Why Attend

Agenda

CLE

Tuesday, December 8

11:15 – 11:30 AM
FDLI Welcome and Introduction
Amy Comstock Rick, President & CEO, FDLI

11:30 AM –12:00 PM
Fireside Chat with FDA
Joseph Franklin, Policy Director for the Principal Deputy Commissioner, FDA
Interviewed by Suzie Loonam Trigg, Partner, Haynes and Boone LLP

12:15–1:15 PM
Federal/State Election Impacts and Legislative Initiatives for Marijuana and CBD Regulation

William A. Garvin, Shareholder, Buchanan Ingersoll & Rooney PC
Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Justin Strekal, Political Director, National Organization for the Reform of Marijuana Laws – NORML
Moderated by Paul Demko, Cannabis Editor, Politico

The 2020 election results brought several significant changes to the legal marijuana and CBD landscape, including the passage of six state-based marijuana legalization initiatives. However, relatively few changes to the House and Senate makeup may minimize the likelihood of large-scale changes to marijuana and CBD legislative efforts at the federal level. This panel will summarize federal and state election results and their impact on the marijuana and CBD industries.

1:15–1:45 PM
Lunch Break

1:45–2:30 PM
CBD Regulatory Updates
Douglas MacKay
, SVP, Scientific and Regulatory Affairs, CV Sciences
Brian J. Malkin, Partner, McDermott Will & Emery
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP

Although FDA has not yet released its Cannabidiol Enforcement Policy Draft Guidance, it has undertaken several information gathering initiatives in the past year. What is the status of FDA’s efforts, and what are the next steps? This panel will address the “Draft Guidance for Cannabidiol” regarding bioequivalence recommendations for generic oral cannabidiol solution; the November public meeting on “CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses;” and reports submitted to Congress on potential regulatory pathways for CBD products and CBD sampling progress and findings.

2:45–3:45 PM

Navigating Drug Preclusion Gaps for Food and Dietary Supplements Containing CBD and Other Cannabinoids

Brad Douglass, Independent Consultant, EAS Consulting Group
Jensen Jose, Regulatory Counsel, Center for Science in the Public Interest
Megan L. Olsen, VP & Associate General Counsel, Council for Responsible Nutrition
Moderated by Robert Durkin, Of Counsel, Arnall Golden Gregory LLP

The push from industry and consumers for FDA to provide a legal pathway for CBD products in foods and/or dietary supplements continues with great impetus. Simultaneously, a myriad of CBD products have entered the market without FDA review, notice, or approval, resulting in products that are contaminated or contain different doses of CBD than indicated on their label. This panel will discuss FDA’s position precluding CBD from regulation as a food or dietary supplement due to its drug status, the agency’s current statements and other analysis on opening one or more new pathways for CBD and other cannabinoids, and regulatory and data requirements for these pathways.

4:00–5:00 PM
U.S. DOJ, DEA, and FTC Approaches to Marijuana and CBD Regulation and Enforcement

John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Larry K. Houck, Director, Hyman, Phelps & McNamara, PC
Moderated by Tom Firestone, Partner, Baker McKenzie

How are other federal agencies approaching marijuana and CBD enforcement? Speakers will discuss the Department of Justice’s current marijuana enforcement practices two years after rescission of the Cole memorandum and how to minimize enforcement risks for state legal businesses, comments received in response to the Drug Enforcement Administration’s (DEA’s) August 2020 interim final rule, ”Implementation of the Agriculture Improvement Act of 2018,” and the Federal Trade Commission’s recent enforcement actions regarding CBD products with COVID-19 prevention or treatment claims.

Wednesday, December 9

11:00 – 11:15 AM
FDLI Welcome and Introduction
Laura A. Brown, Director, Educational Programs, FDLI

11:10 AM –12:10 PM
Regulatory and Practical Research Limitations and Solutions for Cannabis-Derived Products

Deborah Miran, Consultant, DMiran Consulting
Heike Newman, Senior Regulatory Manager, University of Colorado
Evelina Norwinski, Partner, Arnold & Porter LLP

Although FDA has requested more safety and efficacy data for cannabis-derived products to determine appropriate pathways and approvals, researchers must comply with complex regulations, imposed by a number of federal agencies, that govern this research. This panel will explore these rules and offer insights on how best to plan for and perform research while ensuring compliance. Speakers will discuss the impact of FDA’s July 2020 “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry” draft guidance, and how the guidance relates to other FDA research requirements, as well as those of the United States Department of Agriculture (USDA), DEA, and states. The panel will also discuss restrictions on research and how House Bill 3797 aims to work through research hurdles.

