Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches

Abstract

The proliferation in the last few years of cannabidiol (CBD)-containing products in the U.S. markets has been greatly accelerated by changes in the regulatory environment, and by perceptions of their health benefits and presumed safety. The result has been aggressive marketing of many types of products, some of dubious quality, making or implying drug-type claims. The recent approval by the U.S. Food and Drug Administration (FDA) of CBD in the form of Epidiolex®, further complicates the regulatory picture. In addition, a number of studies suggest that, at least at high doses, there may be serious adverse effects or drug interactions associated with CBD. At present, CBD-containing products do not meet the strict definition of dietary supplements, but the FDA is continuing to consider some framework under which they might be allowed. Meanwhile, FDA has adopted a “risk-based” enforcement policy. Possible approaches to a new framework for regulation of CBD products as dietary supplements are discussed here, including expanded research emphasis, a robust corporate stewardship program, and a rigorous adverse event reporting program.

Keywords:

• Cannabidiol
• dietary supplements
• regulations

Declaration of interest

The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of the article.

Additional information

Notes on contributors

Larry A. Walker

Larry A. Walker, PhD is Director Emeritus of the National Center for Natural Products Research (NCNPR) at the University of Mississippi. He was trained in pharmacy and pharmacology, and has worked for much of his 38 yr career on natural products drug discovery, pharmacology, toxicology and metabolism. He has been integrally involved in the design and execution of preclinical and early clinical development studies on drugs and natural products.

Igor Koturbash

Igor Koturbash, PhD 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, Igor has a long-lasting interest 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.

Rick Kingston

Rick Kingston, PharmD, is the President, Regulatory and Scientific Affairs at SafetyCall International P.L.L.C., a multidisciplinary healthcare firm academically affiliated with the University of Minnesota and focused on consumer product pharmacovigilance, regulatory reporting support for adverse events, and product safety. Dr. Kingston’s professional and academic career spans 35 years including previously serving full time as Professor, Department of Experimental and Clinical Pharmacology at the University of Minnesota College of Pharmacy and currently serving as Clinical Professor of Pharmacy. He also holds an adjunct appointment at the rank of Professor at the University of Mississippi College of Pharmacy and its National Center for Natural Product Research. His professional expertise spans the areas of consumer product post-market surveillance and pharmacovigilance, natural product toxicology, clinical toxicology and pharmacology, injury prevention, poison control, and product safety regulatory policy.

Mahmoud A. ElSohly

Mahmoud A. ElSohly, PhD is a Research Professor at The National Center for Natural Products Research, and Professor of Pharmaceutics and Drug Delivery, School of Pharmacy, University of Mississippi (UM) and is the Director of the National Institute on Drug Abuse (NIDA) Marijuana Project at UM. He is also the President and Laboratory Director of ElSohly Laboratories Incorporated, an analytical forensic drug testing and product development laboratory. He received his undergraduate and Masters from Cairo University, Cairo, Egypt and his Ph.D. in 1975 from the University of Pittsburgh, School of Pharmacy, Pittsburgh, PA. He has been with the University of Mississippi since 1975 and has been Director of the NIDA Marijuana Project since 1981. He has over 40 years’ experience working with the isolation of natural products (notably cannabis secondary metabolites), synthetic, analytical and forensic chemistry. He has more than 30 patents and over 300 publications in these areas of science. Dr. ElSohly is also a member of many professional organizations, such as American Society of Pharmacognosy, American Chemical Society, American Academy of Forensic Sciences, Society of Forensic Toxicology, International Cannabinoids Research Society, International Association of Cannabinoid Medicines, to name a few and have received numerous awards.

Charles Ryan Yates

C. Ryan Yates, PharmD, PhD is a Principal Scientist at the National Center for Natural Products Research at the University of Mississippi, Oxford. His research interests include the application of artificial intelligence and machine learning models to elucidate phytochemical mechanism(s) of action in support of discovery and commercialization of unique dietary supplements and botanical pharmacokinetics and pharmacodynamics in humans. Dr. Yates is a serial entrepreneur who most recently founded NPI, LLC to promote affordable access to safe and evidence-based natural product remedies.

Bill J. Gurley

Bill J. Gurley, PhD is a Principal Scientist at the National Center for Natural Products Research at the University of Mississippi, Oxford. His research interests include mechanisms of herb-drug interactions, toxicity of multiple-component herbal dietary supplements, phytochemical modulation of human drug-metabolizing enzymes and drug transport proteins, pharmacokinetics of phytochemicals in humans and botanical supplement use in special populations. Gurley has been conducting pre-clinical and clinical research on botanical dietary supplements for more than 20 years.

Ikhlas Khan

Ikhlas Khan, PhD js the Director of the National Center for Natural Products Research, Director of the FDA Center of Excellence, Distinguished Professor in the Department of Pharmacognosy, University of Mississippi. Dr. Khan’s primary research interests include analytical fingerprinting for standardization of herbal products, and bio-analytical approaches to improvement of product quality and safety. He has 36 years of experience in natural products and published over 700 original research articles, publications, or reviews.