HempFusion Wellness Inc. announces self-GRAS affirmation for its hemp-derived CBD

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HempFusion Wellness Inc. (Denver, CO) has announced that its proprietary hemp-derived CBD extract has achieved self-affirmed GRAS (Generally Recognized as Safe) status. 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 research used in the dossier was conducted in partnership with Verdant Nature LLC, which is HempFusion’s hemp extract supply partner. This marks a significant milestone for HempFusion, one shared by few other CBD brands, which the company expects will drive significant incremental revenue growth at retail.

Jason Mitchell, ND, HempFusion’s co-founder and CEO, told Nutritional Outlook that the company has an obligation to its customers and the law to ensure the safety of its hemp-derived CBD. “The responsibility we have to the consumers that trust us to put products in their hands that are safe for consumption, goes without saying. It’s [also] a legal responsibility for a company and in truth, if you were to follow FDA guidelines, to what is required of you, you have to do this. You don’t really have a choice, the choice comes with the lack of enforcement,” states Mitchell. HempFusion is one of the few brands to invest significant resources into studying the safety of its raw material, and while many more may claim to have self-GRAS affirmation, the majority are not in fact using their own research but applying the findings of other companies to their own products.

“They just use other people’s data and assume that it’s true for them as well which is not the case. Not all these raw materials are created equal. They come from different genetics, different concentrations, they have different chemical makeups,” explains Mitchell. “We spent three years extensively studying our raw material to land in a double-verification, meaning there are two independent toxicology panels that reviewed and deemed that our raw material was safe for human consumption."

GRAS status not only demonstrates safety and transparency on the part of HempFusion, but also prepares the company for a future with a clear regulatory framework for CBD, says Mitchell. Because the proposed legislation on CBD regulation by FDA would simply add hemp-derived CBD to the definition of a dietary supplement, should they pass, GRAS affirmation and new dietary ingredient notifications (NDINs) will be a prerequisite for brands wanting to enter the market. Most of the major retailers currently do not currently stock ingestible hemp-derived CBD because of a lack of regulatory clarity and enforcement from FDA. This will change should legislation pass, and HempFusion is prepared. In addition to self-GRAS affirmation, Mitchell says that HempFusion has already authored a NDIN so that it’s ready for submission immediately. While other brands, namely Charlotte’s Web and Irwin Naturals, submitted NDINs in 2021 ahead of any CBD legislation, FDA rejected them citing the drug preclusion clause of the Food, Drug, and Cosmetic Act.

Despite these setbacks, what is significant is that the body of research demonstrating the safety of hemp-derived CBD for human consumption is growing. As part of its soon to be submitted NDIN, HempFusion has incorporated results from the ValidCare CBD safety study, in which it was a sponsor. “[The ValidCare study] confirms that in an everyday normal-use model, meaning all the inconsistencies you can expect, [hemp-derived CBD] was deemed safe and it saw virtually no liver toxicity. So, by that virtue, it’s showing that we have to be looking at hemp-derived extracts, CBD containing hemp extracts, as something that is safe,” says Mitchell.

HempFusion has been growing rapidly in recent years with the 2019 acquisition of Probulin Probiotics, the company’s largest and fastest growing brand, and the acquisition of two CBD brands in 2021: Sagely Naturals and Apothecanna. At the beginning of 2021, the company also made an initial public offering on the Toronto Stock Exchange. Its products are distributed across over 18,000 U.S. retail locations throughout all 50 states, and also available abroad in China, Mexico, Ireland, the United Kingdom, the United Arab Emirates, South Korea, and Canada.