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Category: Global Regulation

  • FDA Extending Info Collection for Smokeless Products

    FDA Extending Info Collection for Smokeless Products

    The U.S. Food and Drug Administration (FDA) has submitted a proposed extension of an existing information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act, covering warning plans for certain smokeless tobacco products. The collection, assigned OMB Control Number 0910-0671, relates to statutory requirements that smokeless tobacco packaging and advertising carry one of four mandated health warnings, randomly displayed and rotated quarterly in accordance with FDA-approved warning plans. FDA said manufacturers, importers, distributors, and retailers must submit these plans for review, either electronically via the Center for Tobacco Products (CTP) Portal or in paper form.

    Public comments on the proposal must be submitted through reginfo.gov within 30 days of Federal Register publication, and FDA noted that two comments received during an earlier 60-day notice period were not related to paperwork burden issues.

  • Indonesia Hopes Simplifying Excises Will Reduce Illicits

    Indonesia Hopes Simplifying Excises Will Reduce Illicits

    Indonesia is preparing to introduce an additional cigarette excise tax layer in 2026 as part of efforts to curb illegal tobacco and draw illicit producers into the formal market. Finance Minister Purbaya Yudhi Sadewa said the proposal is still under discussion but could be confirmed soon, with regulations potentially issued next week. The move is intended to complement the gradual simplification of the cigarette excise (CHT) structure, which has been reduced from 19 tiers in 2009 to eight under the current framework, while pairing incentives with stricter enforcement for non-compliance.

    Authorities underscored the scale of the illicit trade challenge, noting that Customs and Excise has seized around 1.4 billion illegal cigarettes through more than 20,000 enforcement actions since the beginning of 2025, including a recent seizure of 160 million cigarettes from a warehouse in Pekanbaru, Riau. In value terms, illegal cigarette seizures reached Rp9.8 trillion ($564 million) in 2025, up 2.1% year on year, highlighting the government’s intensified crackdown alongside planned excise reforms.

  • COSH Studies Find Approval of Hong Kong Tobacco Control

    COSH Studies Find Approval of Hong Kong Tobacco Control

    As policymakers in Hong Kong continue tightening smoking restrictions, a new survey commissioned by the Hong Kong Council on Smoking and Health (COSH) says that 89% of residents support expanding smoke-free areas, with 60% supporting a smoking ban in all outdoor areas. The University of Hong Kong-led poll of 5,600 respondents found exposure to secondhand smoke remains a common complaint on pavements and roadsides.

    Hong Kong has already doubled fixed penalties for smoking offences to HK$3,000 ($390) and expanded no-smoking zones, with further measures planned, including restrictions on alternative smoking products and potential future steps such as plain packaging, duty stamps, and a ban on flavored tobacco targeted for 2027.

    In a separate modelling likewise commissioned by COSH, the Chinese University of Hong Kong estimated that increasing the tobacco tax to 75% of the retail price, followed by annual hikes, could lower smoking rates below 10% by 2037.

  • Vietnam Looking to Tighten Tobacco Control, Include Vape and HTP

    Vietnam Looking to Tighten Tobacco Control, Include Vape and HTP

    A draft revision released today (January 13) to Vietnam’s Law on Prevention and Control of Tobacco Harms signals a tougher regulatory stance on cigarettes and next-generation products, with measures aimed at strengthening public-health protections and limiting industry and special-interest influence. The proposal would require health warnings to cover at least 85% of cigarette packaging and expand smoking-cessation and detoxification provisions to include e-cigarettes and heated tobacco products, reflecting reported rising nicotine dependence from alternative products. The amended law is scheduled to take effect January 1, 2027, providing a transition period for regulators, local governments, and consumers, and marks a shift toward more proactive risk control—particularly for youth—by tightening definitions, advertising rules, retail practices, and cessation requirements across the tobacco and NGP categories.

  • Hong Kong Health Org Wants Firm Dates for Tobacco Laws

    Hong Kong Health Org Wants Firm Dates for Tobacco Laws

    Today (January 13), the Hong Kong Council of Smoking and Health (COSH) pressed the government to set a clear timetable for pending tobacco-control measures, warning that several proposals remain stalled ahead of Legislative Council review. COSH chairman Henry Tong said policies such as a ban on non-menthol flavored tobacco, the introduction of plain packaging, and a cigarette stamp duty system are slated for the second quarter of 2027, but lack firm implementation dates. He also urged faster action on banning smoking while walking, arguing that expanding outdoor no-smoking zones—modeled on Shanghai’s fully smoke-free Nanjing Road—could deliver immediate public health benefits.

    Ahead of next month’s fiscal budget, COSH is also calling for a sharp increase in tobacco taxes, recommending a rise to 75% starting in the next fiscal year, followed by automatic annual increases similar to systems used in Australia and the UK. The council further urged officials to define a concrete “smoke-free generation” timeline. Its recommendations are backed by a University of Hong Kong survey of 5,600 respondents conducted between late 2024 and mid-2025, which found nearly half had been exposed to secondhand smoke in the previous week, most commonly in outdoor public spaces such as pavements, crossings, parks, and bars.

