Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience

Abstract

The market for products featuring hemp extracts is large and growing larger. However, safety concerns have been raised by medical and regulatory agencies. Post marketing surveillance of full spectrum hemp extract (FSHE) products manufactured and distributed by CV Sciences (CVSI) and traded under the brand PlusCBD™ was conducted over a 2-year period (2018-2019). The safety of these products was assessed by analyzing adverse events reports. From a total of approximately five million product units sold during the 2-year period, 1,429 (0.03%) adverse events (AE) were reported in 1,151 unique customers. Of those, only two were classified as serious AEs. For orally ingested products, the most common types of AEs reported were gastrointestinal (e.g. abdominal discomfort), while for topically applied products, the most reports mentioned dermatological symptoms (e.g. rashes). There has been no evidence of liver toxicity associated with CVSI products. Based on this longitudinal dataset, the products manufactured using CVSI’s proprietary processes are safe and well tolerated at the recommended doses.

Keywords:

• cannabidiol
• CBD
• full spectrum hemp extract (FSHE)
• dietary supplement
• nutravigilance
• pharmacovigilance
• adverse event
• serious adverse event
• DSHEA
• supplement safety

Acknowledgements

The authors would like to thank Brendan Hawkins and Daniel Degner for pivot table analysis, and to Miles Sarill for final review and for determining the cannabinoid content over time.

Declaration of interest

The authors did not receive compensation to author this paper. SMS and HLL are co-founders and owners of Supplement Safety Solutions, LLC (SSS), an independent regulatory compliance company. SSS receives consulting fees from CV Sciences in order to assess, analyze, perform safety surveillance and report SAEs on their behalf. HLL is a principal and officer of the Center for Applied Health Sciences, LLC., a privately held contract research organization that receives external funding from companies in the dietary supplement, natural products and functional foods/beverages industry. HLL is also co-inventor on multiple patents within the field of dietary supplements, applied nutrition and bioactive compounds. OM is employed by CV Sciences as a Senior Biochemist.

Additional information

Notes on contributors

Stephen M. Schmitz

Stephen M. Schmitz, MD, MPH (Co-Founder, Supplement Safety Solutions, 121 Davis Road, Bedford, MA 01730). He was trained as a family physician and occupational physician, and has worked for 20 years in pharmacovigilance and nutravigilance. Interests include enhancing the safety of dietary supplements through data-driven information, and dispelling inaccuracies of supplement safety and assuring access to high-quality products.

Hector L. Lopez

Hector L. Lopez, MD, MS (Co-Founder, Supplement Safety Solutions, 121 Davis Road, Bedford, MA 01730, Co-Founder, The Center for Applied Health Sciences(CAHS), 4302 Allen Road, Suite 120, Stow, OH 44224) is a physiatrist by training, with specialized training in nutrition and anti-aging medicine. In addition to supplement safety, Dr. Lopez is the co-founder of a full-service CRO (CAHS), specializing in clinical trials in the dietary supplement space, and novel product formulation.

Osvaldo Marinotti

Osvaldo Marinotti, PhD, MS (CV Sciences, 10070 Barnes Canyon Road, San Diego, CA 92121), is a Senior Biochemist and molecular biologist, who was a Professor at the University of Sao Paolo, and who has conducted research at the Harvard School of Public and the University of California-Irvine.