The U.S. Drug Enforcement Administration (DEA) is expected to publish in the September 28, 2018 edition of the Federal Register an order scheduling U.S. Food and Drug Administration (FDA or the Agency)-approved drugs that contain cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols (THC) in Schedule V. By way of background, Schedule V products are those with a lower potential for abuse than Schedule IV (i.e., a drug product that has a low potential for abuse and low risk of dependence) and consisting of preparations containing limited quantities of certain narcotics. Currently, the only FDA-approved drug that meets these criteria is Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
The announcement, made in a pre-publication version of the order appearing in the September 27, 2018 Federal Register, fulfills DEA’s obligation to issue a scheduling order, which it is required to do under the Controlled Substances Act (CSA). As a result of DEA’s scheduling order, all persons in the distribution chain who handle Epidiolex in the U.S. (importers, manufacturers, distributors, and practitioners) are required comply with the requirements of the CSA and DEA’s regulations relating to Schedule V controlled substances (see, e.g., DEA’s valid prescription requirements).
As discussed previously, on June 25, 2018, FDA approved for the first time a drug that contains a purified drug substance derived from cannabis; it was also the first time the Agency had approved a drug for the treatment of patients with Dravet syndrome. CBD is a chemical component of the Cannabis sativa L. plant, sometimes referred to as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from THC, another cannabinoid of the cannabis plant. Also discussed previously, prior to approving Epidiolex, FDA had only approved drug products containing synthetic THC, Marinol and Syndros, as well as Cesamet, which contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.
Under the CSA, CBD is currently a Schedule I substance (i.e., no currently accepted medical use and a high potential for abuse) because it is a chemical component of the cannabis plant. Once FDA approved Epidiolex, the product no longer met the criteria for placement in schedule I of the CSA. See 21 U.S.C. § 812(b) (indicating that while substances in schedule I have no currently accepted medical use in treatment in the United States, substances in schedules II-V do).
While some believe that DEA’s scheduling order will open the floodgates for so-called over-the-counter (OTC), retail CBD products, DEA made it clear that it does not agree. More specifically, DEA said that “any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. § 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.” In other words, CBD products other than Epidiolex continue to be Schedule I. Not surprisingly, DEA did not address in its scheduling order hemp-derived CBD, the legal status of which is fiercely debated (with some arguing, incorrectly, that it is legal in all 50 states). As some may know, Congress is currently debating the 2018 Farm Bill, the Senate version of which contains language to legalize hemp.
Despite CBD’s Schedule I status, FDA has taken a largely hands-off approach to OTC CBD products (i.e., those that are sold at convenience stores, gas stations, and other retail outlets), as long as marketers do not make serious, unproven medical claims regarding the same (as discussed here). However, there are a handful of notable examples of DEA raids and seizures involving CBD products.
We will continue to monitor developments in this area and issue updates, as appropriate.
If you have questions regarding an issue raised in this post, please contact the author or the attorney at the firm with whom you are regularly in contact.