The FDA and DEA Disagree Over CBD Scheduling

The FDA and DEA Disagree Over CBD Scheduling
DEA and FDA are in a bit of a tiff over CBD.

Last week, following the highly-anticipated U.S. Food and Drug Administration (FDA) approval of Epidiolex, G.W. Pharmas oral cannabidiol (CBD) solution for the treatment of seizure associated with Lennox-Gastraut and Dravet syndrome, the Drug Enforcement Administration (DEA) issued a Final Order rescheduling FDA-approved drugs containing cannabis-derived CBD with no more than 0.1 percent THC under Schedule V of the Controlled Substances Act (CSA).

The DEAs decision to reschedule this very specific formulation of FDA-approved CBD was largely influenced by a joint recommendation made by the U.S. Department of Health and Human Services (HHS) and the FDA earlier this year (Memo). However, according to a letter released last week by HHS Assistant Secretary Brett Giroir (Letter), the FDA concluded that CBD and its salts could be removed from control because:

  • There is little indication that CBD has abuse potential or presents a significant risk to the public health;
  • No evidence for a classic drug withdrawal syndrome for CBD, and no evidence that CBD causes physical or psychic dependence;
  • CBD does not appear to have abuse potential under the CSA;
  • There is no signal for the development of substance use disorder in individuals consuming CBD-containing products; and
  • It is unlikely that CBD would act as an immediate precursor to THC for abuse purposes.

Upon sharing its conclusion with the DEA, the FDA was advised that removing CBD from the CSA would violate international drug treaties to which the United States is a signatory. Specifically, the DEA explained that the United States would not be able to keep obligations under the 1961 Single Convention on Narcotic Drugs if CBD were decontrolled under the CSA. Consequently, the FDA revised its recommendation and advised the DEA to place CBD in Schedule Vwhich applies to drugs with demonstrated medical value and deemed unlikely to cause harm, abuse, or addictioninstead. Nonetheless, the FDA declared that [i]f treaty obligations do not require control of CBD, or the international controls on CBDare removed at some future time, the above recommendation for Schedule V under the CSA would need to be revisited promptly.

As we previously discussed, the World Health Organization (WHO) Expert Committee on Drug Dependence submitted a recommendation in July to the United Nations ...

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