Portugal’s Parliament is set to debate tomorrow (Oct. 7) a bill authorizing the government to establish rules governing the manufacture, import, distribution, sale, labeling, advertising, taxation, and enforcement of nicotine pouches. The products are already sold and taxed in Portugal under a category created in the 2026 State Budget, but their regulatory status has prompted debate among health experts and other stakeholders. Pulmonologist Daniel Coutinho of the Portuguese Society of Pulmonology called for tighter restrictions, including on flavors and nicotine concentrations, while other health professionals cited in the consultation process said nicotine pouches could provide a lower-risk alternative to cigarettes and urged regulations that protect adult smokers while preventing youth access.
Tag: Nicotine Pouches
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Austria’s Tobacco Industry Defends Vapes, Pouches
Austria’s tobacco industry is defending e-cigarettes and nicotine pouches as tools to move adult smokers away from combustible cigarettes as the country introduces new regulations for alternative nicotine products. Die Presse reports that Austria collected more than €2 billion in tobacco taxes in 2025, with more than 10 billion taxed cigarettes sold, while companies including Imperial Brands and Japan Tobacco are expanding their alternative-product portfolios. Imperial Brands Austria spokesperson Simone Pibernik said incentives, including flavor and pricing, are needed to encourage smokers to switch, while acknowledging the need for stronger youth protections.
The industry’s comments come as nicotine pouches have been brought under Austria’s tobacco-monopoly system, with sales restricted to licensed tobacconists, while e-cigarettes are moving into a regulated distribution system. Imperial has said it supports age restrictions and responsible marketing, but argues that regulation should balance youth protection with access to potentially lower-risk alternatives for adult smokers.
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Canada Health Minister Rejects Calls to Loosen Pouch Rules
Canadian Federal Health Minister Marjorie Michel said she is not considering changes to Canada’s regulations governing nicotine pouches, which are regulated as smoking-cessation aids and restricted to adult sales through pharmacies. Zonnic, manufactured by Imperial Tobacco, is currently the only authorized nicotine pouch brand, with sales limited to 4 mg pouches and restricted flavors. Unsmoke Canada, part of Philip Morris International’s Rothmans, Benson & Hedges business, has campaigned for allowing pouches to be sold through retail stores, arguing that broader legal availability could address the illicit market.
Michel acknowledged challenges with illicit sales, including online sales of products such as Zyn, while tobacco-control groups called for stronger enforcement rather than looser rules. The groups said nicotine pouch use among Canadian youth is increasing and warned that wider retail availability could increase youth access.
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Relaunched NicoLeaks.com Expands Product Info, Test Results
Haypp Group announced that it has relaunched NicoLeaks.com, a publicly available database of independent nicotine pouch testing results, marking the platform’s fifth anniversary. The redesigned site includes dedicated product pages, expanded product information, and tools to filter and compare laboratory results by nicotine content, pH, moisture levels, and market. Each entry identifies the source and date of analysis, while laboratory reports are available to view and download.
Testing is conducted by Eurofins and covers compositional parameters including nicotine content, pH, moisture, tobacco-specific nitrosamines, and trace metals. Haypp said the testing evaluates product composition only and does not assess health effects. The relaunch coincides with the Tobacco Science Research Conference in Charlotte, N.C., where Haypp scientists are presenting findings from independent testing of more than 400 nicotine pouch products in 2025. The company said it plans to add scientific articles, presentations, and other educational resources to NicoLeaks in the coming months.
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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.
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Marijuana Use Hits High, Cigarette Low: Gallup
Seventeen percent of U.S. adults say they smoke marijuana, matching Gallup’s record high, while cigarette smoking remains at a record-low 11%. The July 1-19 Gallup Consumption Habits poll also found that 15% consume marijuana edibles, 9% vape, and 4% use nicotine pouches. This is the first time Gallup included nicotine pouch use in its survey.
Marijuana use is highest among younger adults, with 23% of those ages 18 to 29 and 25% of those 30 to 49 reporting smoking marijuana. Cigarette smoking is highest among adults ages 30 to 49 at 16%, while vaping reaches 17% among 18- to 29-year-olds. Nicotine pouch use is highest among adults ages 30 to 49 at 7%.
Coffee remains the most popular nonalcoholic beverage, with 49% of adults drinking it daily. Tea and caffeinated soda each are consumed daily by about 20%, while 9% drink energy drinks daily. Gallup also found that 5% of Americans identify as vegetarian and 2% as vegan.
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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.
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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.
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FDA Authorizes Four New on! Nicotine Pouches
The U.S. Food and Drug Administration announced the authorization of four additional on! nicotine pouch products through the premarket tobacco product application (PMTA) pathway: Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg. Manufactured by Helix Innovations LLC, the products were reviewed under the FDA’s nicotine pouch pilot program, which is designed to streamline PMTA reviews and improve review efficiency. The agency said lessons from the pilot are now being applied to other PMTA reviews.
The FDA concluded that the newly authorized products contain lower levels of most harmful and potentially harmful constituents than traditional oral and smokeless tobacco products. The agency said adults 21 and older who completely switch from cigarettes or smokeless tobacco to FDA-authorized nicotine pouches may reduce their exposure to harmful chemicals, while noting that dual use does not provide the same level of risk reduction. With the latest authorizations, the FDA has now authorized 30 nicotine pouch products through the PMTA pathway.
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Australia Tightens Import Controls on Nicotine Pouches
Australia strengthened regulation of nicotine pouches under new rules that took effect over the weekend, placing the products under the Therapeutic Goods Administration’s therapeutic goods framework. The changes restrict the import of unapproved nicotine pouches, extending Australia’s strict regulatory approach beyond nicotine vaping products to another smoke-free nicotine category.
The new rules do not prohibit all nicotine pouch use but require products to meet regulatory approval requirements before they can be legally imported or supplied. The move aligns nicotine pouches with Australia’s existing controls on nicotine products and reflects the country’s continued focus on regulating emerging nicotine alternatives through therapeutic product oversight.