Tag: ATNF

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.

April 24, 2026
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.

April 24, 2026
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.

April 24, 2026
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.

April 24, 2026
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.

April 24, 2026
ATNF Panel Examines State-Level Policy Challenges for Harm Reduction

At the American Tobacco and Nicotine Forum (ATNF), a panel moderated by Beth Oliva, a partner at Fox Rothschild, brought together industry, policy, and regulatory experts to examine how state and local policymaking is shaping harm reduction. Panelists Dr. Jeff Willett from the Progressive Policy Institute, Sarah McQuillan from JTI Liggett, Andrew Nunes from PwC, and Laura Leigh Oyler from Haypp Group, repeatedly emphasized a core issue: a widespread lack of understanding among state lawmakers about federal tobacco regulation and the FDA’s role. Several speakers noted that policymakers are often making decisions without a clear grasp of existing frameworks, definitions, or scientific standards, contributing to fragmented and sometimes contradictory regulations.

A major theme was the disconnect between data and policymaking. Panelists pointed to declining cigarette use alongside growth in alternative products, yet said state responses are often driven more by headlines than evidence. Willett highlighted progress in reducing youth vaping since 2019 and stressed the importance of fact-based policy, while others noted that tax increases, flavor bans, and regulatory gaps can unintentionally push consumers toward illicit markets or cross-border purchases. Nunes and Oyler both underscored how inconsistent tax structures and regulatory approaches across states are distorting markets and complicating compliance for manufacturers and retailers.

The panel also focused heavily on the growth of illicit markets, with speakers linking it to unmet consumer demand and regulatory gaps. Oyler argued that the lack of authorized products has created a “vacuum” filled by unregulated alternatives, while Willett pointed to evidence that high taxes and restrictions are driving illicit sales in markets like New York. Broader inconsistencies—such as stricter rules for nicotine compared to cannabis or alcohol—were cited as further complicating enforcement and public perception. Panelists warned that states are increasingly reliant on tobacco tax revenue, which can influence policy decisions, and called for more coordinated, evidence-based approaches rather than a patchwork of state-by-state rules.

Finally, the discussion turned to communication and public health messaging. Speakers argued that the current narrative around nicotine lacks nuance, with limited recognition of the continuum of risk or the role of reduced-risk products. Several panelists called for the FDA to take a more active role in educating both lawmakers and the public, while also stressing the need for better data to be incorporated into legislative debates. Without improved communication and alignment between federal science and state policy, the panel suggested that regulatory fragmentation and market distortions are likely to persist.

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April 22, 2026
Panel: From Pilot to Progress in Product Authorizations

The panel on the FDA’s nicotine pouch pilot program, moderated by Roxana Weil from McKinney Specialty Labs, was a great discussion between the FDA’s Cristi Stark, Reynolds American’s Carolina Garcia-Canton, Altria Client Service’s Sydana Rogers Hollins, and Kleinfeld, Kaplan, and Becker’s Stacy Ehrlich about the status of the pilot program and what both the FDA and the industry have learned from in the process.

The pouch pilot program was introduced in 2025, and according to Stark, it started with four applicants and is ending with the same four applicants. She stated that the program aimed for more communication and that the program started at filing. Stark noted that one of the biggest changes the FDA made in the pilot program versus the normal authorization pathway was that the regulatory body followed up with the four pilot companies via email rather than just the more formal letters. The panel participants all noted that the use of email communication was a huge benefit because it allowed for more communication, and more informal communication that helped them to get a better understanding of what the FDA is looking for in their applications.

One of the biggest points of discussion and agreement was that the pilot program has been successful in creating better lines of communication between the FDA and the industry when it comes to market authorization applications and what is expected and needed to help move the review process along and get product authorized. According to Garcia-Canton, the biggest success has been communication, not necessarily increasing the speed of the review process. Ehrlich agreed that the communication was much better but stated that the FDA needs to be substantially more transparent.

A point of contention has always been that applicants and the industry feel that the FDA takes too long to review products—the process has taken much longer than the stated 180 days. Ehrlich stated that the process timing needs to be equal for the applicants and the regulatory body; the FDA takes lots of time to review the applications, but companies aren’t necessarily given the time they need to address issues. Stark’s response to the amount of time the process takes was to lay out the process the organization goes through and to emphasize utilizing the pre-submission process and meetings to avoid running into things like timing issues, especially for small companies as they may not have the resources or time to complete longer studies that the FDA may request.

