A study protocol, being developed by clinical research company ValidCare, will commence this July and determine any potential liver toxicity and the safety of CBD. The study—with generous support from several top CBD brands—is being interpreted as a critical stepping stone as it will help to guide the U.S. Food and Drug Administration (FDA) on CBD regulation.
ValidCare will investigate whether or not CBD demonstrates any hepatotoxicity or effects on the liver. The Colorado-based company typically conducts and outsources clinical research for the healthcare and hemp industries. The company’s research was designed with heavy input from a branch of the FDA, and the study will answer specific questions from the organization.
From July through September, 1,000 people will be observed, and their liver health will be monitored.
Hemp Industry Daily reports that because CBD is currently not being considered an investigational new drug (IND), the team will still have to rely mostly on observational data.
ValidCare’s study would have begun last March, but COVID-19, and presumably ongoing protests, pushed the schedule behind several months.
With the study now moving forward, it’s attracted support from the active CBD community. While over 100 CBD brands were invited to take part in the study, seven companies so far jumped on the opportunity.
The study is officially sponsored by the brands CBD American Shaman, Boulder Botanicals, CBDistilllery, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway. Each aforementioned CBD brand donated at least $100,000 to ValidCare’s project—representing the level of commitment to the science behind CBD in medicine. In addition, each CBD brand will have the opportunity to invite their consumers to become participants in the study.
Validcare CEO Patrick McCarthy said that more CBD brands could be added to the list, but the deadline is next week.
Participants must take CBD orally for 60 days prior to the study. Then, they will record their experiences in journals for the course of 30 days. In addition, participants will provide blood samples which will be screened under four liver-function tests. This investigation will provide ValidCare, and subsequently the FDA, with data that will clarify how to move forward.
Charlotte’s Web Holdings, named after child advocate Charlotte Figi, who recently passed away, helped bring awareness to the urgency of CBD regulation. CBD was one of the only medicines that helped ease the burden that Figi endured as a child suffering from intractable epilepsy due to Dravet syndrome. This study could pave the way to easier access to CBD products for children like Figi.
The decision to participate and donate a large sum to the study was based on the formal approach to forming FDA regulations.
“As the market share leader, anchored in science, sponsoring ValidCare’s study made strategic sense for us,” Deanie Elsner, Chief Executive Officer for Charlotte’s Web stated in a press release. “This research will provide important clinical data to guide our entire industry while also showing the FDA we’ve heard their requests and are answering their questions with precise data.”
This particular study will inform the FDA on how to move forward with regulations. Depending on how the FDA proceeds, the data could help CBD products to become more available in places such as pharmacies and grocery stores.
Following the 2018 Farm Bill, last year FDA Commissioner Scott Gottlieb, M.D. indicated that the organization is taking steps to formally evaluate the safety of CBD in products. “It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products,” Gottlieb wrote, “to help inform the FDA’s regulatory oversight of these products—especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods.”
Part of the reasoning behind ValidCare’s study is based on the known side effects from the CBD-based pharmaceutical drug Epidiolex. Past studies have suggested that high doses of Epidiolex elevate liver enzyme levels, perhaps with unknown consequences.
But most people on average aren’t taking high doses in excess of 700mg of CBD, such as the doses of Epidiolex that were observed in studies. In addition, most are taking more natural-occurring CBD found in oils and products.
The FDA is less likely to grant the millions of dollars needed to orchestrate thorough studies on liver toxicity, a quality that makes this particular study unique. Charlotte’s Web Holdings Vice President Tim Orr stated that the study will give the CBD industry a solid chance at disproving past studies on CBD’s effects on the liver. Orr mentioned the University of Arkansas’ study that found toxicity in CBD levels of over 700mg, but that this study will monitor more common doses.
These are the questions that must be answered before the FDA will allow CBD products to be sold with fewer restrictions.