Preliminary results of a new study indicate that hemp-derived CBD consumption does not cause harmful effects to the liver. The results of this human-safety study reportedly show no evidence of liver toxicity, liver disease or elevated liver-function numbers beyond what is common in the average population.
Filling the need for science-based data
The Denver-based medical research firm, Validcare, led this third-party consumer research study, which was sponsored by a dozen CBD brands. The study was commissioned by the FDA and designed in response to the FDA’s requests. The FDA reportedly commissioned this study to help ensure that it had the science-based data needed to determine a regulatory path for CBD products.
According to a recent Validcare release, the purpose of the study was to observe potential liver effects in adults who ingested CBD products for roughly two months. There were 839 consumers who participated in the first round of research, which occurred between August 2020 and February 2021.
On March 23, study investigators reportedly presented their initial findings to the U.S. Food and Drug Administration’s (FDA’s) Cannabis Product Council, which was formerly known as the Cannabis Work Group.
“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,” said Patrick McCarthy, CEO of Validcare. “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.”
A closer look at the results
“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 in the release. Lombardo is a Doctor of Pharmacy and a board-certified oncology pharmacist.
Investigators did observe minor elevations in the liver function tests in less than 10% of the test participants. This reportedly occurred regardless of age, product composition, form or amount consumed. However, these minor elevations were deemed clinically insignificant.
“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,” Lombardo explained.
According to a release, the study’s investigators were surprised to find that about 70% of the study’s participants took medications for a medical condition, but did not report an increase in adverse events.
“This unexpected, positive finding makes the data even more compelling and provides significant data to consider secondary safety measures in the general population,” co-principal investigator Keith Aqua, MD, said in the release.
Looking ahead to the next steps
“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,” Aqua added.
He explained that the study’s investigators will continue analyzing the data and plan to add a second group of participants to the study. By adding this second group, the investigators reportedly hope to increase the statistical certainty of their data, while verifying liver safety across more diverse populations and people living with medical conditions.
“We are excited for our principal investigators to continue, expand and report out on this foundational work in the next few months,” McCarthy said. “Once completed, safety results of this study will be shared with participating brands and the FDA. The investigators also plan to publish in a peer reviewed journal.”
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