BREAKING: FDA Approves CBD-Based Medicine Derived from Marijuana

Written by Cassidy Patnoe, Law Clerk at Gleam Law, PLLC.

The Food and Drug Administration (FDA) has approved Epidiolex, an epilepsy medicine derived from marijuana. The drug’s active ingredient is a non-psychoactive cannabinoid known as cannabidiol (CBD) and is the first marijuana-based medication approved by the FDA. This is a step forward for patients diagnosed with Lennox-Gastaut syndrome and Dravet syndrome, the two rare and severe forms of epilepsy that the drug treats. “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D.

From a regulatory perspective, the approval of a CBD-based medicine will require that CBD be rescheduled from Schedule I of the Controlled Substances Act, which currently defines Marijuana as a drug with no currently accepted medical use and a high potential for abuse. As an approved pharmaceutical, marijuana might be moved to Schedule II or III. Drug Enforcement Agency (DEA) spokesperson Barbara Carreno underscores this sentiment, stating that “it absolutely has to become a schedule II or III.” Currently, the DEA has 90 days from approval to reschedule CBD, which it recently listed as a “marihuana extract” distinctly separate from psychoactive tetrahydrocannabinol (THC). Like all drugs approved by the FDA, studies were performed on the potential side effects of CBD as well as its potential for addiction or abuse.

With a growing body of scientific research on CBD and the approval of Epidiolex, we are likely to see a significant change in the way that CBD is sold and consumed in the United States. While the FDA states it is concerned about the “unapproved CBD-containing products with unproven medical claims,” the way appears to be open for CBD-based medicines. The FDA stated that the “approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market.”