Despite the widespread use and availability of hemp-derived cannabidiol (CBD) products, officials from the Food & Drug Administration (FDA) say they still need to learn more about the safety of CBD before they determine how to regulate it.
In March of last year, the FDA issued a statement highlighting the importance of filling gaps in current knowledge about CBD and encouraged collaboration from industry stakeholders and researchers to help answer important questions about CBD’s safety. One of the FDA’s concerns was CBD’s potential to cause liver failure. In clinical trials of Epidiolex, the only FDA-approved drug containing CBD, 13% of patients treated with the drug had significant liver enzyme elevations which signal inflammation or damage in the liver. However, treatment with Epidiolex uses higher doses of CBD than are taken under normal circumstances by the average consumer. Whether liver injury from consumption of hemp-derived CBD is still a risk at the doses commonly used by consumers is unknown.
A local researcher is working with CBD industry pioneer and market leader, Charlotte’s Web, to generate new data that helps answer this question. Dr. Jeff Lombardo, an assistant professor at the University of Buffalo’s Center for Integrated Global Biomedical Sciences is leading a collaborative research study into CBD’s effects on the liver. Charlotte’s Web, whose development lab is located in Buffalo, is one of twelve companies participating in the study. The initial cohort recently completed the first portion of the study and investigators, including Lombardo, met with the FDA to discuss the results.
The study recruited 839 participants that had been using oral CBD products for the past 30 days. Participants first selected their standard CBD regimen which could include CBD isolate, broad-spectrum, or full-spectrum products from a company of their choice. The sponsoring companies then sent participants the products and had them continue their use for 30 days while documenting it in a journal. Then the participants had to provide blood samples for analysis of liver function enzymes. The study utilized a decentralized clinical research platform created by ValidCare, LLC. The ValidCare platform enabled enrollment of individuals from 49 states and the District of Columbia and allowed for continued participation throughout the COVID-19 pandemic.
The study found that individuals self-medicating with oral CBD had a higher prevalence of elevated liver function enzymes than would be expected in a normal, healthy population, but this rate was no different than what would be seen in the general population. In a healthy, disease-free population you might see liver enzyme elevations in approximately 2.5% of the population. But in the general population, from which the participants in this study were recruited, there are people with medical conditions and taking medications known to increase liver function enzymes, so you’d expect elevations in a higher percentage of the population ~5-10%.
“The percentage of patients’ experiencing elevated liver enzyme levels in our sample was no different than we’d expect to see in the general population. This data supports the notion that self-medication with CBD is safe and does not cause liver failure.” -Lombardo
Lombardo says they’ll now look to repeat this study in cohort 2 and expand their analysis using feedback provided by the FDA. This portion of the study has support from 7 additional companies and should be complete by fourth quarter 2021.
The completion of this study represents an important milestone for the CBD industry. Federal inaction on hemp-derived CBD products has led many states to develop their own set of rules governing the manufacture and sale of CBD products. This means businesses selling CBD products nationwide are subject to a labyrinth of state laws that are constantly in flux. Federal guidance on the issue would provide clarity and validation for both industry stakeholders and consumers.
In this landmark study, competing CBD brands were able to put competition aside and work together to get FDA the data it requested. Hopefully, this data will help bring the FDA one step closer to developing a regulatory approach for hemp-derived CBD products.
“The new data we’ve provided will assist the FDA in developing their regulatory stance on these products. This helps bring a new level of safety and trust to consumers.” -Lombardo
Bio: Jeff Lombardo, PharmD, BCOP is a research assistant professor at the Center of Integrated Global Biomedical Sciences, Translational Pharmacology Research Core, at the University of Buffalo School of Pharmacy & Pharmaceutical Sciences. Dr. Lombardo is also a pharmacist at the Botanist medical cannabis dispensary in downtown Buffalo.