In discussing the differences in the pilot program versus the normal submission process, Rogers Hollins noted that the FDA’s engagement and tone in the pilot program has been “super helpful and impactful.” She noted that communicating via email was very different than her previous experience with the FDA and that it was helpful as well as being able to gain insights on the FDA’s preferences. In her words, “tone, tenor, and transparency” were the key positive differences.

According to Garcia-Canton, she noticed that in the beginning, especially, there was a lot of awkwardness between the scientists and the FDA. The idea that the scientists are worried about saying or doing the wrong thing in the FDA’s eyes was iterated by both Garcia-Canton and Stark, but Garcia-Canton emphasized that “this is the place for scientific debate.”

Stark was asked whether scientists are learning and taking information away from the program. “Change is hard for a lot of people,” Stark said. She noted that there was a lot of confusion over deficiency letters and what was expected from applicants. The FDA’s takeaway, according to Stark, was that it needs to reframe the deficiency letters to better communicate and clear up what the organization needs. She also noted that the scientists, through these communications, are learning that there may be other ways to do things.

One of the big questions to the panel was whether the FDA made expectations clear from the beginning of the program. Ehrlich was quick to say that they were not entirely clear in the beginning. Garcia-Canton noted that she can sympathize with the FDA reviewers and that both sides can do better with communicating information. “I was not surprised by the request for information,” she said. Adding on to Stark’s notes on deficiency letters, Garcia-Canton noted that she did not always understand what the FDA was asking for and even used AI to ask what the letters meant; she received different answers from different AI programs. However, she noted that she believes the program will help with focus and clarity for future submissions. Rogers Hollins was honest that having gone through it, “I still can’t explain the whole process.” She said that getting more insight would be really helpful and that it would be useful to have more information more easily available in a more informal manner.

The conversation turned to many of the misperceptions of the pilot program, which Stark cleared up by discussing the theory that the companies in the pilot program are just being pushed through and rubber stamped. She stated that the organization has “not given up on scientific rigor” and that “100% of what was submitted was reviewed” and that the companies heard about any questions that the organization had. Rogers Hollins confirmed that the FDA has been “upholding the scientific standard,” and Garcia-Canton said that the FDA is “keeping up scientific content” and upholding a very high quality.

An audience member asked if the pilot program is something that can be realistically sustained, to which Stark answered, “Yes, with some changes.” She noted that the FDA needs engaged interaction and increased communication with industry to continue moving forward.

Another valid question for Stark was what small companies can do to prepare for the submission process. “The standard is the same whether small, medium, or large,” she said. Small businesses may need a little bit more development time or may need to use consultants, though. Stark recommended utilizing the pre-submission review process and meeting with the FDA prior to submissions. Her advice was to plan early, communicate with the FDA, and give time to apply guidance before submission.

The question of what the biggest challenge is for the existing applicants that are still waiting was asked. Ehrlich stated that applicants “want to know what the noise is—what don’t we need to do?” She also asked whether the wheel needs to be reinvented every time or if there is a way to rely on the existing data for these, very similar, products to help streamline the process. Her takeaway from that question was one of her own: “What is essential and what are the different ways of getting to that, and what is just noise?”

Stark responded that the FDA is looking at four focused areas for pouches: product characterization, consistent manufacturing, adult benefit, and preventing youth use.

The panel seemed to agree that the definition of “benefit” in this regard concerns relative risk. Stark noted that she does “not personally agree” with the recent media reports on pouches. The FDA is always concerned about youth access, she said.

Stark outlined the many meetings with different groups involved in the review of products that help ensure consistency of applications. This also helped to explain part of why the review process takes so long currently. “Is it changing?” she said. “Yes.” She went on to note that “We don’t need to have six meetings a week anymore.” That being said, she emphasized that they are looking over all information and trying to fill in any holes that may exist as they review product applications.

The panel ended with appreciation of the open conversation and communication. “I’m incredibly excited to be here,” Stark said. “We have a shared effort.” She noted that the pilot program is currently expanding to other programs as well. ENDS is actively progressing, she said. It is no longer a pilot. “We can’t control everything, but we’re looking to learn every step of the way,” Stark said.

April 22, 2026
FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP), sat down for a fireside chat to kick off the second day of the American Tobacco and Nicotine Forum (ATNF) in Leesburg, Va. Christopher Greer, president and CEO of the Nicotine Resource Consortium, led the discussion on behalf of industry leaders eager to hear more about the inner workings of the regulatory agency.

