The Drug Enforcement Administration’s (DEA) recent decision to place GW Pharma’s cannabis-derived anti-epilepsy medication, Epidiolex, into its least restrictive category, Schedule 5, was based on a recommendation of the Food and Drug Administration (FDA), which had approved the drug in June.
According to a recently released internal government letter, reported Marijuana Moment, the FDA actually concluded that cannabidiol, or CBD, which is the primary ingredient in Epidiolex, does not meet the criteria for federal control at all.
It is important to note that while the FDA concluded that CBD should not be scheduled at all, the DEA classified only Epidiolex as a Schedule V drug while continuing to keep CBD itself under the most restrictive category of Schedule I, along with cannabis, heroin, and meth.
In order to bring Epidiolex to market, the FDA evaluated its medical utility and potential for abuse and then submit its findings to the DEA.
Meanwhile, the FDA concluded that CBD should not be scheduled by the DEA at all. Here’s why: “CBD and its salts… do not have a significant potential for abuse and could be removed from the [Controlled Substances Act],” the FDA wrote to the DEA in May.
Therefore, the FDA amended its recommendation, advising the DEA to place CBD in Schedule V, stating in a review that CBD has “negligible potential for abuse,” and a “currently accepted medical use in treatment” and abusing it “may lead to limited physical dependence” similar to other Schedule V drugs, reported Marijuana Moment.
Altogether, there were eight factors that the FDA considered when making its scheduling recommendation. “Upon consideration” of those eight factors, the agency said CBD alone “could be removed from control” under the CSA.
“We reach this conclusion because we find that CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA,” referring to the Controlled Substances Act, signed into law by President Richard Nixon on October 27, 1970.
In its conclusion, the FDA also reiterated that the scheduling of CBD should be “revisited promptly” if international treaty obligations change.
Thus begins a shift...starting with the first time in 46 years that the DEA has changed its stance on cannabis.