DENVER —HempFusion Wellness, a health and wellness company offering probiotic supplements and products containing CBD, said its hemp-derived CBD extract has achieved self-affirmed Generally Recognized as Safe (GRAS) status.
The company expects this to improve retail sales.
“Self-affirmed GRAS status is a major milestone that only a select few highly responsible CBD companies have achieved,” said Jason Mitchell, HempFusion’s co-founder and CEO. “Today, HempFusion and its family of brands are one of the select few CBD companies that stand fully prepared to meet or exceed U.S. and global compliance standards. This puts the business in a position to win with large retailers, and we expect this could open new retail opportunities.”
Under the federal Food, Drug and Cosmetic Act, an expert panel can determine a substance is generally recognized as safe using scientific procedures, the company said. 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, the company said.
“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,” Mitchell said. “We achieved this through an exclusive joint-venture with our hemp extract supply partner Verdant Nature LLC.”
HempFusion and this extended team of research partners spent nearly three years performing all necessary toxicology studies and conducting additional studies using its exclusive and proprietary USDA Organic DNA-verified industrial hemp from Verdant Nature LLC, he said.
“This data provides the necessary safety basis to show that our proprietary hemp extract including CBD is safe for human consumption,” said Mitchell.
In addition, HempFusion has 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 Congress that could open this pathway.
The Denver-based HempFusion portfolio features 112 SKUs including tinctures, topicals, probiotic supplements and skin care products. Available from more than 18,000 U.S. retail locations in all 50 states, HempFusion Wellness products are also available in China, Mexico, Ireland, the United Kingdom, United Arab Emirates, South Korea and Canada.
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