Two human safety studies provide
evidence that further addresses FDA's requests for liver safety
data
DENVER, May 17, 2022
/CNW/ - (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.
Forward-Looking
Information
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",
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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.
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SOURCE: ValidCare:
Answering The Call For CBD Safety; Human CBD Safety Study Outcomes
Presentation to Participating Brands (April 24, 2022)
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SOURCE Charlotte's Web Holdings, Inc.