Validcare shares results of CBD safety study with FDA

April 2, 2021
Sebastian Krawiec

Preliminary findings show no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests.

Validcare (Denver, CO) has shared the preliminary findings of its CBD safety study with the U.S. Food and Drug Administration (FDA). The study was commissioned and designed in response to the FDA’s requests for scientific data to help the Agency confidently determine the appropriate regulatory path for hemp derived CBD products. As part of the study, 13 CBD product brands sponsored the research, providing lot-specific product information as well as recruiting 100 consumers to participate. Participating brands included: Asterra Labs, Boulder Botanical & Bioscience Labs, Care by Design, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Global Widget, HempFusion, Infinite CBD, Kannaway, Medterra CBD, and SunMed CBD.

A minimum of 681 participants were needed to achieve statistical significance, but over 830 consumers completed the study between August 2020 and February 2021. Validcare used its decentralized clinical research platform and partnership with national laboratories to enable participants and investigators to successfully complete the first cohort despite the pandemic. Results were compiled and delivered to brands and FDA within six weeks.

Preliminary findings show no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests. “Our primary endpoint in this study is to observe potential liver effects in adults ingesting oral forms of hemp derived CBD for a minimum of 60 days. What we observed to date is no clinical evidence of liver disease in any participants,” said co-investigator Jeff Lombardo PharmD, BCOP, in a press release. “We observed slight, clinically insignificant elevations of liver function tests in less than ten percent of consumers irrespective of age, product composition and form and the amount consumed. Three of the 839 participants had 3x normal levels of the liver enzyme ALT. These three consumers are taking prescription medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers.”

The researchers were surprised to find that nearly 70% of study participants reported having medical conditions for which they took medications, but there was no increase in reporting of adverse events. While studies of similar populations saw an 11% elevation in liver function tests, this current research demonstrated about 9% elevation.

“This unexpected, positive finding makes the data even more compelling and provides significant data to consider secondary safety measurements in the general population,” said Keith Aqua, MD, co-principal investigator of this IRB-approved study. “We are encouraged by these findings and hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward. We will continue to analyze these real-world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions.”

The principal investigators met with FDA on March 15 and reviewed preliminary liver safety study results in the form of an abstract. They are also discussing the potential of establishing a direct communication feed to FDA so it can receive raw, blinded, aggregate data for its analysis.

“Congressional leadership asked ValidCare almost 18 months ago to engage industry help collect safety data for FDA. We understand the significance, importance and immediate need for CBD safety research for the FDA, industry and the US consumer. This first of its kind, industry led, multi-branded study required trust, collaboration, operational excellence, innovation, and resilience. It demonstrates the incredible potential for decentralized clinical research to increase participant access and accelerate results – even during the most challenging times” said Patrick McCarthy, CEO of Validcare, in a press release. “We are excited for our principal investigators to continue, expand and report out on this foundational work in the next few months. Once completed, safety results of this study will be shared with participating brands and FDA. The investigators also plan to publish in a peer reviewed journal.”