BOULDER, Colo., March 23, 2021 /CNW/ – (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.
