Why Attend

 Agenda

CLE

Wednesday, October 21

10:30 – 10:55 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

11:00 AM – 12:00 PM
FDLI Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, FDLI
Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), FDA

12:05–1:05 PM
Reactor Panel

Brittani Cushman, Senior Vice President of External Affairs, Turning Point Brands, Inc.
Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Paige Magness, Senior Vice President, Regulatory Affairs, Altria Client Services
Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), FDA
Moderated by Clifford E. Douglas, Director, Tobacco Research Network, University of Michigan

Panelists will discuss Director Zeller’s updates and share their perspectives on what they would like to see from FDA in the near future.

1:05 – 1:30 PM
Break

1:30 –2:10 PM
Update on Research into Potential Links between Smoking, Vaping, and Nicotine Use and COVID-19

Aruni Bhatnagar, Professor of Medicine, University of Louisville School of Medicine and Director, American Heart Association Tobacco Regulation Center
Raymond Niaura, Interim Chair of the Department of Epidemiology, Professor of Social and Behavioral Sciences, New York University School of Global Public Health

Many believe that smokers are at a higher risk for complications if they contract COVID-19. However, the early data has divided researchers on whether nicotine may lower one’s risk of contracting COVID-19, with many contending that both smoking and vaping increase the risk of contraction. This session will cover the specific medical concerns for both smokers and vapers, recent research on links between nicotine, smoking, and vaping and COVID-19, theories as to why smokers make up a lower than expected number of hospitalized COVID-19 patients, and the need for clear, science-based risk communication in this area.

2:20 –3:20 PM
Continuing the Conversation on Flavors: Examining the Merits and Consequences of Recent Flavor-Focused Policies

Rima Khoury, General Counsel, Fumari, Inc. and Founding Member, National Hookah Community Association
Jamie Long, Staff Attorney, Public Health Law Center
Stefanie Miller, Managing Director, FiscalNote Markets
Moderated by Eric N. Lindblom, Senior Scholar, O’Neil Institute for National and Global Health Law, Georgetown University

From menthol cigarettes to flavored vapes, premium cigars to hookah tobacco, and moist snuff to tobacco-free pouched products, flavor policies can and often do impact all types of tobacco and nicotine products. Diverse stakeholders will weigh the merits of and drawbacks to recent state and local favor-focused policies, including any unintended consequences. Speakers will also share their thoughts on whether we need a federal policy on flavors, and if so what an ideal policy would entail.

3:20– 3:40 PM
Break 
All program breaks will feature a discussion room with the previous session’s speakers for attendees to connect and ask follow up questions.

3:40–4:40 PM
Trends in Youth Tobacco and Nicotine Use and Prevention Strategies

David Hammond, Professor, School of Public Health and Health Systems, University of Waterloo
Maria Hughes Rahmandar, Medical Director, Substance Use and Prevention Program (SUPP), Ann & Robert H. Lurie Children’s Hospital of Chicago and Assistant Professor, Northwestern University School of Medicine
Gray Taylor, Executive Director, Conexxus and Consultant, National Association of Convenience Stores (NACS)
Moderated by Robyn Gougelet, Director, Health Policy and Regulatory Strategy, Pinney Associates, Inc.

There is general agreement that youth should not use tobacco or nicotine products, however there is little agreement on what is needed to prevent youth initiation. Panelists will discuss trends in youth use as well as existing and emerging strategies and technologies to prevent youth access to tobacco and nicotine products.

4:45 – 5:15 PM
Virtual Welcome Reception

Thursday, October 22

10:30 – 10:55 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

10:30 – 10:55 AM
Connect with FDLI: Learn More About FDLI Membership Membership and Engagement

Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI

11:05–11:45 AM
FDLI Welcome and FDA Update on Public Education Campaigns

Kathleen Crosby, Director, Office of Health Communications, CTP, FDA
Steven Leslie, Assistant Director, Educational Programs, FDLI

11:45 AM –12:00 PM
Break

12:00–1:00 PM
Modified Risk Tobacco Products (MRTPs): Recent Orders, Pending Applications, and Novel Products

Benjamin Apelberg, Division Director, Office of Science, CTP, FDA
Tryggve Ljung, Senior Vice President, Scientific Affairs, Swedish Match
Moderated by J. Benneville “Ben” Haas, Partner, Latham & Watkins LLP

FDA has approved two rounds of MRTP marketing orders, with several pending applications and more to come. Panelists will discuss the role of the MRTP process in risk communication, post-market surveillance requirements, and the extent that marketing orders can or should impact applications for other similar products.

1:00 – 1:15 PM
Break

1:15 –2:15 PM
Nicotine and Harm Reduction

Jonathan Foulds, Professor of Public Health Sciences and Psychiatry, Penn State University College of Medicine
Joe Murillo, Chief Regulatory Officer, JUUL Labs Inc.
John Pritchard, Vice President of Regulatory Science, 22nd Century Group
Moderated by Barry Schaevitz, Partner, Fox Rothschild LLP

Nicotine remains a central part of FDA’s Comprehensive Plan for Tobacco and Nicotine Product Regulation. Panelists will discuss the public health impact of regulating nicotine content across the spectrum of tobacco and nicotine products, how such policies can work in concert to move users down the continuum of risk, and whether a nicotine cap could lead to unintended consequences.

