Why Attend

Agenda

All times are in Eastern Time

CLE

Wednesday, October 27

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

FDA is in the process of reviewing PMTA applications for millions of products that were submitted prior to the September 9, 2020 deadline for non-grandfathered products. This panel will review recent PMTA marketing order decisions, followed by a discussion on whether these decisions were consistent with the protection of public health as intended by Congress, and what these decisions could indicate for still-pending and future applications.

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

The past few years have seen a proliferation of new tobacco and nicotine product-focused laws at the state and local level. These laws have generally implemented bans or restrictions on flavors and sales or imposed new taxes on alternative nicotine products, usually with a stated intent of curbing youth e-cigarette use. However, many have objected that these regulations interfere with FDA’s Congressionally mandated authority under the Tobacco Control Act, and some have been challenged in court on this and other grounds. Panelists will examine recently enacted state and local policies, dissect evidence of effectiveness, and discuss legal challenges and potential conflicts with federal authority.

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

Earlier this year, FDA announced that it will issue two new product standards that will ban menthol in cigarettes and characterizing flavors in cigars, with a stated purpose of reducing youth initiation, helping adult smokers with cessation efforts, and addressing health disparities in communities of color, low-income populations, and LGBTQ+ individuals. This session will include an overview of health disparities in these population groups, followed by discussions on whether the flavor ban is likely to achieve FDA’s stated goals and what additional steps FDA can or should take to further reduce health disparities.

Thursday, October 28

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

Building off the preceding presentation, panelists will discuss harm reduction strategies with a focus on their specific applicability to tobacco and nicotine product usage. Topics will include: the challenges of harm reduction considering the lack of consensus on the harms posed by non-combustible nicotine products; the relative merit of restriction versus public education; and respective approaches stakeholders could apply to improve health outcomes.

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

 

The MRTP pathway allows companies to make reduced risk and/or reduced exposure claims about their products, however it has proven both time consuming and expensive. In this session, panelists will review Swedish Match’s journey through this process, compliance with post-order market surveillance requirements, and discuss what changes could be made to increase its value as a risk-communication tool.

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

Nicotine misperceptions remain persistent among medical professionals and the general public. These misperceptions include misunderstandings on the risks posed by nicotine usage itself and a lack of awareness of the amount of nicotine in various products. This session will feature varied perspectives on current nicotine misperceptions, followed by a discussion on how to improve nicotine awareness while considering the five questions on the future of nicotine regulation posed by FDA.

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

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