Earlier this year, the United States Food and Drug Association (“FDA”) made history by approving a medication derived from cannabis; currently a Schedule I narcotic. Epidiolex, designed to help treat rare and severe forms of epilepsy, contains cannabidiol (“CBD”), a non-psychoactive compound mostly found in industrial hemp.
Once the FDA approved the medicine, the Federal Drug Enforcement Agency (“DEA”) was given 90 days to react, deciding last week to move all FDA-approved prescriptions containing CBD to the Schedule V designation, defined as having a proven medical use and lowest possible risk for abuse, joining other medicines such as codeine.
“We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals, makers of the drug, in a press release.
“With this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA,” said Grover.
It is important to note that the DEA did not re-classify cannabis or even CBD alone – only medications containing CBD that have been approved by the FDA will make the cut. Any other cannabis product on the market remains illegal on the federal level. This comes despite news that the FDA had recommended the DEA reschedule CBD altogether.
“CBD does not produce withdrawal signs or symptoms in a human study three days after drug discontinuation,” according to a 27-page memo first published by Marijuana Moment. “This suggests that CBD does not produce physical dependence. Additionally, there is little evidence that CBD produces rewarding responses in animals or humans, which suggests that the drug does not produce meaningful psychological dependence.”
Proponents of the hemp industry, where much of the nation's CBD is derived from, believe that the 2018 Farm Bill currently being debated by Congress holds the key to helping the nascent market flourish, as it would officially legalize cultivation. However, due to the bickering over provisions in the bill including those relating to food stamps, the Farm Bill is expected to stall until after the midterm elections.
“It’s time to remove the federal hurdles and give [farmers] the opportunity to seize its full potential and once again become the national leader for hemp production,” said Senate Majority Leader Mitch McConnell (R-Kentucky), in June. “That is why I strongly advocated for this measure to be included in the Farm Bill.”
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