In June 2018, the Food and Drug Administration approved the first CBD drug, Epidiolex, manufactured by GW Pharmaceuticals. The approval of a CBD drug, placed on Schedule V, was concerning to the burgeoning CBD industry, as it meant CBD would remain a controlled substance subject to DEA and FDA regulation, giving GW Pharmaceuticals bragging rights over having the only legal CBD medicine available. It also meant that most of the CBD being sold by others was at best semi-licit, if not wholly illegal, as DEA’s position is a controlled substance cannot simultaneously be controlled and not controlled. [If it were otherwise, we would all be able to pop down to our corner mini-mart to pick up a generic 6-pack of Valium.]
Back in 2018, CBD was regarded as just another component of marijuana, hence Schedule I. With the advent of Epidiolex, DEA lowered CBD to Schedule V. Flash forward some 20 months later, on April 06, 2020, GW Pharmaceuticals announced that DEA has de-scheduled Epidiolex.
“This notification from DEA fully establishes that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” said Justin Gover, GW’s Chief Executive Officer. “We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”
The de-scheduling of Epidiolex may prove to be a watershed moment in the hoped-for deregulation of CBD. But, GW Pharmaceuticals’ patents and rights over Epidiolex remain in full force (indeed, the news gave their stock a price bump). But be clear, this is a de-scheduling of Epidiolex only and not a de-scheduling of CBD, nor a waiver of FDA regulatory oversight of CBD. CBD will continue to make the slow walk to the coveted Generally Regarded as Safe (GRAS) status.