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Category: Global Regulation

  • FDA to Host Discussion on PMTAs Feb. 10

    FDA to Host Discussion on PMTAs Feb. 10

    FDA issued a reminder today regarding the Federal Register notice (FRN) roundtable discussion it is hosting tomorrow (February 10) for small tobacco product manufacturers (fewer than 350 employees). The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products and will be held from 9 a.m.–5 p.m. ET.

    The topics to be discussed will include certain components of ENDS PMTAs, such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).

    FDA has also established a docket for public comment on this roundtable discussion. All electronic comments must be submitted on or before March 12. The regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 12.

  • Kyrgyzstan Tightening Hookah Laws

    Kyrgyzstan Tightening Hookah Laws

    Kyrgyzstan opened public consultation on draft legislation that would tighten the regulation of hookah use by banning water pipes, shisha, and nargile in all public places. Under the proposal, hookah consumption would only be allowed in specially designated, licensed venues equipped with ventilation systems and restricted to adults aged 18 and over. The draft also amends the country’s licensing and permitting law, formally requiring businesses offering hookah services to obtain a dedicated operating license, marking a significant step toward stricter oversight of the sector.

  • Dutch Looking to Raise Nicotine Age to 21

    Dutch Looking to Raise Nicotine Age to 21

    The Netherlands plans to raise the minimum legal age for purchasing nicotine products, including cigarettes and vapes, from 18 to 21 under a new coalition agreement between D66, VVD and CDA parties, reflecting growing concern over youth nicotine use, Euractiv reported. The proposal follows a 2025 government study showing 10% of Dutch 12-year-olds have tried vaping and nearly 40% of users aged 12–16 report addiction. The move aligns with a broader European trend, with Latvia already raising the age to 20, Ireland planning to increase the minimum to 21 by 2028 through its “smoke-free generation” strategy, and Finland considering similar changes as part of its 2030 nicotine-free target. Industry groups have criticized the Dutch proposal, arguing it restricts legal adults’ choices and could increase illicit trade and cross-border purchases, while public health advocates support the measure as part of efforts to reduce youth nicotine uptake.

  • Mombasa Traders Fighting Proposed Tobacco Law

    Mombasa Traders Fighting Proposed Tobacco Law

    Retail and hospitality traders in Mombasa are pushing back against Kenya’s Tobacco Control (Amendment) Bill, 2024, warning the proposed reforms could accelerate illicit trade and undermine legitimate businesses. Speaking at a press briefing, business owners cited Kenya Revenue Authority estimates suggesting more than 50% of excisable goods in the market are already illicit or non-compliant, including cigarettes and other regulated products. Traders argue the bill, sponsored by Senator Catherine Mumma, risks worsening the situation by introducing additional restrictions such as a proposed ban on flavored nicotine products, including vapes and nicotine pouches.

    Industry representatives said while protecting minors is important, further product restrictions could drive consumers toward unregulated markets, eroding tax revenue and threatening licensed operators. Coast Bar Owners Association Chairman Patrick Kabundu warned that removing legal product options could create supply gaps quickly filled by black market suppliers, while traders urged lawmakers to focus on enforcing existing laws, including Kenya’s ban on tobacco sales to individuals under 18, rather than introducing new regulatory measures they say could harm businesses and government revenue.

  • Plans to Toughen Vape Trade Licensing in Belarus

    Plans to Toughen Vape Trade Licensing in Belarus

    Belarus is preparing draft legislation to tighten licensing requirements for electronic cigarette and e-liquid trade, with the proposal expected to reach parliament in the first half of 2026. Officials considered both a full ban and stricter regulation, ultimately opting to maintain retail availability while limiting which entities can manufacture, import, and conduct wholesale distribution. President Aleksandr Lukashenko cited rising youth vaping rates as a key concern but warned that an outright ban could fuel illicit cross-border trade, particularly with Russia. Authorities said the new framework would introduce tougher retail licensing standards and stronger enforcement, following inspections that found roughly 70% of retail outlets selling non-compliant products. The proposal, developed by state food industry group Belgospishcheprom, would apply to both vaping devices and nicotine liquids as part of broader public health oversight.

