Category: Global Regulation

  • Geneva Bans Disposable E-Cigarettes

    Geneva Bans Disposable E-Cigarettes

    Geneva’s cantonal parliament voted almost unanimously to ban disposable e-cigarettes, citing health risks for youth and environmental harm. The measure, passed with an emergency clause, takes effect immediately.

    Several Swiss cantons, including Valais, Bern, and Jura, have already adopted similar bans, while a nationwide ban is underway after both houses of parliament backed legislation to outlaw single-use “puff bars.” Rechargeable e-cigarettes remain exempt.

  • Singapore Vape Ban is Tourism Opportunity for Indonesia

    Singapore Vape Ban is Tourism Opportunity for Indonesia

    Officials in Batam, Indonesia say Singapore’s strict ban on vaping could boost cross-border tourism, as Singaporeans seek looser regulations just a 45-minute ferry ride away.

    Batam Tourism Agency head Ardiwinata told The Jakarta Post that restrictions in Singapore historically drive residents to neighboring Batam, citing past examples where tight rules created new tourism opportunities. “As long as it does not violate our regulations, they can choose Batam,” he said.

  • PM South Africa Pushes Harm Reduction in Tobacco Bill Debate

    PM South Africa Pushes Harm Reduction in Tobacco Bill Debate

    Philip Morris South Africa (PMSA) urged lawmakers on Tuesday (August 26) to adopt a science-driven, harm reduction approach in the pending Tobacco Products and Electronic Delivery Systems Control Bill. PMSA argued that the same harm reduction principles that helped South Africa curb HIV/AIDS could accelerate declines in smoking rates if applied to tobacco. Executives told Parliament’s Health Committee that smoke-free alternatives like heated tobacco, e-cigarettes, and oral nicotine are far less harmful than combustible cigarettes, citing global studies and international precedents.

    “The quit or die approach has not been proven to be effective, and we know it will not work,” said Themba Mathebula, PMSA’s director of external affairs. “Without a doubt, smoke-free products can give smokers a fighting chance, not just to survive, but to quit smoking for good.”

    The company called for a risk-proportionate framework that regulates traditional cigarettes more strictly than reduced-risk products, while tightening youth access and banning marketing that could appeal to minors. PMSA said it has submitted extensive scientific data and is committed to making cigarettes obsolete.

    “It is about 19 books’ worth of research that undeniably shows that smoke-free products are less harmful alternatives for adult smokers who make the choice to continue smoking,” said Buhle Binta, PMSA head of Scientific Engagement. “Scientific evidence needs to be the North Star that informs our health policies.

  • Putin Backs Regional Vape Bans in Russia

    Putin Backs Regional Vape Bans in Russia

    Russian President Vladimir Putin has endorsed a proposal to give regions the authority to ban the sale of vapes, following concerns over rising youth use. At a meeting in Sarov, Nizhny Novgorod Governor Gleb Nikitin suggested his region could serve as a pilot area for the ban. Putin called it a “good proposal” and signaled immediate support.

    The move comes a day after the government expanded its mandatory labeling experiment to cover e-cigarettes and heated tobacco devices, tightening controls on the sector.

  • NJOY Sues FDA Over Delays in Flavored E-Cigarette Approval

    NJOY Sues FDA Over Delays in Flavored E-Cigarette Approval

    NJOY LLC, a subsidiary of Altria Group, filed a lawsuit in federal court in Louisiana last week (August 21), accusing the U.S. Food and Drug Administration (FDA) of unlawfully delaying its review of applications to market flavored e-cigarettes. According to NJOY, the FDA has failed to adhere to statutory deadlines stipulated in the Family Smoking Prevention and Tobacco Control Act. The company claims such delays unfairly hinder its efforts to provide adult smokers with reduced-risk alternatives to combustible tobacco.

    According to the filing, in December 2020, the FDA denied NJOY’s application with only one deficiency listed: that the flavored products’ applications did not show they “would increase the likelihood of complete switching among adult smokers, compared to the Rich Tobacco and Menthol varieties” (products that were granted marketing authorization). In March 2021, NJOY responded, providing data showing the flavored products’ switch rates were 29-68% higher than the approved products after six months of use. The FDA has yet to respond despite repeated requests for updates, leading to last week’s lawsuit.

    Additionally, the filing states that documents received during a Freedom of Information Act request revealed that the Office of Science’s epidemiology staff concluded that NJOY adequately addressed the flavor-specific deficiency and that the products were associated with higher rates of cessation, and also that unrequested sales restrictions and reporting requirements offered by NJOY would, according to the Office of Health Communication and Education, mitigate concerns about potential youth initiation.

    The lawsuit underscores growing tensions between major industry firms and the FDA, which is facing a massive backlog of Premarket Tobacco Product Applications, particularly as sales of unauthorized flavored vaping products continue to surge. NJOY argues the delays not only burden its business, but also limit smokers’ access to potentially less harmful products.

  • FDA Seeks Public Comment on Two Tobacco Topics

    FDA Seeks Public Comment on Two Tobacco Topics

    The U.S. Food and Drug Administration (FDA) filed a pair of public inspection documents scheduled to be published tomorrow (August 22) regarding the regulations surrounding children and adolescents purchasing tobacco and nicotine products, and the marketing and labeling of such products. The documents will each open a 60-day public comment period under the Paperwork Reduction Act.

    The first guidance, document  2025-16068, focuses on tobacco retailer training programs, detailing recommended elements that would include federal law requirements restricting access to, and the marketing and promotion of, covered tobacco and nicotine products. It would also focus on company policies, age verification methods, practical refusal techniques, and the health risks associated with tobacco use.

