Why Attend

Agenda

Location & CLE

Agenda Subject to Change
All Times Are Eastern Standard Time

Wednesday, June 7

9:00–9:50 AM     
FDLI Welcome and Keynote Address
Christine Simmon, President & CEO, FDLI
Norman Birenbaum, Senior Public Health Advisor, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA)

10:00–11:00 AM       
Lessons Learned Since the 2018 Farm Bill
Norman Birenbaum, Senior Public Health Advisor, CDER, FDA
Marshall A. Custer, Partner, Husch Blackwell LLP
Gillian Schauer, Executive Director, Cannabis Regulators Association
Moderated by Deborah Miran, Principal, DMiran Consulting

Panelists will join the keynote speaker to review cannabis market developments–both intended and unintended–since the passage of the 2018 Farm Bill, including innovation in hemp-derived cannabinoids, interstate shipping challenges, and evolving illicit markets. Speakers will also discuss state-level efforts to address these developments through regulation and enforcement.

11:00–11:30 AM   
Break

11:30 AM–12:30 PM 
Federal Legislative Opportunities for Improved Cannabis Regulation
Thomas R. Berry, Senior Vice President, Regulatory Compliance, Greenleaf Health, Inc.
Andrew Freedman, Senior Vice President, Forbes Tate Partners and Executive Director, Coalition for Cannabis Policy, Education, and Regulation
Jensen N. Jose, Regulatory Counsel, Center for Science in the Public Interest
Moderated by Libby Baney, Partner, Faegre Drinker Biddle & Reath LLP

Congress is deliberating the provisions of the 2023 Farm Bill, cannabis-specific legislation has been introduced in the House, and FDA has requested additional legislation to create a new pathway to market for Cannabidiol (CBD) products. This session will address opportunities under the Farm Bill to strengthen federal cannabis regulation, cannabis-related bills currently before Congress and their likelihood of success, and what additional legislation is needed for a well-regulated adult-use cannabis market.

12:40–1:30 PM    
Harmonizing Cannabis Terminology and Product Standards
Scott Riefler, Chief Science Officer, SoRSE Technology
Nandakumara D. Sarma, Director, Dietary Supplements and Herbal Medicines, United States Pharmacopeia
Rana Tayyarah, Senior Director, Product Development and Regulatory Affairs, Labstat International Inc.

One of the challenges for the nascent U.S. Cannabis marketplace is ensuring stakeholders “speak the same language;” i.e., that key cannabis terminology is clearly defined and product standards are widely accepted. Panelists will discuss creating science-based definitions for terms such as “intoxicating” and “natural” and current and future efforts towards establishing universal cannabis product standards.

1:30–2:00 PM   
Break

2:00–2:50 PM                 
Packaging and Labeling: Product Safety and Youth Use Prevention
James T. O’Reilly, Volunteer Professor, University of Cincinnati School of Medicine
Kathryn C. Skaggs, Partner, Keller and Heckman LLP
Ryan Vandrey, Professor, Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine

A safe adult-use cannabis marketplace requires ensuring appropriate packaging and labeling of products. Speakers will focus on the role of product containers and labels in delivering safe and effective products with accurate information to adults while also protecting against youth access and appeal.

3:00–4:00 PM    
Key Cases and Filing Trends in State and Private Litigation
William Bogot, Partner, Fox Rothschild
Amy Rubenstein, Partner, Dentons
Kristi L. Wolff, Partner, Kelley Drye & Warren LLP

Substantial market growth, a state-by-state regulatory framework, and limited federal oversight and enforcement has led to an increase in both government and private cannabis litigation. Panelists will review recent filings and areas of focus for district attorneys seeking to enforce state laws, and private consumer litigation under both false advertising and product liability theories.

Thursday, June 8

9:30–10:30 AM   
FDLI Welcome
Steven Leslie, Deputy Director, Educational Programs, Food and Drug Law Institute

Panel Discussion: Re-Scheduling Versus De-Scheduling Non-Hemp Cannabis
Andrew J. Kline, Senior Counsel, Perkins Coie LLP
Shane Pennington, Counsel, Vicente Sederberg LLP
Jessica Wasserman, Partner, WassermanRowe
Moderated by Delia A. Deschaine, Member of the Firm, Epstein Becker & Green, P.C.

