The industry-sponsored study was commissioned and designed in response to FDA’s requests for science-based data, so that FDA can determine the appropriate regulatory pathway for these products.
The preliminary findings showed no evidence of liver disease in the 839 participants, and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions.
Co-investigator Jeff Lombardo, Pharm.D., BCOP, said in the press release: “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. 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.”
Almost 70% of study participants reported having a medical condition and taking medications for these conditions, without an increase in reporting of adverse events; studies of similar populations demonstrate an 11% elevation in liver function tests, while this study demonstrated 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, M.D., Co-principal Investigator. “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.”
Investigators met with FDA on March 15 and reviewed the safety results. They also discussed establishing a direct communication feed to FDA so that it can receive raw, blinded, aggregate data for its analysis.
12 companies provided funding, product, and certificates of authenticity, and assisted with recruitment: Asterra Labs, Care by Design, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Global Widget, HempFusion, Infinite CBD, Kannaway, Medterra CBD, and SunMed CBD.
Patrick McCarthy, CEO of Validcare, said in the press release: “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. 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.”