Thursday, October 20
9:00 – 9:30 AM
Registration and Continental Breakfast
FDLI Welcome and Keynote Address
Christine M. Simmon, President & CEO, FDLI
Brian King, Director, Center for Tobacco Products (CTP), US Food and Drug Administration (FDA)
10:30 – 11:30 AM
Robin J. Mermelstein, Distinguished Professor of Psychology and Director, Institute for Health Research and Policy, University of Illinois-Chicago
Matthew L. Myers, President, Campaign for Tobacco-Free Kids
Barry S. Schaevitz, Partner, Fox Rothschild LLP
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
Panelists will discuss key points made during Director King’s remarks while also providing their own perspectives on the current state of tobacco and nicotine product regulation, policy, compliance, and enforcement in the U.S.
11:40 AM– 1:00 PM
Analyzing FDA’s Recent Premarket Tobacco Product Application (PMTA) Decisions
Brittani Cushman, Senior Vice President, General Counsel, and Secretary, Turning Point Brands, Inc.
Christopher Junker, Vice President, Scientific and Regulatory Affairs, RAI Service Company (Reynolds American, Inc.)
Eric N. Lindblom, Independent Consultant and Senior Scholar, O’Neil Institute, Georgetown Law Center
Moderated by Jim Solyst, Principal, JMS Scientific Engagement
CTP received PMTAs covering over six million products by the September 9, 2020 deadline, followed by additional PMTAs covering approximately one million synthetic nicotine products in 2022. To date CTP has decided on PMTAs covering millions of tobacco-derived nicotine products, issuing a handful of marketing granted orders (MGOs) while issuing marketing denial orders (MDOs) for the rest. Panelists will analyze these decisions, with a particular focus on flavored products receiving MDOs and the Technical Project Lead (TPL) reviews that accompanied MGOs, then assess the likely fates for the million-plus tobacco-derived and synthetic nicotine products still under CTP review.
1:00 – 2:00 PM
2:00 – 3:00 PM
Update on PMTA and Other Litigation
Eric N. Heyer, Partner, Thompson Hine LLP
Adam Lyons, Assistant Director and Special Projects Coordinator, Consumer Protection Branch, US Department of Justice (DOJ)
Dozens of lawsuits have been filed by companies challenging MDOs, and CTP has responded by voluntarily withdrawing some of these orders for additional review while proceeding to defend others in court. Panelists will review these cases and the positions taken by the litigants, then discuss why they believe CTP is revisiting some of its earlier decisions, plus key considerations and anticipated timelines for the litigation that remains pending.
3:10 – 4:10 PM
Product Standards Part One: Combustible Products
Amirala S. Pasha, Assistant Professor of Medicine, Mayo Clinic
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Mark J. Vaders, Associate, Womble Bond Dickinson (US) LLP
Moderated by Agustin E. Rodriguez, Troutman Pepper Hamilton Sanders LLP
CTP recently issued two proposed product standards that would ban menthol as a characterizing flavor in cigarettes and all non-tobacco characterizing flavors for cigars and has also stated its intention to propose a product standard capping nicotine strength in all combustible tobacco products. Panelists will examine the proposed flavor-focused product standards, offer considerations and challenges for a combustible nicotine cap, discuss potential unintended consequences, and identify priority areas for additional research.
4:20 – 5:30 PM
Product Standards Part Two: Non-Combustible and Next Generation Products
Aruni Bhatnagar, Professor, University of Louisville School of Medicine and Director, American Heart Association Tobacco Regulation Center
Martin Steinbauer, Founder, SMOOD, LLC
Moderated by Jennifer H. Smith, Director, Regulatory Strategy, Altria Client Services
While the current discourse has been focused on combustible tobacco, product standards are also an important potential public health tool for electronic nicotine delivery systems (ENDS), heat-not-burn products, and other alternative nicotine products. Panelists will address the role of product standards broadly across FDA-regulated products, then consider a wide range of potential standards for non-combustible and next generation tobacco and nicotine products, including flavor restrictions, nicotine caps, nicotine and other ingredients quality, and device components.
