Initial conclusions of the combined first and second cohorts of a US cannabidiol industry-sponsored liver safety study has indicated a good safety profile for CBD.
The second study cohort combined with the first involved use of 17 commercially available brands and 39 hemp CBD products with a total 1,061 participants. Preliminary findings have indicated:
- no evidence of elevated liver function
- no clinical liver disease
- no product- related adverse events
- no daytime drowsiness
- no testosterone deficiency
Participants in the study were adults 18-75 years of age across the USA who consumed CBD orally for a minimum of 30 days (second cohort – 60 days). All products were accompanied by third-party certificate of analysis (COA) documentation confirmed by a neutral third party and the final study design had the FDA’s blessing.
The study, which we first mentioned back in 2020, was in response to the FDA’s call to “CBD” (Collect Better Data) on cannabidiol; particularly in relation to the potential for liver damage.
“The execution of these two cohorts provides proof of the hemp CBD industry working cooperatively to support rigorous scientific research to inform regulators, the FDA, and the U.S. Congress,” said Charlotte’s Web’s Tim Orr.
Charlotte’s Web was one of the companies involved in the study, which was sponsored by ValidCare.
Cannabidiol is a non-intoxicating cannabinoid that is being used to treat or manage a number of conditions. As is still the case for many cannabis-based medicines, there are always more calls for evidence in terms of CBD’s efficacy and safety. But the availability of this new evidence means one less excuse for the FDA to continue faffng about on cannabidiol regulations; a situation leaving consumers confused about CBD and the industry in limbo.
“The time has come for FDA to regulate CBD and other hemp derivatives,” said the U.S. Hemp Roundtable’s Jonathan Miller. “If FDA does not act, we call on Congress to pass legislation such as HR 841, HR 6134 and S. 1698 which would require the FDA to develop regulatory pathways for the sale of hemp extracts like CBD in ingestible form.”