  • Morocco Creates Mandatory Standard for Smoke-Free Products

    Morocco Creates Mandatory Standard for Smoke-Free Products

    Morocco will implement mandatory standards for smoke-free nicotine products, including e-cigarettes, muassel, and nicotine pouches, from February 2026, under new rules developed by the Moroccan Institute of Standardization, according to Médias24. The framework introduces requirements covering product composition, labelling, traceability, and safety, and will apply to imports as Morocco has no domestic production of these products.

    Consumer groups say the regulations strengthen transparency by requiring detailed labelling, including manufacturer information, ingredients, origin, and production date, while supporting broader legal updates covering emerging nicotine categories such as heated tobacco. Authorities stress the measures are intended to improve consumer protection and market oversight rather than promote product use.

  • Korea to Regulate Synthetic Nicotine as Tobacco

    Korea to Regulate Synthetic Nicotine as Tobacco

    South Korea announced today (Feb. 3) that it will extend full tobacco regulatory controls to synthetic nicotine liquid e-cigarettes from April 24, bringing them in line with conventional tobacco products following amendments to the Tobacco Business Act and National Health Promotion Act. The measures require manufacturers and distributors to include graphic health warnings on packaging and restrict advertising to limited channels, while banning promotional content targeting women or minors or highlighting flavors. The revised framework also prohibits the use of all tobacco and nicotine products, including e-cigarettes and heated tobacco, in designated smoke-free areas, with violations subject to fines of up to 100,000 won ($69). The regulatory expansion, the first major update to the tobacco definition since 1988, aims to close loopholes that previously allowed synthetic nicotine products to be marketed and sold with fewer controls, particularly amid concerns around youth access and public health risks.

  • Bangladesh Bans Tobacco Sales Near Health Facilities

    Bangladesh Bans Tobacco Sales Near Health Facilities

    Bangladesh’s Health Ministry directed field-level health authorities to enforce a ban on the sale of tobacco products within 100 meters of hospitals, clinics, and other health facilities, and to ensure these areas remain tobacco-free under recently tightened anti-tobacco laws. The directive follows amendments to the Smoking and Tobacco Products Usage (Control) Act that expanded the definition of tobacco products and increased penalties, raising fines for smoking or tobacco use in designated public places to Tk 2,000 ($16.40), while also requiring health facilities to display no-smoking signage.

  • FDA Posts New Materials in Zyn MRTP Applications

    FDA Posts New Materials in Zyn MRTP Applications

    The FDA posted new materials today (Feb. 2) related to the modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The documents are available on the Swedish Match USA, Inc. MRTP application webpage. This is the final set of application materials.

    Accordingly, FDA is establishing the closing date for the public comment period on these MRTP applications. Public comments must be submitted to Docket Number FDA-2025-N-0835-0001 by 11:59 p.m. ET on March 4 to be considered. 

    Read the application materials here.

  • Türkiye Looks to Tighten Smoking Regs

    Türkiye Looks to Tighten Smoking Regs

    Türkiye’s Health Ministry is finalizing draft regulations that would restrict the visibility of tobacco products in shops and expand smoking bans in public spaces, including parks, gardens, and playgrounds, as part of efforts to reduce tobacco use and limit children’s exposure. According to local reports, cigarettes would no longer be displayed behind cash registers, and the draft also includes updates to indoor smoking laws and measures addressing electronic cigarettes and other newer tobacco products. Health Minister Kemal Memişoğlu said the proposal, which also calls for expanded smoking cessation services, will soon be submitted to parliament. Türkiye already enforces broad smoke-free laws, plain packaging, and advertising bans, though more than a quarter of the population still smokes.