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Tag: Zyn

  • 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.

  • Haypp Reports Q3 2025 Results Amid U.S. Expansion Investments

    Haypp Reports Q3 2025 Results Amid U.S. Expansion Investments

    Haypp reported Q3 2025 net sales of SEK 952.1 million ($95.2 million), an 0.8% increase, driven by strong performance in nicotine pouches, which accounted for 68% of total oral nicotine volume with like-for-like (LFL) volume growth of 21% (LFL excludes the impact of the ZYN shortage, U.S. state closures, and tobacco sales discontinuations.) Gross margin rose to 18.8%, while adjusted EBITDA reached SEK 53.0 million ($5.3 million) and adjusted EBIT was SEK 33.4 million ($3.3 million). Operating profit fell to SEK 6.2 million ($620,000) and net profit to SEK 4.5 million, reflecting a SEK 17.2 million ($1.7 million) litigation settlement.

    Key developments included the return of ZYN to the U.S. market, early indicators of strong sales, and continued growth in Swedish and German vaping and heated tobacco products, which now make up over 70% of Haypp’s Emerging segment. UK nicotine vaping and HnB sales will be discontinued in Q4 2025 pending regulatory clarity.

    “[The] U.S. return of Zyn, U.S. market developments and gross margin expansion strengthen our foundation for growth,” said Gavin O’Dowd, Haypp president and CEO. “The benefits of Zyn’s return will be realized in Q4 2025 with promising early indicators.”

    Haypp also completed most of its global e-commerce platform migration, improving infrastructure for agile growth. CEO Gavin O’Dowd emphasized that U.S. market developments, innovative product availability, and gross margin expansion are strengthening the company’s foundation for future growth.

  • PMI Reports Strong Q3 Based on Smoke-Free Surge

    PMI Reports Strong Q3 Based on Smoke-Free Surge

    Today (October 21), Philip Morris International reported strong third-quarter 2025 results, with adjusted diluted earnings per share rising 17.3% to $2.24, while reported EPS increased 13.2% to $2.23. The company said it achieved record smoke-free gross profit, supported by higher volumes and favorable pricing. Net revenues grew 5.9% on an organic basis, and adjusted operating income rose 7.5%, driven by strong performance in smoke-free products, despite a 3.2% decline in cigarette volumes.

    PMI’s smoke-free portfolio continued to expand rapidly, now accounting for 41% of total net revenues and 42% of gross profit. Volumes of smoke-free products rose 16.6%, led by the IQOS heated tobacco line and ZYN nicotine pouches. IQOS strengthened its market share across Europe and Asia, while ZYN’s U.S. offtake surged 39% following its return to full availability. The e-vapor brand VEEV also posted a 91% jump in shipments, solidifying PMI’s diversified presence across smoke-free categories.

    Reflecting this momentum, PMI raised its full-year adjusted EPS guidance and boosted its quarterly dividend by 8.9% to $1.47 per share. CEO Jacek Olczak said the company’s smoke-free business “continues to outgrow the industry by a clear margin,” adding that PMI is “on track to exceed” its 2024–2026 growth targets. Despite regulatory challenges in some markets, the company remains focused on transitioning adult smokers toward smoke-free alternatives and expanding its portfolio in 100 markets worldwide.