Despite the rapid proliferation of CBD brands on the market, governmental regulation of the industry has been stalled since the 2018 Farm Act was passed. The Food and Drug Administration (FDA) has maintained that the organization is unable to develop the appropriate regulatory paths due to the lack of science-based data from qualified experts, especially on liver-toxicity.
In response to the FDA’s requests, ValidCare, a market intelligence platform, recruited CBD companies Boulder Botanical & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, HempFusion, and Kannaway for an industry-wide study that will measure the effects of full-spectrum hemp-derived CBD and CBD isolate on the livers of healthy adults. “The lack of regulatory clarity creates risk for the industry and the American consumer,” says Jason Mitchell, CEO of HempFusion. “We realized we have a choice to be part of the process and so we have opted to do so.”
The first step of the study—developed with input from the FDA, the brands involved, the third-party principal investigators, Keith Aqua, M.D., and Jeffrey Lombardo, Pharm.D., medical doctors, and Biostatistics experts—is to gather data from at least 700 healthy American adults who have consumed oral CBD products for at least 60 days. This involves collecting reported product experiences and blood samples in order to observe and understand how the consumers’ livers react. This data will be analyzed in combination with personal history and product data. The study is expected to begin this summer and be completed by the end of 2020. “We are pleased to announce our participation in this study as we continue to provide the FDA with the research needed to move the industry forward,” says Rosemary Mazanet, M.D., Ph.D., chief science officer of Columbia Care. “We hope to reveal real world evidence that supports daily CBD use in healthy adults and with the advancement of this study, we will better equip the cannabis community about its health benefits.”