Wednesday, October 27, 2021
11:00 – 11:50 AM
Welcome, Opening Remarks, and Keynote Address
Amy Comstock Rick, President & CEO, FDLI
Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), FDA
11:55 – 1:00 PM
Reactor Panel: Assessing the Past, Present, and Future of the Comprehensive Plan
Dorothy K. Hatsukami, Professor, Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School
Desmond Jenson, Lead Senior Staff Attorney for Federal Regulation, Commercial Tobacco Control Programs, Public Health Law Center, Mitchell Hamline School of Law
John Pritchard, Vice President of Regulatory Science, 22nd Century Group, Inc.
Valerie Briggs Solomon, Assistant General Counsel and Vice President, RAI Service Company (Reynolds American, Inc.)
Moderated by Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health
In this session, panelists will consider key points of Director Zeller’s keynote address and discuss the current state of and potential future directions for FDA’s Comprehensive Plan for product regulation.
1:00 – 1:30 PM
Break
1:30 – 2:40 PM
Pre-Market Tobacco Applications (PMTAs): Recent Decisions and Surveying the Post-Deadline Landscape
Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Matthew R. Holman, Director, Office of Science, CTP, FDA
Eric N. Lindblom, Independent Consultant and Senior Scholar, O’Neil Institute, Georgetown Law Center
Patricia M. Miller, Managing Director, Regulatory Affairs, Altria Client Services
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
2:50 – 3:50 PM
Examining the Interplay Between Federal, State, and Local Product Regulations
Kathleen Hoke, Law School Professor and Director, Legal Resource Center for Public Health Policy, Francis King Carey School of Law, University of Maryland
Rima Khoury, General Counsel, Fumari, Inc.
Michael Pesko, Associate Professor, Department of Economics, Georgia State University
Moderated by Azim Chowdhury, Partner, Keller and Heckman LLP
4:00 – 5:00 PM
Menthol and Beyond: Addressing Disparities in Racial and Socioeconomic Populations in Product Usage and Outcomes
Krysten Bold, Assistant Professor of Psychiatry, Yale School of Medicine
Phillip Gardiner, Founding Member and Co-Chair, African-American Tobacco Control Leadership Council (AATCLC)
Raymond S. Niaura, Interim Chair of the Department of Epidemiology, Professor of Social and Behavioral Sciences, New York University School of Global Public Health
Moderated by Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Thursday, October 28, 2021
11:00 – 11:45 AM
Welcome and Featured Presentation: Harm Reduction Part One: Harm Reduction 101 and Examples Outside of Tobacco and Nicotine Product Usage
Laura Brown, Director, Educational Programs, FDLI
Sheila P. Vakharia, Deputy Director, Department of Research and Academic Engagement, Drug Policy Alliance
11:50 AM – 1:00 PM
Harm Reduction Part Two: Strategies and Challenges for Tobacco and Nicotine Products
Clifford E. Douglas, Director, University of Michigan Tobacco Research Network and Adjunct Professor, University of Michigan School of Public Health
Damon Jacobs, Associate Fellow, R Street Institute
Mohamadi Sarkar, Fellow, Scientific Strategy and Advocacy, Altria Client Services
Sheila P. Vakharia, Deputy Director, Department of Research and Academic Engagement, Drug Policy Alliance
Moderated by Barry S. Schaevitz, Partner, Fox Rothschild LLP
1:00 – 1:30 PM
Break
1:30 – 2:15 PM
Assessing the Modified Risk Tobacco Products (MRTPs) Pathway
Brian Erkkila, Director of Regulatory Science, Swedish Match
Aaron Williams, Senior Vice President – Scientific & Regulatory Affairs, RAI Services Company (Reynolds American, Inc.)
Moderated by Mark J. Vaders, Associate, Womble Bond Dickinson LLP
2:30 – 3:45 PM
Assessing and Addressing Lingering Nicotine Misperceptions
Aruni Bhatnagar, Professor, University of Louisville School of Medicine and Director, American Heart Association Tobacco Regulation Center
M. Justin Byron, Assistant Professor, Family Medicine, University of North Carolina at Chapel Hill
Meghan Rabbitt Morean, Research Scientist, Yale School of Medicine
Olivia Wackowski, Associate Professor, Department of Health Behavior, Society and Policy, Rutgers School of Public Health
Moderated by Joe G. Gitchell, President, Pinney Associates
4:00 – 4:50 PM
Media Perspectives on Public Health Reporting
Lauren Etter, Reporter, Bloomberg News
Jennifer Maloney, Reporter, The Wall Street Journal
Tom Sheldon, Senior Press Manager, Science Media Centre
Moderated by Jasjit S. Ahluwalia, Professor, Behavioral and Social Sciences and Professor, Medicine, Center for Alcohol and Addiction Studies, Brown University School of Public Health and Alpert School of Medicine
In the United States, the media arguably has the greatest impact on the public’s perception of tobacco and nicotine products. The session will feature leading journalists sharing their perspectives on covering tobacco and nicotine product issues, including determining what topics are of the greatest interest and how one researches for an article.
