Hemp Fusion Wellness, which also markets a line of probiotic products, markets a line of CBD products in tincture, capsule and gummy delivery forms. The company also offers a line of topical products.
Achieving self affirmed GRAS status is a major milestone for the company and demonstrates transparency and a willingness to comply with the laws that govern the dietary supplement sector, said company co-founder and CEO Jason Mitchell, ND.
That’s true even if these products occupy a legal and regulatory limbo at the moment, Mitchell said. The 2018 Farm Bill opened the flood gates for CBD prdoucts to enter the marekt even if it did not clarify many of the issues surrounding these products. The primary issue at the moment is FDA’s position that because CBD was first investigated as a drug, it is not a legal dietary ingredient for use in supplements or foods.
“Self-affirmed GRAS status is a major milestone that only a select few highly responsible CBD companies have achieved,” Mitchell said.
“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,” Mitchell added.
Mitchell also claims that his company has a dossier put together ready to submit for a New Dietary Ingredient Notification. Two companies have submitted NDINs for full spectrum hemp extracts, both of which FDA has rejected, both from the drug exclusion standpoint and because the Agency is reportedly concerned about the safety of the ingredients.
At a high profile public meeting the Agency convened on May 31, 2019 on the subject of CBD, one of the speakers was Igor Kortubash, PhD, of the University of Arkansas. At that time Kortubash and some collabortors had just completed (but had not yet published) a toxicity study which found the potential for liver damage from CBD at high doses. Kortubash’s presentation, one of the more than 100 slots for speakers that day, appeared to make a distinct impression on the panel of FDA experts who were listening to the testimony.
Mitchell said he anticipates the safety and quality assurance work his company has done will prove a point of differentiation when the regulatory logjam finally breaks.
“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,” he said.
“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,” he added.