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Category: News This Week

  • ATNF Talks Challenges in Communicating Tobacco Harm Reduction

    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.

  • Farrelly, Industry Experts Debate Ways to Improve PMTA Pathway

    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.

  • ATNF Panel Focuses on Harm Reduction for Adult Smokers

    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.

  • FDA, Industry Leaders Explore Product Standards at ATNF

    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.

  • ATNF Explores Shifting Dialogue in Tobacco Harm Reduction

    ATNF Explores Shifting Dialogue in Tobacco Harm Reduction

    At the American Tobacco and Nicotine Forum (ATNF), the panel titled “From ‘You Can’t Be Here’ to ‘We Need to Talk’” focused on the evolving relationship between public health advocates and the tobacco and nicotine industry, highlighting a gradual shift from outright exclusion toward cautious engagement. Moderated by Joe Gitchell, the CEO of PinneyAssociates, the discussion centered on the importance of dialogue across opposing viewpoints, with panelists reflecting on how entrenched positions, mistrust, and policy rigidity have slowed progress in reducing smoking-related harm.

    A recurring theme was how perspectives have changed over time. Dave Dobbins, the Principal Consultant of Dobbins Consulting, described moving from skepticism about e-cigarettes—once believed to be a gateway to smoking—to recognizing their potential role in harm reduction, while also criticizing high taxes and prohibition-style policies for slowing progress. Dr. Jonathan Foulds, a professor of Public Health at Penn State University, acknowledged misjudging both the appeal of alternative nicotine products and the industry’s ability to transition away from cigarettes, arguing that regulatory barriers and misinformation have hindered adoption of less harmful options. He emphasized the need to focus on current smokers—particularly older populations who face near-term health risks—while avoiding strategies that could drive youth uptake. Dr. Mark Tyndall, an author and vaping advocate, reinforced harm reduction principles drawn from his experience in HIV prevention, arguing that safer alternatives should be embraced more pragmatically, even as resistance persists within parts of the public health community.

    Panelists also examined the structural and philosophical divides shaping policy. Phil Wilbur, a retired public health expert, representing a traditional tobacco control perspective, stressed that reducing disease and death remains the central goal, while acknowledging past missteps, including an overemphasis on youth prevention strategies that did not fully succeed. The discussion highlighted ongoing tensions around prohibition versus harm reduction, with broad agreement that outright bans are ineffective and risk fueling illicit markets. At the same time, speakers pointed to deep-rooted mistrust of the tobacco industry as a barrier to collaboration, with suggestions ranging from clearer risk communication to restructuring incentives so companies benefit from transitioning away from combustible products. Across the panel, there was consensus that meaningful progress will require more open, evidence-based dialogue—moving beyond binary “good versus evil” narratives toward practical solutions that reflect real-world behavior and market dynamics.

  • PMI Reduces Zyn Production in Owensboro

    PMI Reduces Zyn Production in Owensboro

    Philip Morris International announced it will scale back production at its Swedish Match facility in Owensboro, Kentucky, shifting part of its Zyn nicotine pouch operations from a 24/7 schedule to a 24/5 schedule beginning in early July, according to The Owensboro Times. The adjustment primarily affects the Zyn Flagship department, which will return to a five-day, three-shift model under the terms of the existing collective bargaining agreement.

    The company said the move reflects changing market conditions, with production currently exceeding demand following a period of rapid growth and capacity expansion. PMI invested more than $230 million into the Owensboro site in 2024, increasing output and adding approximately 450 jobs to support strong demand for Zyn products.

    PMI emphasized that the change is a production realignment rather than a reduction in long-term commitment to the facility, noting that other operations, including Zyn Ultra production and maintenance, will remain on a 24/7 schedule. The company said it will work with union leadership on staffing adjustments and indicated the schedule could return to continuous operations if demand increases.

  • Delaware Advances Bill to Raise Nicotine Taxes; Cigs by 71%

    Delaware Advances Bill to Raise Nicotine Taxes; Cigs by 71%

    Delaware lawmakers advanced legislation to significantly increase tobacco taxes and update licensing requirements, with House Bill 215 proposing to raise the cigarette tax from $2.10 to $3.60 per pack while also increasing taxes on vapor products, moist snuff, and other nicotine items. The measure would expand the definition of tobacco to include all nicotine-containing products, raise licensing fees across the supply chain, and is projected to generate up to $26.7 million annually, with implementation beginning in late 2026.

  • Iowa Senate Passes 5-Cent Tax on Vapes, Nicotine Products

    Iowa Senate Passes 5-Cent Tax on Vapes, Nicotine Products

    The Iowa Senate has passed a bill establishing a new excise tax on alternative nicotine products, introducing a 5-cent per-unit tax on nicotine pouches and a 5-cent per milliliter tax on e-liquid used in vape products. The tax applies to both disposable vapes and refill cartridges, creating a standardized levy across emerging nicotine categories that have historically gone untaxed in the state.

    Lawmakers said the extra revenue would go toward pediatric cancer research. “I understand that the level of tax we’re looking at here is not likely to be enough to deter usage, but it is enough to create this investment in pediatric cancer research that we all want to get behind,” Sen. Kara Warme (R-Ames) said.

  • PMI Expands Ducati Partnership to Promote Zyn

    PMI Expands Ducati Partnership to Promote Zyn

    Philip Morris International expanded its long-standing partnership with Ducati Corse, announcing that its Zyn nicotine pouch brand will be featured on MotoGP race liveries at select events starting in the 2026 season. The move marks a new phase in the collaboration, which dates back to 2003, and reflects PMI’s continued focus on promoting smoke-free products through high-profile global platforms.

    PMI said the partnership aligns with its broader strategy to grow its oral nicotine portfolio, with ZYN positioned as a key driver in the company’s transition away from cigarettes. Ducati said the renewed agreement builds on a shared emphasis on innovation and performance, as both organizations look to extend their presence and engagement with adult consumers in international markets.

  • Massachusetts Court Upholds $56M Verdict Against Philip Morris

    Massachusetts Court Upholds $56M Verdict Against Philip Morris

    Massachusetts’ highest court rejected an effort by Philip Morris USA to impose stricter standards on punitive damages, allowing a previously reduced $56 million verdict to stand. The company had sought additional legal limits to curb large punitive awards, but the court declined to adopt new rules.

    The case stems from a lawsuit in which the original $1 billion punitive damages award had already been significantly reduced by a lower court. Philip Morris argued for further reductions and broader changes to how such damages are assessed, but the justices upheld the existing framework.