Last week, Epidiolex became the first cannabis-derived drug approved for legal sale by the federal government. The DEA reclassified the CBD-based epilepsy medicine as a Schedule V drug, the agency’s lowest category. For U.S. Food and Drug Administration (FDA) officials tasked with evaluating the drug, though, the Schedule V denomination is still too restrictive.
According to a 27-page FDA memo sent to the DEA in May and first reported by Marijuana Moment this week, federal officials said that CBD, the main ingredient in Epidiolex, does not pose a significant risk for abuse or dependence, and does not meet the standards necessary for DEA oversight.
“CBD does not produce withdrawal signs or symptoms in a human study 3 days after drug discontinuation,” the FDA memo states. “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.”
But while FDA officials were clear in their assertion of CBD’s safety and negligible potential for abuse, the memo also noted that the United States’ participation in international drug treaties requires that cannabis and all of its extracts remain under federal narcotic watch. As a result, it’s effectively impossible for the DEA to implement the FDA’s findings.
The memo also states that the DEA sent a letter to the FDA in April, writing that “the United States would not be able to keep its obligations under the treaty if CBD were decontrolled under the CSA,” with the memo then noting, “The Controlled Substances Act (CSA) contemplates that scheduling decisions will be made in accordance with treaty obligations.”
In the FDA’s final recommendations for DEA action on Epidiolex, the FDA’s pharmaceutical regulators conceded to the powers of the 1961 Single Convention on Narcotic Drugs and other international treaties, and suggested that Epidiolex be given Schedule V status.
“If control of CBD is required under the treaty obligations of the United States, then to continue maintaining such obligations, and reflecting our scientific findings to the extent currently possible, we recommend CBD and its salts be placed in the least restrictive CSA schedule, Schedule V,” the FDA memo states.
Still, making clear that the federal agency does not actually believe that CBD should be regulated by federal law enforcement officers, the memo concluded with a note instructing the DEA to immediately revisit CBD’s scheduling status if international drug treaties are altered or amended, and remove the medical marijuana treatment from the DEA list as soon as possible.
“If treaty obligations do not require control of CBD, or the international controls on CBD under the 1961 Convention are removed at some future time, the above recommendation for Schedule V under the CSA would need to be revisited promptly to address the change in a key predicate underlying such recommendation.”
Epidiolex is expected to be available by prescription across the United States sometime in the next six weeks.
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