ValidCare to Conduct FDA-focused Study on CBD and Human Health
SANTA ROSA, Calif., Sept. 2, 2020 /PRNewswire/ — Care By Design Hemp, a wholly-owned CannaCraft brand, announced today that it joined several industry leaders in an IRB-approved study to provide real world evidence of safety in cannabinoid product use which commenced this month.
The ValidCare study will measure the effects on the liver from daily use of full spectrum hemp derived CBD and CBD isolate by healthy adults. The resulting third-party data will address the FDA’s repeated request for more scientific data so it can confidently determine the appropriate regulatory path(s) for hemp-derived CBD products.
Care By Design Hemp is one of 13 leading CBD companies to participate in and fund this watershed research, out of more than 100 companies that were invited and screened. Other companies taking part include Charlotte’s Web, Boulder Botanical & Bioscience Labs, CBDistillery, CBD American Shaman, Columbia Care, Global Widget, HempFusion, Kannaway, MedterraCBD, SunFlora, Asterra Lab, and Infinite CBD.
“Clinical data is necessary to the progress of cannabis treatments. Over the years we have commissioned several anecdotal studies with ten-of-thousands of consumers to identify patterns and aggregate data on cannabis’ efficacy and side effects. Ultimately this information provided valuable insight on how we can better meet our customers’ needs,” said Tiffany Devitt, CannaCraft’s Chief Government Relations Officer. “We look forward to participating in the ValidCare study and we know this data will help inform the next wave of innovation in cannabinoid therapies.”
The first step of the process, according to ValidCare’s initial press release, 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. 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.
“Care By Design is a science- and data-driven company so I was ecstatic to hear about the opportunity to participate in a clinical, IRB-reviewed study on CBD’s safety. There’s a real dearth of quality safety data out there as cannabis and CBD have been very challenging to research historically due to federal restrictions,” said Matt Elmes PhD, Head of Research and Development at CannaCraft. Adding, “We welcome this unique opportunity to work alongside our consumers to meaningfully advance cannabinoid science. The valuable data we generate together will undoubtedly impact the future of hemp-derived CBD in the USA.”
The study commenced in late July, and ValidCare targets completion by the end of the year.
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.
About Care By Design
Care By Design is a wellness company with deep roots. Created in 2014 by patients seeking relief, Care By Design earned its success through operating with the highest integrity and making innovative products with unparalleled efficacy. Intent on harnessing the full healing power of cannabis therapeutics, Care By Design pioneered CBD to THC ratios that deliver powerful relief, cultivated by science. Their hemp products are available nationwide while their cannabis products are available in licensed dispensaries throughout California and Colorado. Backed by a team of expert cultivators, in-house scientists, clinicians, and caregivers, Care By Design exists to radically improve the lives of individuals and raise the baseline health of communities. Learn more at www.CBD.org.
Kial Long, VP Corporate Communications | CannaCraft, Inc.
Jim Walsh | Coppertop Media Relations