The rescheduling does not apply to all CBD drugs.
Following the approval of CBD-based epilepsy drug Epidolex by the Food and Drug Administration (FDA), the US federal government has decided that, going forward, it will reschedule all CBD medications that the FDA approves.
As of Friday, the rescheduling order has been published to the official register. While CBD medications becoming legalized is good news for advocates, the excitement was somewhat dampened by just how narrow the order is.
“Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% tetrahydrocannabinols in schedule V,” reads the order.
While this may not read like a big deal, the problem is that the FDA approval process is costly and lengthy, greatly limiting who can actually bring CBD products to market. So far, only Epidolex, made by GW Pharmaceuticals in the United Kingdom, has approval.
“What this does not do is legalize or change the status of CBD oil products,” said a DEA spokesperson. “As of right now, any other CBD product other than Epidiolex remains a Schedule I controlled substance, so it’s still illegal under federal law.”
The DEA takes this tough stance on CBD despite the fact that it carries many medicinal benefits while not providing any of the trademark “high” that marijuana does. Epidolex was deemed by the FDA to be safe enough to be used as treatment for debilitating epilepsy for children as young as or younger than one year old.
Advocates argue that such strict criteria for CBD products means that any medicine, no matter how popular or effective, cannot qualify for FDA approval if it has any trace of THC.
“We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. These are welcome alternatives,” said Paul Armentano, the Deputy Director of NORML. “But these products should not be regulated in such a manner that patients no longer have ready access to herbal cannabis — a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 31 states.”
