Two human safety studies provide evidence that further addresses FDA's requests for liver safety data

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.  

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