Denver, CO—HempFusion Wellness has announced that its exclusive and proprietary hemp-derived CBD extract has achieved self-affirmed GRAS, which the company expects to drive significant incremental revenue growth at retail, according to a press release.

“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.”

This status was accomplished by having an independent panel of qualified experts review HempFusion’s safety dossier on the CBD extract, which included safety and toxicology studies, the published results of those studies, and a comprehensive review of the scientific literature on CBD.

“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 Dr. 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.”

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Additionally, HempFusion has prepared a New Dietary Ingredient Notification, ready for submission to FDA when a regulatory pathway is established for use of CBD as a supplement. The press release notes that there are three bills in front of Congress that could open that pathway:
  1. H.R. 841, which would legalize hemp-derived cannabinoids including CBD in dietary supplements.
  2. H.R. 6134, which would legalize hemp-derived CBD in foods and beverages.
  3. 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.”