DEA Limits Rescheduling of CBD to FDA-Approved Epidiolex

DEA Limits Rescheduling of CBD to FDA-Approved Epidiolex

DEA Limits Rescheduling of CBD to FDA-Approved Epidiolex Posted: 30 Sep 2018 07:45 PM PDT By John A. Gilbert & Larry K. Houck — In a much-anticipated action since the Food and Drug Administration (“FDA”) approved Epidiolex, G.W. Pharma’s oral cannabidiol (“CBD”) solution for the treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, today the Drug Enforcement Administration (“DEA”) issued a Final Order placing “FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols” in Schedule V of the Controlled Substances Act (“CSA”). Schedule of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements, 83 Fed. Reg. 48950 (Sept. 28, 2019).  In taking this action, DEA decided to limit the rescheduling of CBD to a specific formulation of an FDA-approved drug product and re-emphasized that except for this specific formulation,  CBD remains a Schedule I substance. As DEA acknowledged, the Agency was required to take some scheduling action related to CBD once FDA approved Epidiolex because CBD was classified in Schedule I, which by definition means a substance without an accepted medical use. However, DEA also stated that because the United States is a signatory to the Single Convention on Narcotic Drugs, 1961 (“Single Convention”), the Agency’s action must comport with the requirements of the treaty.  Cannabis, cannabis resin and extracts and tinctures of cannabis are listed in Schedule I of the Single Convention.  CBD is an extract of the cannabis plant and therefore also a Schedule I substance under the Single Convention.  Moreover, the CSA provides that DEA is not required to follow the normal procedures involving notice and comment rulemaking to control a drug when such control is required under the Single Convention.   See 21  U.S.C. § 811(d)(1). While DEA could have placed Epidiolex in Schedule II, which would have ensured that the control requirements of the Single Convention were met, it instead placed the drug in Schedule V. Schedule V drugs are considered to have the lowest potential for abuse compared to other scheduled drugs and a low potential for psychological or physical dependence.  Thus, these drugs are subject to less control under the CSA.  DEA stated that it sought and received a scheduling evaluation from the Department of Health and Human Services (“HHS”).  HHS advised DEA “that it found the Epidiolex formulation [of CBD] to have a very low potential for abuse and, therefore, recommended that, if DEA concluded that control of the drug was required under the Single Convention, Epidiolex should be placed in schedule V of the CSA.”  DEA confirmed in the Final Order that it is imposing additional regulatory requirements to ensure compliance with the Single Convention, specifically: import/export permits. In fact, DEA, HHS and FDA have long acknowledged that studies have found that CBD does not have the same affinity and effects as THC, and thus does not produce psychoactive properties in humans. We speculate that the obstacle to descheduling even an FDA-approved CBD formulation was the current classification under the Single Convention.  Thus, it is important to note that on July 23, 2018, the World Health Organization (“WHO”) Expert Committee on Drug Dependence (“ECDD”) submitted a recommendation to the United Nations Commission on Narcotic Drugs (“CND”) that “preparations considered to be pure CBD” should not be scheduled under any of the international drug control treaties.  The CND is responsible for scheduling actions under the international drug control treaties and will consider this recommendation at its annual meeting in March 2019.  The U.S. will be one of the member countries voting on this recommendation. So, while DEA has addressed the immediate scheduling issue related to approval of Epidiolex, several questions remain. First, DEA’s decision to limit the rescheduling to a specific FDA-approved formulation indicates DEA may still have some concerns about CBD abuse potential, but is this supported by the scientific and medical evidence?  Second, if the CND removes CBD from the Single Convention, will DEA support descheduling of Epidiolex?  Finally, will DEA support descheduling of all CBD formulations assuming it is descheduled by the CND? We will continue to monitor these actions and provide an update related to the potential international descheduling.