This July, a study by ValidCare will kickoff to examine the adverse effects that CBD could potentially have on the liver. ValidCare is a clinical research company that aims to keep consumers safe and informed.
Though it was initially scheduled to begin in March, COVID-19 postponed the commencement of the study. The goal of ValidCare’s research is to notify the Food and Drug Administration of any CBD health risks that could warrant regulation.
Fortunately, ValidCare will have no problem attaining data. Several CBD companies have come forward to offer their support. The official sponsors of the study are Charlotte’s Web Holdings, CBDistillery, Columbia Care, Boulder Botanicals, CBD American Shaman, HempFusion, Infinite CBD and Kannaway.
Each of these CBD companies has donated a generous $100,000 to get this study off the ground. Due to their heavy involvement and vested interest, these CBD brands can invite their consumers to be participants in the study.
Deanie Elsner, the CEO Of Charlotte’s Web, states that sponsoring this research made strategic sense. Their company has long tried to comply with the FDA, and they want nothing more than to provide them with the answers and precise data that they’re looking for.
Elsner hopes that ValidCare’s findings will both provide clarity and push the industry forward. Charlotte’s Web is also keen to participate because of Charlotte Figi, their namesake.
Charlotte, a young girl with Dravet syndrome, recently passed away due to medical complications. Growing up, Charlotte struggled with severe seizures. CBD was one of the only medicines that provided relief.
Through this study, Charlotte’s Web hopes that ValidCare and the FDA will be motivated to make CBD products more accessible to people like Charlotte. In Elsner’s words, this research will offer “important data that’ll guide the entire industry.”
ValidCare will observe 1,000 individuals who have consumed a controlled amount of CBD for 60 days before the study.
For the next 30 days, participants will be asked to record their experiences in a journal. For clinical purposes, blood samples and screenings will also be critical components of the process.
Using four liver function tests, researchers will determine if there’s a correlation between CBD usage and liver failure. Their conclusions will dictate the urgency for CBD regulation.
If the results come back positive, the FDA may allow CBD to be sold in pharmacies and grocery stores.
However, there are a series of unanswered questions that the FDA is determined to resolve. They won’t proceed until they’ve satisfied this requirement.
Epidiolex, a CBD-based pharmaceutical drug that’s thought to elevate liver enzyme levels, is why the FDA has reservations about the safety of CBD. Some studies have proposed that CBD is only toxic when consumed in extremely high doses, but the FDA would like to rule out all suspicion.
Many CBD brands argue that consumers seldom ask for 700 milligrams of CBD, which is the supposed amount that could cause unknown consequences. What’s more, Epidiolex is unlike natural CBD that’s generally found in oils and other products.
Another representative at Charlotte’s Web spoke on this issue as well. Tim Orr, who’s a part of their leadership team, stated that ValidCare’s study would give the CBD industry a chance to disprove the findings of the Epidiolex research.
By September, we should know more about where the FDA is at with regulating CBD. Much like the CBD businesses involved, ValidCare is eager to get the ball rolling.
So long as the participants are healthy and safe, they aren’t anticipating any more delays.
With so many consumers and CBD companies willing and able to take part in this crucial study, ValidCare has high hopes that they’ll acquire the observational data that they desperately need.
