Open Book Extracts announces push for research

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At SupplySide West 2021, Open Book Extracts (Roxboro, NC) sat down with Nutritional Outlook to announce its investment in new research to enhance knowledge of its pure cannabinoids, particularly the minor cannabinoids, assessing areas of safety and efficacy. According to Dave Neundorfer, CEO of Open Book extracts, the safety studies are not only an important step to build trust in the ingredients and their products but to underpin either a path to self-affirmed GRAS status or new dietary ingredient notification (NDIN).

“We’re partial to NDIN, which is a little bit of a higher hurdle but more protectable once you get there,” he explained. “But mission number one is that our client brands and their consumers know that what they’re putting into and onto their body is safe.”

After the rejection by FDA of NDINs from Charlotte’s Web and Irwin Naturals on their cannabidiol products, Neundorfer acknowledges that the minor cannabinoids, which are not subject to the drug preclusion clause of the Food, Drug, and Cosmetics Act, may have a more direct regulatory pathway compared to CBD. While placing new emphasis on the minor cannabinoids, safety studies on CBD continue. In May, Open Book Extracts provided ValidCare additional financial support to add a second cohort to its large-scale, human safety study.

Kicking off in November, Open Book Extracts is partnering with Radicle Science on research focused on efficacy, need states, and structure functional claims. “Radicle Science is the perfect partner for us to have as we lean into developing innovative, need state–focused formulations that work,” said Neundorfer. “They provide the data and feedback to make sure we hit the mark with a large population focused on pain, anxiety, and sleep.”

“When you think about trends in our categories and broadly across consumer goods, we’re seeing a focus around need states,” added Nicole Brown, Open Book Extracts’ chief innovation officer. “To develop products that can target a specific desired outcome, be it to help support better joint health or anxiety relief, we approach that by taking each of those minor cannabinoids and defining a formulation that’s very specific to that target and being able to have that ratio and that specific formulation that can hit that target. So, it’s not necessarily about a single isolated cannabinoid but really what they can do when they’re incorporated together into a formulation that’s going to work well and then deliver on that promise to the consumer.”

Finally, Open Book Extracts will also be undertaking clinical trials starting late this year or early next year. According to Neundorfer, with the clinical trials, Open Book will be “leveraging formulations with some of our minor cannabinoids as well as longer-term research enhancing the underlying natural cannabinoid, along one of five dimensions: stability, potency, bioavailability, controlled release, and then tissue targeting.”

All this will not only build upon the body of research of cannabinoids but allow Open Book Extracts to even better serve its clients. As an extractor and formulator, research is invaluable. “Many of the largest brands on the market don’t have in-house formulation teams, they rely on our team and our expertise to help design the products, everything from which ingredients to select, what formulations to design, what is the right delivery mechanism and form factor, and so we’ve become a part of their team and an extension of their team by offering that as a service and a capability,” said Brown. “So, they can come to us with the concept they have or the need they are hearing from the consumer, and then we can build that out from the ingredients to the formulation to the finished goods.”