cbdMD'S Human Clinical Study Demonstrates Strong Pain Benefits
Initial Results from the First of Its Kind Clinical Study Demonstrate cbdMD's Proprietary Broad Spectrum Hemp Extract Reduces Pain in Healthy Adults.
Charlotte, North Carolina--(Newsfile Corp. - November 17, 2022) - cbdMD, Inc. (NYSE American: YCBD) (NYSE American: YCBDpA), one of the nation's leading, highly trusted and widely recognized CBD companies, today announces the first results from its recently concluded human clinical trial conducted at the University of South Carolina. These studies began in the fall of 2020 and the first results to be reported show the Company's proprietary broad spectrum hemp extract reduces pain in healthy adults. The ground breaking randomized, double blind, placebo controlled study was designed to explore the effects of cbdMD's proprietary broad spectrum cannabinoid blend on sleep, immunity, inflammation, mood, and pain in healthy adult subjects to further support the efficacy of the Company's products.
The Company and its subsidiary cbdMD Therapeutics, LLC will be releasing further results from the human clinical as they are finalized over the next few weeks and will eventually be publishing the results in a peer reviewed journal. The Company anticipates these favorable outcomes will form the basis for a number of future cbdMD product formulations. The study's results will also serve as preliminary data for additional future investigational studies executed by cbdMD's Therapeutics Division.
Study participants were given cbdMD's proprietary broad spectrum hemp extract blend containing 100 mg of CBD and other minor cannabinoids once per day for three months. The first results coming out of the study show that the perception and intensity of pain in healthy adults is significantly reduced with daily consumption of the Company's flagship broad spectrum blend. In anticipation of these results, the Company has recently launched a new flagship product in tincture, gummy and softgel which contains the clinically studied broad spectrum hemp extract blend containing 100 mg per serving of CBD. The flagship blend is contained in all of the Company's broad spectrum products, including its industry first NSF for Sport products. In order to make these efficacious products available to more people in need, the Company has repositioned itself to be CBD brand of choice by providing the highest potency products at the best value in the industry.
"Once published, the data from this study will be submitted to the Food and Drug Administration (FDA) for Structure Function Claim Notifications (SFCNs), the process whereby manufacturers inform FDA of their intent to make statements about their products' benefits on the structure or function of their body," said Lance Blundell, cbdMD's General Counsel and Co-Chair of cbdMD Therapeutics, LLC. "cbdMD leads the industry with our commitment to science. We also lead the industry with our belief that as a responsible and trusted dietary supplement manufacturer we must comply with all applicable regulations. We have conducted the required toxicological studies and we have now completed the required human clinical in order to make structure function claims about our proprietary CBD products. We hold a firm belief that our products are not drug precluded as the Citizen's Petition we filed earlier this year stated. Therefore, we will submit our SFCNs to the FDA as all federally compliant dietary supplement companies should. We will continue to advocate and fight for regulatory clarity and fair treatment for our industry. While others are content to sit back and wait, we will pave the way for legal cannabinoid products."
"Our products help solve customers' problems. The data from this study will guide our product development roadmap and ensure we provide our customers with products formulated to make a real impact on their daily lives. This study confirms that our products are efficacious and truly help our customers to support and maintain a healthy lifestyle. We will use this data to educate our customers on the benefits of our products so that their product choices are based upon informed decisions. Once our study is published and we submit our SFCN to the FDA, cbdMD will be the only CBD company able to legally market its CBD products with a pain claim benefit without leaning on additional ingredients for the claim. This study is yet another example of how cbdMD cares about its customers' health and wellness," said Kevin MacDermott, cbdMD's President.
About cbdMD, Inc.
cbdMD, Inc. is one of the leading and most highly trusted and recognized hemp-derived cannabidiol (CBD) brands with a comprehensive line of U.S. produced, THC-free1 CBD products as well as Full Spectrum and Delta 9 THC products. The cbdMD brand currently includes high-quality, premium CBD products including tinctures, gummies, topicals, capsules, sleep aids and more. The Company's Paw CBD brand includes formulated pet products including tinctures, chews and topicals in varying strengths. To learn more about cbdMD and the complete line of products, please visit www.cbdmd.com, follow cbdMD on Instagram and Facebook or visit one of the thousands of retail outlets that carry cbdMD products.
This press release contains certain forward-looking statements that are based upon current expectations and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements can be identified using words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and ''proposes.'' These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict. You are urged to carefully review and consider any cautionary statements, including but not limited to expectations on our clinical studies, and other disclosures, including the statements made under the heading "Risk Factors" in cbdMD, Inc.'s Annual Report on Form 10-K for the fiscal year ended September 30, 2021 as filed with the Securities and Exchange Commission (the "SEC") on December 17, 2021 and our other filings with the SEC. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are generally outside the control of cbdMD, Inc. and are difficult to predict. cbdMD, Inc. does not undertake any duty to update any forward-looking statements except as may be required by law. The information which appears on our websites and our social media platforms, including, but not limited to, Instagram and Facebook, is not part of this press release.
1 THC-free is defined as below the level of detection using validated scientific analytical tools.
Ronan Kennedy, CFO
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