Charlottes Web Holdings Inc CWEB

ONE HEMP Takes Landmark Step in Engaging Congress and FDA; Unveils Groundbreaking CBD Safety Study

LOUISVILLE, Colo., Sept. 19, 2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the industry pioneer and market leader in hemp-derived cannabidiol (CBD) products is proud to announce its founding membership in ONE HEMP, a coalition comprised of top CBD industry stakeholders to support Congress and the U.S. Food and Drug Administration (FDA) through a science and data-backed approach to arrive at sensible dietary supplement regulation.

"As leaders in the hemp-based CBD market that prioritize science, safety, and responsible commerce, we stand united with ONE HEMP to bring clarity and stability to the marketplace. The time for the CBD industry and Congress to act is long overdue," said Jared Stanley, Co-Founder and Chief Operating Officer of Charlotte's Web. "A decade has passed since hemp-based CBD became a wellness choice for more than 45 million daily American CBD consumers*. Over these ten years, rigorous scientific research, innovation, safety, and toxicology studies, current Good Manufacturing Practices, labeling standards, and valuable consumer feedback have demonstrated the self-regulation that responsible CBD suppliers have implemented to scaffold an entirely new industry."

Mr. Stanley continued, "Today, the uncertainty faced by thousands of companies and American farmers coupled with the confusion for millions of CBD consumers is unacceptable. It is time for Congress to clarify the FDA's mandate and definitively regulate CBD products as dietary supplements once and for all."

ONE HEMP unites leading CBD industry stakeholders in a pivotal moment to work toward more stringent regulatory standards, including independent third-party testing and accurate labeling. ONE HEMP took a milestone step by submitting to Congressional leaders comprehensive new insights and safety studies in response to a Request for Information from the House and Senate committees of jurisdiction. ONE HEMP is confident that the time for federal CBD policy reform has arrived during this Congressional session and is fully prepared to be the leading subject-matter resource for bipartisan action to support Congress and collaborate with the FDA. Charlotte's Web and ONE HEMP invite CBD industry partners who seek the regulatory standards that consumers deserve to join this historic coalition.

Playing a prominent role in ONE HEMP's consolidation of relevant scientific data presented to Congress was Dr. Marcel Bonn-Miller Ph.D., Chief Scientific Officer at Charlotte's Web and a prominent cannabinoid scientist.  Most recently, Dr. Bonn-Miller was part of a research team under the leadership of Dr. Rayetta G. Henderson Ph.D., Senior Managing Scientist at ToxStrategies LLC, that conducted a landmark study to derive potential upper oral intake limits for safe CBD usage by consumers. Upon critical review of all publicly available human and animal studies of CBD that assessed safety, a recommended upper intake limit of 70mg/day was determined for healthy adults and a limit of up to 160mg/day was identified for healthy adults excluding those trying to conceive, or currently pregnant or lactating. Healthy adults were defined in this study as those without medical conditions or taking medications. This study was specifically designed to address concerns regarding potential liver and reproductive toxicity, such as those raised by FDA, and appropriate dietary supplement thresholds for CBD safety. 

Dr. Henderson presented the study's findings during an informal legislative meeting and pointed out that "The study's suggested Upper Intake Limits for dietary supplement use by healthy adults not only closely correspond with the recommendations put forth by leading regulatory bodies (Health Canada, TGA, FSA), they provide a sufficient margin of safety for potential adverse effects and help to establish a safe framework for CBD consumption."

Dr. Bonn-Miller says, "This study will help to inform legislators and regulators as they determine manufacturing and labeling requirements for supplement products containing CBD.  Implementing scientifically based safety limits is crucial to protecting consumers. This research is also aligned with ONE HEMP's recommendations for accurate product labeling and, ultimately, holding CBD companies accountable for manufacturing and selling quality and safe products."

Charlotte's Web Holdings, Inc., a Certified B Corporation headquartered in Louisville, Colorado, is the market leader in innovative hemp extract wellness products under a family of brands that includes Charlotte's Web™, ReCreate™, CBD Medic™, and CBD Clinic™. Charlotte's Web whole-plant CBD extracts come in full-spectrum and broad-spectrum options, including ReCreate™ by Charlotte's Web, broad-spectrum CBD certified NSF for Sport®. ReCreate is the official CBD of Major League Baseball©, Angel City Football Club™ and the Premier Lacrosse League™. Charlotte's Web branded premium quality products start with proprietary hemp genetics that are North 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. Charlotte's Web product categories include CBD oil tinctures (liquid products) CBD gummies, CBD capsules, CBD topical creams and lotions, as well as CBD pet products for dogs.  Through its substantially vertically integrated business model, Charlotte's Web maintains stringent control over product quality and consistency with analytic testing from soil to shelf for quality assurance. Charlotte's Web products are distributed to retailers and health care practitioners throughout the U.S.A, and online through the Company's website at www.charlottesweb.com.  

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ONE HEMP's founding mission is to demand regulatory standards by Congress and the FDA that treat CBD products as dietary supplements and serve as a leading scientific resource to policymakers to ensure consumer safety and consistency. ONE HEMP is an industry working group comprised of leading voices and CBD market leaders. The group has enlisted some of the world's foremost cannabinoid researchers and toxicologists, ensuring that their approach is firmly rooted in robust scientific research and a deep understanding of CBD's safety profile. ONE HEMP aims to set industry benchmarks, nurturing trust and innovation in the CBD sector.

Industry leaders that have joined ONE HEMP include -- among others -- Charlotte's Web, Kazmira, and OBX (alphabetical order). Taken together these leaders represent the largest providers of CBD products.

To Join ONE HEMP, please contact Kelly D. Fair at kelly.fair@dentons.com.

Certain information in this news release constitutes forward-looking statements and forward-looking information within the meaning of applicable securities laws (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 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 statements containing forward-looking information. Although these statements containing forward-looking information are based on assumptions the Company considers to be reasonable based on the information available on the date such statements are made, such statements are not guarantees of future performance and readers are cautioned against placing undue reliance on forward-looking information.

The material factors and assumptions used to develop the forward-looking information herein include, but are not limited to, international and political considerations; regulatory changes; and 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 Annual Report on Form 10-K and quarterly report on Form 10-Q as amended, and other filings with the Securities and Exchange Commission available on www.SEC.gov. 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. 

*Brightfield US CBD Consumer Insights, 2022-23 

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SOURCE Charlotte's Web Holdings, Inc.