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Tag: Nicotine Pouches

  • FDA Authorizes Four New on! Nicotine Pouches

    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.

  • Australia Tightens Import Controls on Nicotine Pouches

    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.

  • ALP Accelerating UK, European Expansion

    ALP Accelerating UK, European Expansion

    ALP announced its expansion into the UK and European markets as part of its international growth strategy. Founded in late 2024 as a direct-to-consumer brand, ALP said it became the top DTC nicotine pouch brand in the U.S. before entering retail, reaching nearly 1% of U.S. convenience store nicotine pouch sales within 90 days of its retail rollout, according to Nielsen data. The company is launching across 11 European markets in July, with a goal of becoming one of Europe’s leading nicotine pouch brands by 2030. ALP said it will support the expansion through retail partnerships and marketing initiatives, including a global partnership with UFC fighter Conor McGregor.

  • Macau Tightens Tobacco Control Regs

    Macau Tightens Tobacco Control Regs

    Macau’s Legislative Assembly approved a bill expanding outdoor smoke-free areas, with the new law set to take effect on Jan. 1, 2027. The legislation prohibits smoking in designated public areas, including parts of Alameda Dr. Carlos d’Assumpção, the Border Gate checkpoint, and the Ruins of Saint Paul’s. Also, it bans smoking within 10 meters of entrances to hospitals, schools, and childcare facilities. Designated smoking areas will still be permitted in certain locations.

    The law also strengthens restrictions on alternative nicotine products and tobacco packaging. Possession and use of e-cigarettes in public areas will be prohibited from July 1, 2027, alongside higher fines for the use of nicotine pouches, herbal cigarettes, and water pipes. In addition, tobacco packaging will be required to display health warnings covering 85% of the front and back surfaces (70% for cigars) beginning July 1, 2028.

  • Spain Looks to Include Most Nicotine Products as It Extends Smoking Ban

    Spain Looks to Include Most Nicotine Products as It Extends Smoking Ban

    Spain’s government unveiled draft legislation that would ban smoking on outdoor bar and restaurant terraces while significantly expanding the country’s smoke-free areas and applying the same public-use restrictions to vaping products, heated tobacco products, nicotine pouches, hookahs, and herbal inhalation devices as conventional cigarettes. The proposal, which still requires parliamentary approval, would also prohibit smoking within 15 meters of entrances to public buildings, schools, healthcare facilities, and playgrounds, as well as at sports venues, universities, public swimming pools, work vehicles, and public events.

    The hospitality sector has opposed the terrace smoking ban, warning it could shift smoking into private homes and negatively affect businesses.

  • Australia’s Tobacco Use Down, Pouches & Black Market Up: Survey

    Australia’s Tobacco Use Down, Pouches & Black Market Up: Survey

    Australia’s latest National Drug Strategy Household Survey shows daily smoking continues to decline, with the number of daily smokers falling by more than half since 2001 to about 1.3 million Australians, while 68.7% of people aged 14 and older report never having smoked. The 2025 survey also found daily e-cigarette use has largely plateaued since 2022, with frequent vaping among 18- to 24-year-olds dropping from 11.3% to 5.8%.

    However, researchers highlighted emerging challenges, including rising illicit tobacco use and nicotine pouches. The survey found one in three smokers now purchase black-market cigarettes — double the proportion reported in 2022 — while use of three or more nicotine products has tripled since 2019, signaling growing concern over poly-nicotine use despite overall declines in smoking.

  • Nicotine Pouches May Cause Receding Gums: Study

    Nicotine Pouches May Cause Receding Gums: Study

    A new Swedish study suggests tobacco-free nicotine pouches may cause gum recession, redness, and oral discomfort, with effects comparable to — and in some cases greater than — those associated with traditional snus. Researchers at the Karolinska Institute found that 45% of nicotine pouch users exhibited receding gums, compared with 52% of snus users and just 6% of non-users, with damage typically occurring where the pouches were placed. The study also found nicotine pouch users experienced more gum irritation than snus users, which researchers said may be linked to flavoring ingredients. While the absence of tobacco eliminates exposure to many known carcinogens, the authors said the long-term health effects of nicotine pouches remain unclear and warrant further study.

  • India Seeks to Quash Adani’s Duty-Free Pouch Challenge

    India Seeks to Quash Adani’s Duty-Free Pouch Challenge

    India’s government is seeking to dismiss Adani Group’s legal challenge over the sale of nicotine pouches at Mumbai’s Chhatrapati Shivaji Maharaj International Airport, arguing that the products represent a “substantive violation” of drug laws and a public health risk. Authorities said nicotine pouches, which are classified as drugs under Indian law, remain unapproved and cannot be sold simply because they are imported, stored in customs-bonded warehouses, or marketed to departing international passengers. “The fact that they are stored in a customs-bonded warehouse does not mean they ⁠are not physically present in India,” the government said.

    Adani argued that drug regulations should not apply to duty-free sales and has challenged the regulatory interpretation in court, a case that could set a precedent for how India handles the sale of nicotine pouches at international airports. The government maintained that nicotine is an addictive chemical and warned that allowing unapproved products could expose consumers to products with unverified safety and quality standards.

  • Netherlands Makes One of the Largest Illicit Nicotine Busts in Its History

    Netherlands Makes One of the Largest Illicit Nicotine Busts in Its History

    Dutch authorities seized 277,000 illegal flavored vapes and 150,000 nicotine pouches in one of the country’s largest enforcement actions against illicit nicotine products. The Dutch Food and Consumer Product Safety Authority (NVWA) said customs officers discovered the flavored vapes during a routine inspection of a haulage company’s warehouse in Rotterdam, while the nicotine pouches were found at storage facilities in Rotterdam and Utrecht.

    Officials believe the products were destined for the Dutch black market. All seized products were destroyed, with disposal costs charged to the warehouse owners.

  • Indian Court to Decide if Pouches Can be Sold at Airport’s Duty-Free Shops

    Indian Court to Decide if Pouches Can be Sold at Airport’s Duty-Free Shops

    An Indian government investigation found that nicotine pouches were being sold without required approvals at duty-free shops operated by a joint venture led by the Adani Group at Mumbai International Airport, prompting authorities to order sales to be halted and licenses obtained. According to court documents reviewed by Reuters, Adani is challenging the action, arguing India’s Drugs and Cosmetics Act does not apply to duty-free shops. The case, scheduled for a July 14 hearing, could establish how India regulates nicotine pouch sales at airport duty-free outlets as the government increasingly views the products as an unapproved public health risk.