5:30 – 7:00 PM
Networking Reception (In-Person Attendees Only)
Friday, October 21
8:45 – 9:15 AM
Registration and Continental Breakfast
FDLI Welcome and Panel Discussion
Steven Leslie, Deputy Director, Educational Programs, FDLI
The Tensions Between Politics, Science-Based Regulation, and Stakeholder Engagement
Tony Abboud, Executive Director, Vapor Technology Association
Scott Ballin, Tobacco and Health Policy Consultant
Matthew Holman, Vice President of US Scientific Engagement & Regulatory Strategy, PMI
Moderated by Elizabeth Oestrich, Senior Vice President, Regulatory Compliance, Greenleaf Health
Public opinion and scientific evidence do not always align, which can create tension between elected officials and regulatory agencies. For tobacco and nicotine products, these tensions are compounded by the inherent lack of scientific evidence on long term use of new and novel nicotine products, along with long-standing hesitancy towards engaging with industry. Panelists will explore what they believe is the role of all tobacco and nicotine product stakeholders in advancing scientific research and education to improve health outcomes, plus potential mutually agreed upon guidelines and parameters for industry engagement.
Networking and Refreshment Break
11:00 AM – 12:10 PM
Advancing Health Communication: Modified Risk Tobacco Products (MRTPs) and Nicotine Perceptions
Cristine Delnevo, Director, Rutgers Center for Tobacco Studies and Professor of Health Behavior, Society & Policy, Rutgers School of Public Health
Moira Gilchrist, Vice President Strategic and Scientific Communications, Philip Morris International (PMI)
John Pritchard, Vice President of Regulatory Science, 22nd Century Group, Inc.
Moderated by Robyn Gougelet, Vice President, Health Policy and Regulatory Strategy, Pinney Associates, Inc.
Health communication is an important component of harm reduction; however, there are concerns over the effectiveness of the MRTP application process and granted orders in adequately communicating risks, compounded by lingering misperceptions about nicotine-specific harms. Panelists will review available post-market data on products with granted orders, recent research on public and health care professional nicotine perceptions, and the most pressing challenges and opportunities to improve the overall understanding of tobacco and nicotine product health risks.
12:10 – 1:20 PM
1:20 – 2:20 PM
Improving Public Health Outcomes: The LGBTQ+ Community, Indigenous People, Asian Americans, and Native Hawaiians and Pacific Islanders
Patricia Nez Henderson, Vice President, Black Hills Center for American Indian Health
Rod Lew, Executive Director, Asian American Partners for Empowerment, Advocacy, and Leadership (APPEAL)
Scout, Executive Director, The LGBT Cancer Network
Moderated by Jasjit Singh Ahluwalia, Professor of Behavioral and Social Sciences and Professor of Medicine, Brown University
Using commercial combustible tobacco products is harmful for anyone, but the impact is not evenly distributed across all population groups, and attempting to improve health outcomes for one group can worsen health disparities relative to disadvantaged populations. Panelists will examine disproportional impacts to four population groups–the LGBTQ+ community, indigenous people, Asian Americans, and Native Hawaiians and Pacific Islanders–then offer strategies to improve health outcomes for these populations.
2:30 – 3:40 PM
Novel Products and Future Innovation: How Would New or Streamlined Pathways to Market Impact Public Health?
Kimberly Agnew-Heard, Director, PMTA Submissions, Altria Client Services
Azim Chowdhury, Partner, Keller and Heckman LLP
Dorothy K. Hatsukami, Professor, Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School
Moderated by Beth G. Oliva, Partner, Fox Rothschild LLP
Bringing a new tobacco or nicotine product to market is costly and time-consuming, and many have argued the process is inaccessible for smaller companies and will stifle future innovation. Panelists will address the practical side of the PMTA and Substantial Equivalence (SE) pathways and how CTP could lessen the burden of bringing a product to market, while also considering whether a wider array of products would increase public health risks, including greater nicotine use among youth and young adults.