The Epidiolex Effect: Will Other CBD Drugs Receive FDA and DEA Approval?
Though it doesn’t get users high like THC-dominant products, CBD is all the rage these days due to its medical benefits and gray-area legality.
On September 28, the DEA designated Epidiolex—a plant-based CBD pharmaceutical manufactured by the UK-based GW Pharmaceuticals—a Schedule V drug in the government’s list of controlled substances. All other CBD formulations remain in Schedule I, which is for drugs with a “high potential for abuse” and “no currently accepted medical use.” Schedules III to V are for “drugs with lower potential for abuse.”
This move reinforced a federal ruling on April 16 that affirmed the December 2016 DEA decision to create a new Schedule I code for cannabis extracts, including CBD extracts. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee concluded that Epidiolex was safe, effective and had negligible abuse potential. On the basis of their review, the agency approved Epidiolex for use in treating rare forms of childhood epilepsy (Lennox-Gastaut syndrome and Dravet syndrome).
A month later, on May 16, the Department of Health and Human Services approved the FDA’s Epidiolex recommendation.
Frontier Data predicts total sales of all CBD products in the U.S. will top $1.9 billion by 2022.