Self-Affirmed GRAS status and recent regulatory achievements position HempFusion to meet or exceed US & global standards for CBD products
DENVER–(BUSINESS WIRE)–$CBD.U #CBD–HempFusion Wellness Inc. (TSX:CBD.U) (OTCQB:CBDHF) (FWB:8OO) (“HempFusion” or the “Company”), a leading health and wellness Company offering premium probiotic supplements and products containing CBD, announces that its exclusive and proprietary hemp-derived CBD extract has achieved self-affirmed Generally Recognized as Safe (GRAS) status. The Company expects this to drive significant incremental revenue growth at retail.
“Self-affirmed GRAS status is a major milestone that only a select few highly responsible CBD companies have achieved,” said Jason Mitchell, N.D., HempFusion’s co-founder and Chief Executive Officer. “Today, HempFusion and its family of brands are one of the select few CBD companies that stand fully prepared to meet or exceed US & global compliance standards. This puts the business in a position to win with large retailers, and we expect this could open new retail opportunities,” Dr. Mitchell continued.
Under the federal Food, Drug, and Cosmetic Act (FD&C Act), an expert panel can determine a substance is generally recognized as safe using scientific procedures. In accordance with FDA requirements, an independent panel of qualified experts reviewed HempFusion’s safety dossier on its hemp-derived CBD extract, which included safety and toxicology studies, the published results of these studies, and a comprehensive review of the scientific literature on CBD. HempFusion is one of the only select few companies to achieve a status of this kind, whereby the expert panel deemed HempFusion’s hemp-derived CBD extract safe for human consumption, thus providing a legal pathway for use in foods and beverages and making the extract eligible for use in dietary supplements.
“HempFusion has gone to extraordinary lengths to earn the trust of consumers and retailers by providing scientific data demonstrating our hemp-derived CBD extract is safe when used as intended. We achieved this through an exclusive joint-venture with our hemp extract supply partner Verdant Nature, LLC. HempFusion and this extended team of esteemed research partners spent nearly three years performing all necessary toxicology studies and conducting additional studies using our exclusive and proprietary USDA Organic DNA-verified industrial hemp from Verdant Nature, LLC. This data provides the necessary safety basis to show that our proprietary hemp extract including CBD is safe for human consumption,” commented Dr. Mitchell.
New Dietary Ingredient Notification Readies HempFusion for Anticipated FDA Changes
In addition to this self-GRAS status, HempFusion has also prepared a New Dietary Ingredient Notification (NDIN) and will submit the dossier when a regulatory pathway for the use of CBD as a dietary supplement is established. Currently, there are three Bills in front of Congress that could open this pathway:
- H.R. 841, which would legalize hemp-derived cannabinoids including CBD in dietary supplements.
- H.R. 6134, which would legalize hemp-derived CBD in foods and beverages.
- S. 1698, which would legalize hemp-derived cannabinoids including CBD in food, beverages, and dietary supplements.
“GRAS status and a successful NDIN will likely be the standard by which major retailers and big box companies vet brands for the safety of their billions of loyal consumers, and HempFusion is one of the few CBD companies with a completed dossier and ready to act,” said Dr. Mitchell. “It’s a common misconception in the industry that when one company achieves this level of compliance, it applies to all other companies. In fact, every validation is unique, requiring every company to independently evaluate whether a dossier should be prepared and submitted, based on the specific ingredient they are using and the raw material source.”
With self-affirmation of GRAS, upcoming NDIN, and the recent publishing of our toxicology manuscript, HempFusion is now poised to address major compliance issues that large retailers and online sellers seek to overcome. International conglomerates, many of whom have been anxiously waiting for clarity, will likely begin acquiring compliant brands to move quickly to market.
Investors can learn more in the November 29, 2021 edition of Hemp Industry Daily where Dr. Mitchell details Why Every Company Should Prepare Their Own NDIN.
One of a select few hemp-derived CBD companies that are today fully prepared to meet or exceed expected global guidance. HempFusion Wellness Inc. is a leading health and wellness company whose family of premium consumer brands include HempFusion™, Sagely Naturals™, Apothecanna™, and Probulin Probiotics™, one of the fastest-growing probiotics companies in the United States according to SPINs reported data.
One of only a few CBD companies to have achieved Self-Affirmed GRAS status, the HempFusion family of brands’ product portfolio comprises 112 SKUs including USDA Organic Certified Tinctures, proprietary FDA Drug Listed Over-The-Counter (OTC) Topicals, probiotic supplements and skin care products, a Doctor/Practitioner line, a White Label division and more. With a strong focus on research and development, HempFusion Wellness has 43 products under development.
Available from more than 18,000 US retail locations across all 50 states, HempFusion Wellness products are also available in China, Mexico, Ireland, United Kingdom, United Arab Emirates, South Korea and Canada and may be purchased online from each brand’s website, The Probulin Store on Amazon.com, Alibaba’s Tmall.com, the world’s largest cross-border online marketplace, and a multitude of additional e-commerce sites.
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 brand and retail expansion plans, future opportunities around hemp-derived CBD products 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 “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” in the annual information form of the Company dated March 31, 2021, 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.
Jason Mitchell, N.D.
Chief Executive Officer and Director