Global Widget part of first-of-its-kind industrywide clinical study reporting no evidence of liver toxicity in adults using CBD
TAMPA, Fla., March 23, 2021 /PRNewswire/ -- Global Widget, the manufacturer and distributor of iconic CBD brands Hemp Bombs®, Nature's Script™ and Perfect Paws Hemp™, is one of 12 CBD companies whose customers took part in a recent Validcare clinical investigation that reports no preliminary evidence of liver disease in the over 800 adults taking CBD as part of the trial.
Validcare, which conducts patient-centered clinical trials, said in its press release that a team of principal investigators has 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 of the 12 CBD companies, including Global Widget, completed the study between August 2020 and February 2021.
The study's investigators — calling the findings "validating and reassuring" — were surprised to find almost 70% 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% elevation1.
"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."
About Us
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.
1 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.
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SOURCE Global Widget
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