences, strengthen the role of modern oral products in the marketplace, and further our ambition of achieving a smoke-free future,” said Dor Matot, head of Zyn UK and Ireland.

    The launch is backed by a nationwide marketing campaign aimed at highlighting strength choice and attracting first-time pouch users.

  • PMI Expands Partnership with Scuderia Ferrari HP

    PMI Expands Partnership with Scuderia Ferrari HP

    Philip Morris International announced an expanded partnership with Scuderia Ferrari HP and the Ferrari Challenge Trofeo Pirelli for the 2026 season and beyond. As part of the deal, PMI’s ZYN nicotine pouches will appear on select Scuderia Ferrari HP Formula 1 liveries, debuting at the Abu Dhabi Grand Prix on December 7.

    Stefano Volpetti, PMI’s President of Smoke-Free Products, said the collaboration reflects a shared drive to innovate and engage adult consumers. “By further enhancing our partnership with Scuderia Ferrari HP, we hope to accelerate the replacement of cigarettes, and we want our adult consumers of nicotine products, like ZYN, to embrace and enjoy every moment of this thrilling ride,” he said.

    Ferrari’s Lorenzo Giorgetti highlighted the partnership’s longevity and shared values, saying, “Our renewed collaboration with PMI continues a relationship that has lasted for over fifty years, grounded in scientific progress and long-term thinking.”

  • CEO Breaks Down PMI’s Smoke-free Future for Investors

    CEO Breaks Down PMI’s Smoke-free Future for Investors

    Philip Morris International used its appearance at the Morgan Stanley Global Consumer & Retail Conference yesterday (December 2) to reinforce that its smoke-free transition is a structural, irreversible shift, not a cyclical phase. CEO Jacek Olczak framed the dynamic succinctly, noting that smokers who switch to alternatives “very rarely” return to combustible cigarettes and that “smoke-free is essentially a one-way street.”

    Immediately before the event, PMI issued a brief communication to stabilize expectations, reaffirming the company’s guidance from Q3.

    Olczak said that PMI’s three-platform system—IQOS, ZYN, and vapor—is the most effective way to replace combustibles across all usage occasions. “Our objective is to equip the smoker with all three platforms. This is the best way to keep them away from smoking,” he said.

    ZYN remains PMI’s central U.S. growth engine. Following a one-time $100 million activation after supply shortages, “brand equity parameters of ZYN shot up by double-digits,” with the product capturing more than half of category growth despite maintaining a premium price.

    Internationally, IQOS is in its 11th consecutive year of expansion. Japan is nearing a 50/50 split between combustibles and smoke-free products, and prior category pauses were, Olczak said, “just a blip on the graph.” Upcoming Japanese tax equalization and European flavor bans are viewed as temporary disruptions rather than structural threats.

    PMI is also restructuring around a U.S./International dual-engine model, retiring its traditional regional setup. “We don’t really run the business by regions anymore,” Olczak said, positioning the company for future IQOS ILUMA authorization in the United States.

    Capital demands remain modest, with Olczak stressing that “adding extra capacity is only a few hundred million dollars — not a disturbing factor.” Overall, his message to investors was clear: the smoke-free shift is a one-way trajectory, and PMI believes it now has the platforms, structure, and regulatory environment to accelerate it.

  • FDA Schedules TPSAC Review of ZYN Applications

    FDA Schedules TPSAC Review of ZYN Applications

    The U.S. Food and Drug Administration announced a January 22, 2026, virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA for 20 ZYN nicotine pouch products. These products—already authorized for sale through the PMTA pathway in January 2025—include flavors such as Cool Mint, Citrus, Coffee, Peppermint, and Wintergreen, each in 3 mg and 6 mg strengths. The company is seeking permission to market the pouches with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    Under federal law, MRTP applications must demonstrate that a product, as actually used by consumers, reduces individual health risks and benefits overall population health. TPSAC’s review will focus on scientific evidence regarding ZYN’s relative health risks, consumer comprehension of the proposed claim, and the potential public health impact of granting a modified risk order. The meeting will be held virtually, open to the public, captioned, and recorded.

    Public comments may be submitted to Docket No. FDA-2025-N-0835 through January 21, 2026, with comments received by January 7 provided directly to TPSAC. The FDA is also inviting individuals to request oral presentation slots during the meeting’s public comment period. Redacted MRTP application materials are available on the FDA’s website, and the agency will consider all public input and TPSAC recommendations before issuing a final decision.