Hemp and CBD producer Charlotte’s Web (TSX: CWEB) is sponsoring a new study to answer repeated requests from the U.S. Food and Drug Administration for more scientific data on the effects of CBD on human health.
On Wednesday, the Colorado-based company said it is joining six other U.S. CBD brands to fund the study led by ValidCare, a private hemp research company.
ValidCare said the clinical trial will focus on the effects of daily use of hemp-derived CBD in the liver of healthy adults and provide third-party scientific data directly to the FDA.
The study aims to address the FDA’s ongoing questions about the potential harms of CBD products that were highlighted in a March 5 report to U.S. Congress, “including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness.”
Read more: FDA’s update on CBD regulations is ‘frankly absurd’
Since the U.S. farm bill passed in 2018 and made hemp products legal, the FDA has banned the marketing of hemp-based CBD food, drink and pet products until more research is conducted.
Companies hope the research will give the FDA confidence to speed up its regulatory framework for hemp-derived CBD products.
“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,” Charlotte’s Web CEO Deanie Elsner said in a statement.
Read more: Revenue growth stagnates for Charlotte’s Web
While the company is the CBD market share leader in the U.S., it has blamed a lack of a clear framework for its declining CBD sales in the last two quarters.
Colorado-based Charlotte’s Web is the CBD market share leader in the U.S., but has reported stagnating sales in the last two quarters due to a lack of regulatory guidance for the touted wellness extract. Press photo
CBD study results expected by end of 2020
ValidCare says they’ve been talking to the FDA about how to best design the study and has also named two third-party medical doctors to review the research.
The study is planned to start in July and is expected to be completed by the end of the year. The research will collect data from a minimum of 700 Americans who have consumed CBD products orally for at least 60 days.
ValidCare says the data will be combined with personal history, blood tests and product data to provide investigators with the opportunity to understand multiple variables across populations, products and lifestyles.
ValidCare CEO Patrick McCarthy called the study a “water-shed moment” for the industry while praising the seven CBD brands for stepping up to fund the research.
“With over 3,500 brands vying for market share, these brands put a premium on science, data and consumer safety over just marketing and revenues,” he said in a statement. “ValidCare is proud to sponsor this research and help answer important questions for the industry, while preserving intellectual property and rights to re-use this data with FDA for individual product submissions at a later date.”
Watch the interview of leading companies participating in our #CBD liver study to inform FDA regulation https://t.co/KbRuGXHCib
— Validcare (@ValidCare1) June 10, 2020
The other six companies sponsoring the study include multi-state cannabis operator Columbia Care (NEO: CCHW), as well as five private CBD companies: Boulder Botanical & Bioscience Labs, CBDistillery, CBD American Shaman, HempFusion, and Kannaway.
“At this time, the FDA continues to assert that, without additional data from qualified experts, they’re unable to develop an appropriate regulatory scheme specific to CBD,” CBDistillery CEO Chase Terwilliger said.
“That’s why continued data collection is vital for all parties involved, and why, as a group, we’ve engaged industry and academic experts to develop the study protocol,” he said. “We are confident in our products and processes and are committed to consumer safety. This data will help pave the path forward for our industry.”
The FDA has issued several warning letters in the last year to CBD producers for marketing their products online as effective treatments for various conditions including anxiety and arthritis.
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Top image via Deposit Photos
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