There is a certain level of confusion reverberating throughout the cannabis community right now over the DEA’s recent decision to make Epidiolex, the cannabis-based epilepsy drug created by GW Pharmaceuticals, a Schedule V controlled substance. Some folks are convinced that since this FDA-approved medication is pure cannabidiol (CBD) that all CBD products fall into the same category.
Sadly, this is not true. The federal government still considers all other cannabis-derived CBD products to be a violation of federal law.
The DEA’s official statement in the Federal Register, which published Friday, indicates “this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V.”
What this means is the only CBD medicine considered to have, well, actual medicinal function as far as Uncle Sam is concerned is Epidiolex. The rest of it is still wrapped up in the federal marijuana ban.
However, it is perfectly understandable how the Epidiolex deal led to a state of disarray. In fact, it was the DEA’s fault that most folks got the wrong impression in the first place.
Over the summer, right after the U.S Food and Drug Administration cleared Epidiolex for distribution in the United States -- making it the first drug comprised entirely from the cannabis plant to receive this honor -- Barbara Carreno, a spokesperson for the DEA’s public affairs office, told Business Insider that the agency had 90 days to put CBD in a lower classification.
"We don't have a choice on that," she said. "It absolutely has to become Schedule 2 or 3."
Of course, word quickly spread that this popular cannabis component was about to be released from the confines of its Schedule I categorization. I even penned an article on the subject called “Is DEA Being Forced To Reschedule The CBD Compound?” which questioned whether the arena of science and medicine wasn't about to witness some additional research opportunities on the heels of this development.
Attorney Shawn Hauser, a senior associate with Denver-based Vicente Sederberg LLC and director of law firm’s Hemp and Cannabinoid Group, later clarified that the media had misconstrued what was happening with Epidiolex – and big time.
“There is misunderstanding that cannabis or CBD will be immediately rescheduled, but that is not the case; it will be Epidiolex itself,” she told New Frontier Data.
“What is getting scheduled is the Epidiolex itself, pursuant to the new drug application, relating to its medical efficacy and low potential for abuse," she added. "That will inform the federal law for the future. Marijuana is still a Schedule I substance; CBD is not scheduled itself, but as a substance derived from marijuana.”
So what’s the best cannabis hopefuls can expect now that there is an FDA-approved cannabis medicine about to be distributed across the United States?
Well, as Leafly editor Ben Adlin wrote in his analysis of the situation, probably not much more than additional CBD medicines ushered in by the deep-pocked powers of Big Pharma.
“The rescheduling move does open the door for additional high-CBD medicines to enter the US market, however, and it will likely attract other CBD drugmakers to jump in,” He wrote. “But many popular products in existing medical cannabis markets, such as Canada or certain US states, will be ineligible due to the amount of THC they contain.”
CBD derived from hemp is a non-issue -- has been for sometime. But for the DEA to reschedule cannabis-based CBD, it must apply the change to the entire cannabis plant. And that doesn't appear likely to happen anytime soon.
Mike Adams is a contributing writer for Forbes, Cannabis Now and BroBible. His work has also appeared in High Times. Follow him on Facebook, Twitter and Instagram.