Validcare Shares CBD Safety Study Backed By Columbia Care, Charlotte's Web, HempFusion And Others

Research company Validcare has released the preliminary results from a cannabis industry-sponsored study focused on the safety of hemp-derived CBD products.

The seven months-long study was requested by the The U.S. Food and Drug Administration (FDA) to obtain necessary data for the creation of adequate regulatory paths for hemp-derived CBD products.

“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,” co-investigator Jeff Lombardo PharmD, BCOP stated. “What we observed to date is no clinical evidence of liver disease in any participants."

BCOP 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, Lombardo added.

And while three of the 839 participants had 3 times higher levels of the liver enzyme ALT, they were all taking “medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers,” he said.

The goal of the study was to provide the 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," Keith Aqua, MD, co-principal investigator of this IRB-approved study, said. 

Companies who supported the study, by providing finances and products, among others, included: 

• Asterra Labs
• Care by Design,
• CBDistillery,
• CBD American Shaman,
• Charlotte’s Web CWEB CWBHF,
• Columbia Care CCHW CCHW CCHWF 3LP,
• Global Widget,
• HempFusion CBD OTCQX: CBDHF)),
• Infinite CBD,
• Kannaway MJNA,
• Medterra CBD
• SunMed CBD