This post has been updated.
Roughly three months after the Food and Drug Administration approved the cannabis-derived pharmaceutical Epidiolex for the treatment of epilepsy disorders, the US government has officially rescheduled drugs that contain CBD—but only if they’ve already been greenlighted by the FDA.
“Any other CBD product other than Epidiolex remains a Schedule I controlled substance.”
The rescheduling order, released Thursday and set to officially publish in the Federal Register on Friday, is far narrower than many cannabis advocates had hoped. “Specifically,” it says, “this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V.”
[Update: The full order as it appeared in the Federal Register on Friday is included at the bottom of this article.]
In other words, rather than apply generally to all CBD-based products, the order applies to only those that have cleared FDA’s expensive and time-consuming approval process. For now, the number of pharmaceuticals covered by the order is one: Epidiolex, made by UK-based drugmaker GW Pharmaceuticals.
“What this does not do is legalize or change the status of CBD oil products,” DEA spokesperson Rusty Payne told NBC affiliate WTHR. “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.”
That statement—that other CBD products remain Schedule I substances and illegal under federal law—is a controversial one. While the DEA maintains that position, the hemp industry and medical cannabis advocates argue that CBD derived from hemp is legal—at least if the hemp was grown legally under state pilot program. (For more, see Leafly’s explainer.)
The rescheduling move does open the door for additional high-CBD medicines to enter the US market, however, and it will likely attract other CBD drugmakers to jump in. But many popular products in existing medical cannabis markets, such as Canada or certain US states, will be ineligible due to the amount of THC they contain.
The effectiveness of an epilepsy medicine produced by Canadian producer Tilray, for example, has in recent months inspired UK lawmakers to soften their stance on medical cannabis. But because the medicine has a CBD-to-THC ratio of 50-to-1, the drug will remain a Schedule I controlled substance in the United States despite the rescheduling order. (Full disclosure: Tilray and Leafly are both owned by private equity firm Privateer Holdings.)
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. That’s tens of thousands of dollars more than high-CBD medicines currently on sale, whether derived from hemp or cannabis.
“We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. These are welcome alternatives,” NORML Deputy Director Paul Armentano said in a statement following the rescheduling news. “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.”
GW Pharmaceuticals said in a statement Thursday that the company is “working hard to make Epidiolex available within the next six weeks.”
Federal Register: Placement… by on Scribd