On Monday, a Food and Drug Administration (“FDA”) communication from May was publicly released on the subject of cannabidiol (“CBD”).
As former Vice President Joe Biden might say, it’s a Big Frickin’ Deal (“BFD”).
You likely heard last week that the Drug Enforcement Administration (“DEA”) re-scheduled Epidiolex, and any future FDA-approved CBD drug, under Schedule V of the Controlled Substances Act (“CSA”). (Discussed more fully here),
We’ve now learned that the DEA’s position was deeply influenced by a May 16 memorandum from FDA Assistant Secretary Brett Giroir (full memo here) that concludes:
“CBD and its salts…could be removed from control under the CSA.”
After a thorough scientific review and analysis, FDA argues:
- “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.”
- “It is unlikely that CBD would act as an immediate precursor to THC for abuse purposes.”
Nevertheless, the FDA had been advised by the DEA that federally de-scheduling CBD altogether would violate international treaty obligations. Accordingly, the FDA recommended that CBD be placed in the least restrictive category, Schedule V. However, the FDA left the door open to complete de-scheduling in the immediate future:
“If treaty obligations do not require control of CBD, or the international controls on CBD…are removed at some future time, the above recommendation for Schedule V under the CSA would need to be revisited promptly.”
What does this all mean?
It is important to understand that this scheduling discussion is limited to marijuana-derived CBD formulations such as Epidiolex.In our opinion, hemp-derived CBD is already exempted from the Controlled Substances Act in the 2014 Farm Bill’s pilot program regime, and would be permanently and explicitly exempted from the CSA by the Hemp Farming Act, which we are very optimistic will be passed as part of the 2018 Farm Bill. (More on that here).
However, the DEA has obfuscated that point, and there still is a lot of confusion in the marketplace. That’s why the FDA letter is such a BFD. It makes clear that the federal agency with primary jurisdiction over the health and welfare of the American public has taken the formal position that CBD should not be treated as a controlled substance.
Furthermore, while there still is some debate over what international treaties require (we disagree with DEA’s position), all signs point to more clarity soon under international law that CBD should not be scheduled as a controlled substance. As discussed here, the World Health Organization in August recommended that CBD not be scheduled under international drug conventions.
All in all, the BFD FDA CBD announcement is yet another signal that the future of hemp products is bright. Stay tuned to these pages for more updates.