Has CBD Been Rescheduled? No, Only Epidiolex
The FDA approved the first-ever CBD drug to be sold in pharmacies nationwide. While this led to the rescheduling of FDA approved CBD drugs in the Controlled Substance Act, it didn’t include CBD in itself, as many advocates had anticipated.
It’s no lie that the legalities around cannabis-based CBD in the U.S. are confusing: You have state laws vs. federal laws that have a combination of contradicting laws that can leave many unsure of what is legal or not. Well, to add to that confusion, the Food and Drug Administration (FDA) announced this past June that they have approved of Epidiolex- a cannabis-based CBD drug used to treat two rare forms of epilepsy- to be distributed by prescription in pharmacies nationwide. This caused a stir of excitement as many in the Cannabis Industry and advocates had anticipated that this would push a rescheduling of CBD entirely.
Currently, all forms of cannabis or hemp derived CBD are considered a Schedule I narcotic: Drugs with high risk for abuse with no known medical purpose. So, in result of the FDA’s acceptance of Epidiolex to be distributed nationally, it became necessary that the Drug Enforcement Agency (DEA) reschedule CBD to a lower level on the Controlled Substance Act (CSA) within 90 days. It is the only way that this drug can be sold legally in the United States. According to Business Insider, the DEA’s public affairs spokesperson, Barbara Carreno, in response to the FDA’s decision stated that, CBD, “absolutely has to become Schedule 2, 3, 4, or 5.” Creating hope for many that Epidiolex may cause cannabis-derived CBD to be rescheduled.
But this past Friday, September 28th the DEA did not reschedule cannabis-derived CBD, they announced that only Epidiolex and other FDA approved cannabis-based drugs will be reclassified as a Schedule V drug- the lowest level on the CSA. This leaves all other cannabis and hemp-derived CBD products on the market today as Schedule I narcotics and federally illegal.
The acceptance of Epidiolex to be prescribed nationally serves as a huge milestone for the U.S. being that it is the first-ever cannabis-based drug to be approved by the FDA. This may open the door for more research around the medicinal uses of CBD and lead other CBD drugs to be approved by the FDA. In their press release, FDA Commissioner Scott Gottlieb, M.D. states, “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.” While the FDA admits that cannabis can have medical purpose, they still have strict policies for cannabis-based drugs such as proof of proper clinical trials and that drugs cannot contain more than .1% THC.
Others are concerned that with the FDA regulating specific CBD drugs, big pharmaceutical companies will take advantage of the market, affecting patient’s access to affordable treatment. Leafly editor Ben Adlin states, “Some in the cannabis community have expressed concern that by narrowly opening the door to only certain CBD pharmaceuticals, patients may actually have a harder time obtaining—and affording—CBD medicine. Epidiolex, for example, is anticipated to cost $32,500 per year, which GW Pharmaceuticals’ CEO has said is roughly in line with other brand-name epilepsy drugs.” While other CBD drugs may become FDA approved, it may affect the already affordable CBD market that exists in states where marijuana has been legalized.
To clear up any confusion, here is what you should take away from all of this: Cannabis-based CBD was not rescheduled, only Epidiolex and other FDA approved drugs (which currently is only Epidiolex). All other cannabis-based (that includes hemp) CBD products are still Schedule I narcotics and federally illegal. So, if a product is hemp or cannabis derived CBD, you have to abide by the state and federal laws regarding cannabis. But there are CBD products available that are not derived from the genus cannabis and are not on the CSA, therefore legal nationwide.