By: Rachel Gillette and Nabil Rodriguez
In June of 2018, the United States Food and Drug Administration (“FDA”) approved of Epidiolex CBD Oral Solution – the first cannabis-derived drug to be accepted for medical use and treatment in the United States.
Epidiolex survived rigorous FDA testing and was ultimately approved for the treatment of seizures associated with two severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
Published September 28, 2018, the Federal Drug Enforcement Agency (“DEA”) and Federal Department of Justice (“DOJ”) released Final Order billing code 4410-09-P “Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements.” Under this Final Order, a product approved by the FDA which contains CBD derived from cannabis and “no more than 0.1 percent” [one tenth of one percent] THC automatically becomes a Schedule V controlled substance.
By definition under the Controlled Substances Act (“CSA”), a Schedule I controlled substance “has no currently accepted medical use in treatment in the United States.” However, for the first time in U.S. history, the Federal Government has acknowledged cannabis – a Schedule I drug – as having medical use. In essence, the FDA’s approval of Epidiolex evidences a cannabis-derived product with accepted and proven medical benefits. However, in general, cannabis-derived CBD extracts, derivatives and products that do not have FDA approval remain Schedule I controlled substances under the CSA.
In light of Epidiolex’s approval, a persistent wave of confusion and misinformation has flooded both the cannabis and hemp industries. At this time, it is critical for cannabis and hemp industry operators to remain mindful and aware of rapidly changing laws. Greenspoon Marder’s expanding Cannabis Law Practice Group is committed to remaining active and alert for legislative adjustments at both the federal and state levels in order to best advise our clients.
Should you have any questions regarding the current legal status of CBD, hemp or other cannabis derived products, please reach out to your Greenspoon Marder attorney. The Final Order was published here on September 28, 2018.