DEA Schedules a FDA-Approved CBD Drug

By on October 5, 2018

As beverage manufacturers mull the creation and distribution of cannabidiol (CBD)-infused products, the US Drug Enforcement Administration’s (DEA) recent actions regarding an approved CBD drug merit exploration. CBD is one of many chemicals in the cannabis plant, and the US Food and Drug Administration (FDA) has stated that CBD does not produce the same euphoric effect as tetrahydrocannabinol (THC), marijuana’s psychoactive component.

In June, FDA approved the first drug comprised of an active ingredient (CBD) derived from marijuana, Epidiolex. FDA approved the CBD oral solution for patients two years of age and older who have seizures associated with two forms of severe epilepsy. According to DEA and FDA, the CBD in Epidiolex is extracted from the cannabis plant and is a purified drug substance. Though it is derived from the cannabis plant, the FDA-approved drug has no more than 0.1 percent residual THC.

Last week, DEA announced an order scheduling Epidiolex under the least restrictive schedule of the Controlled Substances Act (CSA), schedule V. Notably, DEA still considers marijuana (which includes industrial hemp) and marijuana compounds other than Epidiolex to be schedule I controlled substances under the CSA. As a result, beverage manufacturers should carefully consider all legal implications prior to developing products that contain CBD.

DEA still considers any CBD extract that is not approved by the FDA to be within schedule I of the CSA. DEA reaffirmed that the handling and distribution of CBD derived from marijuana is “against the law, except for the limited circumstances” when FDA determines there is a “medically approved benefit.” The FDA Commissioner also noted in June that the FDA has taken actions when the agency “see[s] the illegal marketing of CBD-containing products.”

DEA’s scheduling action should not be considered a significant change in federal policy with respect to CBD and is more akin to a technical correction. Although FDA approved Epidiolex for medical use, it remained listed as a schedule I controlled substance under the CSA, like marijuana and other schedule I compounds. Under the CSA, schedule I drugs have not currently accepted medical use in treatment. The DEA’s action last week addresses that inconsistency and schedules Epidiolex into schedule V. The scheduling action noted that the federal government determined that the CBD drug has a “very low potential for abuse.” Since Epidiolex is now a schedule V controlled substance, manufacturers, importers, distributors and health care practitioners will need to follow the CSA’s requirements and relevant DEA regulations when handling the CBD drug.