Will the DEA Reclassify CBD?
Approval by the Food and Drug Administration of a new drug that contains cannabidiols could prove to be the step needed for the Drug Enforcement Agency to reclassify at least one derivative of marijuana.
Cannabidiols--known as CBD--are used in the drug Epidiolex. In June, the FDA approved the use of the drug for children who experience severe epileptic seizures. The drug includes CBD taken from marijuana plants.
CBD does not cause the “high” associated with cannabis.
It’s the first cannabis-based drug approved by the FDA. That’s a big enough deal, but it also might force an equally groundbreaking decision.
In the DEA’s court.
The federal government lists marijuana as a Schedule I drug--the highest level for an illegal drug. To give you some perspective, other Schedule I drugs include heroin, LSD, mescaline and methylenedioxymethamphetamine (better known as “ecstasy”).
Getting listed as Schedule I means a drug has a high potential for abuse and no health benefits.
Clearly, the FDA decision on Epidiolex contradicts that stance on marijuana--at least when it comes to CBD. An advisory committee for the FDA referred to the Schedule 1 status of CBD in reporting its decision to the DEA, which is part of government protocol in these situations. The committee wrote: “An overall assessment of the abuse-related data from preclinical and clinical studies leads to the finding that CBD has negligible abuse potential.”
The DEA now must consider whether to reclassify CBD as a legal substance. That could potentially have a significant impact on the marijuana industry, where CBD products are increasingly popular.
What Epidiolex does.
The Epidiolex drug is aimed at treating both Dravet and Lennox-Gastaut syndromes. Both cause severe, daily seizures. Typically, the syndromes begin at a very young age, which is why the FDA approved use of the drug for those ages two or older.
Epidiolex is the only drug approved for treatment of Dravet syndrome, according to the Washington Post.
London-based GW Pharmaceuticals developed Epidiolex. In a press release, the company said rescheduling by the DEA will be needed to make the drug available to patients everywhere in the U.S..
“Rescheduling is expected to occur within 90 days,” the company reported, adding that Epidiolex should be available to “appropriate patients” by the fall of this year.
In approving the drug, the FDA noted that the approval of Epidiolex shows how new drugs can be developed if proper procedures are followed. The FDA has voiced concerns in the past about CBD products hitting the market that make health claims not backed up by rigorous research and clinical trials.