On June 25, 2018, the U.S. Food and Drug Administration (FDA or the Agency) approved 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.
Epidiolex represents the first FDA approval of a drug that contains a purified drug substance derived from cannabis; this is also the first time the Agency has 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 tetrahydrocannabinol (THC), another cannabinoid of the cannabis plant.
As 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 Controlled Substances Act, 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. Now that FDA has approved Epidiolex, the U.S. Drug Enforcement Administration (DEA or the Administration) is required to make a scheduling determination regarding the same, which it will do after it receives from the Agency (through the U.S. Department of Health and Human Services (HHS)) a medical and scientific analysis. DEA's scheduling decision is required within 90 days of the Administration’s receipt of the HHS/FDA analysis, although, as Laurie McGinley pointed out in her recent Washington Post article, it is not yet clear whether the Administration’s order will apply to CBD generally, to the highly purified CBD in Epidiolex only, or to something else. If DEA’s order applies to the CBD in Epidiolex only, some believe the Administration could schedule the product as low as Schedule IV (i.e., low potential for abuse and low risk of dependence) or even Schedule V (lower potential for abuse than Schedule IV and consisting of preparations containing limited quantities of certain narcotics).
In reflecting on FDA’s approval of Epidiolex, Commissioner Scott Gottlieb, M.D., noted that the Agency will "continue to support rigorous scientific research on the potential medical uses of marijuana-derived products," but also indicated that FDA is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims." Not only is the Agency prepared to take such enforcement action, but it has a history of already doing so (as discussed here, related to CBD product Warning Letters). While the Commissioner did not say as much directly in FDA's press release, one has to wonder whether Gottlieb's remarks mean that the Agency will continue to take a largely hands-off approach to "over-the-counter" 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.
We will continue to monitor developments in this area and issue updates, as appropriate.
