Seven U.S. CBD companies are collaborating in a study measuring the effects on the liver from daily use of full spectrum hemp derived CBD and CBD isolate.
Back in August last year, the U.S. Food and Drug Administration said it was “excited” about cannabidiol but needed more data to determine its safety. FDA Principal Associate Commissioner for Policy – Office of Policy, Lowell Schiller, JD, quipped that the Administration needed to make informed scientific decisions about cannabidiol and that required a focus on a different CBD: “Collect Better Data”.
In the meantime, the FDA’s opinion on CBD remain very cautious and it cannot conclude cannabidiol is generally recognized as safe (GRAS).
The new study, sponsored by ValidCare, may help fill gaps in the FDA’s knowledge.
The other companies involved are:
- Botanical & Bioscience Labs
- CBD American Shaman
- Charlotte’s Web
- Columbia Care
“ValidCare is proud to sponsor this research and help answer important questions for the industry, while preserving intellectual property and rights to re-use this data with FDA for individual product submissions at a later date,” said ValidCare CEO Patrick McCarthy.
The study is planned to start early in the third quarter of this year and expected to be completed by the end of 2020. A minimum of 700 consumers will be involved, with data to be combined with personal history, blood tests and product information to provide investigators with an opportunity to understand multiple variables across populations, products and lifestyles.
The final design of the study is based on feedback from the FDA, brands and third-party principal investigators on a preliminary study design.
There has been some previous research of the impact of CBD on liver function. For example, a 2019 study of mice demonstrated when delivered orally to mice in the form of a concentrated extract, CBD has the potential to cause liver injury. However, in that study very high doses of CBD were used. As the old adage goes – “the dose makes the poison”.
A much earlier study (2011) indicated cannabidiol improved brain and liver function in a fulminant hepatic failure-induced model of hepatic encephalopathy in mice. Hepatic encephalopathy (HE) is a syndrome seen in patients with end-stage liver disease.