Here’s the good news – the Food and Drug Administration (FDA) just approved a prescription cannabidiol (CBD) medicine. So, that means CBD is now legal, right? Unfortunately, no, CBD is still considered a Schedule I drug by the Federal Drug Enforcement Agency (DEA).
The newly approved drug is called Epidolex and is used to treat a rare and severe form of epilepsy. This is is big news as it is the first FDA-approved drug that contains a purified drug substance derived from marijuana.
The FDA’s press announcement took pains to distinguish CBD from tetrahydrocannabinol (THC), which is the primary psychoactive component of marijuana. The announcement also stresses that because it is a chemical component of the cannabis plant, CBD remains a Schedule I substance under the Controlled Substances Act (CSA).
Although there now appears to be support on the federal level for some medical marijuana therapies, CBD and/or any other medical marijuana treatments will only be approved if subject to the FDA’s rigorous approval process. Accordingly, the FDA states that it will
…continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
Again, it is important to understand that this approval does not constitute the legalization of CBD. Notably, the FDA’s press release state does not state whether it will change Epidolex’s Schedule I status. But, the reclassification of Epidolex to Schedule II or III would appear to make sense in light of the proven medical efficacies of the drug.
Undoubtedly some will be disappointed that this does not constitute the legalization of all CBD products. The approval of Epidolex by the FDA, however, represents a huge leap forward in terms of mainstreaming research and development of medical marijuana therapies. It also confirms what until now had largely remained unproven in the U.S. – the medicinal properties of CBD.
For more information on the regulation of marijuana businesses in Washington State, please contact Heather Wolf.