Results of Validcare Study of 839 Adults Ingesting CBD Report No Liver Toxicity
BOULDER, Colo., March 23, 2021 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the CBD industry pioneer, market leader and a Certified B Corporation, today reports the clinical results of a Validcare study conducted over the past seven months. The study's results reaffirm the safety of Charlotte's Web™ hemp derived CBD extracts. Charlotte's Web and 11 other companies supported the study to provide sound scientific data on liver toxicity to federal and state regulators including U.S Congress and the U.S. Food and Drug Administration ("FDA"). Researchers reported of the 839 participants, zero liver toxicity or disease was detected.
"We support using clinical science to inform our nation's health regulators, lawmakers, state and federal regulators but most importantly, we believe in using clinical science to build longterm consumer trust," said Deanie Elsner, Charlotte's Web CEO. "Relevant science and regulatory oversight should work hand-in-hand for the benefit of all Americans."
The FDA requested very specific liver toxicity data last March in its letter to Congress. This important Validcare study is responsive to the FDA's request.
The study's methodology used a decentralized, observational approach with adult consumers of full and broad spectrum hemp extracts and CBD isolates. The Company provided Charlotte's Web™ full-spectrum hemp extract products to its recruited participants. Each participating CBD company recruited a cohort of participants who are already CBD users and who have been prior users of CBD for a minimum of 30 days to meet study inclusion criteria. The study called for a minimum of 681 participants to achieve statistical relevance; the study netted at 839 participants who agreed to requirements of the study including blood lab work.
"Charlotte's Web was among the first companies to step up and commit to support for this liver safety study," said Patrick McCarthy, CEO of Validcare. "We are grateful for their leadership."
"The findings validate our view. Charlotte's Web is committed to safety studies to support regulators and confident consumer access to hemp-derived dietary supplements like Charlotte's Web products," said Tim Orr, Senior Vice President of Charlotte's Web and President of its CW Labs division.
About Charlotte's Web Holdings, Inc.
Founded in 2013 by the pioneering Stanley Brothers, Charlotte's Web's mission is to unleash the healing powers of botanicals through compassion and science, benefitting the planet and all who live upon it. Charlotte's Web Holdings, Inc., a Certified B Corporation headquartered in Boulder, Colorado, is the world's most trusted hemp extract. The Charlotte's Web family of brands includes Charlotte's Web™, CBD Medic™, CBD Clinic™, and Harmony Hemp™. The Company's premium quality wellness products start with proprietary hemp genetics that are 100-percent American farm grown under certified organic practices and manufactured into whole-plant hemp extracts containing a full spectrum of naturally occurring phytocannabinoids including CBD, CBC, CBG, terpenes, flavonoids and other beneficial hemp compounds. Charlotte's Web product categories include CBD oil tinctures, CBD gummies, CBD capsules, CBD topical creams and lotions, as well as CBD pet products for dogs. Charlotte's Web is the number one selling CBD brand in the U.S. and is distributed through more than 22,000 retail locations, select distributors 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. The Company weighs sound business decisions with consideration for how its efforts impact its employees, customers, the environment, and underserved communities. Charlotte's Web donates a portion of its pre-tax earnings to numerous charitable organizations in support of the greater good.
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This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "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" or "will" be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Charlotte's Web to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including assumptions as to the efficacy and results of research; the adverse impact of the COVID-19 pandemic to the Company's operations; and such risks contained in Charlotte's Web's annual information form dated March 27, 2020 and filed with Canadian securities regulators available on Charlotte's Web's issuer profiles on SEDAR at www.sedar.com. Readers are cautioned that the foregoing list of factors is not exhaustive.
SOURCE Charlotte's Web Holdings, Inc.