Friday, October 29, 2021
10:30 – 11:00 AM
FDLI Student Member Debrief
The FDLI Student Member Debrief will feature a space for student members to discuss the ongoing conference, network with other FDLI student members, and hear about other opportunities for those new to the food and drug law field.
11:00 – 11:50 AM
Welcome and Featured Session: Clearing the Smoke Twenty Years Later
Steven Leslie, Deputy Director, Educational Programs, FDLI
Kathleen Stratton, Scholar, National Academy of Sciences, Engineering, and Medicine (NASEM)
Kenneth E. Warner, Avedis Donabedian Distinguished University Professor Emeritus of Public Health and Dean Emeritus, University of Michigan School of Public Health
Moderated by Clifford E. Douglas, Director, University of Michigan Tobacco Research Network and Adjunct Professor, University of Michigan School of Public Health
This discussion will revisit the seminal 2001 publication “Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction,” exploring its genesis, the process behind creating the final product, and why it remains relevant after significant changes in the tobacco and nicotine product landscape over the ensuing twenty years.
12:00 – 12:50 PM
Substantial Equivalence and Rethinking Pathways to Market
Beth G. Oliva, Partner, Fox Rothschild LLP
Vivienne Tedesco-Ciavarra, Regulatory Services Manager, Synchrogenix
Moderated by J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP
Going forward, we are likely to see greater use of the SE pathway by companies seeking to get new products into the market. However, this pathway could be challenging for novel nicotine products considering there are unlikely to be substantially similar products in the US market. When combined with the financial burdens associated with a new PMTA, there are concerns about future product innovation, particularly by smaller companies. This panel will include an exploration of the SE pathway, followed by a discussion on whether revising current pathways or creating new ones would lead to further innovation in harm reduction products and increase improvement to public health.
1:00 – 1:50 PM
Technological Solutions to Preventing Youth Marketing and Access
Michael Shane Benson, Compliance Counsel, Turning Point Brands, Inc.
Parker David Kasmer, Vice President, Regulatory Engagement, JUUL Labs
Moderated by Agustin E. Rodriguez, Partner, Troutman Pepper Hamilton Sanders LLP
The 2020 amendment to the Prevent All Cigarette Trafficking (PACT) Act requires age verification for online sellers of e-cigarettes, and many states have already implemented strict age verification requirements. Additionally, FDA announced it will prioritize enforcement against e-cigarette sellers who market their products to youth. Meanwhile, industry is actively exploring technological solutions to prevent youth access to e-cigarettes. Panelists will assess the current state of technology designed to prevent youth marketing, access, and usage, and what developments we might expect to see in the near future.
2:00 – 3:00 PM
What Can We Learn from Alternative Nicotine Product Usage in Other Countries?
Gizelle Baker, Vice President of Global Scientific Engagement, Philip Morris International
Clive Bates, Director, Counterfactual Consulting Limited
Tryggve Ljung, Vice President Scientific Affairs, Swedish Match
Karl Erik Lund, Senior Researcher, Norwegian Institute of Public Health (pre-recorded video only)
Moderated by Scott Ballin, Tobacco and Health Policy Consultant
The United States is not the only country grappling with the effective regulation of tobacco and nicotine products. This session will look at regulation and usage in three other countries – specifically e-cigarettes in Great Britain, pouched tobacco in Norway, and heat-not-burn tobacco in Japan – then discuss what elements of these regimes can or should be implemented in the U.S.
3:10 – 4:15 PM
Looking Ahead: Impactful – and Achievable – Steps Towards Improved Regulation and Enforcement over the Next Year
James Baumberger, Senior Director, Federal Advocacy, American Academy of Pediatrics
Joe Murillo, Chief Regulatory Officer, JUUL Labs, Inc.
Erika Sward, National Assistant Vice President, Advocacy, American Lung Association
Moderated by Thomas J. Glynn, Adjunct Lecturer, Stanford University School of Medicine
The conference will conclude with multiple stakeholders offering their perspectives and predictions on the most important issues and trends they are tracking over the next year, including what each would like to see to improve the current state of tobacco and nicotine product regulation and enforcement.
4:00 PM
Conference Adjournment