2025 Session 2 Seminars

In this session, Tim Phillips will focus on the latest consumer and industry data trends in the US, while also discussing the stratospheric growth of illicit markets worldwide.  This specifically poses a major risk to the sector's reputation and has implications for how these products could be regulated.

To accelerate the reduction in tobacco-caused mortality and morbidity, standards on combusted tobacco to make them non-addictive and/or non-appealing should be considered for implementation. This goal can be achieved by dramatically reducing the nicotine content in cigarettes, banning flavors or all additives, and/or banning filter ventilation or filters altogether. At the same time, smoking cessation products need to be made easily accessible and affordable. But for those who smoke and are not interested in using medicinal products or quitting nicotine use, appealing non-combusted tobacco or nicotine products must also be available.  This presentation will highlight what we need when a product standard for combusted products is implemented to facilitate intended consequences and minimize unintended consequences.

This presentation evaluates the public health consequences following the judicial exemption of e-cigarettes from U.S. drug regulation in 2010. For approximately six years, e-cigarettes occupied a regulatory vacuum until being classified as tobacco products subject to FDA regulation under the Tobacco Control Act in 2016. During this period of limited oversight, there was substantial innovation in e-cigarette technologies, as evidenced by increased patent applications. The session explores how this innovation impacted public health, revealing that—contrary to historical trends in tobacco industry innovation—e-cigarettes significantly reduced cigarette smoking rates and associated mortality. Using a comparative analysis across demographic groups, the research demonstrates greater smoking declines and mortality reductions among groups initially characterized by high smoking prevalence, a pattern not observed following the introduction of nicotine replacement therapy as a regulated drug in 1984. Overall, e-cigarettes are estimated to have saved approximately 677,000 life-years between 2011 and 2019, roughly one-third of the benefit attributed to early HIV/AIDS treatments up to the year 2000. The presentation concludes by discussing how insights from this unique regulatory case can inform current and future approaches to e-cigarette regulation under the Tobacco Control Act.

Under new leadership at HHS and FDA, dramatic changes appear to be on the way for U.S. nicotine and tobacco policy.  Though the pace and scope of change within FDA and CTP are unprecedented and controversial, it should be recalled that the nicotine vaping marketplace was uniformly seen to be in disarray by all stakeholders, with some 90% of available products being illicit.  Is it possible to achieve a new nicotine and tobacco policy that is capable of producing consensus support – recognizing that there is a need to be mindful of the different interests and concerns of legacy tobacco companies, tobacco control groups, small manufacturers, and consumers?  Given that prior landmark tobacco control measures were enabled by an agreement between tobacco control and industry actors—most notably the Master Settlement Agreement and the Tobacco Control Act itself—it is essential to analyze the likely perspectives of the various stakeholders.  The goal would be to determine the potential for overlapping support for elements of a reformed policy and thereby identify the "art of the possible” when it comes to nicotine and tobacco policy reform.

Several rigorous clinical trials have found that e-cigarettes can help people stop smoking and appear to do so better than nicotine replacement therapy. It is now time to consider how we can maximize the benefits of harm reduction. Dr. Smith will share recent secondary analyses of a large randomized clinical trial of e-cigarettes in which we assess the impact of e-cigarette flavoring and a variety of baseline demographic and smoking variables on key outcomes. She will also discuss the utility of a harm reduction approach for different populations.

This presentation will outline the radical and non-incremental reform overhaul that is necessary to fix America's broken and increasingly lawless tobacco and nicotine market. Marginal changes will not cut it, but is a deeper reform agenda possible under the existing Tobacco Control Act. It is not only possible but necessary and urgent. In my view, the much-admired 2017 Comprehensive Plan is not for purpose and never was; the incoming FDA leadership needs a new 2025 Comprehensive Plan based on realistic, deliverable policies and an unswerving commitment to reduce disease and death as deeply and rapidly as possible.

Industry, Society & Nicotine

• Are alternative nicotine products fundamental to delivering on a potential VLNC policy
• Is increased population nicotine use an acceptable cost for ending smoking
• Did the PMTA create a black market, or has the implementation failed to deliver on its potential
• What would a well-regulated nicotine market look like? Can it reduce demand for some and meet supply for others simultaneously?
• Is nicotine use in society inevitable, and if so, how much and by whom