By David Feldman and Courtney Barnes
In the United States, 37 states have legalized medical cannabis, and 19 states have legalized cannabis for adult use. Yet, the U.S. federal government continues to regulate cannabis as a Schedule I controlled substance – akin to heroin – and more tightly controlled than fentanyl, oxycodone, and cocaine.
It was, therefore, major news when, on October 6, 2022, U.S. President Joe Biden made three major announcements effecting the U.S. cannabis industry. First, he issued a presidential proclamation pardoning all U.S. citizens and lawful permanent residents who committed or have been convicted of the offense of simple possession of cannabis under federal law. Second, he called upon all state governors to act to pardon all individuals convicted of corresponding cannabis offenses under state law. Third, and pertinent to the discussion in this Part II of our series, he asked“the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.”
In the United States, controlled substances (i.e., “drugs”) are regulated pursuant to the federal Controlled Substances Act (CSA). The CSA classifies drugs into five schedules based on their respective psychological and physical harms, potential for abuse, and any redeeming therapeutic value. Cannabis is classified as a Schedule I controlled substance, meaning the federal government considers it to have a high potential for abuse, no currently accepted medical use in treatment in the U.S., and a lack of accepted safety for use under medical supervision. President Biden’s call to action requests that the Secretary of Health and Human Services (HHS) and the Attorney General initiate administrative proceedings to reconsider how cannabis is currently scheduled under federal law and determine whether the compound should be “rescheduled”; that is, moved from Schedule I to a different schedule or, potentially, “descheduled” – meaning removed from regulation under the CSA entirely.
While the President directs its request, in part, at the Attorney General, whom the CSA expressly grants authority to reschedule or deschedule controlled substances, the Attorney General has delegated that scheduling authority to the Drug Enforcement Administration (DEA). Accordingly, the DEA Administrator has the ultimate responsibility for completion of this process – subject to some restrictions.
Proceedings for amending or repealing controlled substances regulations may be initiated by the DEA Administrator in one of three ways: (i) on his own motion; (ii) at the request of the HHS Secretary; or (iii) on the petition of any interested party. After a petition is received, but before initiating any scheduling proceedings, the DEA Administrator must request that HHS perform a scientific and medical evaluation of the drug and submit its recommendations as to whether the drug should be so controlled or removed to the DEA Administrator for review. Eight different factors are considered by HHS in making a scheduling recommendation, including, among others, abuse potential, risks to public health, and the state of current scientific knowledge. The recommendations from HHS to the DEA Administrator are binding as to its scientific and medical conclusions.
As one might imagine, numerous citizen-initiated petitions to change the federal government’s scheduling of cannabis have been filed with the DEA Administrator over the past few decades, yet none have resulted in policy reform. HHS consistently cites the lack of “currently accepted medical use in treatment in the United States” as its rationale for refusing to recommend a scheduling change. Nonetheless, this is the first time a sitting President has directly requested that such a review be completed, acknowledging explicitly that “no one should be in jail just for using or possessing marijuana” . . . and that sending “people to prison for possessing marijuana has upended too many lives and incarcerated people for conduct that many states no longer prohibit.” In addition, studies continue to consistently demonstrate that cannabis does provide real medical benefit.
While we believe it is clear that cannabis is incorrectly classified as a Schedule I compound, the potential implications of both rescheduling and descheduling are vast and uncertain. For example, if cannabis is rescheduled – as opposed to descheduled – its manufacture and sale would be directly subject to the purview of the U.S. Food and Drug Administration and likely only initially benefit pharmaceutical companies that have obtained FDA approval to produce and sell cannabis-derived drugs. The scope and nature of resulting federal oversight in the event of federal descheduling of cannabis is even more difficult to predict. We urge the U.S. government to speedily review the current science and its seemingly arbitrary regulatory approach to cannabis; however, many questions remain as to whether and how the President’s request will impact our Nation. In conclusion, while we acknowledge and empathize with those who believe he should have gone farther, we applaud President Biden for taking these first significant steps and look forward to continuing to report on these exciting developments.