Second Cohort Joins Safety Study to Gather Data for FDA

Decentralized Clinical Trial Allows for Consumer Participation During COVID

(DENVER, Colo.) — April 15, 2021 — Validcare announced today the addition of a second cohort of CBD brands participating in a large scale, human safety study, a significant and widescale endeavor to answer the FDA’s call for additional safety data. This second cohort expands the reliability of 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.

“We welcome the participation of industry-leading Garden of Life, as well as Impact Naturals, Tauriga Sciences, Inc. (OTCQB:TAUG) and others in this important industry led research,” said Keith Aqua, MD, co-principal investigator of this IRB approved study. “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. All of these measures are important to FDA and consumers.”

Safety results from Cohorts 1 and 2 will ultimately 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.

Additional financial support for the study has come from Open Book Extracts. “As an ingredient manufacturer and product development house that helps brands bring safe and effective products to market, we are pleased to support this meaningful safety research that benefits our clients and the industry at large,” said Dave Neundorfer, the company CEO.

The following twelve product companies participated in Cohort 1: Asterra Labs, Care by Design, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Global Widget, HempFusion, Infinite CBD, Kannaway, Medterra CBD and SunMed CBD. Over 830 consumers completed the study in early February 2021, despite the challenges presented by COVID-19, surpassing the original goal of 681 consumers. Data collection associated with Cohort 1 is being analyzed by investigators. Preliminary results were blinded and shared with the FDA in mid-March to help the agency make progress in determining the appropriate regulatory paths for orally consumed CBD products.    

“Now is the time for brands to build trust with regulators and consumers,” said Jeff Lombardo PharmD, BCOP, co-investigator. “This unique crowd-sourced approach to research has competing brands working side by side to get the FDA the data it has requested. With over 3,500 brands on the market in the United States, consumers are smart to evaluate products from those brands who are confident enough to invest in safety science.”

Patrick McCarthy, CEO of Validcare, agrees, “We are excited to have our state of the art, decentralized trial technology overcome the hurdles of performing research during a pandemic. We have demonstrated in challenging times that patients who participate in decentralized trials, with appropriate planning and study design, can successfully clarify product safety and effects. From enrollment through journaling and blood collection to real time data visibility for investigators, we have streamlined the research process while better understanding outcomes.”

About Validcare

Validcare provides patient-centered research solutions to transform the delivery of life sciences and nutraceutical products. Our technology and services place the patient’s voice at the center of product research, resulting in greater patient participation, improved scientific data, more reliable product claims and accelerated product development. Founded by experts with more than 20 years of industry experience, Validcare offers the leading solution for best practices in streamlining research for regulatory compliant, life-improving products.

For more information, visit Validcare or call 844-825-4322.