Enters Safety Assessment Phase to Await Approval
DENVER, July 1, 2022 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web Holdings, Inc., ("Charlotte's Web" or the "Company"), the market leader in full-spectrum cannabidiol ("CBD") hemp extract wellness products, has passed validation in its Novel Food applications from the Food Standards Agency ("FSA") in the United Kingdom for its Original Formula full-spectrum hemp extract product.
This marks a milestone for its Original Formula. Charlotte's Web is the only substantially vertically integrated US company with a full-spectrum hemp extract to have passed the Validation phase and advance to the safety Assessment Phase. This uniquely positions Charlotte's Web in the growing UK CBD market.
The Company's dedication to and investment in vertical integration, with oversight over all stages of product quality from seed and soil to final product, has been recognized by the leading authorities in the EU and UK jurisdictions, as its gained approval in this next stage of the Novel Food application process. The significant research and safety data provided by Charlotte's Web for its products speaks to the commitment of the Company to truly be The World's Most Trusted Hemp ExtractTM as it prepares to expand distribution to the UK, EU, and countries worldwide.
"Charlotte's Web understands that product quality, safety, and brand values matter to global health seekers who are demanding premium full-spectrum products," said Jacques Tortoroli, CEO of Charlotte's Web, "It's critical to scaffold these emerging markets with the high bar set by our proprietary hemp genetics, scientific rigor and innovation practices. International audiences are only now learning the difference between full-spectrum and isolate CBD products, which provides a great opportunity for education, product differentiation and consumer adoption as they begin to understand the health advantages inherent in full-spectrum products."
Novel Foods
Novel Foods are ingredients which have not been widely consumed by people in the UK or European Union (EU) before May 1997. This includes cannabidiol ("CBD") and other consumable derivatives of the hemp plant, including whole-plant hemp extract. Novel Foods needs to be authorized by the FSA before they can be included on the list of novel foods and marketed for sale in the UK.
The FSA is the Central Competent Authority for food safety that issues guidance to support consistency in approach in the United Kingdom. The FSA's rigorous Novel Food authorization process for CBD offers regulatory stability and a viable path to full commercialization for CBD products within the UK. A validated Novel Food FSA authorization is required to legally sell ingestible CBD products such as oils, gummies, and capsules beyond March 2021. Charlotte's Web's applications with comprehensive toxicity and safety studies have been validated and will proceed for risk assessment. This status allows Charlotte's Web to continue selling its products in the U.K.
In addition to its Novel Foods application, Charlotte's Web is collaborating with The European Industrial Hemp Association (EIHA) which is part of the Secretariat Advisory Board (SAB), a European consortium of the UK's and Europe's leading CBD and hemp trade bodies and groups collaborating to provide hemp industry views, innovation and research, and includes the Scottish Hemp Association and the British Hemp Alliance. The SAB is focused on encouraging the development of clear UK regulation for CBD that reflects evidence-based policy to safely serve the public and wider national interests engaged in public wellness.
UK CBD Market
According to the Brightfield Group the CBD market in the UK has grown rapidly, with the number of CBD consumers virtually doubling in 2019 to reach over 7% of the adult population in 2020, representing sales of more than US$250M in 2020, growing to an estimated US $1.3 billion by 2025.1
The UK has a large populace of 67 million people with a predisposition toward natural wellness products making the UK CBD market well-positioned to thrive. With the FSA's support for a uniquely well-defined regulatory framework, the UK's CBD market is expected to continue on an upward trajectory.
Charlotte's Web Products in the U.K.
Charlotte's Web products can be legally purchased online today through the Company's exclusive UK distributor Savage Cabbage Ltd., one of the oldest and most trusted CBD companies in the UK, serving an active and loyal customer base of wellness seekers. Savage Cabbage is a Member of EIHA (European Industrial Hemp Association) and distributes a large portfolio of Charlotte's Web whole-plant, full spectrum products that contain all the beneficial compounds that exist in the hemp plant as well as CBD. Under the new Novel Foods regulatory framework, Savage Cabbage will leverage its extensive distribution network in the UK to expand the presence of Charlotte's Web in retail distribution channels and on the high street, with a growing number of notable retailers.
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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
- Brightfield Group market sizing and projections account only for ingestible products that have gone through formal Novel Foods authorization. www.brightfieldgroup.com
Forward-Looking Information
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. Specifically, this news release contains forward-looking information relating to, among others: the future of Charlotte's Web and the impacts of management 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. The material factors and assumptions used to develop the forward-looking information herein include, but are not limited to, the following: the impact of the COVID-19 pandemic; the regulatory climate in which the Company currently operates and may in the future operate; consumer interest in CBD; successful sales of the Company's products; and the success of sales and marketing activities. 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 Report on Form 10-K for the year ended December 31, 2021 available on www.SEDAR.com and www.sec.gov , and other risk factors contained in other filings with the Securities and Exchange Commission available on www.sec.gov and filings with Canadian securities regulatory authorities available on www.sedar.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 Charlotte's Web Holdings, Inc.