FDA approves cannabis-derived medicine; DEA must weigh in

(This is an abridged version of a story that appears at Hemp Industry Daily.)

The U.S. Food and Drug Administration has approved a naturally derived CBD drug, a landmark decision that will trigger the health agency to seek rescheduling for the cannabinoid from the Drug Enforcement Administration (DEA).

The FDA signed off on the use of Epidiolex, a drug from Britain’s GW Pharmaceuticals, to treat two kinds of epilepsy. The decision caps decades of work by the company to gain approval in the U.S. for a medicine derived from the cannabis plant.

FDA officials noted the significance, signaling a new approach to looking at a plant still defined in federal law as having “no currently accepted medical use.”

“Sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Dr. Scott Gottlieb said in a statement released Monday by the agency.

Prior approval has been granted for medicines derived from synthetic cannabinoids.

Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide. The agency may ignore the FDA’s position, but that is considered unlikely in this case.

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Kristen Nichols can be reached at [email protected]

4 comments on “FDA approves cannabis-derived medicine; DEA must weigh in
  1. Clifton Middleton on

    These are disgraceful agencies that have criminalized marijuana for 100 percent racist political reasons. There has never been any health hazard with the herb, only beneficial amelioration of human maladies from a plant that the people can grow themselves.

    Reply
  2. Christopher Simmons on

    These politicians in their arrogance regarding “Gods Plant”, will come up with absurd legislation allowing Epidiolex to be used as medicine, while simultaneously keeping other CBD products on Schedule 1. This will be completely absurd, illogical and irrational. Anything to keep the DEA’s failed war on drugs going, because we all know that they have to maintain their federal budgets and incarcerate people for consuming Cannabis to justify their existence. It’s easy to go after Joe Sixpack for smoking cannabis. The DEA is truly hesitant to go after the big cartels because that is scary and too high risk for its agents.

    Reply
  3. Lezli Engelking on

    They are recommending rescheduling of Epidiolex, NOT CBD.

    CBD is not on the Schedule 1 drug list.

    Epidiolex will be reviewed because it contains .3% THC – which is on the Schedule 1 list.

    Reply
  4. Willy Workman on

    It’s great to see that the steady pressure from the CBD and Cannabis related communities have finally begun shifting the FDA’s perception on the uses of CBD. Thx & great job to every one that is actively adding to this pressure!

    Reply

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