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Category: Global Regulation

  • France Suspends Decree Banning Nicotine Pouches

    France Suspends Decree Banning Nicotine Pouches

    France’s Council of State suspended a government decree that would have banned the manufacture, sale, and export of nicotine pouches from April 2026, pending a full legal review. The decision follows a challenge by EVLB Group, which argued the decree violated EU free trade rules and gave manufacturers insufficient time to reorganize operations. The court agreed, ruling that companies should have been granted a longer transition period and suspending the decree until a final judgment, expected by June 2026.

    The Council of State noted, however, that the marketing of nicotine pouches is already prohibited under France’s Public Health Code outside pharmaceutical use, meaning the suspension is unlikely to change current retail conditions. The Health Ministry said it takes note of the ruling and emphasized that the ban on marketing and possession remains in effect for now, while industry groups welcomed the pause as an opportunity for a more thorough review of the products.

  • Bangladesh Approves Strict New Tobacco-Control Measures

    Bangladesh Approves Strict New Tobacco-Control Measures

    Bangladesh’s Council of Advisers approved the Smoking and Tobacco Products Usage (Control) (Amendment) Ordinance 2025 on December 24, paving the way for stricter tobacco control measures. The ordinance proposes a ban on the use, production, and marketing of emerging tobacco products, including e-cigarettes, heated tobacco products, and “similar items,” while expanding the definition of tobacco products to include nicotine pouches.

    The amended law also prohibits the use of all tobacco products in public places and public transport, with designated smoking areas subject to government directives. Advertising, promotion, and display of tobacco products—including online marketing—would be fully banned, and enforcement powers strengthened through expanded definitions of public places and transport.

    In addition, the ordinance increases mandatory health warnings on tobacco packaging from 50% to 75% of the pack surface. The government said the measures are aimed at significantly reducing tobacco use and strengthening public health protection nationwide.

  • FDA Hosting PMTA Roundtable for Small ENDS Manufacturers

    FDA Hosting PMTA Roundtable for Small ENDS Manufacturers

    The U.S. Food and Drug Administration issued a Federal Register notice announcing a roundtable discussion with small tobacco product manufacturers on February 10, 2026, from 9 a.m. to 5 p.m. ET. The meeting will focus on gathering feedback on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) and is open for public viewing.

    Participation in the roundtable is limited to 30 representatives from manufacturers with fewer than 350 employees who have previously submitted an ENDS PMTA, including applications that are still pending with the FDA. The discussion will give small manufacturers an opportunity to share their experiences and perspectives on the PMTA process, including challenges related to product characterization, manufacturing controls, pharmacological studies, adult benefit research, and toxicological assessments.

    Manufacturers interested in participating as panelists must send an email to register by January 27, 2026, with selections made on a rolling basis and limited to one representative per company. Non-panelists and members of the public will be able to watch the roundtable virtually via information posted on the FDA’s Center for Tobacco Products website. The meeting will be recorded and captioned.

  • Irish Retailers Lose Fight Against ‘Irrational’ License Fees

    Irish Retailers Lose Fight Against ‘Irrational’ License Fees

    A retailers’ group failed in a High Court challenge against Ireland’s new licensing fees of up to €1,800 for selling tobacco and nicotine products. Justice Rory Mulcahy ruled that the former health minister acted lawfully in setting the fees under the Public Health (Tobacco Products and Nicotine Inhaling Products) Act 2023, finding the charges were justified on public health grounds and not arbitrary.

    The new regime, effective from February, replaces a one-off €50 registration fee with renewable annual fees of €1,800 for tobacco and nicotine products, €1,000 for tobacco only, or €800 for nicotine products only. The court rejected claims that the fees were irrational or disproportionately harmful to small retailers, noting that discouraging tobacco sales would not make the regulations unlawful.

  • Philippines Requires Licenses for Vape Products With Health Claims

    Philippines Requires Licenses for Vape Products With Health Claims

    The Philippines’ Food and Drug Administration (FDA) mandated that all establishments selling vaporized nicotine and non-nicotine products (VNNPs) and novel tobacco products (NTPs) with medicinal or therapeutic claims must secure a License to Operate. Under Advisory 2025-1487, manufacturers, importers, distributors, wholesalers, and retailers are required to apply for licenses as pharmaceutical establishments.

    The FDA also said such products must be registered as pharmaceutical products through the Center for Drug Regulation and Research. The agency urged stakeholders to comply, citing the need to ensure the safety, efficacy, and quality of vape and novel tobacco products making health-related claims.

