09 Jun Leading CBD Brands Collaborate to Sponsor Observational Research Aimed at Answering FDA’s Safety Concerns
ValidCare to capture Real World Evidence on product composition, effects and liver function
Centennial, Colo. – June 9, 2020 – ValidCare announced today that Boulder Botanical & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, HempFusion, and Kannaway will participate in an industry-wide study measuring the effects on the liver from daily use of full spectrum hemp derived CBD and CBD isolate by healthy adults. The companies are answering FDA’s repeated request, including the agency’s March 5, 2020 report to Congress for science-based data so it can confidently determine the appropriate regulatory path(s) for hemp derived CBD products.
“After inviting and screening over 100 brands to participate in this water-shed research, seven companies have chosen to demonstrate real leadership, collaboration and commitment to consumer safety,” said Patrick McCarthy, CEO of ValidCare. “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. 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.”
Regulation of hemp derived CBD products by FDA has been stalled since the passage of the 2018 Farm Act despite thousands of brands being available for purchase. “The lack of regulatory clarity creates risk for the industry and the American consumer,” said 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 process is to collect and provide “real world evidence” from healthy American adults who have consumed oral CBD products for at least 60 days. Measures include reported product experiences and a blood sample to understand how the consumer’s liver reacts. “Charlotte’s Web invests in precision science through our CW Labs and also through important research studies such as this ValidCare study because this research will provide much needed data,” said Tim Orr, Vice President of Innovation at Charlotte’s Web. “By being both science and data-driven we can secure long term consumer trust, while also addressing the FDA’s safety concerns with CBD products.”
“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,” said Chase Terwilliger, CEO of CBDistillery. “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. 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.”
“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,” said Rosemary Mazanet, MD PhD, and Chief Science Officer, Columbia Care Inc. “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.”
“We received and considered feedback from FDA on a preliminary study design, then combined it with feedback from brands and third-party principal investigators, namely Keith Aqua, MD and Jeffrey Lombardo PharmD, BCOP, respected and peer reviewed medical doctors and PhDs in Biostatistics, and constructed this observational study to answer FDA’s questions,” said McCarthy. The study is planned to start in early Q3, 2020 and is expected to be completed by year end. The design calls for participation by a minimum of 700 consumers. This 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.
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ValidCare, LLC provides clinical research outsourcing (CRO) and consumer intelligence solutions for the consumer packaged goods (CPG) and life sciences industries. ValidCare’s proprietary platform supports virtual research powered by real world evidence (RWE) including self-reported consumer data to deliver insights that help improve research, regulations, product development and consumer health. For more information, visit www.validcare.com or call 844-825-4322.