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Tag: Zyn

  • PMI U.S. Launching Campaign Around Zyn’s ‘Click’

    PMI U.S. Launching Campaign Around Zyn’s ‘Click’

    Philip Morris International’s U.S. businesses are launching “When It Clicks,” a national Zyn brand campaign built around the sound of the nicotine pouch’s signature click and the idea of staying present in everyday moments. Following a soft launch this summer, the campaign will scale nationally in the fourth quarter across point-of-sale, digital, out-of-home, and cultural events targeting legal-age adult nicotine consumers.

    The campaign will be introduced to retailers and distributors at the National Association of Convenience Stores Show in October, followed by activations spanning music, entertainment, sports, and art. Zyn also plans to launch limited-edition metal cases featuring artwork from American and U.S.-based artists in the fourth quarter; the accessories will not contain nicotine pouches.

  • Article Examines Move Toward Higher-Strength Pouches

    Article Examines Move Toward Higher-Strength Pouches

    An article published today (Aug. 27) by Financial Times reports that major tobacco companies are accelerating their push into higher-strength nicotine pouches as competition intensifies in the U.S. market, valued at about $5.2 billion. Higher-strength products now account for 17% of U.S. pouch volumes, according to Stifel analyst Matt Smith, with Philip Morris International’s 11mg Zyn Ultra becoming the highest-strength nicotine pouch cleared by the FDA. BAT plans to launch Velo Max in 8mg and 12mg strengths, while Altria is preparing a national expansion of its 12mg On! Plus.

    Nearly 21 billion pouches were sold in the U.S. last year, according to Euromonitor, while smokeless nicotine product sales increased more than 8% in the first half of 2026 as cigarette sales declined 2.4%, according to NielsenIQ and Goldman Sachs. The companies are also expanding strength and format options as consumers develop preferences for stronger and higher-moisture products, with the FDA’s recent regulatory changes facilitating faster product introductions.

  • FDA authorizes 11 additional ZYN nicotine pouches

    FDA authorizes 11 additional ZYN nicotine pouches

    Today (Aug. 21), the U.S. Food and Drug Administration authorized 11 new nicotine pouch products from Swedish Match USA under the Zyn Ultra brand through the premarket tobacco product application pathway. The products include 10 9-milligram varieties and one 11-milligram variety, covering flavors such as Chill, Citrus, Cool Mint, Deep Freeze, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen.

    The FDA said its review found the products contain lower levels of most harmful and potentially harmful constituents than other oral and smokeless tobacco products. The agency also said product-specific data indicated the pouches appeal primarily to adults who currently smoke cigarettes or use smokeless tobacco and could provide sufficient nicotine to reduce cravings and withdrawal symptoms, potentially supporting switching among adult tobacco users.

    “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.” 

    The authorizations bring the number of FDA-authorized nicotine pouch products to 43, including 23 approved through the agency’s nicotine pouch pilot program. The FDA said the pilot has streamlined PMTA reviews and reduced the time needed to resolve deficiencies, with efficiencies now being applied to other tobacco-product applications.

  • Reuters: Nicotine Pouches Emerge as Big Tobacco’s Key Growth Bet

    Reuters: Nicotine Pouches Emerge as Big Tobacco’s Key Growth Bet

    Reuters reports that nicotine pouches are attracting increasing investor attention as cigarette sales decline, with rapid volume growth, strong margins and relatively light regulation in many markets making brands such as PMI’s Zyn and BAT’s Velo a major focus for tobacco companies. BAT expects the global pouch market to grow from £4 billion in 2025 to £11 billion by 2030, while pouch volumes in its Asia, Middle East and Africa markets increased 27.5% to about 700 million in the first half of 2026.

    Reuters said the category also offers higher profitability than several competing alternatives. PMI reported that its U.S. oral nicotine business generated eight times the gross profit per 1,000 units of its international cigarette business in 2024, compared with 2.4 times for IQOS heated tobacco. Analysts said pouch performance is increasingly influencing tobacco-company valuations, while the products’ lack of smoke or vapor allows them to be used in locations where other nicotine products may be restricted.

