PhytoPharmacology Review
ADVISORY BOARD MEMBER
SPEAKER
MEDICINE
There is a paucity of data on the safety of hemp extracts in real-world use. While the number of
clinical trials is building, the subject numbers are limited and conditions frequently do not mimic
consumer use. Using a retrospective analysis of post-marketing surveillance data on full-
spectrum hemp extract products (FSHE-Charlotte’s Web TM ) the frequency of adverse events
(AEs) and serious adverse events (SAEs) of these products was assessed by analyzing AE reports
and evaluating the total number of AEs against the total number of product units sold. From a
total of approximately 1,939,172 product units sold during the 18-month period, 431 AEs were
reported from 304 unique individuals, followed by a physician assessment. The incidence of AEs
was 0.022% per unit sold. Seven AEs were classified as serious. The most common type of AEs
reported were Grade 1 (CTCAE v5.0), and defined as asymptomatic or mild symptoms in the
area of gastrointestinal (e.g. general abdominal discomfort) and nervous system disorders (e.g.
dizziness/headache). Based on this dataset of spontaneous consumer reporting the FSHE
products were determined to result in consumer reports of AEs (0.022%) and SAEs (0.00036%)
and to be well tolerated at the recommended doses. These data, with the limitations of self-
reports, are intended to be a starting point and we encourage more companies to explore post-
marketing surveillance until more robust data are available.
Kevin Spelman, Ph.D., MCPP is a researcher, clinician, educator and industry consultant that has advised the White House and the Department of Defense on natural products for regulatory guidelines and research on effective battlefield hemostatics, respectively. Dr. Spelman studied brain cancer, as well as CB1 and CB2 receptor binding as a Postdoctoral Fellow at National Institutes of Health and was the first researcher to elucidate cannabinoid ligands in Zanthoxylum spp. He has also carried out malaria and natural products research as a Marie Curie Research Fellow in the European Union and has focused on molecular techniques to elucidate the pharmacology of phytochemicals on human physiology and has 27 peer reviewed publications on medicinal plants. He has also been a senior R&D executive for multiple companies over the last decade. Dr. Spelman has considerable experience in medicinal plant, nutraceutical and cannabinoid research and has coordinated new product development, analytical and QC guidelines, research activity and educational curricula for industry and universities over the last 30 years.
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