Validcare is leading an industry-sponsored liver-toxicity study to deliver aggregated, “real-world experience” data that will help answer federal health officials’ safety concerns about consumer use of CBD.
After speaking with the FDA, McCarthy said, “We came up with an approach where we can bring multiple vendors together who can fund this study and then take data from people that are already using BCD products.”
Each participant will take one baseline blood test and another at the end of the study. In between, they will journal their experiences on ValidCare’s CBD+me app. According to the company the proprietary app combines self-reported consumer data with advanced machine learning to deliver aggregated insights that help improve product quality, consistency, effectiveness, and the adoption of industry standards.
The study, which was supposed to run March through June, has been put on hold due to coronavirus concerns. McCarthy said they’re waiting to deploy until everyone is known to be safe.
When asked about using existing research from other countries, McCarthy said the FDA has been looking at a lot of the global data, but most research has been done on marajuana. He said that GW Pharmaceuticals has conducted a lot of high level research when developing its drug Epidiolex, however, that data is skewed toward the drug side. Epidiolex is an oral CBD medication that treats several epilepsy disorders.
McCarthy said there is also a number of other cannabinoids such as CBG and CBN that are attracting attention. “Of course those are not addressed in the Farm Bill, it’s only CBD. So the question raised again is ‘what is it?’”
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