Since the 2018 Farm Bill legalized the cultivation and sale of industrial hemp and its extracts, the CBD industry has been steadily growing. Effective against a wide range of ailments and most importantly, devoid of cannabis’ infamous high, cannabidiol has quickly become the go-to ingredient for people who have lost faith in pharmaceuticals. However, the industry is barely regulated, and the U.S. Food and Drug Administration (“FDA”) has repeatedly called for stakeholders to provide reliable scientific data, especially on the effects of long term use on the liver.
A group of CBD brands is doing just that. They have sponsored a study to determine any potential liver toxicity and the safety of CBD, and the study will be carried out by Colorado-based clinical research company ValidCare. Slated to commence this July, the clinical study, which was designed with heavy input from a branch of the FDA, is being interpreted as a critical step in providing the agency with scientific data that will guide its efforts to regulate CBD.
The study is officially sponsored by CBD American Shaman, Boulder Botanicals, CBDistillery, Charlotte’s Web Holdings, Columbia Care, Hempfusion, and Kannaway. Each brand donated at least $100,000 for the study, and they will each have the opportunity to invite their consumers to become participants in the study. It was scheduled to start last March but the coronavirus pandemic and the civil unrest currently sweeping through the U.S. pushed the schedule several months ahead.
1,000 subjects will be observed and their liver health monitored from July through September. They will be required to take CBD orally for 60 days before the study then they will record their experiences in journals for the course of 30 days. Additionally, they will also provide blood samples that will be screened under four liver function tests.
“As the market share leader, anchored in science, sponsoring ValidCare’s study made strategic sense for us. 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,” says Deanie Elsner, Chief Executive Officer for Charlotte’s Web.
Ever since CBD products hit the shelves, the FDA has been apprehensive and has warned consumers that most of these products may not be safe. The research carried out by ValidCare will provide crucial data on CBD’s effect on the liver and it will inform the FDA on how to move forward with regulating CBD.
It is widely believed that the entire cannabis industry, including Green Growth Brands Inc. (CSE: GGB) (OTCQB: GGBXF), will be keen to see the results from this first of a kind study into cannabidiol.
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