    The FDA would advise retailers to require employees to pass written tests before selling tobacco products, with refresher training held at least annually, and to keep such training records for four years to demonstrate compliance. The guidance also encourages strong hiring and management practices, such as informing staff of youth access laws, conducting internal compliance checks, and documenting corrective actions.

    “We assume that 75% of tobacco retailers already have some sort of age and identification verification training program in place,” the filing made by Grace R. Graham, deputy commissioner for Policy, Legislation, and International Affairs, said. “We expect that some of those retailer training programs already meet the elements in the guidance, some retailers would update their training program to meet the elements in the guidance, and other retailers would develop a training program for the first time. Thus, we estimate that two-thirds of tobacco retailers would develop a training program that meets the elements in the guidance.”

    FDA estimates the proposal will affect about 79,700 retailers nationwide, creating an annual reporting burden of nearly 2 million hours, plus over 191,000 hours for recordkeeping.

    The second guidance, document 2025-16067, reminds tobacco companies of their obligation to notify the agency before using new advertising or labeling formats for cigarettes and smokeless tobacco. The requirement, authorized under the Federal Food, Drug, and Cosmetic Act, aims to ensure compliance with restrictions on tobacco marketing and promotion.

    Under federal regulations (21 CFR part 1140), manufacturers, distributors, and retailers of cigarettes or smokeless tobacco must submit notice to FDA at least 30 days in advance if they plan to use a form of advertising or labeling that is not already permitted, such as where newspapers, magazines, billboards, point-of-sale materials, and direct mail are permissible.

    Comments can be made for either guidance online at www.regulations.gov, or mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

  • Turkmenistan Ramps Up Tobacco Ban Ahead of 2025 Deadline

    Turkmenistan Ramps Up Tobacco Ban Ahead of 2025 Deadline

    Turkmenistan is pushing to go tobacco-free by the end of 2025, forcing its few smokers underground with bans, high taxes, and fines of up to 200 manats ($57). Cigarettes now cost $14–$49 a pack — up to 11% of the average monthly salary — with many buying single sticks from kiosks supplied by neighboring countries.

    According to the WHO, only 4% of the Central Asian nation’s residents smoke.

    While authorities stage cigarette burnings and televised pledges to quit, residents say tobacco won’t vanish but will move to the black market.

  • Taiwan Groups Accuse HPA of Undermining Tobacco Control

    Taiwan Groups Accuse HPA of Undermining Tobacco Control

    The Alliance of Banning Cigarettes Taiwan and parent groups accused the Health Promotion Administration (HPA) of undermining tobacco control by greenlighting 14 products recently without disclosing details on brands, devices, or flavor additives, despite Taiwan’s flavored tobacco ban.

    Warning that illegal online ads for newly approved heated tobacco products threaten students’ health, parents cited dozens of websites and social media channels openly promoting flavors, fast delivery, and new models.

    The HPA defended its approvals as based on risk assessments and promised stricter enforcement, including fines up to NT$25M ($766,000) for illegal online sales and penalties for retailers selling to underage patrons.

  • Hong Kong Tobacco Inspectors to Wear Body Cameras

    Hong Kong Tobacco Inspectors to Wear Body Cameras

    Hong Kong’s Tobacco and Alcohol Control Office will equip inspectors with body cameras starting today (August 20) as they enforce the city’s smoking ban. The move comes after fixed penalty notices for smoking offences rose nearly 31% last year, with 13,488 citations. New enforcement measures, including plain-clothes officers and extended surveillance, have been credited with the increase in penalties.

    The Department of Health said cameras will document enforcement activities and conflicts, with individuals notified before recording. Footage without evidential value will be deleted after 31 days.

    Lawmakers are also reviewing broader anti-smoking proposals, including expanded non-smoking zones near entrances to schools, hospitals, and elderly homes, a ban on public use of alternative smoking products from April 2026, and restrictions on flavored tobacco sales from mid-2027.

  • FDA Denies Marketing for blu Disposable E-Cigarette

    FDA Denies Marketing for blu Disposable E-Cigarette

    Today (August 19), the U.S. Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) for Fontem US, LLC’s blu Disposable Classic Tobacco 2.4% e-cigarette, prohibiting its marketing or sale in the United States. The decision bars the product due to insufficient evidence that it would help adult smokers quit cigarettes—and raises concerns about dual use increasing overall toxicant exposure. FDA emphasized that only e-cigarettes supported by robust evidence showing reduced harm or smoking cessation benefits have been granted market authorization.

    “While FDA-authorized e-cigarettes are a lower-risk alternative for adults who smoke cigarettes – especially if they completely switch – not all e-cigarettes are equal,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “FDA’s rigorous scientific review ensures authorized e-cigarettes provide a net benefit to public health.

    “In this case, the company did not provide sufficient evidence of a benefit that outweighs the risk, particularly given evidence that adults who smoke generally do not stop or significantly curtail consumption of cigarettes when using this product.”

    Tobacco products that receive an MDO from the FDA may not be introduced or delivered for introduction into interstate commerce and must be removed from the market. Manufacturers, distributors, and retailers who sell or distribute this product in interstate commerce are violating the law and are at risk of enforcement action. The company may submit a new application for the product subject to this MDO.

    Industry observers interpret today’s decision as part of an increasingly stringent FDA posture, where even incumbent market players face rejection unless they clearly demonstrate both consumer and public health benefits. FDA-authorized products to date are limited to those with compelling evidence, and remain largely within tobacco-flavored, closed-system formats

    Fontem joins smaller U.S.-based e-cigarette companies ECS Global, Texas Select Vapor, Fumizer, and American Vapor Inc. that received MDOs in the last month.

    See the FDA’s notification.