Thursday, October 24
Registration and Continental Breakfast
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute
Mitchell Zeller, Director of FDA’s Center for Tobacco Products (CTP), will provide updates on key aspects of FDA’s comprehensive plan for tobacco and nicotine regulation, including the agency’s nicotine policies and science-based review of tobacco products. Director Zeller will also highlight key efforts of the agency’s youth tobacco prevention plan, including the latest actions to prevent youth access to tobacco products, curb marketing of tobacco products aimed at youth, and educate teens about the dangers of using any tobacco product (including e-cigarettes).
Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
In this session, panelists will discuss Director Zeller’s comments on FDA’s comprehensive plan for tobacco and nicotine reduction, FDA efforts to prevent youth tobacco and nicotine product use, and address other current policy initiatives.
David Dobbins, Chief Operating Officer, Government Affairs, Truth Initiative
Moira Gilchrist, Vice President, Scientific and Public Communications, Philip Morris International
Kathleen Hoke, Director, Legal Resource Center for Public Health and Policy, University of Maryland Carey School of Law
Moderated by Dean Cirotta, President and COO, EAS Consulting Group
10:45–11:15 AM | Networking and Refreshment Break
In this session, panelists with diverse perspectives will take a broad look at how the relative risks of tobacco and nicotine products should be communicated to adults. The discussion will include the roles of government, public health, and industry; ways to communicate beyond public education campaigns; and how to coordinate messaging across all stakeholders. Barriers to communication and the impact on consumers and the public will also be discussed.
Marissa G. Hall, Assistant Professor, Department of Health Behavior, University of North Carolina Gillings School of Public Health
Cheryl Healton, Dean, New York University College of Global Public Health
Mitchell A. Neuhauser, Vice President and Assistant General Counsel, RAI Services Company (RAISC)
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP, Member, FDLI Board of Directors
12:15–1:15 PM | Luncheon with Guest Speaker
Thomas J. Miller, Attorney General, Iowa
Introduced by Laura Brown, Director of Educational Programs, FDLI
1:15–1:30 PM | Transition
We can all agree that youth should not begin using e-cigarettes or other Electronic Nicotine Delivery Systems (ENDS). In this session, panelists will review recent youth vaping statistics and current FDA efforts to combat youth use, then turn to a discussion of what roles public health, industry, retailers, schools, law enforcement, and technological solutions can and should play in such efforts in the future, including the Trump Administration’s proposed ban on all non-tobacco flavors for e-cigarettes.
David Abrams, Professor of Social and Behavioral Sciences, New York University College of Global Public Health
James Baumberger, Senior Director, Federal Advocacy, American Academy of Pediatrics
Parker David Kasmer, Regulatory Counsel, JUUL Labs
Moderated by J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP
3:30–4:00 PM | Networking Break and Refreshment Break
5:00–6:30 PM | Networking Reception
Friday, October 25
Registration and Continental Breakfast
FDLI Welcome and Announcements
Steven Leslie, Assistant Director, Educational Programs, Food and Drug Law Institute
A Conversation with David A. Kessler on the Future of Youth e-Cigarette Use and Regulation
David A. Kessler, Chairman, Board of Directors, Center for Science in the Public Interest, and former FDA Commissioner
Discussion with Amy Comstock Rick, President & CEO, Food and Drug Law Institute
10:30–10:45 AM | Networking and Refreshment Break
12:15–1:15 PM | Luncheon with Table Top Discussions
1:15 –1:30 PM | Transition
The session will feature an overview of the key elements of FDA’s proposed rule for substantial equivalence, as well as a question and answer session.
Barry S. Schaevitz, Partner, Fox Rothschild LLP
Currently, if a tobacco or nicotine product is modified or altered after a PMTA is submitted, a new PMTA would need to be submitted for the altered product. This results in substantial costs to manufacturers and restricts the number of reduced risk products in the marketplace by hindering innovation. In this session, panelists will discuss post-application product modifications in light of FDA’s proposed rule for PMTAs, as well as potential alternatives and their respective benefits and drawbacks.
Matt Holman, Director, Office of Science, CTP, FDA
Patricia Miller, Senior Director, Premarket Tobacco Applications, Altria Client Services LLC
Moderated by Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health
From cigarettes to cigars to chewable tobacco to e-cigarettes, flavored tobacco and nicotine products are widely available…for now. This session will feature a comprehensive discussion of flavors, including why manufacturers use flavors, responsible marketing of flavored products, how flavors fold into public health goals, and FDA guidance on and enforcement discretion of flavored products.
Tony Abboud, Executive Director, Vapor Technology Association
Aruni Bhatnagar, Chair, School of Medicine, University of Louisville and co-Director, American Heart Association Tobacco Center for Regulatory Science
Moderated by Seth A. Mailhot, Partner, Husch Blackwell LLP
4:00 PM | Conference Adjournment