Cannabidiol and Other Cannabinoids: From Toxicology and Pharmacology to the Development of a Regulatory Pathway

abstract

Cannabidiol (CBD) is a non-psychotropic constituent of Cannabis sativa that has grown in popularity during the last decade. CBD is the active component of EPIDIOLEX®, a U.S. Food and Drug Administration (FDA)-approved drug designed for the treatment of drug-resistant pediatric epileptic seizures associated with several rare syndromes. Furthermore, CBD has been proposed as a treatment for a number of other diseases for which clinical trials are now ongoing. Accumulating evidence indicates that the number of “CBD-containing” products, available mostly online, is growing exponentially. However, the U.S. FDA currently prohibits sales of CBD as a dietary supplement (DS) or ingredient in conventional food. Further, clear federal regulatory and quality oversight does not exist, which has led to an uncontrolled CBD market that, in turn, threatens to result in negative health effects experienced by a trusting public. Thus, there are open questions demanding answers in the very near future: For which medical purposes is CBD provably effective? Can it be used safely as a non-prescription product? At what level? Is a hemp extract that contains CBD a different ingredient than isolated CBD? Is CBD safe for everyone? What is a future path for hemp products with CBD as well as for other cannabinoids? Should CBD be allowed as a drug only, or is there a way for hemp extracts to be listed as a dietary supplement and food ingredient? This Special Issue, the first of its kind on CBD and other phytocannabinoids, is devoted to answering those and other questions by publishing articles in the fields of pharmacology, toxicology, and regulation.

Keywords:

• Cannabidiol
• cannabis
• CBD
• dietary supplement
• endocannabinoid system
• hemp
• phytocannabinoids
• quality control
• regulations
• safety

Acknowledgements

We would like to take this opportunity to thank all the authors who contributed with their manuscripts for this Special Issue. We would also like to take this opportunity to thank all reviewers who kindly agreed to provide their valuable feedbacks on the submitted manuscripts. Last, but not list, we would like to thank Melody Harris, Sarah (Holstein) Williams, and Anjana Bhargavan from the Journal of Dietary Supplements Editorial Office and Taylor & Francis for all their efforts on this Special Issue.

Declaration of interest

The authors report no conflict of interest.

Additional information

Notes on contributors

Igor Koturbash

Igor Koturbash is an Associate Professor at the Department of Environmental and Occupational Health and Co-Director of the Center for Dietary Supplements Research at the University of Arkansas for Medical Sciences (UAMS) Fay W. Boozman College of Public Health. Being both MD and PhD, Dr. Koturbash has long been interested in diet and dietary supplements and their impact on human health. Therefore, the major focus of his research is safety, efficacy, and mechanisms of action of dietary supplements and understanding how diet and dietary supplements can modulate tissue response to cancer therapy. Igor is heavily involved in a number of safety and efficacy studies on various dietary supplements and herbs, including methionine supplementation, green tea extract, and cannabidiol (CBD), to name a few. Igor has published 90+ peer-reviewed articles and book chapters, and his research has received uninterrupted extramural funding from various sources since the beginning of his independent career.

Douglas MacKay

Douglas “Duffy” MacKay, N.D. is a Senior Vice President for Scientific and Regulatory Affairs at CV Sciences, Inc., manufacturers of a hemp extract with cannabidiol (CBD). Dr. MacKay is responsible for scientific and regulatory affairs functions that drive product quality, safety and innovation. Dr. MacKay comes to CV Science after a ten-year career with the Council for Responsible Nutrition (CRN) where he served as the SVP, scientific and regulatory affairs. Dr. MacKay oversaw the scientific and regulatory affairs department, ensuring that the association’s scientific, policy and legislative positions were based on credible scientific rationale. He also serves, on the CRN Board of Directors; Journal of Dietary Supplements, Associate Editor; American Botanical Council (ABC), Advisory Board and FDLI Cannabis-Derived Products Committee, as well as the editorial boards of Integrative Medicine a Clinician’s Journal, and Natural Medicine Journal.