  • Taipei to Announce Plans for Smoke-Free City in 2026

    Taipei to Announce Plans for Smoke-Free City in 2026

    Taipei City is moving toward tighter controls on public smoking, with Mayor Chiang Wan-an saying the city is considering various options and expects to roll out a “smoke-free Taipei” plan by the end of 2026. Chiang said officials are studying overseas models, including Tokyo’s use of designated smoking areas and booths, which he described as effective in reducing secondhand smoke and litter, signaling a likely approach that would ban smoking in principle while allowing limited, clearly defined exceptions in public spaces.

  • Türkiye Looking to Increase Smoking Controls

    Türkiye Looking to Increase Smoking Controls

    Türkiye plans to further tighten its already strict tobacco control regime, with Health Minister Kemal Memişoğlu saying legislative work to expand smoking bans in enclosed spaces is nearing completion and expected to reach parliament soon. Memişoğlu said the measures aim to strengthen the fight against tobacco addiction by reinforcing smoke-free environments while scaling up smoking cessation clinics and mobile outreach teams nationwide. The move builds on Türkiye’s long-standing controls, including comprehensive indoor smoking bans, plain packaging, advertising prohibitions, and e-cigarette restrictions, as smoking rates remain above a quarter of the population despite years of enforcement.

  • Pakistan Bill Would Treat Vape Like Cigarettes

    Pakistan Bill Would Treat Vape Like Cigarettes

    Pakistan’s Senate Standing Committee on National Health Services approved the Electronic Nicotine Delivery Systems (Regulation) Bill, clearing the way for its introduction in the Senate as authorities move to curb rising youth vaping, particularly in Islamabad. The bill would impose strict controls on the import, sale, marketing, and use of e-cigarettes, including a ban on sales within 50 meters of schools and colleges, a minimum purchase age of 18, and a prohibition on vape use in public transport, government buildings, parks, and other shared spaces.

    The proposed legislation would regulate vapes similarly to traditional tobacco products, banning all advertising—especially marketing aimed at minors—and requiring product standards such as nicotine caps of 40 mg/ml, child-resistant packaging, health warnings, and mandatory age verification for e-commerce sales. Penalties include fines of up to Rs 50,000 ($175) for first offenses, with escalating sanctions for repeat violations and smuggling. The bill is undergoing inter-ministerial review before formal Senate consideration, signaling tighter oversight for the nicotine and vaping market in Pakistan.

  • FDA Pushed on ‘De Facto’ Vape Ban by 5th Circ.

    FDA Pushed on ‘De Facto’ Vape Ban by 5th Circ.

    A panel of the U.S. Court of Appeals for the Fifth Circuit signaled skepticism yesterday (January 6) toward the Food and Drug Administration’s claim that it has not effectively banned flavored refillable e-cigarette products, suggesting the agency’s near-total rejection of applications amounts to a de facto prohibition. During oral arguments, Judge Cory T. Wilson noted that the FDA has approved only six applications out of hundreds of thousands of premarket tobacco product applications (PMTAs), remarking that “if you’re effectively at 100% denial on a certain class of products, then it is a de facto ban.”

    The case was brought by VDX Distro Inc., which is challenging the FDA’s refusal to authorize its menthol-flavored refillable vaping products. Government attorney Ben Lewis argued that no ban exists because some products have been approved, but judges pressed the agency on whether it has ever approved a flavored e-cigarette without evidence showing it provides greater smoking cessation benefits than tobacco-flavored products. Counsel for VDX argued the FDA violated the Tobacco Control Act by imposing new, unwritten standards without notice-and-comment rulemaking, effectively blocking all open-system refillable devices.

    Industry amici echoed those concerns, with an attorney for R.J. Reynolds Vapor Co. arguing the FDA applies stricter standards to flavored vaping products than to other nicotine products, such as pouches. The panel did not rule from the bench, but the pointed questioning underscores growing judicial scrutiny of FDA tobacco regulation, with potential implications for future authorization pathways for flavored vaping products closely watched by the tobacco and nicotine industries.

  • Guam Tobacco Retail Compliance Tops 97%

    Guam Tobacco Retail Compliance Tops 97%

    Compliance inspections found that 97.1% of Guam tobacco retailers complied with laws prohibiting sales to minors in 2025, according to data released January 5 by the Guam Behavioral Health and Wellness Center (GBHWC) and the Department of Revenue and Taxation (DRT). The compliance rate increased from 94.8% in 2024, well above the federally required minimum of 80% under the Synar Amendment.

    Out of 277 eligible retailers inspected, only eight were cited for selling tobacco or disposable ENDS products to minors ages 16–20, and one retailer failed to post a required “No Sale Under 21” sign. The nine establishments received citations ranging from $2,000 to $4,000.

    Officials credited strong enforcement and education efforts, including GBHWC’s Merchant Education Outreach Program, launched in 2025, which provides door-to-door education and compliance resources.