Philip Morris Japan announced it plans to expand sales of its oral nicotine pouch product “Zyn by IQOS” in Tokyo, with a broader rollout beginning May 11 across IQOS stores and convenience retailers. The product will be offered in Cool Mint, Spear Mint, Apple Mint, and Peach flavors, each with “low” and “medium” strength options. The company said the expansion reflects growing demand for discreet, smoke-free alternatives that can be used in a wider range of settings.
Category: News This Week
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South Korea Delays Enforcement of New E-Cig Rules
South Korea’s Ministry of Health and Welfare announced that it has postponed enforcement of new regulations on liquid-type e-cigarettes just hours before they were set to take effect, creating confusion among local governments. The revised Tobacco Business Act, which classifies liquid e-cigarettes as tobacco and enables their restriction in no-smoking zones, officially came into force on April 24; however, the ministry announced a two-month delay until June 23, citing the need for a “grace period” to address existing stock that falls outside the scope of the new law.
The last-minute reversal led to inconsistent enforcement across municipalities, with some proceeding with crackdowns while others halted planned actions. The ministry said the delay is based on a supplementary provision limiting the law’s application to products imported or manufactured after the implementation date, meaning previously stocked products cannot yet be regulated. Local officials have criticized the move, noting that guidance issued earlier this year had encouraged immediate enforcement, and warning that ongoing ambiguity—particularly around verifying product dates—could complicate compliance even after the grace period ends.
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Spain Moves to Restrict Vape Sales
Spain’s two main political parties—the Spanish Socialist Workers’ Party (PSOE) and the Popular Party (PP)—agreed to support restrictions on the sale of vaping products to licensed and controlled retail channels. The non-legislative proposal, approved by a parliamentary commission, would limit the sale of e-cigarettes, nicotine pouches, and related products to tobacconists and specialized stores, excluding online platforms and general retail outlets.
The measure is aimed at reducing youth access and improving oversight in a market authorities say has significant control gaps, particularly around imported and non-compliant products. While the proposal seeks to strengthen age verification, traceability, and regulatory compliance, it comes as Spain’s broader anti-smoking legislation, currently under consultation, does not include similar controls on points of sale, highlighting ongoing policy inconsistencies.
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Pakistan Investigating Undocumented Acetate Tow Issues
A sharp decline in documented imports of acetate tow has raised concerns about growing illicit supply channels and significant tax losses, according to the Business Recorder. Imports fell 53% between 2023 and 2025, dropping from 6.9 million kg to 3.7 million kg, despite stable cigarette production levels of 60–80 billion sticks annually. According to an unnamed industry expert, the gap suggests a substantial shift toward undocumented or smuggled inputs following the imposition of a PKR 44,000 ($158.40) per kg Federal Excise Duty.
Industry sources estimate that the trend has cost the government approximately Rs 300 billion ($1.1 billion) in lost tax revenue and distorted market competition. Legal manufacturers complying with import and tax requirements face increasing pressure as illicit operators expand market share, now accounting for more than half of total sales, Business Recorder said.
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Philippines: Latest Crackdown Sinks $13M Illicit Operation
Philippine authorities dismantled a large-scale illegal cigarette manufacturing and distribution operation, seizing nearly 800 million pesos ($13 million) worth of raw materials and equipment. The Philippine National Police said the network had been operating since the third quarter of 2025 and was part of a broader illicit trade impacting government revenues.
Officials warned that such operations significantly reduce excise tax collections intended for public services, including healthcare. Authorities have already taken similar enforcement actions in Luzon and plan to expand crackdowns to the Visayas region as part of ongoing efforts to combat the illicit tobacco trade.
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Hong Kong Believes Vape Ban Won’t Impact Tourism
Hong Kong health officials say an upcoming ban on alternative smoking products, including vapes and heated tobacco, is not expected to impact tourism as a public awareness campaign ramps up ahead of enforcement beginning April 30. The new rules will prohibit possession and use of such products in public, with penalties of up to HK$50,000 ($6,500) and six months in prison. Authorities are working with tourism and transport agencies to inform visitors through signage, outreach, and media, while maintaining measures aimed at reducing smoking rates, currently at 8.5%, and addressing health risks associated with alternative nicotine products.
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ATNF Talks Challenges in Communicating Tobacco Harm Reduction
At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Tobacco Harm Reduction: Communicating to Adults Who Smoke” brought together public health experts, physicians, and industry representatives to examine why reduced-risk messaging is failing to reach adult smokers. Moderated by Cliff Douglas, president of Tobacco Control Law and Policy Consulting, the discussion focused on the disconnect between scientific evidence, regulatory communication, and real-world consumer understanding, with panelists pointing to a significant opportunity to better engage healthcare providers as trusted intermediaries. Douglas said the number of contrasting views from “authorities” in government and industries has eroded trust of consumers across most markets.
