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Thursday, October 25

8:15 – 8:55 AM
Registration and Continental Breakfast

8:55–9:00 AM
FDLI Welcome and Opening Remarks
Amy Comstock Rick
, President & CEO, Food and Drug Law Institute

9:00–9:45 AM
Keynote Address | Speakers Slides
Mitchell R. Zeller
, Director, Center for Tobacco Products (CTP), Office of Medical Products and Tobacco, FDA

9:45–10:45 AM
Reactor Panel 
Panelists will respond to Director Zeller’s comments regarding effective dialogue among stakeholders, updates on the Advanced Notice of Proposed Rulemakings, and other current policy initiatives.
Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), Office of Medical Products and Tobacco, FDA
Brittani Cushman, Senior Vice President, External Affairs, Turning Point Brands, Inc.
Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Jose Luis Murillo, Vice President, Regulatory Affairs, Altria Client Services LLC
Moderated by Barry Schaevitz, Partner, Fox Rothschild LLP

10:45–11:15 AM
Networking and Coffee Break

11:15 AM–12:15 PM
Ensuring an Effective Tobacco and Nicotine Regulatory Framework | Speakers Slides 
As information evolves, should the regulatory framework for how tobacco and nicotine products are regulated be updated? How do you strike a balance between regulation and innovation and balance competing interests? Panelists will discuss the current FDA regulatory landscape and desired characteristics for a modernized approach.
Katherine Ciambrone, Senior Vice President and Chief Compliance Officer, ITG Brands
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative
David Sweanor, Adjunct Professor of Law, University of Ottawa
Moderated by Scott Ballin, Tobacco and Health Policy Consultant

12:15–1:15 PM
Networking Lunch

1:15–2:15 PM
The Latest on Product Standards and Other Potential Regulatory Action | Speakers Slides
In March 2018, FDA released three Advanced Notices of Proposed Rule Making (ANPRM) seeking comments on a potential product standard for nicotine levels in cigarette products, the role of flavors in tobacco products, and the regulation of premium cigar products. In this session, panelists will discuss those ANPRMs and the next set of issues on which FDA has said it will focus, including product pathways, Tobacco Product Manufacturing Practices, and product standards for batteries and liquids in e-vapor products.
Tony Abboud, Executive Director, Vapor Technology Association
Mitchell A. Neuhauser, Vice President and Assistant General Counsel, RAI Services Company (RAISC)
James Vail, Director of Communications, 22nd Century Group, Inc.
Moderated by Dean R. Cirotta, President & COO, EAS Consulting Group, LLC

2:15–3:15 PM
Premarket Applications and the Element of Uncertainty | Speakers Slides
Commissioner Gottlieb and Director Zeller have said FDA will propose foundational rules about what is expected in premarket applications, including SE, PMTAs and MRTPs. In this session panelists will address how manufacturers and FDA have been making decisions in this complex and changing regulatory environment, and what they think should be included in these foundational rules.
Raymond Niaura, Professor, Department of Social and Behavioral Science, New York University
James M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Moderated by Bryan Haynes, Partner, Troutman Sanders LLP

3:15–3:45 PM
Networking and Coffee Break

3:45–5:00 PM
Protecting Youth: Targeting Appropriate E-Cigarette Users | Speakers Slides
In May 2018, FDA, in conjunction with FTC, initiated enforcement actions aimed at addressing youth use of nicotine, and e-vapor products in particular, including issuing warning letters to companies for selling e-liquids resembling juice boxes and to retailers for selling popular nicotine products to underage youth. In this session, panelists will discuss these enforcement actions, the role of FDA and industry to address the use of tobacco products by kids, and the threat youth uptake poses to the role these products could play in tobacco harm reduction.
Kathleen Crosby, Director, Office of Health Communication and Education, FDA – CTP
Mark Greenwold, Senior Consultant, Campaign for Tobacco-Free Kids
Carrie Wade, Director of Harm Reduction Policy and Senior Fellow, R Street Institute
Moderated by J. Benneville (Ben) Haas, Partner, Latham and Watkins LLP

