SOT and the US Food and Drug Administration Center for Food Safety and Applied Nutrition (US FDA/CFSAN) cordially invite you to join us for our May 8, 2024, colloquium, “Current State of the Science: Toxicology of Cannabidiol and Other Cannabinoids.” There is no charge for this webcast. The SOT FDA Colloquia are an update on toxicological science rather than a public forum for discussion of toxicology regulatory issues. The co-chairs of this session are Luísa Camacho, PhD, US FDA/NCTR, and Barbara Kaplan, PhD, Mississippi State University.
Overview
Cannabidiol (CBD) is a psychoactive, non-intoxicating cannabinoid found in marijuana and hemp. Following the passage of the 2018 Farm Bill, which legalized the production of hemp in the US, CBD has become widely available and used in myriad consumer products. CBD has been reported to treat insomnia, anxiety, pain, and inflammation and other immune diseases; however, thus far, only a purified form of CBD is marketed in the US as an FDA-approved drug—Epidiolex for the treatment of refractory epilepsies in children. Given the widespread use of CBD-containing products, it is critical to understand both its pharmacological and toxicological effects.
This colloquium will describe CBD in the context of marijuana, hemp, and other minor cannabinoids, summarize potential target organs/systems, and provide an overview of the pharmacokinetics and potential liver toxicity and drug-drug interactions of CBD. It will then focus on two areas of action or potential toxicity: the central nervous system and the reproductive system. The final presentation will review potential exposures and biological activities of other minor cannabinoids. The colloquium will conclude with a panel discussion on these and other active areas of CBD research.
Schedule (US EDT, UTC -4)
9:00 AM–9:10 AM
Welcome and Opening Remarks
Namandjé Bumpus, PhD, US FDA Principal Deputy Commissioner, Silver Spring, MD
9:10 AM–9:40 AM
Cannabidiol Overview: Clinical Considerations, Regulatory Status, and Marketplace Concerns
Robert Welch, PharmD, University of Mississippi, Oxford, MS
9:40 AM–10:10 AM
Pharmacokinetics of Cannabidiol
Ryan Vandrey, PhD, Johns Hopkins University, Baltimore, MD
10:10 AM–10:40 AM
Central Nervous System Effects of Cannabidiol
Ethan Russo, MD, CReDO Science, Vashon, WA
10:40 AM–11:00 AM
Break
11:00 AM–11:30 AM
Effects of Cannabidiol on the Male Reproductive System
Renata Mazaro-Costa, PhD, Universidade Federal de Goiás, Goiânia, Brazil
11:30 AM–12:00 Noon
Beyond CBD: Exposure, Chemistry, and Toxicity of “Minor” Cannabinoids
Michael Santillo, PhD, US FDA/CFSAN/OARSA, Laurel, MD
12:00 Noon–12:45 PM
Roundtable Discussion Featuring All Speakers
Moderators: Luísa Camacho and Barbara Kaplan
1:00 PM–1:45 PM
Speaker Discussion with FDA Employees (limited to colloquium organizers and FDA employees)