The line, called HempFusion, is the brain child of Jason Mitchell, ND, who is president of parent company MetaCan, which houses several other businesses that are within the medical marijuana sphere. HempFusion launched at the recent Natural Products Expo East trade show in Baltimore, MD. The line features a full spectrum hemp extract as its base ingredient, and includes a number of branded ingredients that pair with it in formulas aimed at sleep, stress and digestive support indications.
Mitchell said this is far from his first rodeo in the dietary supplement industry. He is the former chief science officer of Country Life Vitamins and also owns another supplement company manufacturing a line of probiotic products branded as Probulin. Mitchell said basing the products on a full spectrum hemp extract, as opposed to honing in on the cannabidiol (CBD) fraction, as many other supplement formulators have done, was a decision taken on both regulatory and functional grounds.
“I am a dietary supplement industry executive who’s been around this industry for a long time. We came together as a group to provide products that help people, but we knew that we had to do it right, not because this is a hot space that we think we can make some money in,” Mitchell told NutraIngredients-USA.
Full spectrum extract is the key
For Mitchell, using a full spectrum extract—that is, using the suite of compounds as they exist in the plant and not trying to boost the levels of certain constituents, such as CBDs—is a key regulatory distinction. HempFusion brands this as Whole Food Hemp Extract. Mitchell likens the current situation with hemp extracts to the earlier experience of the industry with red yeast rice, in which some early formulators sought to boost the amount of lovastatin in the finished extracts. It was a product development path that eventually brought FDA down on the category’s head, with the agency ruling that this effort took the natural product over the line into the drug category represented by prescription forms of statins.
Mitchell said he believes a similar issue exists within the hemp sphere, with the added huge complexity that wasn’t the case with red yeast rice in that the high THC cultivars of Cannabis sativa are on the Drug Enforcement Administration’s Schedule 1 list of banned substances. Cultivars with ultra-low THC content fall within the definition of industrial hemp (though they can contain higher levels of CBDs). FDA has ruled recently that isolated, concentrated CBDs are not legal dietary ingredients and should not appear in dietary supplements. The base reasoning given for this ruling is that CBDs are already the subject of drug development via a couple of Investigational New Drug applications filed by English company GW Pharmaceuticals. Mitchell said the legal advice he has received leads him to conclude that this ban does not apply to a hemp extract in which the CBDs are presented in their natural concentrations. Mitchell said that this not only quells regulatory concerns, but also captures the ‘entourage effect.’ CBDs have a significant amount of research behind them, he said, but they are not the only important fractions of hemp and may in the end turn out to not be the most important fractions.
“We need to understand the FDA. There are those who just want to fight the FDA and are building war chests to do that. The rules are written down, and I think if you are creative and you really understand those rules you can create a map that would allow you a drastically risk-reduced path to market,” he said.
“The more we depart from food, the more we move toward being a drug. We took the stance that we were not going to selectively isolate CBDs. We wanted everything that is in the plant,” Mitchell said.
Claims linked to other ingredients
Another issue with hemp extracts as used in dietary supplements is what a company might be able to say about them within compliant claims language. The HempFusion line works around this with claims based on the branded ingredient contained within each product. The labels claim the inclusion of phyotcannabinoids, and that allows consumers to draw their own conclusions from that based on their own research, Mitchell said. Two of the products just contain the extract as the primary ingredient and make no structure/function claims.
The formal claims are based on research connected to the branded ingredients, which include: PharmaGABA, a fermented form of the neurotransmitter manufactured by Japanese firm Pharma Foods International (sleep support), Sensoril, a proprietary ashwagandha extract from Natreon (stress support/adaptogenic) and MATrek 3-D, a proprietary probiotics delivery system that uses seaweed extract encapsulation that was pioneered in the Probulin line (digestive support).
“It is undeniable that phytocannabinoids are valuable. But more research needs to be done to hone in on what they do, what we can say about that and what we should be allowed to say,” Mitchell said.
Mitchell said his experience in the industry also includes working in his family’s line of health food stores around the time that DSHEA was put into effect, which gave him a long-term view of what kind of marketplace that regulation created. He said that while he does not always agree with FDA, he’s a strong supporter of DSHEA and the access it provides to products that can support consumers’ health.
“DSHEA was about guaranteeing access. If you do it right you can enjoy the fruits of your labor and provide products that help people. I hope we can provide an example of what companies within this space should be striving for,” Mitchell said.