Cannabis Legal Activity Update

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On 28th September 2018 the DEA reclassified Epidiolex, the cannabis-based epilepsy drug created by GW Pharmaceuticals to a Schedule V controlled substance.  This order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V of the Controlled Substances Act (“CSA”).

Although the federal health regulatory agency have previously concluded that CBD shouldn’t be scheduled in any manner, the drug enforcement agency—citing international treaty obligations—opted to put Epidiolex in Schedule V and otherwise continue to classify CBD itself under the most restrictive category of Schedule I.

The DEA’s 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 issued on May 16th 2018 (see letter in full in link below).

In response to this DEA move  HHS Assistant Secretary Brett Giroir on the 1st October 2018 released an internal government letter 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.”

The FDA concluded that cannabidiol doesn’t meet the criteria for federal control at all.  Currently we know the FDA have an active ‘watch team’ within their body observing the cannabis industry.

There is a strong view that since Epidiolex is pure cannabidiol (CBD) that all CBD products fall into the same category.  There is no sign if this becoming a reality at the minute.


From a higher point of view

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The United Nations Commission on Narcotic Drugs (“CND”) is scheduled to consider the descheduling of CBD at its annual meeting in March 2019.  In July of this year the United Nations Commission on Narcotic Drugs (“CND”) stated that “preparations considered to be pure CBD” should not be scheduled under any international drug treaty.

However, even if the CND were to deschedule CBD, the DEA would be free to ignore the FDA’s recommendation and continue resisting a broader rescheduling of CBD and refusing to join the global medical community, which favors its use and descheduling.  Futhuremore if CBD were to be descheduled at the global level, the United States, specifically the DEA (i.e., Jeff Session’s Department of Justice), would struggle to use their standpoint on international treaties to protect their position.









Further reading if interested

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Official DEA statement

https://www.federalregister.gov/documents/2018/09/28/2018-21121/schedules-of-controlled-substances-placement-in-schedule-v-of-certain-fda-approved-drugs-containing

U.S. Department of Health and Human Services (“HHS”) and the FDA jpint memo |  16th May 2018

https://hempindustrydaily.com/wp-content/uploads/2018/10/DHS-DEA-letter-2018-0014-0002.pdf?_ga=2.205388819.221633313.1538568567-731547511.1538568567


Additional reading

https://www.forbes.com/sites/mikeadams/2018/09/28/no-the-dea-did-not-reschedule-the-cbd-compound/#31263b2d1bef

https://www.marijuanamoment.net/fda-says-marijuana-ingredient-cbd-doesnt-meet-criteria-for-federal-control/

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf

https://www.cannalawblog.com/category/federal-law-and-policy/