Dr. Mohamadi Sarkar, a fellow in regulatory affairs for Altria Client Services, emphasized the scale of misinformation, noting that many smokers believe vaping is as harmful as smoking and that nicotine pouches cause cancer—perceptions he said are not supported by current evidence. He argued that while regulators acknowledge a continuum of risk, that message is not reaching consumers due to communication restrictions and slow dissemination of scientific findings. Sarkar also highlighted that even physicians often lack awareness of tobacco regulation and product differences, suggesting that a grassroots, evidence-based approach—combined with better education of healthcare providers—could gradually shift understanding and influence patient decisions.
Dr. Mark Tyndall, an author and vaping advocate, framed harm reduction through a clinical lens, arguing that abstinence-only messaging is ineffective and that switching to lower-risk products should be treated as a pragmatic health intervention. He compared nicotine alternatives to substitution therapies in other areas of medicine, stressing that providing safer options is both ethical and necessary. Dr. Julie Gunther, a physician based in Boise, Idaho, reinforced the practical challenges physicians face, noting limited patient interaction time and a lack of nuanced education within the medical system. She said most healthcare environments do not differentiate between nicotine products, while real influence increasingly comes from peers, pharmacists, and social media. Across the panel, speakers pointed to stigma, regulatory constraints, and inconsistent public health messaging as key barriers, with calls for clearer, fact-based communication to help adult smokers make more informed choices.
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Farrelly, Industry Experts Debate Ways to Improve PMTA Pathway
At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Building Lasting Regulatory Reforms: Solutions for a Better PMTA Pathway,” brought together legal, regulatory, and scientific experts to examine persistent challenges within the FDA’s premarket tobacco application (PMTA) process and explore potential reforms. Moderated by Issa Abuaita, the head of legal in the U.S. for Haypp Group, the discussion focused on the disconnect between the statutory framework and real-world market dynamics, with panelists broadly agreeing that the current system is slow, costly, and misaligned with both innovation and enforcement realities.
Industry representatives emphasized the need for clearer guidance and more practical tools to navigate the process. Paige Magness, a senior vice president at Altria Client Services, highlighted the “irony” of a system where youth usage has increased in products that remain unauthorized, raising questions about whether the framework is effectively managing real-world outcomes. Kellsi Booth, the Chief Legal Officer for Black Buffalo, pointed to the gap between regulatory language and day-to-day application, suggesting that decision trees or clearer pathways could help companies determine requirements more efficiently. Piotr Kozarewicz, the global head of regulatory affairs for smoke-free products at PMI, argued for a more product-focused and market-informed approach, stressing that regulators should evaluate how products are actually used rather than relying heavily on predictive behavioral studies that may not reflect reality.
Clive Bates, the director of Counterfactual, delivered the sharpest critique, arguing that the PMTA system has become “untethered from reality,” with high evidentiary burdens effectively stifling innovation and contributing to the growth of a large illicit market. He noted that while only a small number of vaping products have been authorized, thousands of combustible products remain on the market, creating a regulatory imbalance. Bates called for a shift toward a more pragmatic framework focused on product safety and marketing controls, alongside faster review timelines closer to the statutory 180-day standard. He also suggested that a compliance-based system, where products meeting defined standards receive expedited review, could improve outcomes and reduce barriers to entry.
Representing the FDA on the panel was Dr. Matthew Farrelly, the director of the Office of Science for the Center for Tobacco Products, who offered several counterpoints, defending the agency’s process while acknowledging its limitations. He noted that the vast majority of PMTA denials stem from incomplete applications, particularly the lack of evidence demonstrating benefits to adult smokers. Farrelly emphasized that FDA is bound by the existing statutory framework and must base decisions on robust scientific evidence, even as it works to clear backlogs and improve engagement with industry. He encouraged earlier dialogue between applicants and regulators and suggested that incremental product changes could be reviewed more efficiently than entirely new designs.
The panel ultimately underscored a shared recognition that while progress is being made, meaningful reform will require clearer standards, better communication, and a more balanced approach to risk, innovation, and enforcement.
