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US Reschedules CBD Drug—but Not CBD Itself

September 27, 2018
cbd rescheduling header(David Zalubowski/AP)
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.”

Rusty Payne, DEA spokesperson

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.]

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FAQ: What to Know About the DEA’s CBD Rescheduling Order

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.)

Related

Is CBD Oil Legal Now? With Epidiolex Approved, It’s Still Not Clear

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.)

Related

Is This the UK’s ‘Charlotte’s Web’ Moment?

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.

Explore Hemp-Derived CBD Products on Leafly

“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

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Ben Adlin

Ben Adlin is a senior editor at Leafly who specializes in politics and the law. Follow him on Twitter: @badlin

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  • Open Minds

    Monty Python would have a ball doing a sketch on the absurdity of this scenario. Ministry of Silly Walks anyone?

    • Scooter Bell

      Exactly! Seems the U.S. FDA/DEA won’t accept/see the facts.
      Like the Black Knight in Monty Python and the Holy Grail:

      Black Knight: ‘Tis but a scratch.
      King Arthur: A scratch!? Your arm’s off!
      Black Knight: No, it isn’t.
      King Arthur: Well, what’s that then?!
      Black Knight: I’ve had worse.
      :]

  • Dante-the-cat

    Good Lord, you guys are so lost. I feel really sorry for Americans. Patients don’t deserve this treatment.

  • Lee Butcher

    As always, the FDA is a paid off fed department. Aspartame, agreed by researchers to be terrible for humans, was passed the day Bush jr took office because Rumsfeld, a lawyer and officer of the company that would make billions on it, had the FDA ok it, and the rich got richer and the sick got sicker. Same with canola oil. Previously used for industrial lubrication and paint manufacturing, a plant that even animals won’t eat in the wild, was passed off as safe after enough money was paid to the FDA, and then promoted as the greatest thing since sliced bread, is rape seed oil, which is hazardous to anything consuming it. So, Big Pharma has once again driven over the people’s will and has created their own little world of massive profits on cbd, but no one else is allowed to. When will we demand the US government to quit letting corporations shanghai plants that are for the good of the citizens, capitalize on non-inclusive patents and trademarks (make believe ownership of God’s creations)?? Of course, I’m still pissed off at Obama for not getting the legalization of cannabis as a whole accomplished when he was in office. And Trump lied about getting it done when he ran for office. (No surprise there).

  • Happinessisadd

    It sounds like big pharma wants a step in the door before it’s even opened… It’s controlled and pricey, sounds like every other prescribed medical you needed. It’s all about that ‘dollar dollar bill’.

  • BruceIshikawa

    It’s all about Big Pharma. It’s not useful unless shareholders are making a profit.

    At least it’s a step.

    Tell your friends: you can grow weed cheap and heal yourself.

  • I realized the full effect of our laws when planning to drive across country. I couldn’t legally take cannabis out if Colorado for my 19 year old son to use for his epilepsy. He was paralyzed by a seizure that made him fall and has nerve pain so he needs benefits of the full plant. Once again the pharmaceutical companies win and the average sick person suffers. Thanks everyone. America is supposed to be run by us.

  • Mcozy333

    @ least that Botanical Drug Substance was not placed into schedule two. then it would have been ten more years to have it… how long will we stand for phamra being allowed this molecule while man is not allowed it?

  • 360dunk

    And cannabis HAS been proven effective…..just not by the chimpanzees at the FDA.

  • 360dunk

    Dear FDA, thank you for creating so many opioid addicts. Your absolute stupidity when it comes to cannabis paves the way for doctors to over-prescribe so many addictive drugs like Vicodin, Percocet, and Oxycodone.

    Are you knuckleheads trying to put us in a collective stupor?

  • familyguy

    Quit complaining and go vote for representatives that represent you. So far we know republican politicians are willing to ignor the people they represent and will suppress and legalization efforts in congress and senate.