  • FDA Authorizes Six on! PLUS Nicotine Pouch Products

    FDA Authorizes Six on! PLUS Nicotine Pouch Products

    The U.S. FDA authorized the marketing of six nicotine pouch products from Helix Innovations LLC under the on! PLUS brand through the premarket tobacco product application (PMTA) pathway.

    These authorizations mark the first decisions from a pilot program launched in September to streamline the review process for nicotine pouch applications while maintaining the agency’s rigorous scientific standards. Authorized products include mint, tobacco, and wintergreen flavors in 6 mg and 9 mg nicotine strengths. The FDA noted that these products contain lower levels of harmful constituents compared with other smokeless tobacco products and do not contain measurable levels of several carcinogens linked to oral cancer.

    “While today’s actions permit these specific nicotine pouch products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved,’” FDA said in a statement.  

    All packaging will feature certified child-resistant cans.

  • Georgia Wants Declining Smoking Rate Down Quicker

    Georgia Wants Declining Smoking Rate Down Quicker

    Georgia’s National Center for Disease Control and Public Health presented new findings from studies conducted under the Global Tobacco Surveillance System, finding 25.4% of adults and 14% of young people in the country use tobacco products. Despite the gradual decline in overall consumption, Health Minister Mikheil Sarjveladze said reducing tobacco use remains a key public health priority and stressed the importance of evidence-based policymaking in shaping effective tobacco control measures. While welcoming the downward trend, the NCDC noted that stronger action is still needed to further reduce tobacco use.

    The nationwide surveys, carried out between 2023 and 2025, have already informed Georgia’s National Tobacco Control Strategy for 2026–2030.

  • EU to Tighten Cross-Border Tobacco, Alcohol Limits?

    EU to Tighten Cross-Border Tobacco, Alcohol Limits?

    Several EU member states have proposed tightening single-market rules on the personal import of tobacco products, as part of discussions on revising the Tobacco Taxation Directive (TED), according to Euractiv. Denmark, which holds the EU Council presidency, floated the idea in early December, suggesting stricter limits on cross-border tobacco imports under Article 32 of the Excise Duty Directive, alongside more moderate tax increases. The move aims to curb cross-border shopping that undermines high-tax anti-smoking policies in countries such as France.

    Currently, individuals can import up to 800 cigarettes for personal use. A number of countries, including France, Germany, Finland, and Estonia, have expressed openness to lowering this threshold, with some also supporting limits on alternative tobacco products like heated tobacco.

    The European Commission has been cautious, indicating that changes to Article 32 may fall outside the scope of the TED. Some member states have also noted that the rules apply to alcohol as well, prompting calls from countries such as Finland, Estonia, and Germany to extend any revisions to alcoholic beverages.

  • Ireland Moving Toward Single-Use Vape Ban

    Ireland Moving Toward Single-Use Vape Ban

    Ireland’s Minister for Public Health, Wellbeing and the National Drugs Strategy, Jennifer Murnane O’Connor, on behalf of the Minister for Health, Jennifer Carroll MacNeill, will today (December 17) begin the passage of the Public Health (Single-Use Vapes) Bill 2025 through the Oireachtas. The Bill, introduced at Second Stage in Dáil Éireann, proposes a ban on the sale of single-use vapes. The measure aims to reduce smoking and vaping rates and to prevent children and young people from starting to use nicotine.

    The Government has highlighted the rapid growth of single-use vapes in Ireland, rising youth vaping rates, and concerns that their low cost, ease of use, and appealing designs target young people. The legislation also addresses environmental impacts, citing the waste and damage caused by disposable vaping products. O’Connor described the legislation as a preventative step to curb nicotine addiction among young people and prevent long-term dependence.

  • Vape Reps Appeal Mississippi Law to 5th Circ.

    Vape Reps Appeal Mississippi Law to 5th Circ.

    A coalition of businesses that sell vape products containing synthetic nicotine appealed a U.S. federal court’s refusal to block a Mississippi law restricting the sale of those products. The groups are taking the case to the U.S. Court of Appeals for the Fifth Circuit after the U.S. District Court for the Southern District of Mississippi denied their request for a temporary injunction.

    The contested state law, House Bill 916, which took effect in July 2025, bans the sale of e-cigarette products containing synthetic nicotine in Mississippi. Enforcement, including penalties and product confiscations, began later in the year.

    The plaintiffs, including industry groups such as the Vapor Technology Association and several retailers, argue the law is preempted by federal authority under the U.S. Constitution’s Supremacy Clause, asserting that it effectively conditions sales on FDA marketing authorization—a domain they say belongs exclusively to the federal government.

    Mississippi’s Department of Revenue Commissioner Chris Graham is named as the defendant in the appeal.