We recently wrote about President Joe Biden’s pardon of federal marijuana convictions and raised some cautions concerning possible proposed rescheduling of marijuana under the Federal Controlled Substances Act (CSA). Even if President Biden is successful in persuading his administration to move to either deschedule or reschedule marijuana, we wouldn’t expect to see any significant change for many months, if not years.
To recap, 39 of the 50 states have adopted laws authorizing the medical use of marijuana notwithstanding federal prohibition under the CSA. Nineteen of those states have gone further, authorizing adult use marijuana under their state laws without regard to medical need. The state-level legalization of adult use marijuana appears to be accelerating. Just as the early advocates for medical marijuana legalization showed little concern for federal illegality, the adult use advocates seem unlikely to slow their move for broad legalization, whatever the federal government decides to do.
As we previously observed, rescheduling marijuana under the CSA is likely to create more difficulties for state medical marijuana compliance with the U.S. Food and Drug Administration (FDA). Therefore, descheduling – removing marijuana from the CSA completely – appears to be the most viable and prudent goal to reconcile federal and state regulation of marijuana. But whether the future of marijuana under the CSA is descheduling or rescheduling, the process will be complex.
The CSA authorizes the attorney general, working with subsidiary Department of Justice agencies like the U.S. Department of Health and Human Services (HHS), the FDA and the U.S. Drug Enforcement Administration (DEA), to reschedule, or even deschedule, substances after consideration of the drug’s medical use and its potential for abuse and dependence. However, the statutory process the DEA is required to follow to change the status of an already controlled substance is incredibly arduous.
The CSA mandates scheduling decisions be made by the DEA in conjunction with the HHS and the FDA based on medical and scientific data considering the relative abuse potential of a drug. The HHS must consider the following eight factors in making its recommendation:
- The drug’s actual or relative potential for abuse.
- The drug’s scientific evidence of its pharmacologic effect, if known.
- The state of current scientific knowledge regarding the drug.
- The drug’s history and current pattern of abuse.
- The drug’s scope, duration and significance of abuse.
- The risk, if any, to public health.
- The drug’s psychic or physiological dependence liability.
- Whether the drug is an immediate precursor of a controlled substance.
The HHS’ recommendations are then binding on the DEA as to scientific and medical matters. Rescheduling marijuana from a Schedule I to a Schedule II controlled substance, at a minimum, would require proof that marijuana has a currently accepted medical use in the United States. Descheduling marijuana would require a finding that it does not meet any of the criteria for scheduling. However, in response to a 2016 petition to reclassify marijuana, the FDA concluded that it has no accepted medical use in the U.S., has a high potential for abuse and lacks an acceptable level of safety for use even under medical supervision. Accordingly, the DEA denied the petition.
The rescheduling and descheduling processes involve similar analyses under the CSA, but both are unlikely to occur at this time. The DEA remains powerless to reschedule marijuana without a finding from the HHS that it has an accepted medical use or to deschedule without evidence that it should not be scheduled under the CSA at all. The current Schedule I status of marijuana makes it difficult for researchers to receive federal sources of funding to obtain the evidence-based clinical research necessary to support the rescheduling or descheduling of marijuana. While recent DEA policy has expanded the number of marijuana cultivators for research, the HHS is still far from obtaining the evidence necessary to support a change.
Beyond the regulatory roadblocks, the scheduling of marijuana also impacts the international treaty obligations of the U.S. The U.S. is a party to a United Nations treaty, the Single Convention on Narcotic Drugs, which requires the U.S. to control marijuana in the schedule that the DEA Administrator deems most appropriate. The courts have previously held that marijuana must be scheduled in Schedule I or II to satisfy the obligations under the treaty.
Even if a change is possible in the future, maintaining marijuana on the controlled substances list likely raises more problems than it solves. A more prudent approach is to deschedule it completely. However, because these processes are riddled with roadblocks, it is unlikely that the current scheduling of marijuana will change any time soon.
For questions about any marijuana-related issue, please contact Bob Hendricks, Al Rogalski or a member of Warner’s Cannabis Industry Group.