    The story noted that wider adoption remains uncertain, particularly in markets without an established oral nicotine culture. Analysts cited consumer familiarity with inhaled products as a key barrier, while regulators are increasingly scrutinizing youth uptake, marketing and high nicotine strengths. France has banned pouches, while Finland, the EU and Britain are tightening rules. Despite expectations for continued growth, PMI and BAT say no single alternative will replace cigarettes, with diverse portfolios needed to accommodate different consumer preferences.

  • PMI U.S. Opens $1.2 Billion Colorado Manufacturing Campus

    PMI U.S. Opens $1.2 Billion Colorado Manufacturing Campus

    Philip Morris International’s U.S. businesses announced the official opening of its $1.2 billion manufacturing campus in Aurora, Colorado, expanding domestic production capacity for Zyn nicotine pouches and strengthening the company’s U.S. supply chain and export capabilities. The 780,000-square-foot facility, located on a 148-acre site, began full commercial production in July 2026 and represents PMI U.S.’s first greenfield manufacturing complex in the United States. The campus integrates production, packaging, warehousing, distribution, and operations, and will support markets across Asia, Latin America, and the Caribbean.

    The investment, originally announced as a $600 million project in 2024, doubled in planned capital expenditures through 2028, including manufacturing equipment, infrastructure, facility development, and future production expansion. “Aurora represents an important milestone for PMI U.S. and our continued investment in our business here,” said Stacey Kennedy, CEO of PMI U.S. “This facility expands our production capacity, strengthens our supply chain, and enhances our ability to serve growing demand in the United States and around the world.”

    The facility is expected to directly employ approximately 500 people and contribute to broader economic activity in Colorado, with PMI estimating the site will support around 1,000 indirect jobs.

  • Smoke-Free Gains Push PMI Over $11B in Q2

    Smoke-Free Gains Push PMI Over $11B in Q2

    Philip Morris International reported strong second-quarter 2026 results, with net revenues exceeding $11 billion for the first time as smoke-free products drove growth. Reported diluted EPS fell 7.7% to $1.80 due to a $511 million non-cash impairment charge tied to PMI’s Rothmans, Benson & Hedges investment, while adjusted diluted EPS rose 15.2% to $2.20, or 13.6% excluding currency. Shipments increased 2.5%, led by a 7.5% rise in smoke-free products. Net revenues grew 10.4% to $11.2 billion, with smoke-free products representing about 42% of sales, while operating income increased 22% to $4.5 billion.

    The international smoke-free business remained PMI’s main growth driver, with revenue up 14.2% and volumes rising 8%. IQOS heat-not-burn shipments increased 7.6%, maintaining PMI’s leading position in the category, while growth continued across Europe and other key markets despite challenges from Japan’s excise increase and Poland’s flavor restrictions. PMI said it would increase investment in Zyn as the nicotine pouch volumes expanded globally, with the brand now available in 60 markets, while VEEV e-vapor shipments rose 55.1% as PMI continued expanding its smoke-free portfolio.

    International combustible sales also grew, supported by pricing and market gains, while the U.S. business remained under pressure. Combustible revenue increased 9.8%, with cigarette growth in Turkey, Indonesia, and Egypt, while Marlboro gained market share. U.S. revenue declined 0.7% due to weakness in cigars and wellness products, though Zyn shipments rose 1.8% to 2.9 billion pouches following portfolio expansions. PMI maintained its 2026 outlook, forecasting adjusted EPS growth of 9.5% to 11.5%, organic revenue growth of 5% to 7%, and continued investment in smoke-free products.

    According to Reuters, PMI’s shares rose ​about 5% in early trading even though the company also cut its annual profit ​forecast for the third time this year due to negative currency effects.

  • Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    A report published yesterday (July 14) by The Examination and STAT raised questions about the U.S. Food and Drug Administration’s review process for Philip Morris International’s Zyn nicotine pouches, alleging that agency scientists had unresolved concerns about the composition and potential health implications of the pouch material before the product was authorized for sale. The report said FDA toxicologist Christy Leppanen questioned whether regulators had adequately assessed possible microplastic exposure after conducting informal tests that found Zyn pouches did not dissolve when exposed to saliva or other conditions. Leppanen alleged that the FDA did not seek additional information from PMI about the pouch material before approving the product, while former FDA officials cited in the report questioned whether the agency fully evaluated all product components as required under federal law.

