
New clinical research has demonstrated that using cannabidiol (CBD) products does not lead to any additional risks of liver harm. Since CBD is usually take topically, meaning applied to the skin, or orally – passing through the digestive system – the question of the cannabinoid’s effect on the liver has come into question.
The liver metabolized cannabinoids and other compounds, and it also accumulates toxins and other substances to be excreted as human waste.
This process has led to theoretical concerns over the long term impact and accumulation of CBD on the liver itself. Another compound in cannabis, the psychotropic THC, is already known to be harmless to the liver, although the human liver can metabolize -9-THC into Hydroxy-11-∆-9-THC, which is significantly more potent than THC itself.
Study shared with FDA for review
John Agostinelli reports that Validcare, which conducts patient-centered clinical trials, said in a press release that a team of its principal investigators recently met with members of the Food and Drug Agency’s Cannabis Product Council (formerly known as the Cannabis Work Group) to share initial findings.
“The safety, efficacy and quality of our products is our No. 1 priority,” said Margaret Richardson, Global Widget Chief Compliance and Legal Officer. “As the FDA readies its guidance for the CBD industry and hemp-derived CBD products, it is imperative that science-based data such as this be presented so the administration can issue proper regulatory guidance in the months ahead.”
A minimum of 681 participants were needed to achieve the desired statistical significance. Over 830 consumers from among customers selected from 12 CBD companies, including Global Widget, completed the study between August 2020 and February 2021.
‘Reassuring results’ from large scale study
The study’s investigators — calling the findings “validating and reassuring” — were surprised to find almost 70 percent of study participants reported having a medical condition and taking medications for those conditions, without an increase in reporting of adverse events. Studies of similar populations demonstrate an 11% elevation in liver function tests, while this research demonstrated about a 9 percent elevation*.
“We understand the significance, importance and immediate need for CBD safety research for the FDA, industry and the US consumer,” said Patrick McCarthy, CEO of Validcare. “We are excited for our principal investigators to continue, expand and report out on this foundational work in the next few months. Once completed, safety results of this study will be shared with participating brands and FDA. The investigators also plan to publish in a peer-reviewed journal.”
* Kariv, R., Leshno, M., Beth-Or, A., Strul, H., Blendis, L., Kokia, E., Noff, D., Zelber-Sagie, S., Sheinberg, B., Oren, R., & Halpern, Z. (2006). Re-evaluation of serum alanine aminotransferase upper normal limit and its modulating factors in a large-scale population study. Liver international : official journal of the International Association for the Study of the Liver, 26(4), 445–450.
Global Widget, founded in 2016 and headquartered in Tampa, Florida, is a vertically integrated manufacturer, distributor and marketer of CBD and health and wellness products, and a leader in gummy production and packaging. The company is the trusted powerhouse behind the iconic CBD brands Hemp Bombs, Nature’s Script and Perfect Paws Hemp for pets. With more than 110,000 square feet of facility space and more than 200 employees, Global Widget is one of the nation’s largest CBD companies and a leading contract manufacturer providing quality products and support services to retailers and distributors worldwide. www.globalwidget.com.
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