Did the U.S. Just Reschedule CBD?
The U.S. Drug Enforcement Administration (DEA) maintains a schedule for drugs under the federal Controlled Substance Act (CSA). Cannabis, along with drugs like ecstasy and heroin, is classified in the most dangerous category as a Schedule I drug, meaning the drug has a high potential for abuse with no currently accepted medical use. Possession, use, prescriptions for and sales of marijuana remain illegal at the federal level even though many states have legalized medical cannabis use, recreational cannabis use or both. Although marijuana has been a Schedule I drug for quite some time, in 2016, the DEA specifically added cannabis-derived CBD oils to the Schedule I list.
In June, the FDA approved the first cannabis-derived drug called Epidiolex, a highly purified form of CBD that has proven anti-epileptic results according to clinical trials. The drug is owned by British company GW Pharmaceuticals. At the time, many Americans thought that Epidiolex or CBD or cannabis had been descheduled, but it has not.
With the FDA approval of Epidiolex, the drug was bound to be rescheduled. In late September, the DEA did, in fact, reschedule a category of the drug called “approved cannabidiol (CBD) drugs.” These drugs were moved to Schedule V, meaning the drugs have the lowest potential for abuse and do show medical benefit.
How does the DEA define an “approved cannabidiol (CBD) drug”? The definition provided says in order to be on Schedule V, the drug product must be in the finished dosage formulation and approved by the FDA. The drug must be derived from natural cannabis, contain CBD, and not contain more than 0.1 percent of THC compounds, the hallucinogenic chemicals known for creating the marijuana “high.”
Right now, only Epidiolex meets that criteria, although several other drug manufacturers will likely seek FDA approval for similar drugs. All other cannabis-derived CBD products remain illegal, but the DEA’s decision does set a significant precedent to pave the way for other CBD products. After all, the DEA’s late September decision does represent the first time in decades that any cannabis-derived product has been outside Schedule I. With the ruling, it is the first time the federal government has acknowledged CBD’s medical potential.
Many insiders say that it is just a matter of time before the DEA reclassifies CBD outside of Schedule I. When that happens, research on CBD’s and cannabis’ potential could go wide open. The Schedule I status essentially bars U.S. research on controlled substances, other than to study drug addiction. Other countries have paved the way in research to show CBD’s promising medical benefits. GW Pharmaceuticals obtained permission to do the required research for Epidiolex under a federal charter in the United Kingdom.
Looming on the DEA’s horizon is re-scheduling of THC-based cannabis products, but that is likely to be an uphill battle due to the hallucinogenic qualities of THC. The battle to reschedule all CBD products will likely be much easier.