Charlotte’s Web Holdings (CWEB.T) is banding together with six other CBD brands to support ValidCare’s scientific study to answer questions posed by the Food and Drug Administration (FDA) about the efficacy of CBD products.
CBD arrived on the scene last year in a whirlwind of hype and promises. Companies were offering everything from CBD pills for your anxious dog to facial skin creams and companies were courting opprobrium from the FDA with their thinly-veiled claims about the miraculous ability of cannabinoids to cure everything from cancer to depression. Most of these companies played it safe, adding the necessary disclaimers where they were required to stay on the right side of the law, but occasionally the FDA had to get involved and class action lawyers made money.
Specifically, made a report to congress on March 5, 2020, requesting additional science-based data from the CBD industry, and ValidCare has answered the call. Out of the myriad health claims that CBD advocates claim, the FDA has selected the liver, and the human trial will determine if daily use of full spectrum derived CBD or CBD isolate has any impact on the liver.
“As the market share leader, anchored in science, sponsoring ValidCare’s study made strategic sense for us. This research will provide important clinical data to guide our entire industry while also showing the FDA we’ve heard their requests and are answering their questions with precise data” said Deanie Elsner, chief executive officer for Charlotte’s Web.
ValidCare provides clinical research outsourcing and consumer intelligence for the hemp and healthcare industries. Their platform supports virtual research powered by real world evidence, including self-reported consumer data, to deliver information and help improve research, regulations, product development and consumer health.
In the past, the FDA approved a CBD-based drug called Epidiolex, which had been researched and constructed by Greenwich Biosciences. During the FDA’s first public hearing in May 31, 2019, the company’s vice-president of U.S. professional relations, Alice Mead, indicated to the FDA that CBD could potentially be a liver toxin.
The studies on CBD’s affects on the liver are both few and unclear in their findings.
One study indicates that 10% of subjects developed high liver enzymes and had to stop using CBD for this reason, while other research suggests that CBD can improve liver function. The studies done on Epidiolex indicates that CBD is metabolized by the liver.
As if this issue weren’t complicated enough—products with CBD oil may not provide the exact amount listed on the packaging. The consumer might be using more or less than they think, and this is especially true of over-the-counter supplements and e-cigarettes. Now that CBD oil is appearing in different products, anyone with liver damage should be aware of this.
“This is a particularly important time for research on the science behind hemp-derived CBD as we advocate for FDA regulation of our category. Charlotte’s Web invests in scientific research, including internal and external independent studies such as ValidCare’s. Prioritizing the science is essential to ensuring product safety, effectiveness and consumer trust,” said Tim Orr, vice president of innovation for Charlotte’s Web.
Charlotte’s Web is one of seven companies that agreed to participate and fund the research out of more than 100 that were invited.
Maybe now we can get some answers.
—Joseph Morton
