Clinical research and data firm ValidCare LLC is joining major CBD companies on an industrywide studying focusing on the effects cannabidiol has on the liver.
The participants in the study will include Boulder Botanical & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web CWBHF, Columbia Care CCHWF, HempFusion and Kannaway.
The analysis will focus on measuring the effects on the liver from daily use of hemp-derived CBD and CBD isolate by healthy adults.
The companies are answering the FDA’s repeated request for commentary on the topic, including the agency’s March 5 report to Congress, where it asked for science-based data to confidently determine the appropriate regulatory paths for hemp derived CBD products.
The CBD Study: The observational study was designed with significant input from the FDA, the brands and third-party principal investigators Keith Aqua, MD and Jeffrey Lombardo PharmD, BCOP – both respected and peer reviewed medical doctors and PhDs in biostatistics.
The study is expected to start in the third quarter and wrap by the end of the year. The design calls for participation by a minimum of 700 consumers and will collect personal histories, blood tests and product data, to provide investigators with the opportunity to understand multiple variables across populations, products and lifestyles
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“By being [the data] both science and data-driven we can secure long term consumer trust, while also addressing the FDA’s safety concerns with CBD products," Tim Orr, Charlotte's Web vice president, told Benzinga.
Why It Matters: Last year, the FDA issued a consumer advisory regarding products containing cannabis or cannabis-derived compounds.
The agency said CBD has “the potential to harm,” and “can cause liver injury.” The agency added that it has seen only limited data about CBD safety, and that it pointed to real risks that need to be considered before taking CBD for any reason.
This comes at a time when both the FDA and FTC have issued warnings and complaints to companies marketing CBD products with unproven medical claims and that are of unknown quality.
Studies such as this one by ValidCare could provide valuable real-world data to inform future FDA rulings on the science, safety and quality of products containing CBD.
“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,” said Rosemary Mazanet, chief science officer at Columbia Care.
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Lead image by Ilona Szentivanyi. Copyright: Benzinga.
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