On healthcare by popular appeal: critical assessment of benefit and risk in cannabidiol based dietary supplements

ABSTRACT

Introduction: In recent decades, federal legislation in the U.S. has recognized a new paradigm of pharmacotherapy in which ideology and popular demand, as opposed to sound clinical evidence, drives the marketing of ostensible herbal therapeutics as ‘dietary supplements’. This vogue of democratizing medicine has more recently manifested in the ongoing legalization of cannabis products at the state level, where an arbitrary variety of definitions, restrictions, and assumed therapeutic uses are applied to a family of phytochemicals with no definitive evidence of efficacy or safety. With the recent publication of clinical trials submitted to the FDA in efforts to gain approval of the cannabidiol based therapeutic Epidiolex, a rare opportunity exists to examine high-quality data for a drug which has in recent years been marketed as a greatly unregulated dietary supplement.

Areas covered: A critical analysis is offered of data regarding efficacy, dosing, exposure, adverse events, drug–drug interactions, and non-specific effects associated with CBD – all of which raise questions regarding the wisdom of assuming the safety and efficacy of cannabinoids in particular and dietary supplements in general.

Expert opinion: Ongoing lack of meaningful regulation of cannabinoid supplements continues to put consumers at undue risk without clear evidence of therapeutic value.

KEYWORDS:

• Cannabidiol
• CBD
• dietary supplement
• adverse events
• regulation
• risk assessment

Article highlights

• Federal regulations and definitions of ‘dietary supplements’ are arbitrary and inadequate to protect consumers from the risks of consuming chemicals marketed as unsubstantiated therapeutics.

• Current state-level tolerance of cannabinoid supplements, most particularly cannabidiol, being sold as therapeutic agents is no more defensible than the inadequate federal regulation of dietary supplements.

• Available data regarding the efficacy of cannabidiol for the treatment of any specific condition are equivocal at best and may be explained, at least in part, by pharmacokinetic interactions and non-specific effects. This calls into question expectations of therapeutic utility of cannabidiol for any given indication.

• Available data on adverse events associated with cannabidiol, its demonstrated pharmacokinetic interactions with other drugs, and a lack of experience with its arbitrary dosing place consumers at undue risk.

• The ongoing fanciful treatment of ‘dietary supplements’ as something other than drugs, coupled with regulations which restrict any meaningful research into the potential therapeutic value of cannabinoids, have created an impasse to effective FDA oversight of the growing cannabidiol supplement market. States which allow or advocate for the sale of cannabinoid supplements bear an ethical obligation to take on responsibility for implementing effective oversight.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.