Cannabidiol, or CBD, is a non narcotic fraction of Cannabis sativa. It has been documented to have physiological effects including seizure suppression and pain relief. The anti-seizure indication is promising enough to induce drug company GW Pharmaceuticals to file an Investigational New Drug (IND) application on the compound in a drug called Epidolex as a treatment for childhood epilepsy in 2013.
In a recent guidance on the marijuana sector, FDA included a section on CBD, and flatly stated that because of the IND application, the use of the ingredient for dietary supplement applications is precluded.
“If a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement,” the agency wrote.
Call for input
FDA did seem to hedge its bets a bit, though. The agency called on stakeholders to come forward if they have information that might put this determination in doubt.
Will Cleidon, CEO of California-based Ojai Energetics, is of of those who thinks FDA got it wrong. The question hinges on whether CBD-based supplements were on the market prior to the filing of the INDs. You can take an existing supplement ingredient and further refine it (or substitute it with a synthetic version) and turn it into a drug; this has happened on a number of occasions, notably in the fish oil sector. But according to law you can’t file an IND application and then decide later to step back down into the supplement realm.
“We think it’s a knee-jerk reaction. That’s the opinion of our attorneys as well. Our position is that there is plenty of evidence that CBD supplements are not in violation of this provision,” Cleidon told NutraIngredients-USA. “We have been advised by our advisory board to carry on. It’s a complex issue and we respect FDA’s opinion, but our board believes that when FDA is presented with more evidence they will change their position.
“I’m trying to get a market-wide coalition, an effort for people to come together to present this information to FDA so that we aren’t the only one footing the bill.”
Schedule 1 substance
Cleidon said a company called Dixie Elixirs has had a CBD-based dietary supplement on the market since at least 2012, and there are probably others, he said. That part of making the pre-IND argument might be relatively straightforward, but other aspects of the question are less clear. One issue that could dog the effort to provide FDA with the proof is the question of what being “legally” on the market means; can a supplement legally be based on an ingredient derived from a plant that is a Schedule 1 substance according to the Drug Enforcement Administration (DEA)? And how do the various state medical marijuana and recreational cannabis laws figure into the picture? Does FDA as a federal agency have a mechanism for regulating supplement ingredients that might be above board in one state, but not in another?
For Cleidon, one of the determining factors is where a company is deriving its CBD, basing this view on a Ninth District Court of Appeals ruling from 2004 that ruled in favor of the Hemp Industries Association in a case against DEA.
“We do ours from the stalk and stem of the plant only. We don’t use any leaves or buds. We think the ruling is clear that products from stalk and stem only don’t fall under DEA’s jurisdiction,” Cleidon said.
Social mission
Cleidon has set up his company as a B Corp, adhering to a so-called “triple bottom line.” B Corps are a style of corporate organization that allows a social mission to be written into the company’s founding documents, something that heretofore was only possible in a non profit scenario.
“We went out to formulate something that is completely holistic and have done so in a clean, environmentally friendly manner. Our hemp is not certified organic, but it is grown under those conditions, and non GMO and organic certifications are part of our future plans. We want to ensure that everyone, including the planet, is winning in everything we do,” Cleidon said.
In addition to bringing together a coalition around the question of CBD’s supplement legality, Cleidon said the sector needs to come together to decide questions of the ingredient’s basic specifications.
“There is synthetic CBD coming out of China as well as botanical sourcing from China, and you could potentially have some heavy metals contamination questions there,” he said.