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

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.

Brittani Cushman, Senior Vice President, External Affairs, Turning Point Brands, Inc.

Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids

Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), Office of Medical Products and Tobacco, FDA

Jose Luis Murillo, Vice President, Regulatory Affairs, Altria Client Services LLC

Moderated by Barry Schaevitz, Partner, Fox Rothschild LLP

10:45–11:00 AM

Networking and Coffee Break

11:00 AM–12:00 PM

Ensuring an Effective Tobacco and Nicotine Regulatory Framework

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, Centre for Health Law, Policy and Ethics, University of Ottawa

Moderated by Scott Ballin, Tobacco and Health Policy Consultant

12:00–12:15 PM

Transition

12:15–1:15 PM

Networking Lunch

1:15–2:15 PM

The Latest on Product Standards and Other Potential Regulatory Action

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 – Regulatory, RAI Services Company (RAISC)

James Vail, Director of Communications, 22nd Century Group, Inc.

Moderated by Dean R. Cirotta, President & Chief Operating Officer, EAS Consulting Group, LLC

2:15–3:15 PM

Premarket Applications and the Element of Uncertainty

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.

Carole B. Folmar, Director, Regulatory and Scientific Affairs, ITG Brands

Raymond Niaura, Professor, Department of Social and Behavioral Science, New York University College of Global Public Health

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

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

Adjournment

5:00–6:30 PM

Networking Reception