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Category: Global Regulation

  • Manufacturers Tell FDA They Need Benchmarks, Communication

    Manufacturers Tell FDA They Need Benchmarks, Communication

    During yesterday’s (Feb. 10) afternoon session of the U.S. Food and Drug Administration’s “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products,” Dr. Lynn Hull, acting senior science advisor in the Office of Science at FDA’s Center for Tobacco Products (CTP), moderated the Pharmacological Panel along with the FDA’s supervisory pharmacologist in CTP’s Division of Individual Health Science, Dr. Carolina Ramôa.

    Manufacturers warned that conducting studies has been prohibitively expensive and unpredictable without clear performance benchmarks. They also urged the FDA to allow greater use of modeling and data-bridging approaches, though regulators signaled that such alternatives would face strict validation requirements and may not replace product-specific clinical testing.

    “How can we simplify and have more communication and lean more toward product characteristics to model and understand abuse liability?” Dr. Willie McKinney, founder and CEO of Mckinney Regulatory Sciences asked. “How do we have more meetings regardless of where our application is in the process to understand what you are currently thinking?”

    The agency maintained that measuring nicotine delivery and addiction potential is essential when determining whether products meet public health standards, highlighting clinical pharmacokinetic (PK) data as the most reliable evidence.

    “I absolutely understand where you’re coming from,” said Dr. Ramôa, “where you want to make it as efficient as possible, but understand where I’m coming from, where I have a duty to the American public to make sure I make the correct decision that does not impact them negatively.”

  • India ‘Illogical’ in Keeping Alternative Ban

    India ‘Illogical’ in Keeping Alternative Ban

    India has ruled out easing its 2019 ban on e-cigarettes, confirming that the prohibition will continue to include heat-not-burn tobacco products. The Health Ministry said the government is not considering amendments to the law and remains committed to evidence-based tobacco control measures, reinforcing restrictions in one of the world’s largest cigarette markets, where more than 100 billion cigarettes are sold annually and tobacco use is blamed for over 1 million deaths each year.

    The decision is a setback for Philip Morris International (PMI), which had lobbied Indian officials for years to allow its IQOS heated tobacco device, a move analysts viewed as a significant IQOS driver of future expansion. By maintaining the ban, according to Reuters, India effectively blocks PMI from introducing its flagship smoke-free product into a high-volume market that the company had hoped would support its long-term transition strategy.

    In an interview with Reuters, Jacek Olczak, the firm’s chief executive, said he had engaged with various people in India, adding that it was “illogical” for the market to be closed to smoking alternatives such as heated tobacco and vapes, but not cigarettes.

  • FDA PMTA Roundtable Being Held

    FDA PMTA Roundtable Being Held

    Today (February 10), the U.S. Food and Drug Administration is hosting its much-anticipated “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products.”  Center for Tobacco Products (CTP) director Dr. Matthew Farrelly offered his opening remarks, which led into the “product characterization” panel moderated by deputy director Dr.  Todd Cecil.

    Dr.  Matthew Walters, Dr. Karen Coyne, Dr. Lynn Hull, and Dr. Carolina Ramôa rounded out the early sessions for FDA. Industry representatives said that unclear product characterization standards are limiting the long-term viability for smaller ENDS manufacturers, argued that the absence of objective, measurable benchmarks create uncertainty around PMTA compliance, and raised questions about defining testing ranges for open-system products and the ability to update long-pending PMTAs. FDA said it wants to create a dialogue with manufacturers, but statutory requirements constrain its regulatory flexibility.

    The afternoon panels were led by Cecil, Dr. Benjamin Apelberg, Dr. Mollie Miller, Dr. Amy Gross, Dr. Mary Irwin, and Dr.  Hans Rosenfeldt, and were still being held at the writing of this article. Tobacco Reporter will update the proceedings as the information becomes available.

  • Estonian Groups Want Disposable Vapes Banned by 2027

    Estonian Groups Want Disposable Vapes Banned by 2027

    A coalition of 50 organizations and school leaders, led by the Estonian Green Movement, submitted a public appeal to several Estonian government ministries calling for a nationwide ban on disposable e-cigarettes by 2027. The appeal, sent to the Ministries of Social Affairs, Climate, Economic Affairs and Communications, and Justice and Digital Affairs, argues that single-use vapes pose growing risks to youth health, contribute to nicotine addiction, and create significant environmental waste due to discarded batteries and plastics. The coalition also highlighted public backing for the measure, noting that a related initiative gathered more than 2,000 signatures by the end of 2025, and urged authorities to prohibit disposable devices while allowing stricter regulation of reusable alternatives.

  • NSW Increasing Tobacco-Inspector Staff by 62%

    NSW Increasing Tobacco-Inspector Staff by 62%

    New South Wales (Australia) will recruit 30 additional full-time tobacco inspectors to strengthen the state’s Centre for Regulation & Enforcement, expanding the statewide compliance team to 78 staff as authorities intensify efforts against illicit tobacco and vaping products. Since tougher enforcement laws took effect in November 2025, NSW Health and police have closed 66 retailers, including five Sydney Inner West tobacconists last week, while January inspections seized approximately 560,000 cigarettes, 98 kilograms of illicit tobacco, and more than 6,000 illegal vaping products valued at about A$830,000 ($589,000). The government is advancing further legislative measures, including landlord liability provisions and penalties exceeding A$1.5 million ($1.1 million) and seven years’ imprisonment for commercial-scale illicit tobacco offences, as officials warn high federal excise taxes continue to drive demand for illegal products and fuel evolving retail tactics such as QR code and social media-based sales.

  • Bangladesh Professionals Pushing Parliament for Tobacco Control

    Bangladesh Professionals Pushing Parliament for Tobacco Control

    Leaders of several professional and business organizations in Bangladesh are urging the government to pass the Smoking and Tobacco Products Usage (Control) (Amendment) Ordinance 2025 into law during the first session of the 13th National Parliament, arguing that formal legislative approval is critical for effective enforcement. The call was made during a public health meeting in Dhaka organized by Dhaka Ahsania Mission, where speakers described the ordinance as a major step toward reducing tobacco-related illnesses and deaths. Officials emphasized that continued political support from the next elected government will be key to advancing the measure.

    Citing Tobacco Atlas 2025 data, speakers said more than 21.3 million Bangladeshi adults use tobacco, and government representatives said Bangladesh generates about Tk40,000 crore ($3.6 billion) annually in tobacco revenue, but related costs surrounding healthcare, productivity losses, and premature deaths exceed Tk87,000 crore ($7.9 billion) each year.

  • 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.