Two human safety studies provide evidence that further addresses FDA’s requests for liver safety data
DENVER – (TSX: CWEB) (OTCQX: CWBHF) – Charlotte’s Web Holdings, Inc. (“Charlotte’s Web” or the “Company”), the science-driven CBD industry pioneer and global market leader, today shared the conclusions of the combined first and second cohort of the industry-sponsored liver safety study. Cohort two added another 222 adults who daily consumed hemp CBD tinctures orally for 60 days. The second cohort combined with the first study cohort used 17 commercially available brands and 39 hemp CBD products across a total of 1,061 participants, increasing statistical certainty to 98%. The investigation’s preliminary findings mirror the first cohort’s results: no association of increased prevalence of increased liver function test, no clinical liver disease, zero product related adverse events and new data concluding no daytime drowsiness and no testosterone deficiency.
“We were asked by Congressional leadership to understand and get answers to important safety questions posed by the FDA so they can confidently regulate these products. Together, we achieved our goal – with feedback from FDA and participation by 17 brands, we oversubscribed and operated a nationwide, decentralized clinical study in the midst of the COVID pandemic,” said Validcare’s Chief Operating Officer Rod Nuss.
The Food and Drug Administration (FDA)’s earlier requests for scientific data on liver safety have now been formally addressed through safety investigations of 1,061 adults who supplied blood lab samples and maintained daily journals. Validcare, the contract research organization (CRO) which ran the study, gained FDA feedback on the IRB approved protocol and augmented the protocol over time to collect additional lab results at the request of FDA.
While liver safety outcomes were the announced primary focus of the study, secondary outcomes from the study include1:
- No increase in daytime drowsiness reported per Stanford Sleep Scale.
- CBD use by male study participants does NOT increase prevalence of low testosterone at any age. Data suggests CBD use may be helpful in preventing low testosterone in older individuals.; and
“We are excited that these two cohorts will provide the FDA with the scientific data the government agency had requested of the CBD industry on liver safety for those who ingest CBD daily. These results provide further evidence to support policymakers in shaping a much-needed federal regulatory framework for hemp CBD products,” said Charlotte’s Web Co-founder and Chief Operating Officer Jared Stanley. “Charlotte’s Web will continue to support and invest in hemp CBD studies as we are a science-driven company.”
“The execution of these two cohorts provides proof of the hemp CBD industry working cooperatively to support rigorous scientific research to inform regulators, the FDA, and the U.S. Congress,” said Charlotte’s Web Sr. Vice President and the Company’s President of its CW Labs Division, Tim Orr. “The 17 leading hemp CBD industry brands have advanced the science for hemp CBD by providing real world, evidence-based outcomes in liver safety, drowsiness, and testosterone levels.”
About Charlotte’s Web Holdings, Inc.
Charlotte’s Web Holdings, Inc., a Certified B Corporation headquartered in Denver, is the market leader in innovative hemp extract wellness products under a family of brands which includes Charlotte’s Web™, CBD Medic™, CBD Clinic™, and Harmony Hemp™. Charlotte’s Web branded premium quality products start with proprietary hemp genetics that are 100-percent American farm -grown using organic and regenerative cultivation practices. The Company’s hemp extracts have naturally occurring botanical compounds including cannabidiol (“CBD”), CBC, CBG, terpenes, flavonoids, and other beneficial compounds. The Company’s CW Labs R&D division advances hemp science at two centers of excellence in Louisville, Colorado, and the Hauptmann Woodward Research Institute at the University at Buffalo, part of the State University of New York (SUNY) network. Web product categories include full-spectrum hemp CBD oil tinctures (liquid products), CBD gummies (sleep, stress, exercise recovery), CBD capsules, CBD topical creams and lotions, as well as CBD pet products for dogs. Through its vertically integrated business model, Charlotte’s Web maintains stringent control over product quality and consistency with 20+ product lot testing for quality assurance. Charlotte’s Web products are distributed to more than 15,000 retail, over 8,000 health care practitioners, and online through the Company’s website at www.CharlottesWeb.com
Charlotte’s Web is a science-driven and a socially and environmentally conscious company. It is committed to using business as a force for good and a catalyst for innovation. Charlotte’s Web donates a portion of its pre-tax earnings to numerous charitable organizations in support of the greater good. Charlotte’s Web was founded in Colorado by the seven Stanley Brothers with a mission to unleash the healing powers of botanicals through compassion and science, benefiting the planet and all who live upon it.
Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, ”forward-looking information”). In some cases, but not necessarily in all cases, forward looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, ”is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to the Company’s expansion activities and growth strategy; the Company’s expectations regarding future cash flow and its financial position; the results of cost saving efforts; the impact and results of the Company’s reorganization; market share expectations; and impacts of regulatory changes.
Statements containing forward-looking information are not historical facts but instead represent management’s current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information. Important factors that could cause actual results and financial condition to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the “Risk Factors” section of the Company’s most recently filed annual information form available on www.SEDAR.com and in the Company’s most recently filed Form 10, as amended, and other filings with the Securities and Exchange Commission available on www.SEC.com. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
|1||SOURCE: ValidCare: Answering The Call For CBD Safety; Human CBD Safety Study Outcomes Presentation to Participating Brands (April 24, 2022)|
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