Tobacco and Nicotine Products Regulation and Policy Conference

October 24–25, 2024   In-Person & Virtual Event

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Agenda

Subject to Change
All Times Are Eastern Standard Time

To view the session description, please click on the session title. 

Thursday, October 24

FDLI Welcome
Christine M. Simmon, President & CEO, FDLI

Fireside Chat with Brian King
Brian King, Director, Center for Tobacco Products (CTP), FDA
Moderated by Kenneth Michael Cummings, Professor, Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina

Perhaps no tobacco and nicotine product issue is more vexing than determining what APPH means during PMTA review. This session will feature both FDA and stakeholder perspectives on how CTP applies APPH to marketing order determinations for new tobacco and nicotine products.

Matthew Farrelly, Director, Office of Science, CTP, FDA
Matthew Holman, Vice President of US Scientific Engagement & Regulatory Strategy, PMI
Moderated by Mark J. Vaders, Associate, Womble Bond Dickinson (US) LLP

11:00–11:15 AM | Networking Break

FDA uses product standards in its regulation of pharmaceuticals and food, but they have not yet been established for regulating e-cigarettes and other non-combustible nicotine products. Panelists will discuss how product standards might be developed in this space, and the pros and cons of such an approach.

Tony Abboud, Executive Director, Vapor Technology Association
Todd Cecil, Deputy Director for Regulatory Management, Office of Science, CTP, FDA
Rachael Trimpert Schmidt, Regulatory Compliance Consultant, Chemular Inc.
Jessica Zdinak, Chief Research Officer, Applied Research and Analysis Company LLC (ARAC)
Moderated by Elizabeth Oestreich, Senior Vice President, Regulatory Compliance, ELIQUENT Life Sciences

Thomas J. Miller, Miller Monitoring and Consulting

This is an in-person session. A post-event recording will be available.

On June 10, FDA and the U.S. Department of Justice (DOJ) announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. This session will feature perspectives from the member agencies on their roles and objectives in this important endeavor.

Queena Fan, Director, Interagency Collaboration Division, Office of Trade, U.S. Customs and Border Protection
Alan Phelps, Deputy Director, Consumer Protection Branch, U.S. Department of Justice
John Verbeten, Director, Office of Compliance and Enforcement, CTP, FDA
Moderated by Jarred L. Reiling, Of Counsel, DLA Piper LLP (US)

As the illegal e-cigarette marketplace has proliferated, state and local legislators and regulators have enacted measures to combat it. Hear updates on these efforts, notably flavor bans and registration lists, and commentary on their effectiveness and whether they enhance or impede federal enforcement efforts.

David Fernandez, Vice President, Government Affairs and Public Policy, Altria Client Services LLC
Bryan Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
Michael Pesko, J. Rhoads Foster Professor, Department of Economics, University of Missouri
Moderated by Barry S. Schaevitz, Partner, Fox Rothschild LLP

3:50–4:10 PM | Networking Break

Diverse tobacco and nicotine product stakeholders will share their perspectives on both regulation and enforcement, including reactions to earlier presentations and their own insights on streamlining application reviews for new products and combatting the illicit e-cigarette market.

Alex Clark, Chief Executive Officer, Consumer Advocates for Smoke-free Alternatives Association (CASAA)
Dave Dobbins, Principal, Dobbins Consulting
Joe Murillo, Chief Regulatory Advisor to the CEO, Juul Labs
Moderated by Lillian Ortega, Regulatory Consultant, Chemular Inc.

5:30–6:45 PM | Reception (In-Person Only)

Friday, October 25

FDLI Welcome
Paige Samson, Director, Educational Programs and Director, Publications, FDLI

Current Litigation and Beyond: PMTA Challenges, First Amendment Considerations, and More
Panelists will review the current status of legal challenges to CTP determinations (including the pending SCOTUS review of Triton), what recent SCOTUS rulings on federal agency deference might mean for future CTP decisions, and potential First Amendment challenges to planned regulations such as graphic warnings for combustible tobacco.

Clifford E. Douglas, President and CEO, Global Action to End Smoking
J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP
Eric N. Heyer, Partner, Thompson Hine LLP
Moderated by Beth G. Oliva, Partner, Fox Rothschild LLP and Member, FDLI Board of Directors

10:20–10:40 AM | Networking Break

As the debate over the value of alternative nicotine products in helping adult smokers quit versus their attractiveness to youth continues, panelists will address the multitude of factors that must be weighed and considered when making such determinations, and how stakeholders can strike the right balance in preventing youth initiation while promoting products to adults that can prevent premature combustible tobacco deaths.

Ethan A. Nadelmann, Founder and Former Executive Director, Drug Policy Alliance
Jacob Rich, Policy Analyst, Reason Foundation Drug Policy Project
Olivia Wackowski, Associate Professor, Department of Health Behavior, Society, and Policy, Rutgers School of Public Health
Moderated by Katherine Ellen Foley, Director, Media Relations, Global Action to End Smoking

Effectively advancing U.S. tobacco and nicotine product policy likely requires general consensus on the ultimate objective. Diverse stakeholders will debate the relative merit of a tobacco-free versus nicotine-free U.S. marketplace, then opine on strategies to move toward these respective goals.

Clive Bates, Director, Counterfactual Consulting Limited
Aruni Bhatnagar, Professor of Medicine; Chief, Division of Environmental Medicine and Director, Christina Lee Brown Environmental Institute/American Heart Association Tobacco Regulation Center
Moderated by Jasjit S. Ahluwalia, Brown University

2:30 PM | Conference Adjournment