HempFusion Wellness Inc, 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 the status 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.” 

 

Under the federal Food, Drug, and Cosmetic 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,” said Mitchell. “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.” 

 

HempFusion Positioned for FDA Changes

 

In addition to the 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, the following three bills are before Congress that could open this pathway:
 

“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 Mitchell.