More brands sign up for large-scale CBD safety study

A second batch of major CBD brands have signed up to participate in the first large-scale study into the safety of the cannabinoid.

US research body, Validcare, has announced a second cohort of brands participating in its large-scale, human safety study, to answer the FDA’s call for additional data on CBD.

This second cohort expands the reliability of Validcare’s recently completed findings in Cohort one, regarding liver safety in healthy adults ingesting either full or broad-spectrum hemp-derived CBD.

Preliminary findings showed no evidence of liver disease in 839 participants, following seven months of clinical investigation.

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 for hemp derived CBD products.

“We welcome the participation of industry-leading Garden of Life, as well as Impact Naturals, Tauriga Sciences, Inc. and others in this important industry led research,” said Keith Aqua, MD, co-principal investigator of the 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 both groups 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.

Additional financial support for the study has come from Open Book Extracts.

CEO Dave Neundorfer, said: “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.”

Companies participating in Cohort 1 include: 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 analysed by investigators.

Preliminary results were blinded and shared with the FDA in mid-March to help the agency make progress in determining the appropriate regulations.

“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, agreed, commenting: “We are excited to have our state of the art, decentralised trial technology overcome the hurdles of performing research during a pandemic.

“We have demonstrated in challenging times that patients who participate in decentralised trials, with appropriate planning and study design, can successfully clarify product safety and effects. From enrolment through journaling and blood collection to real time data visibility for investigators, we have streamlined the research process while better understanding outcomes.”