Koplow said the agency has made significant progress in reducing its backlog of premarket tobacco applications, cutting it by roughly 70% over the past year and eliminating the acceptance queue. He noted that while the FDA has reviewed approximately 27 million applications, only a small number have been authorized, largely because most submissions lacked the scientific data required to demonstrate public health benefits.

Koplow said the agency is working to improve transparency and guidance for applicants, including plans to share lessons learned from the review process to help companies better meet regulatory standards. He also pointed to efforts to streamline evaluations in certain product categories, such as nicotine pouches, where a pilot program enabled faster authorizations and is expected to inform broader regulatory approaches.

On enforcement, Koplow highlighted increased action against illicit products, including major seizures of unauthorized e-cigarettes in coordination with federal agencies, with most originating from China. He acknowledged ongoing challenges in balancing harm reduction for adult smokers with youth protection, noting declines in youth vaping but continued concerns about public understanding of nicotine risks and the need for stronger evidence on comparative benefits of alternative products.

April 22, 2026
OWNiT Panel Talks Women in Law, Tobacco Industry at ATNF

At the American Tobacco and Nicotine Forum (ATNF), the OWNIT panel brought together leading women in the legal side of the tobacco and nicotine industry to discuss career paths, leadership, and their experiences navigating a traditionally male-dominated field. Moderated by Beth Oliva, a partner with Fox Rothschild, the panel featured Stacy Ehrlich, partner with Kleinfeld Kaplan and Becker LLP, Carole Folmar, a senior director and associate general counsel for ITG Brands, Kym Wellons, co-founder, COO, and general counsel for Sanova, and Angela Ho-Chen, managing counsel at RAI Services, each sharing personal experiences on entering the profession and building careers in a complex regulatory environment.

Ehrlich said she was drawn to law early on and described the tobacco sector as a “fascinating” area to work in, while emphasizing the importance of maintaining work-life balance and prioritizing wellness. Folmar highlighted the need for persistence and confidence, particularly in encouraging women to speak up in professional settings, noting she has seen progress in female representation in regulatory roles. Wellons reflected on navigating her career as a single parent, stressing the importance of taking risks and embracing change, while also managing expectations and long-term career growth.

Ho-Chen spoke about the influence of mentors and the importance of stepping outside comfort zones, particularly early in her career, while also addressing the challenges of balancing professional demands with family responsibilities. Across the panel, speakers emphasized mentorship, setting boundaries, and aligning personal and professional priorities, with Oliva noting that sharing these experiences can help drive broader changes in workplace culture and leadership within the industry.

April 21, 2026
ATNF Panel Examines Role of AI in Nicotine Product Innovation

A first-of-its-kind panel at the American Tobacco and Nicotine Forum (ATNF) focused on the role of artificial intelligence in product research and development, with moderator Dr. Stan Gilliland, managing partner for Sapphire Sciences, highlighting the importance of using the right tools in a highly regulated environment. He framed AI as a potential support across the product lifecycle—from identifying unmet needs to designing studies—but stressed that its use must be carefully managed, documented, and validated, particularly given regulatory scrutiny.

Panelists offered differing views on AI’s role. Dr. Jessica Zdinak, founder and Chief Research Officer for Applied Research and Analysis Company, expressed skepticism, emphasizing the importance of human expertise and warning against overreliance on AI, particularly in areas lacking clear regulatory endpoints. Dr. Ian Jones, behavioral science manager for JTI Liggett, described AI as a support tool that can improve efficiency, data handling, and communication, but said human oversight remains essential to interpret results and ensure scientific integrity. Dr. Elsa Larson, vice president at M/A/R/C Research, said her organization is taking a cautious approach, limiting AI use to lower-risk applications and avoiding regulatory studies for now due to concerns about reliability and oversight.

Nick Kadysh, founder and CEO for PharmAla Biotech, and Gavin O’Dowd, CEO for Haypp Group, took a more forward-looking stance, with Kadysh saying AI is already essential in areas such as product design and regulatory strategy, particularly as data complexity increases. O’Dowd highlighted the broader technological shift underway, noting that advances in computing power could accelerate the transition toward reduced-risk products if properly harnessed, but emphasized the need for industry-specific tools and human expertise. Across the panel, speakers pointed to ongoing challenges around data quality, transparency, regulatory acceptance, and the balance between efficiency and scientific rigor.

April 20, 2026