The DEA's proposal to reschedule marijuana from Schedule I to Schedule III of the CSA was published on the Federal Register on May 21, 2024. The proposal was released in draft form on May 17, 2024 and was published on the 21st without changes. By publishing the proposal on the Federal Register, the DEA officially opened a 62 day public comment period that ends on July 22, 2024.
The DEA's proposal formally initiates the rescheduling process for marijuana that is the culmination of President Biden's directive to examine marijuana's federal legality in 2022. While the document is largely focused on medical factors that contributed to the DEA's determination, it also lays out important procedural details and legal considerations.
Most notably, the DEA clarified that marijuana's proposed rescheduling will not affect the federal legal status of synthetically derived THC (using delta-10-tetrahydrocannabinol as an example); hemp; or any other drug product containing marijuana or THC (referring to Marinol and Syndros). Marijuana, if rescheduled, would remain subject to applicable provisions of federal law, including of the Food, Drug, and Cosmetic Act and related approvals through the Food and Drug Administration.
The proposal also confirms the procedure for submitting public comments. The Federal Register provides the best channel to submit comments and the proposal can be found under Docket No. DEA-1362. Interested parties may also request hearings with the DEA to provide factual evidence and expert opinion related to the proposal.
From a factual medical perspective, the proposal lays out the reasons why the DEA has reconsidered marijuana's place on the Schedule of Controlled Substances. The DEA attributes much of its change in position to the data and evidence emerging from state-level marijuana markets (both medical and adult-use). The factors considered when determining a substance's Schedule include its actual or relative potential for abuse; available scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the substance; its history and current pattern of abuse; the scope, duration and significance of abuse; what risk there is to the public health; its psychic or physiological dependence liability; and whether the substance is a precursor of a substance already Scheduled. In sum, the DEA concluded that the factors when applied to marijuana reveal that it is improperly Scheduled alongside drugs without any currently accepted medical uses like heroin and LSD.
What does this mean for the state-level cannabis and nascent hemp industries? They now have a formal channel to submit evidence, expert opinions, and other testimony that will be part of the DEA's record when issuing an Interim Final Rule or Final Rule. The DEA is seeking additional information regarding the medical uses of marijuana, data regarding public safety as related to marijuana use, and other information related to the medical and factual evidence that the DEA will consider when issuing its ultimate Rule. Interested parties should prepare to take advantage of the public comment period to ensure their interests are not forgotten.
Once the public comment period closes, the DEA will examine the record and may schedule additional hearings to collect information. We expect the DEA to receive substantial amounts of information, which may require months to parse through and to take into consideration before issuing a Final Rule. There is also a possibility for judicial interference in the process, which could delay the DEA's rulemaking. It remains to be seen how rescheduling will impact state-level marijuana businesses and McDonald Hopkins' cannabis attorneys are closely monitoring developments related to rescheduling.
Xavier Jaillet, a law clerk at McDonald Hopkins, assisted with the writing of this article.
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