    The allegations come as nicotine pouches have become one of the fastest-growing segments of the tobacco and nicotine market. The U.S. nicotine pouch market is estimated to grow 37% in 2026 to $6.8 billion, according to TobaccoIntelligence, with companies promoting pouches as lower-risk alternatives to combustible cigarettes because they deliver nicotine without smoke exposure. The FDA has authorized certain nicotine pouches, including Zyn, based on a review of whether the products are appropriate for the protection of public health, weighing potential risks such as youth uptake against potential benefits for adult smokers transitioning away from cigarettes. PMI defended the authorization process, citing the FDA’s scientific review, while the FDA said its evaluation did not identify additional concerns regarding the ingredients or materials used in Zyn products. Concerns raised by Leppanen and other scientists center on whether pouch materials could release microscopic particles during use and what long-term effects those exposures may have. The FDA’s recent decision allowing PMI to communicate that Zyn use instead of cigarettes lowers the risk of certain smoking-related diseases represented a major regulatory milestone for the category, but, according to The Examination, the allegations in the report may fuel additional debate over product standards, disclosure requirements, and the depth of scientific reviews for emerging nicotine products.

  • CAPHRA Says FDA’s Pouch Pivot Should Trigger Policy Rethink 

    CAPHRA Says FDA’s Pouch Pivot Should Trigger Policy Rethink 

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates is urging governments across the Asia-Pacific region to review the U.S. Food and Drug Administration’s recent authorization allowing 20 Zyn nicotine pouch products to carry reduced-risk claims for adult smokers. CAPHRA said the FDA’s decision recognizes the principle of relative risk following scientific review and should encourage regulators to distinguish between combustible cigarettes, high-risk smokeless tobacco products, and lower-risk smoke-free nicotine alternatives.

    The group called on policymakers to adopt evidence-based, risk-proportionate regulation, strengthen youth access restrictions and product standards, and ensure adult consumers receive accurate information about the comparative risks of nicotine products, arguing that treating all nicotine products as equally harmful undermines public health objectives.

  • FDA Issues MRTP Orders for 20 Zyn Products

    FDA Issues MRTP Orders for 20 Zyn Products

    The U.S. Food and Drug Administration issued Modified Risk Tobacco Product orders for 20 Zyn nicotine pouch products manufactured by Swedish Match USA, making Zyn the first nicotine pouch brand authorized to market reduced-risk claims compared with cigarettes. The FDA-authorized claim states that using Zyn instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The authorization applies to 10 Zyn flavors in both 3 mg and 6 mg nicotine strengths and builds on the products’ January 2025 authorization for sale through the FDA’s premarket tobacco product application pathway.

    The FDA said its decision followed an extensive scientific review of the products’ relative health risks, consumer understanding of the claim, youth use data, and overall population health impact. The agency concluded that the modified-risk claim is scientifically supported, that consumers understand its meaning, and that allowing the claim is expected to benefit public health. The authorization requires Swedish Match USA to conduct post-market surveillance and behavioral studies, and the orders will expire after five years unless renewed. The FDA also noted it retains the authority to withdraw the orders if continued marketing no longer benefits public health, including if youth uptake increases.

    Separately, Philip Morris International said the decision expands its portfolio of FDA-authorized modified-risk products, which also includes IQOS heated tobacco products and General snus. PMI U.S. CEO Stacey Kennedy said the authorization provides adult nicotine consumers with FDA-reviewed, science-based information about the health benefits of switching completely from cigarettes to Zyn.

  • Haypp Announces Zyn Ultra Launch Across U.S.  

    Haypp Announces Zyn Ultra Launch Across U.S.  

    Haypp Group announced that Zyn Ultra nicotine pouches are available through its U.S. online retailers, Nicokick.com and Northerner.com, as of June 15. The new Zyn format contains 20 pouches per can, compared with 15 in the flagship lineup, and will initially launch in 9 mg strength across eight flavors, with an 11 mg range scheduled to follow later in June. Haypp said the rollout expands its portfolio of more than 300 nicotine pouch products and follows the resumption of direct-supplied Zyn sales in the U.S. in September 2025.