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Category: Global Regulation

  • 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.

  • Azerbaijan Sets New Vape Laws

    Azerbaijan Sets New Vape Laws

    Azerbaijan plans to set fines and enforcement mechanisms for the use of electronic cigarettes through secondary legal acts following the adoption of a new law, MP Soltan Mammadov, a member of parliament’s Health Committee, said. Mammadov said the bill seeks to clearly classify traditional tobacco, heated tobacco products, and electronic cigarettes, and is informed by international regulatory practices. He cited World Health Organization data indicating that e-cigarette use is significantly higher among minors than adults.

    The proposed legislation “aims to restrict tobacco and e-cigarette products containing harmful or carcinogenic substances and address the rising use of e-cigarettes among schoolchildren.” Details on penalties and enforcement measures will be defined after the law is enacted.

  • Two More Arrested in Hong Kong, Smuggling 60K Vapes

    Two More Arrested in Hong Kong, Smuggling 60K Vapes

    Hong Kong authorities sentenced two men to six months in prison after 60,000 alternative smoking products were found in their luggage upon arrival from Japan, the Department of Health (DH) said. The Tobacco and Alcohol Control Office (TACO) made the arrest after it was notified by Hong Kong Customs on December 15.

    Since amended tobacco control legislation took effect on September 19, granting arrest powers to TACO inspectors, 14 importation cases involving alternative smoking products have been prosecuted. Sixteen people have been convicted, receiving prison sentences of two to six months.

    Under Hong Kong law, importing alternative smoking products—including e-cigarettes, heated tobacco products, and herbal cigarettes—can result in fines of up to HK$2 million ($260,000) and imprisonment of up to seven years.

  • South Korea to Define All Nicotine Products as ‘Cigarettes’

    South Korea to Define All Nicotine Products as ‘Cigarettes’

    South Korea’s Cabinet moved to close regulatory and taxation gaps surrounding liquid e-cigarettes, including those using synthetic or nicotine-substitute substances, amid what is says are growing safety concerns. At a Cabinet meeting today (December 16) chaired by President Lee Jae-myung, the government approved the promulgation of amendments to the Tobacco Business Act that legally classify liquid e-cigarettes as tobacco products. The revised law expands the definition of cigarettes from products made from tobacco leaves to all products containing tobacco or nicotine, bringing synthetic-nicotine liquid e-cigarettes under formal regulation.

    President Lee highlighted concerns that nicotine substitutes have been distributed without adequate safety verification and called for stronger institutional oversight. Reports of suspected lung damage linked to liquid e-cigarettes were also raised during the meeting.

    Deputy Prime Minister and Finance Minister Koo Yoon-cheol said products released four months after the law takes effect will be regulated and taxed as cigarettes. However, he noted regulatory limits regarding so-called “nicotine-free” products manufactured before the law’s implementation, stressing the need for separate management and hazard assessments.

    The revision aims to eliminate regulatory and taxation blind spots while gradually strengthening safety management for nicotine substitutes.

  • Malaysia Banning Vapes in 2026

    Malaysia Banning Vapes in 2026

    Malaysia is moving toward a nationwide ban on vaping, with the Health Ministry aiming to finalize and implement the policy by the end of 2026, Health Minister Datuk Seri Dr. Dzulkefly Ahmad said. He said the Cabinet has already agreed in principle to ban vape products, stressing that the issue is no longer whether vaping will be banned, but when. The ministry is expected to bring the matter back to the Cabinet early next year to complete regulatory and legislative processes.

    Dzulkefly cited growing public health concerns, particularly cases of drug-induced psychosis linked to adulterated vape liquids and synthetic substances. He said such cases are being monitored by a special Health Ministry task group in collaboration with medical experts.