Last week, a document unveiled by the Department of Health and Human Services (HHS), following a request under the Freedom of Information Act by Houston attorney Matthew Zorn, shed light on the agency's August 2023 recommendation for the Drug Enforcement Administration (DEA) to reclassify marijuana from Schedule I to Schedule III under the Controlled Substances Act. This document marks a significant shift from both the DEA's long-standing position and HHS's own stance in 2016, reflecting a change in the perception of marijuana from a political perspective rather than a strictly legal or scientific viewpoint.
On October 7, 2022, alongside announcing a large-scale pardon for federal convictions of simple marijuana possession, President Joe Biden instructed HHS and Attorney General Merrick Garland to review the scheduling of marijuana under federal law. He criticized the current classification of marijuana alongside substances like heroin and LSD in Schedule I, noting its incongruity, especially when compared to drugs like fentanyl and methamphetamine, which are in lower schedules despite their roles in the overdose epidemic.
The HHS's eventual recommendation to lower marijuana's schedule was not based on new scientific findings but rather on a reinterpretation of the criteria for Schedule I, a change that could have been implemented earlier if there had been openness to this perspective from HHS, the DEA, or encouragement from past administrations.
Under the Controlled Substances Act, Schedule I is meant for drugs with high abuse potential, no accepted medical use in the U.S., and no safety for use under medical supervision. Traditionally, the DEA, as delegated by the attorney general, has interpreted "accepted medical use" to require meeting the Food and Drug Administration's (FDA) standards for prescription drug approval.
In contrast, the FDA had already approved medications like Marinol, Syndros, and Epidiolex, which contain components derived from marijuana, for medical use, placing them in lower schedules. However, marijuana itself remained in Schedule I due to the DEA's strict interpretation of the CSA.
The HHS's new recommendation, in response to President Biden's directive, challenges this interpretation. It proposes a two-part test for determining a drug's medical use. The first part examines whether licensed health care practitioners (HCPs) in the U.S. are currently using the drug medically under state-authorized programs. With 38 states allowing medical marijuana, this criterion is easily met. The second part looks for credible scientific support for at least one of the medical conditions treatable by the drug. HHS found substantial evidence supporting marijuana's use for conditions like pain, nausea, vomiting, and anorexia related to other medical conditions.
Moreover, the HHS report addresses the 'potential for abuse' criterion of Schedule I. It notes that while marijuana is popular for its psychological effects and there is evidence of its abuse, the majority of users do not experience harmful outcomes. The report points out that marijuana-related risks are relatively low compared to drugs like heroin and cocaine, and even some lower-scheduled substances.
This shift in HHS's position marks a significant departure from the long-held view that marijuana is a Schedule I drug. The implications of reclassifying marijuana to Schedule III are multifaceted. For state-licensed marijuana businesses, it could alleviate high effective tax rates imposed by Section 280E of the Internal Revenue Code. It would also simplify medical research by reducing specific regulatory requirements tied to Schedule I drugs.
While rescheduling marijuana would not legalize it for prescription use, except for FDA-approved products, nor resolve the conflict between state and federal laws regarding marijuana use, it represents a notable shift. This move by HHS implicitly acknowledges that the long-standing classification of marijuana in Schedule I was more a matter of drug policy rhetoric than a reflection of its actual risks and medical potential. It recognizes the growing acceptance of marijuana's medical benefits and lower risk profile, aligning federal stance more closely with state-level legalization trends and public opinion.