A cannabidiol (CBD) and hemp-focused health and wellness company has announced initial findings from a toxicology study on CBD and the liver.
HempFusion Wellness Inc. (HempFusion) on Tuesday announced that study investigators had found no evidence of liver toxicity among trial participants so far.
The company says it believes the study, coordinated by Validcare, is the largest human observational liver human toxicology study to date.
The study is in response to FDA requests, including a 2020 report to the U.S. Congress highlighting the need for science-based data to identify potential health risks and help guide the regulatory process for CBD products.
Following seven months of clinical investigation, Validcare’s team of principal investigators met with the United States Food and Drug Administration (FDA) to share initial findings.
“We are encouraged by these findings and are hopeful this study provides the FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” says Co-Principal Investigator Dr. Keith Aqua. “We will continue to analyze this real-world data. Due to the overwhelming success, we 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.”
Principal investigators met with the FDA on March 15 to review an abstract on preliminary study results.
According to HempFusion, investigators and the FDA talked about establishing direct communication with the agency for sending raw, blinded, and aggregate data for analysis.
HempFusion Co-Founder and CEO Jason Mitchell, N.D. says that the study is a pivotal step for the CBD industry.
“Participating in what is believed to be the largest human liver toxicology study on CBD was a tremendous honor, and the initial findings are incredibly validating for consumer safety,” says Mitchell. “When specifically looking at how our products performed in the study, having no liver toxicity only bolsters what we have always stated about our products. We believe they are safe.”
Validcare CEO Patrick McCarthy says that they will share results with the FDA and participating brands once the study is complete.
McCarthy says that investigators also plan to publish the results in a peer-reviewed journal.