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Charlotte’s Web Steps Up to Support Research to Address FDA’s Request for More Scientific Data

June 9, 2020
in Science
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Charlotte’s Web Steps Up to Support Research to Address FDA’s Request for More Scientific Data
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BOULDER, Colo., June 9, 2020 /PRNewswire/ – (TSX: CWEB) (OTCQX: CWBHF) Charlotte’s Web Holdings, Inc. (“Charlotte’s Web” or the “Company”), the company behind the world’s most trusted hemp extract™ and the CBD industry market leader, announced its sponsorship, with six other CBD brands, of ValidCare’s scientific study, to address the Food and Drug Administration’s (FDA) prior public questions about CBD products.  ValidCare will be conducting a human trial study to ascertain if daily use of full spectrum hemp-derived CBD or CBD isolate has any impact on the human liver. In its report to Congress dated March 5, 2020, the FDA requested additional science-based data from the CBD industry. The ValidCare study will provide third-party scientific data intended to directly address some of the FDA specific requests.

“As the market share leader, anchored in science, sponsoring ValidCare’s study made strategic sense for us,” said Deanie Elsner, Chief Executive Officer for Charlotte’s Web. “This research will provide important clinical data to guide our entire industry while also showing the FDA we’ve heard their requests and are answering their questions with precise data.”

Charlotte’s Web is one of only seven companies that agreed to participate in and fund this important research, out of more than 100 that were invited to take part.

“This is a particularly important time for research on the science behind hemp-derived CBD as we advocate for FDA regulation of our category,” said Tim Orr, Vice President of Innovation for Charlotte’s Web. “Charlotte’s Web invests in scientific research, including internal and external independent studies such as ValidCare’s. Prioritizing the science is essential to ensuring product safety, effectiveness and consumer trust.”

About ValidCare

ValidCare, LLC provides clinical research outsourcing (CRO) and consumer intelligence solutions for the hemp and healthcare industries.  ValidCare’s proprietary platform supports virtual research powered by real world evidence (RWE) including self-reported consumer data to deliver insights that help improve research, regulations, product development and consumer health. For more information, visit www.validcare.com or call 844-825-4322.

About Charlotte’s Web Holdings, Inc.

Founded by the seven Stanley Brothers in Colorado to unleash the healing power of botanicals through care, compassion and science, Charlotte’s Web Holdings, Inc. is the market leader in the growing, production and distribution of innovative hemp-derived cannabidiol (“CBD”) wellness products. The Company’s exceptional quality products, tested more than 20 times, start with proprietary hemp-derived CBD extracts naturally containing a full spectrum of phytocannabinoids, including CBD, terpenes, flavonoids and other beneficial hemp compounds. Industrial hemp products are non-intoxicating. Charlotte’s Web product categories include CBD Oil tinctures (liquid products), CBD capsules, CBD topicals, as well as CBD pet products. Charlotte’s Web hemp-derived products are sold in more than 11,000 brick and mortar stores, and online at www.CharlottesWeb.com. The rate the Company pays for agricultural products reflects a fair and sustainable rate driving higher quality yield, encouraging regenerative farming practices, and supporting U.S. farming communities.

Charlotte’s Web is a socially conscious company and 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 affect its employees, customers, the environment, and the communities where its employees live and where it does business, while maximizing profits and strengthening its brands. The Company’s management believes that socially- and environmentally-conscious actions have a positive impact on the Company, its employees, its shareholders and society. Charlotte’s Web donates a portion of its pre-tax earnings to charitable organizations.

Shares of Charlotte’s Web trade on the Toronto Stock Exchange (TSX) under the symbol “CWEB” and are quoted in U.S. Dollars in the United States on the OTCQX under the symbol “CWBHF”. As of May 13, 2020, Charlotte’s Web had 71,945,914 Common Shares outstanding and 92,455.575 Proportional Voting Shares convertible at 400:1 into Common Shares, for an effective equivalent of 108,928,144 Common Shares outstanding.

Subscribe to Charlotte’s Web news

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”, “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. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

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. These forward-looking statements include, but are not limited to, statements relating to the results and efficacy of the ValidCare study, and the ability of the study to address certain FDA-specific questions.

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 the study; the FDA’s consideration of the study; 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.

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