Why Attend

Agenda

Location & CLE

Thursday, October 24

8:15–8:50 AM
Registration and Continental Breakfast

8:50–9:00 AM
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

In this session, panelists will discuss how modified risk tobacco products (MRTPs) should be marketed and advertised to adults, considering both their value as alternative to combustible products and the interest in preventing youth use. Panelists will consider research that has been conducted by MRTP applicants and research and analysis of current risk communication efforts.

Cynthia Cabrera, President, The Cating Group
Sarah Evans, Director of FDA Science, Turning Point Brands, Inc.
Moderated by Bryan M. Haynes, Partner, Troutman Sanders LLP

3:30–4:00 PM | Networking Break & Coffee Break

An important part of FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation to reduce smoking is limiting nicotine in combustible tobacco products to minimally or non-addictive levels. In this session, panelists will review research on Very Low Nicotine Content (VLNC) products, discuss what an ideal nicotine product standard would like, and predict what legal or other challenges may arise in implementing such a rule.

Jonathan Foulds, Professor of Public Health Sciences and Psychiatry, Penn State University College of Medicine
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
John D. Pritchard, Vice President of Regulatory Science, 22nd Century Group
Moderated by Robyn Gougelet, Senior Associate, Pinney Associates, Inc.

5:00–6:30 PM | Adjournment and Networking Reception

Friday, October 25

8:30–8:55 AM
Registration and Continental Breakfast

8:55–9:00 AM
FDLI Welcome and Announcements
Steven Leslie, Assistant Director, Educational Programs, Food and Drug Law Institute

9:00–9:45 AM 
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

FDA recently finalized its “Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS)” guidance. FDA also issued a marketing order for IQOS in accordance with the guidance. In this session, panelists will consider the impacts of both the finalized guidance and the marketing order on industry and public health, then discuss what effect each may have on pending and future PMTAs.

Priscilla Callahan-Lyon, Deputy Director, Division of Individual Health Science, FDA – CTP
Mark Greenwold, Senior Consultant, Campaign for Tobacco-Free Kids
Eric N. Lindblom, Director for Tobacco Control and Food and Drug Law, O’Neil Institute for National Global Health, Georgetown Law
Jim Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Moderated by Scott Ballin, Tobacco and Health Policy Consultant

11:00–11:15 AM | Networking and Coffee Break

The Tobacco Control Act (TCA) establishes a novel population impact standard for reviewing applications for new products and health claims. In this session, panelists will discuss computational modeling of tobacco product impacts on public health, various types of modeling systems used for nicotine products, and what factors should be considered or included when utilizing these models to support an application.

Ryan Black, Altria Client Services LLC
David Levy, Professor, Lombardi Comprehensive Cancer Center, Georgetown University Global Health Initiative
Moderated by Saul Shiffman, Professor of Psychology, University of Pittsburgh and Senior Scientific Advisor, Pinney Associates

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. Manufacturers contend this will result in significant cost and restrict 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, FDA – CTP
Patricia Miller, Senior Director, Premarket Tobacco Applications, Altria Client Services LLC
Moderated by Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health

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