SANTA ROSA, Calif. – Care by Design Hemp, a wholly-owned CannaCraft brand, is pleased to announce that the groundbreaking clinical study exploring the effects of CBD on liver health has concluded after seven months of research. The IRB-approved study, which included the brand’s expertly formulated CBD products, was commissioned, designed and conducted by ValidCare in response to requests in early 2020 by the US Food and Drug Administration (FDA). The results showed the study’s participants exhibited no evidence of liver toxicity after using CBD daily for a minimum of 60 days. The FDA, which requested science-based data to help inform regulatory decisions for hemp-derived CBD products, has been informed by ValidCare investigators about the positive results of the study.
“This clinical study was performed with a collaborative spirit and provides the critical evidence that CBD consumers, the FDA, and the cannabis industry as a whole need to feel confident about the safety of the products being produced by this innovative industry,” said Matthew Elmes, Ph.D., Director of Scientific Affairs for Care By Design.
Care By Design, along with 11 other leading hemp CBD brands, assisted ValidCare in the recruitment and funding of the study, which observed 839 adults’ daily use of CBD for over 30 days followed by a blood test to evaluate liver function tests. No participants in the study showed signs of liver disease. Of all 839 daily CBD consumers that were tested, only 3 exhibited clinically relevant elevations of the liver enzyme ALT, and all 3 of these participants were found to also be taking prescription medications known to elevate liver enzymes, so the data from these few participants are currently under further investigation.
Care By Design customers were given the opportunity to participate through the company’s newsletter. Of the 1000 customers who replied, approximately 100 met all eligibility criteria and were selected to participate in the study ranging in age from 19-74 years old. Care By Design donated a three-month supply of Care By Design’s all-natural, triple-tested products in tincture or soft gel form to all of its study participants.
“With this Validcare clinical study, I feel that the legal cannabis industry did something truly special by putting ‘competition and capitalism’ aside in order to work together and answer some very important scientific questions regarding daily CBD consumption,” added Dr. Elmes.
Validcare offers sponsors, CRO’s and investigators a brandable, real-time platform as a service (PaaS) to power patient centered clinical research. Founded by experts with more than 20 years of industry experience spanning pharmaceuticals, biologics, medical products, medical devices and supplements, Validcare leverages technology and best practices to ensure measurable results from study design through completion in onsite hybrid and decentralized settings. As an organization, Validcare is passionate about improving patient access, diversity and participation in clinical research to power creation of life changing healthcare products. For more information, visit www.validcare.com.
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.