DENVER--(BUSINESS WIRE)--HempFusion Wellness Inc. (TSX:CBD.U) (OTCQX:CBDHF) (FWB:8OO) ("HempFusion" or the "Company"), a leading health and wellness CBD company utilizing the power of whole-food hemp nutrition, is pleased to announce that it has submitted its dossier to the United Kingdom's Regulatory Food Safety Agency (the "FSA").
HempFusion, in conjunction with its strategic and exclusive supply chain partner, has submitted its novel foods application to the FSA with the coordination of a leading regulatory agency in Europe. This submission represents the first step in the United Kingdom’s (the “UK”) regulatory approval process required to allow products that contain CBD to be sold on the shelves of retailers in the UK. The submission includes a detailed analysis of the quality, stability and safety of HempFusion's raw ingredients and many unique product formulations. In addition to proprietary heirloom hemp-sourcing and state-of-the-art low pressure and low-temperature C02 extraction methods, the submission also includes compliant labeling and testing requirements and complete toxicology data.
The Company's focus on compliance and sourcing premium raw materials further substantiates the quality of HempFusion's exclusive Organic Panoramic Hemp Extract and strategically positions HempFusion for continued sales within one of the largest markets in Europe, the UK. HempFusion believes the submission is an essential step in preparing for anticipated European Union (the “EU”) regulations.
"We believe the UK's decision to allow CBD companies to obtain a Novel Food Authorization from the FSA is a tremendous step forward for the global CBD industry," commented Jason Mitchell, N.D., HempFusion's Co-Founder and Chief Executive Officer. "HempFusion was built on the pillars of regulatory compliance. We have invested significant time, resources, and energy to ensure our products meet the highest standards, and we are pleased to report our submission includes completed toxicology data, which may represent one of the most complete submissions to date. We look forward to working with the FSA as regulations continue to evolve within the UK. This submission firmly establishes HempFusion as a future leader within the UK market,” continued Dr. Mitchell.
The novel food application's primary function is to assess CBD product safety, including detailed toxicology studies. HempFusion places significant importance on safety for its consumers as evidenced by its participation and co-sponsoring of many studies and clinical trials, such as the Company’s participation in ValidCare’s liver and reproductive toxicity study, believed to be the largest CBD human observational study to date.
The Company has recently entered Europe through Ireland and looks forward to maintaining its long track record of compliance by meeting the requirements of the FSA ahead of its broader planned expansion throughout the UK and the EU to further establish it as a global leader.
HempFusion is a leading health and wellness CBD company utilizing the power of whole-food hemp nutrition. HempFusion distributes its family of brands, including HempFusion, Probulin Probiotics, Biome Research, and HF Labs, to approximately 4,000 retail locations across all 50 states of the United States and select international locations. Built on a foundation of regulatory compliance and human safety, HempFusion’s diverse product portfolio comprises 48 SKUs including tinctures, proprietary FDA Drug Listed Over-The-Counter (OTC) Topicals, Doctor/Practitioner Lines and more. With a strong focus on research and development, HempFusion has an additional 30 products under development. HempFusion is a board member of the US Hemp Roundtable, and HempFusion’s wholly-owned subsidiary, Probulin Probiotics, is one of the fastest-growing probiotics companies in the United States, according to SPINs reported data. HempFusion’s CBD products are based on a proprietary Whole Food Hemp Complex™ and are available in-store or by visiting HempFusion online at www.hempfusion.com or www.probulin.com.
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This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements“) that relate to HempFusion’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result”, “are expected to”, “expects”, “will continue”, “is anticipated”, “anticipates”, “believes”, “estimated”, “intends”, “plans”, “forecast”, “projection”, “strategy”, “objective” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward-looking statements relating to the Company’s continued sales within the UK, preparation for anticipated EU regulations, compliance with the requirements of the FSA, planned expansion throughout the UK and the EU and the Company’s other plans, focus and objectives.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond HempFusion’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID-19 pandemic and other factors set forth under “Forward-Looking Statements” and “Risk Factors” in the final long form prospectus of the Company dated December 17, 2020 and available under the Company’s profile on SEDAR at www.sedar.com. HempFusion undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for HempFusion to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.