2:15 – 2:30 PM
Break

2:30–3:30 PM
Recognizing and Addressing Disparities in Tobacco and Nicotine Product Use and Outcomes

Aruni Bhatnagar, Professor of Medicine, University of Louisville School of Medicine and Director, American Heart Association Tobacco Regulation Center
Daniel Giovenco, Assistant Professor, Sociomedical Sciences, Mailman School of Public Health, Columbia University
Carol McGruder, Founding Member and Co-Chair, African American Tobacco Control Leadership Council (AATCLC)
Moderated by Stacy Ehrlich, Partner, Kleinfeld Kaplan & Becker LLP

Tobacco and nicotine product use patterns differ among population groups and result in disparate health outcomes. Panelists will address the history of advertising to and product use in different population groups, the current state of health disparities and inequities, and steps that can be taken to address these issues.

3:30– 3:45 PM
Break

3:45–4:45 PM
The Roles and Responsibilities of All Stakeholders when Communicating Risk to Both Youth and Adults

Steve Roulet, Global Head of Behavioral Research Insights, Philip Morris International
Steven Schroeder, Professor, Department of Medicine and Director, Smoking Cessation Leadership Center, University of California San Francisco Helen Diller Family Comprehensive Cancer Center
David T. Sweanor, Adjunct Professor, Faculty of Law, University of Ottawa
Moderated by K. Michael Cummings, Professor, Medical University of South Carolina

The debate continues on how to balance the dual risk communication goals of preventing youth initiation while conveying to adults the benefits of switching to less risky products. Panelists will discuss recent examples of risk communications, including those in response to COVID-19, and share their thoughts on appropriate guidelines for all stakeholders when discussing relative risk.

 

Friday, October 23

10:30 – 10:55 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

10:30 – 10:55 AM
Connect with FDLI: Learn More About FDLI Membership Membership and Engagement
Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI

11:05–11:45 AM
FDLI Welcome and Featured Presentation: What Can We Learn from Public Health Protection Strategies Outside of those for Tobacco and Nicotine Products

Cheryl Healton, Dean, New York University School of Public Health
Steven Leslie, Assistant Director, Educational Programs, FDLI

11:45 AM –12:00 PM
Break

12:00–1:00 PM
The Post-PMTA Deadline Landscape: What Happens After September 9th?

Stacey Younger Gagosian, Managing Director, Public Policy, Truth Initiative
Bryan M. Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
Kathleen Hoke, Law School Professor and Director, Legal Resource Center for Public Health and Policy, University of Maryland Carey School of Law
Moderated by Dean Cirotta, President, EAS Consulting Group and Member, FDLI Board of Directors

In order to lawfully remain on the market, manufacturers must have submitted a PMTA for all non-grandfathered tobacco and nicotine products by September 9, 2020. However, questions about enforcement, compliance, and the review of submitted applications remain. Panelists will discuss current concerns and look ahead to what could and should happen to products without submitted PMTAs, and what those who have submitted PTMAs should expect.

1:00 – 1:15 PM
Break

1:15–2:15 PM
How Can Collaboration and Cooperation Among Researchers be Improved?

Maria Gogova, Vice President, Regulatory Sciences, Altria Client Services LLC
John Hughes, Professor of Psychology Emeritus, University of Vermont
Robin J. Mermelstein, Distinguished Professor of Psychology and Director, Institute for Health Research and Policy, University of Illinois-Chicago and Chair, Tobacco Products Science Advisory Committee (TPSAC)
Moderated by Scott Ballin, Tobacco and Health Policy Consultant

All tobacco and nicotine product stakeholders have clear incentives to conduct and promote accurate, scientifically sound research. However, many stakeholders are unwilling to accept or consider any industry-sponsored studies. Panelists will share their respective views on and experiences with collaborating with industry, and also discuss what would be needed to promote and improve research collaboration and cooperation

2:15 – 2:30 PM
Break

2:30–3:30 PM
So What’s Next? A Roundtable Discussion on What is Needed to Move Forward Over the Next Year

Azim Chowdhury, Partner, Keller and Heckman LLP
Darlene Huang, Legislative and Policy Counsel, Campaign for Tobacco-Free Kids
Mitchell A. Neuhauser, Vice President and Assistant General Counsel, RAI Service Company (Reynolds American Inc.)
Moderated by Thomas J. Glynn, Adjunct Lecturer, Stanford University School of Medicine

The conference will conclude with a brief summary of the key issues and points raised in earlier sessions, followed by a broad discussion on important developments to watch over the next year, including key deadlines and cases, plus predictions on what is needed to move tobacco and nicotine product regulation and policy in a positive direction.

3:30 PM
Conference Adjournment