By Peter Stavropoulos and Robert T. Hoban
Hoban & Feola, LLC
CALIFORNIA — On August 12, 2016 The United States Drug Enforcement Agency (DEA) denied a petition to initiate the rescheduling of marijuana from a Schedule I to a Schedule II substance.
Despite recent outcry from many within the industry, this should not be considered a blow to the cannabis industry in the United States. This was in fact expected.
Earlier in the year, the DEA commissioned a report from the US Department of Health and Human Services (HHS) that found that, “marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.”
Therefore, HHS recommended that marijuana remain a Schedule I substance. In an apparent attempt to cure the question of marijuana’s potential for abuse and medical use, the DEA has allowed for the expanded research on the cannabis plant. Additionally, the DEA stated that due to the United States participation in international drug control laws, the only rescheduling in the future would be to Schedule II from Schedule I.
There are many reasons that this move by the DEA should not come as a surprise to those in the industry. First, it is simply not realistic for the DEA and HHS to change any policy regarding marijuana given the pending election for the Presidency. This election is one of the most contested and hotly debated in recent history. If governmental agencies don’t change their stances, then one or both of the main presidential candidates could infer that the current Presidential administration had used undue influence. The agencies must at the very least appear to be impartial and deferent to the science of cannabis and marijuana.
Secondly, the only federally permitted research facility to grow marijuana is at the University of Mississippi. Currently, there are approximately 15 researchers whom are licensed to research the plant, but less than half were provided research samples in 2015. The DEA’s decision does include a thorough analysis of the effects, pharmacokinetics and potential for abuse but tends to gloss over many of the current published studies stating that existing studies did not rise to the level of a controlled study that various federal governmental agencies would require in approving or disapproving a new drug. It should be noted that these current stringent rules would most likely prevent aspirin from being federally approved in 2016.
Additionally, the DEA report does state that cannabis, and marijuana specifically, is not known to be a “gateway drug.” The report indicates that though many individuals with a drug abuse disorder may have tried cannabis as their first drug, there is no causality because it cannot be inferred that many or most individuals who try marijuana eventually develop a drug abuse disorder.
Cannabis is one of the oldest cultivated plants. It has been used not only for its psychoactive effects, but also for food and for its fiber. Periodically, petitions are submitted to the DEA for rescheduling. It is hardly surprising that in this current political climate, and with half of the states allowing for medical use (not to mention the handful allowing recreational use), that the DEA would disallow the petition to reschedule. As time progresses, and as more research is conducted to FDA standards, cannabis will eventually be seriously evaluated for rescheduling.
In the end, there are some things that need to change before rescheduling takes place. While the empirical scientific data and the common sense position both support express acknowledgement that cannabis has tremendous ‘medicinal’ value, the term ‘medicinal’ is problematic because it carries with it the connotation that is often confused with FDA approval and/or pharmacological recognition. This term has consumer, patient, and legal significance beyond cannabis. And it will be difficult for mainstream health care to grasp and/or recognize this accordingly.
With the newly authorized allowance for the development of and research surrounding FDA-approved cannabis based medicine, this terminology must change. As FDA-approved cannabis based medicine evolves under a pharmaceutical model, it is essential that we reexamine the terminology on the natural products side — the nutraceutical side — of cannabis and look at the replacement of the word “medicinal,” with something more akin to ‘wellness’ or ‘herbal’ cannabis.
This will make it easier for mainstream health care, science, policy makers, and consumers/patients to distinguish between the two. And more importantly, it will set the table for pharmaceutical/FDA cannabis-based medicine (distributed through pharmacies) to exist side-by-side with, and exclusive of, nutraceutical/natural products cannabis (produced and sold through existing state-regulated dispensary-system channels). This is critical for the cannabis industry and policy makers to understand and to adopt for patients and for existing cannabis industry stakeholders. Unless and until this paradigm is understood and implemented, rescheduling will remain a goal slightly out of arms reach.
About the Authors: Peter Stavropoulos is an attorney licensed to practice in New York and is Counsel to Hoban & Feola, LLC, the nation’s original cannabusiness law firm since 2008. Robert T. Hoban is Managing Partner at Hoban & Feola, LLC.
BLOOM Cannabis Group/PR
Caroline Rustigian Bruderer