5:00 PM
Closing Remarks

5:00–6:30 PM
Networking Reception

Friday, October 26

8:15–8:55 AM
Registration and Continental Breakfast

8:55–9:00 AM
FDLI Welcome and Announcements

9:00–10:15 AM 
Risk Communications: Educating the Public About Harm Reduction | Speakers Slides
As part of its comprehensive approach to regulating tobacco and nicotine products, FDA placed nicotine as the keystone of their efforts, including promoting innovation across noncombustible tobacco and nicotine products and consideration of a maximum nicotine standard in combustible products. A potential barrier to the success of this integrated approach is the public’s belief that nicotine itself is the cause of smoking-related diseases, while science indicates that it is the byproducts of combustion that are responsible for the majority of harm. This session will focus on ways to overcome this risk communication challenge and  consider the array of opportunities and barriers to success for overcoming risk communication challenges.
Clive Bates, Director, Counterfactual Consulting Limited
Cliff Douglas, Vice President for Tobacco Control, American Cancer Society
Michiel Reerink, Vice President, Global Regulatory Strategy, Japan Tobacco International
Moderated by
Stacy Ehrlich, Partner, Kleinfeld, Kaplan, & Becker, LLP and Member, FDLI Board of Directors

10:15–10:45 AM
Networking and Coffee Break

10:45 AM–12:00 PM 
How to Identify and Interpret Quality Science | Speakers Slides
Scientific studies form the basis of many tobacco and nicotine laws and regulations. What are the important criteria to consider when analyzing science to ensure it is sound? This session will focus on how to identify good science from bad science and how FDA and the tobacco industry can utilize data to drive science and public communications.
David B. Abrams, Professor, Department of Social and Behavioral Sciences, New York University
Robert Guzman, Regulatory Counsel, Thompson Hine LLP
Michael Fisher, Senior Principal Scientist, Regulatory Affairs, Altria Client Services, LLC
Moderated by Eric N. Lindblom, Director, Tobacco Control and Food & Drug Law, O’Neill Institute for National and Global Health Law, Georgetown University Law Center

12:00–1:15 PM
Luncheon Address 

1:30–2:30 PM 
The Future of Nicotine Products and FDA’s Nicotine Steering Committee | Speakers Slides
FDA established the Nicotine Steering Committee to analyze opportunities for nicotine containing tobacco products, like e-vapor products, to be approved as drug products. In August, FDA issued draft guidance with the promise of additional guidance to be issued this fall. Panelists will discuss this guidance, the latest developments with the Nicotine Steering Committee, and what it could all mean for pathways for orally inhaled nicotine containing products at CTP and CDER.
Marc S. Firestone, President, External Affairs and General Counsel, Philip Morris International
Joseph Gitchell, President, PinneyAssociates, Inc.
Dorothy Hatsukami
, Professor, University of Minnesota
Grail Sipes, Director of Regulatory Policy, FDA – CDER
Moderated by Mark Vaders, Counsel, Womble Bond Dickinson (US) LLP

2:30–3:30 PM 
Illicit Trade of Tobacco and Nicotine Products | Speakers Slides
What impact will a product standard on nicotine levels in cigarettes and flavors have on the illicit trade of tobacco and nicotine products? FDA issued a draft concept paper on this topic and asked for public comment. Panelists will discuss illicit trade issues that could result from product standards on nicotine and flavors.
Alex Clark, Chief Executive Officer, Consumer Advocates for Smoke Free Alternatives Association (CASAA)
Christopher Griffiths, Policy Counsel, FDA – CTP
Eric Heyer, Partner, Thompson Hine LLP
Clarissa Manning, Director of Business Operations, BOTEC Analysis
Moderated by Seth A. Mailhot, Partner, Michael Best & Friedrich LLP

3:30 PM
Conference Adjournment