There is significant momentum to change marijuana’s status as a Schedule I drug under the Controlled Substances Act; however, there is disagreement as to whether it should be placed on a different schedule or removed as a federally controlled substance entirely. Panelists will debate marijuana’s ultimate fate in light of known science and other drugs, substances, and chemicals under the purview of the Drug Enforcement Agency.

10:40–11:30 AM    
Assessing Social Equity Initiatives in State Cannabis Programs
Frederika McClary Easley, Director of Strategic Initiatives, The People’s Ecosystem
Damian Fagon, Chief Equity Officer, New York State Office of Cannabis Management
Christina Sava, Associate, Troutman Pepper Hamilton Sanders LLP
Moderated by Sheri Orlowitz, Founding Partner, Artemis Holding Group LLC and Board Chair, Center for Federal Cannabis Regulation

Many states have implemented cannabis programs that include social equity components, with a particular focus on redress for the disproportionate negative impact of the “war on drugs” on communities of color. Discussants will examine the early returns on existing social equity programs and consider new and novel approaches for addressing this critical issue.

11:30 AM–12:00 PM
Break

12:00 PM–1:00 PM 
Steering Cannabis Business Operations Through the Patchwork of State Laws
Craig Besnoy, CEO and General Counsel, Dope Diagnostics
Khristopher Johnson-DeLoatch, Associate, Steptoe & Johnson LLP
Joe Smith, Partner, Thompson Hine LLP
Moderated by James R. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati

This session will offer guidance and best practices for manufacturers and retailers of cannabis products on multistate regulatory compliance when conducting business operations. Topics will include conducting research, managing supply chains and distribution networks, and marketing, labor, and financial considerations.

1:10 PM–2:00 PM 
The Future of Cannabis-Derived Substances in Animal Supplements and Vet Products
Bill Bookout, Founder and Chairman of the Board, National Animal Supplement Council
Charlotte Conway, Deputy Division Director, Division of Animal Food Ingredients, Center for Veterinary Medicine (CVM), FDA
Jeannie M. Perron, Partner, Covington & Burling LLP

From hemp as animal feed to CBD in dog treats, there is a growing interest in–and concern about–cannabis-based animal products. Panelists will address current trends and issues such as residual cannabinoids in food-producing animals, cannabis-based veterinary medicine, and new and emerging cannabinoids in pet products.

2:00–2:30 PM
Break

2:30–3:30 PM
Improving Patient Access to Medical Cannabis and Prioritizing Research Needs
Karen Jaynes, Medical Cannabis Science & Therapeutics, University of Maryland-Baltimore, School of Pharmacy
Heike Newman, IND/IDE Program Director, University of Colorado
Moderated by Brian J. Malkin, Partner, McDermott Will & Emery

It is well-settled that medical cannabis has benefits for certain patients, yet lingering questions about safety and effectiveness continue to impact patient access. This session will offer perspectives on improving access to medical cannabis in situation where the benefits are clear and well understood and identify the most pressing areas for additional research to address current unknowns.

3:40–4:30 PM    
Can U.S. Tobacco and Alcohol Regulation Inform Federal Cannabis Regulation?
Alva C. Mather, Partner, McDermott Will & Emery
Elizabeth Oestreich, Senior Vice President, Regulatory Compliance, Greenleaf Health, Inc.
Moderated by Don Becker, Deputy General Counsel, Vice President Legal Affairs, Turning Point Brands, Inc.

Many products have long been commercially available despite known health risks and abuse potential. Panelists will outline the U.S. approach to two such product categories, tobacco and nicotine products and alcoholic beverages, and opine on where federal regulatory bodies would benefit from a similar structure and approach for cannabis products.

4:30 PM    
Closing Remarks and Adjournment