Thursday, October 24
Registration and Continental Breakfast
FDLI Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute
Mitchell Zeller, Direrctor 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, Office of Medical Products and Tobacco, 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
Moria 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 Coffee 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.
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
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
3:30–4:00 PM | Networking Break & Coffee Break
5:00–6:30 PM | Adjournment and 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
Moderated by Amy Comstock Rick, President & CEO, Food and Drug Law Institute
11:00–11:15 AM | Networking and Coffee Break
1:00–2:00 PM | Luncheon with Table Top Discussions
This session will focus on the FDA’s proposed substantial equivalence (SE) rule, that is intended to establish requirements for the content and format of reports to demonstrate that a tobacco product is substantially equivalent to a product already on the market. Panelists will discuss whether the proposed rule provides the “rules of the road” many parties want for the SE pathway, covering issues such as minor modifications, quantity changes, and issues specific to small manufacturers.
Carole B. Folmar, Director of Regulatory and Scientific Affairs, ITG Brands
Moderated by Barry S. Schaevitz, Partner, Fox Rothschild LLP
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