Open Book Extracts (OBX) said it will support the latest large-scale human safety study undertaken by Validcare, results of which will provide the U.S. FDA with the information requested to support the safety of CBD.
 
“In order to inform the regulatory framework surrounding hemp derived, non-THC cannabinoids, the FDA has requested additional safety data from the industry,” said Dave
Neundorfer, co-founder and CEO of OBX. “Together with Validcare, OBX is advancing that research, and we look forward to evaluating the safety of cannabinoids used for health and wellness via scientific rigor.”
 
OBX is a Roxboro, N.C.-based manufacturer, distributor, and formulator of cannabinoid ingredients and finished products that helps brands in the CBD space bring safe and effective products to market.
 
In April, Validcare added a second cohort of CBD brands participating in this study. According to its own news release, this second cohort expands Validcare’s recently completed findings in Cohort 1 regarding liver safety in healthy adults ingesting either full or broad-spectrum hemp-derived CBD. The study is designed to respond to the FDA’s repeated requests, 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.
 
“The addition of this cohort strengthens the statistical reliability of the liver safety results as well as whether drowsiness or testosterone levels are impacted by long-term CBD consumption,” said Keith Aqua MD, co-principal investigator of the IRB-approved study. “All of these measures are important to FDA and consumers.”
 
Neundorfer commented, “OBX believes that this research is essential to optimize the targeted benefits of cannabinoids to consumers around the world.”
 
It is anticipated that the safety results from Cohorts 1 and 2 will be published in peer-reviewed journals later this year. Non-safety related data will be shared with participating brands and made available by license to help the industry and investors better understand the needs and impact of these products on consumers.
 
In addition to working with Validcare, Neundorfer said, OBX is pioneering the development of cannabinoid therapies through strategic partnerships with leading research institutions. While much of the company’s product development work is client-guided, OBX recently embarked on several of its own research-backed product development initiatives, targeting the nutraceutical, skin care, and veterinary markets. OBX expects to commercialize its findings through licensing deals and/or joint venture partnerships with well-known, widely distributed consumer brands.