New Validcare Clinical Study Reports Preliminary Results of CBD Liver Safety

DENVER, March 23, 2021 /PRNewswire/ -- Balanced Health Botanicals™ (BHB), a family of hemp-derived CBD brands including their flagship brand CBDistillery™, announced today their involvement in the newly released preliminary findings of Validcare's CBD Liver Safety Study. Preliminary findings showed no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions.

The study comes as a response to the FDA's 2020 call for increased science-backed data in order for the federal agency to make any recommendations on regulation. This study is the first step in increasing that research and opening a direct line of communication with the FDA as principal investigators of the study met with FDA on March 15 and reviewed the preliminary liver safety results in the form of an abstract.

"There continues to be an increased need for science-backed data to aide in supporting very welcomed FDA regulation of this compound that has been used in medicine for thousands of years, but until recently, not allowed to be sold in the United States," said Chase Terwilliger, CEO of Balanced Health Botanicals. "We're excited and honored to be a part of this ongoing research, specifically with Validcare's recent findings. This is a major step for the hemp industry as a whole, and CBDistillery will continue to provide products, insight and resources where needed to ensure additional research can be done."

In total, twelve product-based CBD companies, including CBDistillery, led the industry in this initial study cohort, providing funding, product, certificates of authenticity and assisted with recruitment of adult US based consumers. Over 830 consumers completed the study between August 2020 and February 2021. Use of Validcare's decentralized clinical research platform and partnership with national laboratories enabled participants and principal investigators to successfully complete this first cohort, despite the pandemic, and compile and deliver results to brands and FDA within six weeks.

All CBDistillery™ products are third-party lab-tested to ensure the highest quality and consistency. CBDistillery™ products are also U.S. Hemp Authority-certified and formulated using non-GMO industrial hemp grown in the USA using natural farming practices.

For more information on BHB's CBDistillery™ product line and the brand's mission, please visit: https://www.thecbdistillery.com/.

About Balanced Health Botanicals
Balanced Health Botanicals™ (BHB) is a family of hemp-derived CBD brands that includes CBDistillery™ and BOTA™. Flagship brand CBDistillery™ was founded in Denver in 2016 to pursue a rapidly growing and predominantly untapped market. It has since evolved into one of the largest and most cost-effective brands in the CBD market, sold in retailers nationwide. The all-new BOTA™ is a line of premium plant-powered skincare and supplements that combines powerful natural botanicals with hemp-derived CBD. BHB's mission is to provide the highest quality, U.S. grown, hemp-derived CBD products at fair prices and to be the premier CBD education resource. BHB has made significant investments in its infrastructure, supply chain capabilities, world-class manufacturing facilities, and product portfolio to solidify itself as the leader of the #CBDMOVEMENT™.

About Validcare
Validcare offers sponsors, CRO's and investigators a brandable, real-time platform as a service (PaaS) to power patient centered clinical research. Founded by experts with more than 20 years of industry experience spanning pharmaceuticals, biologics, medical products, medical devices and supplements, Validcare leverages technology and best practices to ensure measurable results from study design through completion in onsite hybrid and decentralized settings. As an organization, Validcare is passionate about improving patient access, diversity and participation in clinical research to power creation of life changing healthcare products.

For more information, visit www.validcare.com or call 844-825-4322.

SOURCE Balanced Health Botanicals

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