• A group of seven CBD brands (Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway) have committed to collectively sponsor ValidCare (a clinical trial outsourcing and market research company) in conducting observational research to evaluate the impact of daily CBD use (both full-spectrum, hemp-derived CBD and CBD isolate) on the liver function of healthy adults.
  • According to a press release issued by ValidCare on June 9, 2019, the liver study, the results of which will be provided to the U.S. Food and Drug Administration (FDA) for consideration in its efforts to regulate CBD, is scheduled to begin in July 2020 and expected to be completed by the end of this year.  The study intends to aggregate data from at least 700 consumers, which will be combined with information regarding personal history, blood tests, and product information.
  • Participants will be provided with oral CBD products from the study’s supporting brands for consumption in connection with the study.  Participants will be required to attest that they have used the products for at least 60 days prior to the start of the study, and continue consuming the products for the duration of the study.  Participants will document their CBD use and any observable effects for 30 days, and provide blood samples.  The study is observational (not a randomized double-blind placebo controlled human clinical study), and FDA’s treatment, consideration, and evaluation of these results has yet to be seen.  As previously reported here on this blog, FDA recently announced that it made “substantial progress” towards a goal of providing additional guidance on ingestible CBD products, but offered no specific details and continued to emphasize its ongoing questions and concerns about the science, safety, effectiveness, and quality of CBD products (which include concerns regarding liver toxicity).
  • We will continue to monitor the situation for any developments.