Why Attend

Agenda

 

 

CLE

Tuesday, May 24

11:45 AM-1:00 PM
FDLI Welcome and Panel Presentation: Update on Federal Cannabis Legislation Proposals, State-Level Legalization, and Regulatory Activity
Amy Comstock Rick, President & CEO, FDLI (FDLI Welcome)
Norman Birenbaum, Managing Director, Pear Tree Strategies and Founding President, Cannabis Regulators Association (CANNRA)
William Bogot, Partner, Fox Rothschild LLP
Jae Kim, Associate, DLA Piper
Moderated by Sarah A. Chase, Executive Director, Council for Federal Cannabis Regulation (CFCR)

There are several recent or expected legislative attempts to reform federal cannabis law, specifically the States Reform Act (SRA), the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, and the Cannabis Administration and Opportunity Act (CAOA). However, as Congress weighs federal reform, states have continued to enact and implement legislation for both medical and recreational cannabis use. This panel will review the proposed federal bills, discuss recent state legislative and regulatory activity that address both psychoactive and non-psychoactive cannabinoids, and discuss what a final federal regulatory scheme might entail and its potential impact on existing state laws.

1:00– 1:40 PM
Break

1:40–2:40 PM
Identifying and Meeting Cannabis Research Needs for Effective Federal Regulation
Madeleine Giaquinto, Manager, Regulatory Affairs, Greenleaf Health
Suzanne Sisley, President and Site Principal Investigator, Scottsdale Research Institute and Adjunct Professor, Humbolt Institute for Interdisciplinary Marijuana Research, California State Polytechnic University
Moderated by Brian J. Malkin, Partner, McDermott Will & Emery

While there is a large market for medical and recreational cannabis products and compounds, far more research is needed for effective regulation by FDA and other federal agencies. In this session, panelists will discuss improved access to cannabis for research purposes, the current state of endocannabinoid research, and identify the greatest needs for more scientific studies.

2:50-3:50 PM
Addressing Cannabis Product Health and Safety Concerns
Lila McKinley, Staff Attorney, Connecticut Department of Consumer Protection
James T. O’Reilly, Volunteer Professor, University of Cincinnati School of Medicine
Moderated by Kay Doyle, Director of US Public Policy and Public Affairs, Jazz Pharmaceuticals PLC

All products come with health and safety concerns, and these concerns are heightened for cannabis products due to current scientific and regulatory uncertainties. This session will cover a myriad of safety concerns for both youth and adults, including packaging, contamination, adverse reactions, and risks specific to delivery mechanisms (edibles, topicals, vapes, etc.).

4:00–4:50 PM
The New Scooby Snacks? Animal and Veterinary Products Containing CBD and Other Cannabinoids
Bill Bookout, Founder and Chairman of the Board, National Animal Supplement Council (NASC)
Todd Harrison, Partner, Venable LLP
Robert J. Silver, Adjunct Faculty, Lincoln Memorial University, College of Veterinary Medicine and Founder and Medical Director, Well-Pet Dispensary
Moderated by Elizabeth Butterworth Stutts, Principal, Elizabeth Butterworth Stutts, Esq., PLLC

The market for cannabinoid-containing products extends to pets and other animals as well, and includes medicines, foods, and dietary supplements. This panel will review cannabinoid use for animals, such as CBD for muscle recovery and THC for pain and nausea, then survey current federal, state, and local regulatory approaches to cannabinoids in animal and veterinary products.

5:00–5:30 PM
Featured Presentation
Ted Thompson, Board Member, CFCR and Senior Vice President, Public Policy, The Michael J. Fox Foundation for Parkinson’s Research

Wednesday, May 25

11:00 AM –12:20 PM
FDLI Welcome and Panel Discussion: Harmonizing Lab Testing and Quality Standards for Cannabis Products
Steven Leslie, Deputy Director, Educational Programs, Food and Drug Law Institute
Elisabeth Berry, Chief Operating Officer, PSI Labs
Tara Lin Couch, Senior Director of Dietary Supplement and Tobacco Services, EAS Consulting Group LLP
Alena Rodriguez, Managing Director, Rm3 Labs
Nandakumara D. Sarma, Director, Dietary Supplements and Herbal Medicines, United States Pharmacopeia
Moderated by Andrew J. Kline, Senior Counsel, Perkins Coie LLP

Laboratory testing requirements vary across states with legal cannabis use programs, and there are no consensus standards for cannabis products. This raises serious concerns for interstate commerce, consumer safety, and product quality. In this session, panelists will discuss efforts towards a uniform approach to national lab testing and quality standards to create a safer, more efficient cannabis marketplace.

12:30–1:20 PM
Cannabis Litigation Risks: Hyperbolic Claims, Hidden THC, and Other Marketing and Labeling Perils
Theodore L. Caputi, Public Health Research Consultant, Data Science Solutions
Daphne O’Connor, Partner, Arnold & Porter LLP
Emily A. Sellers, Associate, Shook, Hardy & Bacon LLP
Moderated by Jessica Wasserman, Partner, WassermanRowe LLC and Chair, Science and Regulatory Affairs Committee, CFCR

As industry and advocates continue to tout the benefits of cannabis and cannabis-derived ingredients, there have also been warning letters for unsubstantiated claims and lawsuits alleging mislabeled THC content. This panel will review cannabis marketing trends, discuss potential false advertising claims, and consider manufacturing defect and failure to warn product liability risks.

1:20–2:00 PM
Break

1:40–2:00 PM
The FDLI Student Member Debrief
For Student Members Only

The FDLI Student Member Debrief will feature a space for student members to discuss the ongoing conference, network with other FDLI student members, and hear about other opportunities for those new to the food and drug law field.

2:00–3:00 PM
Potential Structures to Create Social Equity in the Cannabis Industry
Shawn “Pepper” Roussel, Attorney at Law, Green Pepper Solutions
Cedric Sinclair, Chief Communications Officer, Cannabis Control Commission, Commonwealth of Massachusetts
Mathew R. Swinburne, Associate Director, Network for Public Health Law – Eastern Region, University of Maryland Francis King Carey School of Law (sub)
Benjamin C. Varadi, Senior Fellow & Visiting Research Scholar, Vermont Law School Center for Agriculture & Food Systems

Some have estimated the US cannabis market will reach $44 billion in legal sales by 2025. However, this economic opportunity is not equitably enjoyed, as it is also estimated that 81% of cannabis business owners are white. This session will cover state efforts towards improving access to retail and agricultural business opportunities for racially diverse entrepreneurs, as well as perspectives on additional approaches to be considered at the state, federal, and local levels.

3:10-4:15 PM
Facilitating Stakeholder Collaboration to Improve Future Cannabis Regulation
Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Shanita Penny, Senior Advisor, Coalition for Cannabis Policy, Education, and Regulation (CPEAR) and Senior Vice President, Forbes Tate Partners
Moderated by Deborah Miran, Consultant, DMiran Consulting and Chair, FDLI Cannabis-Derived Products Committee

This forward-looking discussion will consider how to improve stakeholder collaboration as we move towards a more comprehensive federal regulatory scheme, including both coordination between federal agencies and cooperation amongst regulators, industry, academia, patient advocates, and public health interest groups. Panelists will also discuss the recent ruling by the Ninth Circuit Court of Appeal that hemp-derived Delta 8 THC is legal under the 2018 Farm Bill, and the likely impact on both federal and state regulation.

4:15 PM
Closing Remarks and Adjournment