2024 - Session 2 Seminars

In this presentation, Prof Benowitz will consider the commonalities and differences between cannabis and nicotine use including safety and health impacts and the implications for potential societal acceptance. The use of cannabis products has become normalized in the U.S. over the past 75 years, including the legalization of recreational cannabis use in many states and Canada. The transition from an illicit drug to a socially acceptable drug was driven by evidence of possible medicinal benefit and a marked change in public perception about its harm. Combusted tobacco use has had a devastating effect on public health in the U.S. for more than 100 years.  Many former smokers would like not to smoke for health reasons but would like to use nicotine in a less harmful form. In recent years a number of non-combustible nicotine products, both inhaled and oral, have been marketed. However, these products have not gained general public acceptance. This appears to relate in part to the tobacco industry’s role in promoting cigarettes, raising public skepticism of industry marketing of nicotine as a legitimate drug, and due to concerns about youth adoption of nicotine use. While nicotine drives combusted tobacco use, most of the harm from smoking is caused by products of combustion of tobacco leaf, not from nicotine. However, public perception strongly links nicotine to the harms of smoking. The experience with cannabis normalization suggests that the public perception of nicotine will need to change before non-combusted nicotine products are accepted as appropriate for public health. Part of this education might include a comparison of the benefits vs risks of cannabis v nicotine.

While US cigarette use among youth and young adults has plummeted, cigarette use has stayed relatively constant among older adults. At the same time, e-cigarette use continues to grow in the US, with much of the growth in disposables, such as Elfbar. Oral nicotine pouch use has also increased, and heated tobacco products are poised to take off. For each of these nicotine delivery product submarkets, this talk will present sales growth, the composition of firms selling the products (focusing on cigarette vs independent companies), and obstacles faced by firms in each of these markets. Special attention will be focused on the role of FDA regulations and other tobacco control policies.

Over the past decade, governments worldwide have introduced an array of policies to reduce the health burden of tobacco and nicotine use. Typically targeting product characteristics, prices, or access, these regulations range from taxes to limits on nicotine concentration, to packaging requirements and marketing restrictions, to prohibitions on flavors or even complete sales prohibitions for certain products. Evidence suggests that consumers often substitute between various nicotine and tobacco products when policies make one less accessible or more expensive, while firms respond with new products or marketing to evade restrictions. Given these dynamics, determining which combination of policies will best reduce the harm from tobacco and nicotine use is exceedingly complex, but also vital for public health. This talk will give an overview of modern nicotine and tobacco regulations, including what the evidence suggests about their intended and unintended effects, in order to clarify regulatory opportunities with the greatest potential to promote public health.

"Insight must precede application", said great German physicist Max Planck. The first challenge of exerting control over the market for nicotine is to understand it. That means understanding the complex adaptive system of the demand and supply for nicotine before attempting to regulate it. Is it possible that modern technologies and commerce are beginning to render this market ungovernable?  What can and should be done, and are we in need of a reboot of tobacco control? What will Tobacco Control 2.0 look like?

As this E-Cigarette Summit commemorates the 60th anniversary of the historic 1964 Advisory Committee Report on Smoking and Health to the US Surgeon General (SG), my talk will focus on the lessons learned from that report and those that followed in terms of the implications for tracking the evolving science on vaping.   The 1964 report was certainly ground-breaking in establishing the basis for defining the causal relationship between cigarette smoking and disease.  However, the 1964 report did not end the debate on smoking and health it only marked the beginning of the modern era of tobacco control that relied on continuous updating of the science to alert the public about the dangers of smoking and guide public policies to curb the harms from smoking.  Science based tobacco product regulation as it relates to vaping requires a process that ensures the continuous review and updating of scientific evidence much like what was done for smoking and health with reports issued annually as was done following the 1964 SG report.  In a regulated market, we need to find ways for industry to share their science more widely so that public health authorities can critically review and update evidence available about products so consumers can rely on the information coming from government authorities.

This session will focus on the FDA’s struggles with the PMTA review process.  Those struggles were first seen with the Agency’s initial scheduling of the PMTA deadline – with a federal court ultimately requiring the Agency to pull the deadline forward by two years.  They have continued with FDA’s review decisions, where the Agency has chosen to institute what appears to be a de facto product standard (i.e., a flavor ban) by simply denying every application for an e-cigarette product in a flavor other than tobacco.  FDA is increasingly encountering setbacks from the federal bench for these PMTA decisions, including most notably in a recent, extremely critical, 5th Circuit en banc decision against the Agency. Brian Yagi will share his views on how the FDA can get the PMTA decision-making process on track and, thereby, increase the chances that regulated harm reduction can make a positive impact on American public health.

• Is THR a public health principle or an industry strategy?
• Is nicotine use in society inevitable and if so, should it ever be acceptable?
• How can the U.S. regulatory and policy process adapt to such a fast-evolving nicotine market?
• What are the costs of pursuing a policy for a smoke-free and nicotine-free future?