Post-market surveillance supports safety and tolerability of PlusCBD products
During 2018 and 2019, approximately five million PlusCBD product units were sold and 1,429 adverse events (AE) were reported in 1,151 unique customers. This was equivalent to 0.029%.
The analysis, which was published Monday in the Journal of Dietary Supplements, covers both orally ingested products and topically applied products.
“There has been no evidence of liver toxicity associated with CVSI products,” wrote Dr Stephen Schmitz and Dr Hector Lopez from Supplement Safety Solutions, and Dr Osvaldo Marinotti from CV Sciences. “Based on this longitudinal dataset, the products manufactured using CVSI’s proprietary processes are safe and well tolerated at the recommended doses.”
Adding to the rapidly growing body of literature that suggests that there is little to no risk of adverse liver effects
Commenting on the new paper, Douglas “Duffy” MacKay, ND, Senior Vice President of Scientific and Regulatory Affairs, CV Sciences, told NutraIngredients-USA: “As a responsible hemp derived CBD company CV Sciences ensures our finished products are safe while at the same time we want to provide FDA data to help establish a clear regulatory path for hemp-derived CBD as a dietary supplement.
“CV Sciences published the first pre-clinical safety data on our PlusCBD ingredient and we were the first company to establish our ingredient as Generally Recognized as Safe (GRAS).
“To further confirm the safety of our products, we maintain a rigorous post-market safety surveillance program. CV Sciences utilizes a program called Nutravigilance, modeled after pharmaceutical post market surveillance, to track product complaints and adverse events. We decided to support the publication of this manuscript to add to the rapidly growing body of literature that suggests that there is little to no risk of adverse liver effects and a potential for hepatoprotection at the lower doses of CBD commonly used in dietary supplements.
“This is why regulatory bodies in Australia and the UK have proceeded with regulating these products for use without a prescription, which we hope FDA does soon.”
Data & analysis
The paper is reportedly the first report of a longitudinal 2-year post marketing safety analysis of a full line of full spectrum hemp extract products. The authors explained that, although full spectrum hemp extracts and CBD are not technically considered a dietary supplement by the US Food and Drug Administration, CV Sciences uses the safety reporting approach advocated in the Dietary Supplement Health Education Act (DSHEA, 1994) and the Federal Food Drug and Cosmetic Act Adverse Event Reporting Law (AER Law, 2006).
Drs Schmitz, Lopez, and Marinotti found 1,429 AEs, and of those only two were classified as serious. Addition analysis suggested that in the first of these the product was unlikely to have contributed to the adverse events. The second report was classified as an acute hypersensitivity reaction, “but after temporarily discontinuing product, the consumer resumed taking the supplement without apparent adverse effect. This is not consistent with a true acute hypersensitivity reaction.”
The authors noted that the conclusions around safety and tolerability can only be applied to PlusCBD products and cannot be reliably extrapolated to other CBD products because of differences between formulations, doses, hemp sources, and other factors, which may impact “absorption, exposure and the safety profile”.
“The amount of published human safety data is small,” they added. “However, other companies manufacturing CBD products could utilize this longitudinal approach for their product formulations, and contribute to the literature on the safety of low-dose CBD by providing consumers and the FDA actual data to support product safety.
“CVSI will continue to carefully monitor the safety profile of its products through post marketing surveillance and ongoing human studies,” they concluded.
Source: Journal of Dietary Supplements
Published online ahead of print, doi: 10.1080/19390211.2020.1767255
“Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience”
Authors: S.M. Schmitz, H.L. Lopez, O. Marinotti