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ATNF Panel Focuses on Harm Reduction for Adult Smokers
At the American Tobacco and Nicotine Forum (ATNF), the panel titled “Adults Who Smoke: The Beneficiaries of Harm Reduction Reform” focused squarely on adult smokers as the primary population that stands to benefit from expanded access to reduced-risk nicotine alternatives. Moderated by Dr. Jasjit Ahluwalia, a professor at Brown University, the discussion challenged prevailing narratives in public health, particularly the strong emphasis on eliminating all nicotine use and the skepticism toward dual use. Ahluwalia argued that quitting smoking is often a process rather than a single event, and that transitional behaviors—such as using both cigarettes and alternatives—should not be automatically dismissed if they move individuals toward lower-risk products.
Panelists brought personal and advocacy-driven perspectives to the conversation. Consumer advocate Phillip Kirschberg, a consumer advocate, described how vaping enabled him to move away from a heavy smoking habit after multiple failed quit attempts, arguing that alternatives should be more readily available and not stigmatized given their potential to save lives. Consumer advocate Kim “Skip” Murray echoed the real-world nature of behavior change, noting that many smokers initially adopt alternatives situationally rather than with the explicit goal of quitting. Elizabeth Hayes, lead of external affairs for the Consumer Choice Center, emphasized that many smokers transition simply because alternatives are more appealing, adding that clearer differentiation between product categories is needed so adult consumers understand relative risks and available options.
A central theme of the panel was the gap between scientific understanding and public perception. Speakers argued that misinformation and lack of communication have left many adults believing that alternatives like e-cigarettes are as harmful as cigarettes, limiting their willingness to switch. Panelists also stressed the importance of flavors and product variety in supporting switching, while acknowledging the political sensitivity of the issue. Across the discussion, there was a consistent call for more honest, evidence-based communication, greater inclusion of consumer voices in policymaking, and a shift toward policies that recognize harm reduction as a pragmatic tool to reduce smoking-related disease—particularly for older, long-term smokers who may not otherwise quit.
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FDA, Industry Leaders Explore Product Standards at ATNF
At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Streamlining Product Reviews Through Smokefree Product Standards” brought together regulators, consultants and scientists to examine how standardized frameworks could improve the efficiency of FDA product reviews. Moderated by Dean Cirotta, president of EAS Consulting Group, the discussion centered on whether clearer product standards could reduce uncertainty in the PMTA process, shorten timelines, and create more predictable pathways for bringing reduced-risk products to market.
Andrew Joyce, the co-founder and president of Sanova, emphasized the need for earlier engagement with regulators and clearer guidance on expectations, arguing that companies are often navigating an unclear “playing field” when designing studies and preparing submissions. Dr. Aruni Bhatnagar, the director of the Christina Lee Brown Envirome Institute at the University of Louisville, framed the issue more broadly, noting that regulation must account for product design, user behavior, and market dynamics, and that product standards could serve as “guardrails” to define acceptable risk thresholds. Rachael Schmidt, a senior consultant for ALINC, highlighted the political and practical challenges, pointing out that PMTA approvals can take five to eight years and span multiple administrations, creating uncertainty that discourages innovation and investment. She stressed the need for interim solutions, such as consensus standards, to avoid prolonged delays that can keep compliant products off the market.
Dr. Todd Cecil, deputy director of the Office of Science at the FDA’s Center for Tobacco Products, provided detailed views into the agency’s perspective, underscoring both the importance and complexity of establishing formal product standards under Section 907, which gives the FDA authority to do so. He explained that the process is resource-intensive, requiring the agency to review and respond to thousands of public comments, and can take years to finalize, but once implemented, such standards would become non-negotiable benchmarks for applications. Cecil made clear that while FDA supports faster approvals, the agency has yet to receive a submission that is complete and ready for approval at the outset, reinforcing the need for higher-quality applications. He also encouraged greater collaboration with industry groups like CORESTA and stressed that better communication from manufacturers—who understand their products best—could improve review efficiency. While acknowledging industry frustration, Cecil noted that FDA leadership is committed to advancing improvements and that draft standards could provide valuable interim guidance.
A key tension throughout the discussion was the balance between innovation and regulation. Panelists agreed that while product standards could streamline approvals, they also introduce rigidity that may slow innovation or require costly adjustments. Cecil addressed this directly, warning against trying to “solve everything at once” and suggesting incremental progress may be more realistic. Schmidt added that without clear pathways to modify products post-approval, companies risk being locked out of the market for years if standards shift. Overall, the panel highlighted cautious optimism that clearer standards and improved dialogue between FDA and industry could reduce bottlenecks, but also underscored that meaningful change will require time, coordination, and sustained effort across stakeholders.