12:10–12:40 PM
Lunch Break

12:40–1:40 PM
To IND or Not IND: That is the Question for CBD and Marijuana Products

Rodney William Butt, Senior Vice President – Strategic Solutions, Nutrasource Pharmaceutical & Nutraceutical Services
Kelly Fair, US General Counsel, VP US & European Affairs, Canopy Growth Corporation
Alice P. Mead, Senior Advisor, Greenwich Biosciences
Moderated by Tish E. Pahl, Partner, Olsson Frank Weeda Terman Matz PC

What are a company’s goals in seeking drug approval for a CBD or marijuana-based product? Does lack of meaningful enforcement of drug claims on non-drug products make drug approval worthwhile? This session will first discuss the research and approval process undertaken for Epidiolex, the only FDA-approved, plant-derived prescription cannabinoid product. The session will compare and contrast the goals of pharmaceutical-based research in pursuit of drug approval with initiatives not seeking such approval. It will also explore difficulties of obtaining an IND for cannabis products due to restrictions on research. The differences between the drug pathway requirement and those for natural products will also be discussed, using the Amarin fish oil product Lovaza as case study.

1:55–2:25 PM
Concurrent Breakout Sessions

  • Managing Biomass and Biowaste from the Hemp and Cannabis Industries

Keith Matthews, Of Counsel, Wiley LLP
Stephanie McGraw, Partner, Shook, Hardy & Bacon LLP

As CBD and THC demand drive the production of hemp and cannabis, biomass and other waste products increase as well. Some estimates place cannabis and hemp bio “waste” at nearly 1 million tons in North America in 2019. What can producers do with that material and what regulations apply to this bio waste? Speakers will also examine other challenges for handling, transporting, and disposing of hemp and cannabis biomass and waste.

  • State Quality Issues for Marijuana and CBD

Tara Lin Couch, Senior Director for Dietary Supplement and Tobacco Services, EAS Consulting Group
Andrew Freedman, Director of Cannabis Coordination, State of Colorado (former), Senior Vice President, Forbes Tate Partners
Darwin Millard, Member, ASTM International Technical Committee D37 on Cannabis, and owner, TSOC LLC

What marijuana and CBD quality regulations have been established at the state level that can be extrapolated to other states and even federal regulation? This panel will discuss essential quality elements, such as good manufacturing practices and finished product specifications, that certain states have established. The panel will also discuss highlights of ASTM International’s Technical Committee D37 on Cannabis in the area of standards development for ensuring product quality and environmental and consumer health and safety.

2:40–3:20 PM
The Patchwork Quilt of State Hemp Laws

Mai T. Dinh, Assistant General Counsel, Marketing, Regulatory, and Food Safety Programs, Division Office of the General Counsel, USDA
Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Steven N. Levine, Partner, Husch Blackwell LLP

USDA announced in September that it would reopen the comment period for the interim final rule (IFR) on domestic hemp production. The IFR provides USDA with authority to approve state or tribal plans for regulating hemp production. The agency received over 1,000 comments on issues including disposal and remediation of non-compliant plants, sampling methodology, and whether testing labs needed to be registered with DEA. What comments did the agency receive and what are next steps? This panel will also discuss how some state plans may have unintended consequences, such as effectively classifying some hemp-derived products (such as CBD) as controlled substances, and how companies can reduce compliance risk.

3:35–4:20 PM
International Cannabis Regulation and Market Opportunities

Michael Krawitz, Executive Director, Veterans for Medical Cannabis Access, Serving as a Civil Society Focal Point, World Health Organization, Expert Committee on Drug Dependance, Cannabis Critical Review Process
Eileen M. McMahon
, Senior Partner, Torys LLP

What is the status of cannabis law and regulation at the international level and what business opportunities do opening markets provide? This session will first review the World Health Organization’s recommendation that the United Nations Commission on Narcotic Drugs reschedule cannabis to a less restrictive category in the Single Convention on Narcotic Drugs. Speakers will explore possible rescheduling outcomes and their ramifications on national cannabis policy in the 186 countries that are signatories to the treaty. The panel will also discuss how the legal status of cannabis, hemp, and CBD in other countries, such as Canada and European Union member states, is affecting market opportunities for US-based companies.

4:20 PM
Closing Remarks and Adjournment