Hemp Fusion Wellness, which also markets a line of probiotic products, markets a line of CBD products in tincture, capsule, and gummie forms. The company also offers a range of topical products.
Achieving self-certified GRAS status is an important 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 though those products are currently in legal and regulatory limbo, Mitchell said. The 2018 Farm Bill opened the floodgates for CBD products to hit the market, even if it didn’t clear up many of the issues surrounding those products. The main issue right now is the FDA’s position that since CBD was first studied as a drug, it is not a legal food ingredient for use in dietary supplements or edibles.
“The self-certified GRAS status is an important milestone that only a select few, highly responsible CBD companies have achieved,” said Mitchell.
“Today, HempFusion and its family of brands are one of the few CBD companies fully prepared to meet or exceed U.S. and global compliance standards. This positions the company to win at major retailers and we expect this could open up new retail opportunities,” Mitchell added.
Mitchell also claims that his company has put together a dossier ready to submit a new food ingredient notification. Two companies have submitted NDINs for full-spectrum hemp extracts, the FDA rejected bothBoth from a drug exclusion perspective and because the agency is reportedly concerned about the safety of the ingredients.
At the a high-level public meeting convened by the agency on May 31, 2019On the topic of CBD, one of the speakers was Igor Kortubash, PhD, from the University of Arkansas. At the time, Kortubash and some associates had just completed (but not yet released) a toxicity study that found the potential for liver damage from CBDat high doses. Kortubash’s presentation, one of more than 100 slots for speakers that day, seemed to make a significant impression on the panel of FDA experts listening to the testimony.
Mitchell said he expects the safety and quality assurance work his company has done will be a differentiator when the regulatory deadlock finally breaks.
“GRAS status and a successful NDIN will likely be the standard by which major retailers and conglomerates assess brands for the safety of their billions of loyal consumers, and HempFusion is one of the few CBD companies with a full dossier and ready to act. “, he said.
“It’s a common misconception in the industry that when one company achieves this level of compliance, so does every other company. In fact, each validation is unique and requires each company to independently assess whether a dossier should be prepared and submitted based on the specific ingredient they use and the raw material source,” he added.