The FDA is going to obtain information from a third-party consumer study on CBD’s effects over the liver in humans so that it can move ahead with regulation. The study is set to start in July. It’s sponsored and going to be conducted by ValidCare, the Colorado-based company that performs both clinical and market research in the healthcare and hemp sectors. When it comes to the study’s protocol, this has been developed in collaboration with the FDA’s CBD-focused working group.
Many CBD Brands Joined ValidCare
ValidCare got the support of 7 CBD brands that are willing to cooperate with funds for the study and recruitment of participants. These brands are Boulder Botanicals, CBD American Shaman, Charlotte’s Web Holdings, CBDistillery, HempFusion, Kannaway and Columbia Care. Each of these companies contributed with over $100,000 to the research.
More Companies Consider Joining
It seems that more companies consider joining ValidCare, however the deadline for participation to the study is next week, as the CEO of ValidCare, Patrick McCarthy said. Here are his exact words on this:
“We talked to well over 100 brands, some of the largest brands that you would see in retailers or online or otherwise. And seven have stepped forward to wear the white hat, to lead an industry, to actually come forward and produce this data, to make certain that consumers can have a good understanding of what is safe and what’s not.”
Consumer Safety to be Measured
Focused on CBD liver toxicity, the research was set to start in March. However, it got delayed because of the COVID-19 pandemic crisis. It’s going to gather data from about 1,000 participants, stating with July and until September. This study is rather unique because it’s neither the investigational new drug (IND), nor the dietary ingredient (NDI) type. Instead, it focuses on observing and understanding what effects the daily consumption of CBD can have over the liver function in healthy adults.
Products from Participant Brands to Be Used
The participants to the study will be given some specific CBD products from the brands involved in the research. They will have to attest the consumption of the oral CBD formulas for at least a period of 60 days before the study, also to continue consuming those products. Besides, they’re going to journal how much CBD they’re using and the effects felt for 30 days. Blood samples will be taken, whereas their liver function will be checked 4 times for the entire duration of the study.
Why Does the FDA Needs This Data?
Columbia Care’s chief science officer, Dr. Rosemary Mazanet, says the FDA needs a “real-world” study on CBD daily consumption’s effects on the liver because the Epidiolex drug, which is formulated with CBD and FDA approved, has caused liver enzyme elevations in those consuming it. Here are her words on what the study is aimed at precisely:
“Most of us are giving people doses that are a lot less than 700 milligrams a day. We’re not looking for a therapeutic dose to prevent seizures; we’re looking for doses that are going to give some wellness or health benefit.”
She continued by saying that US and European health regulators are aware of the fact that increased doses of Epidiolex can cause liver damage.