Rescheduling Cannabis Under the Controlled Substances Act

In a recent executive order, President Donald J. Trump directed the Attorney General to complete the process of rescheduling marijuana from Schedule 1 to Schedule III under the Controlled Substances Act (CSA). President Trump emphasized the need for federal support of increased research into medical marijuana and cannabidiol. The announcement follows a recommendation during the Biden Administration by the U.S. Department of Health and Human Services that the Drug Enforcement Agency (DEA) reschedule the drug.

The CSA, which is primarily enforced by the DEA, in collaboration with the U.S. Department of Justice and the U.S. Food and Drug Administration, classifies drugs and other substances into five schedules based on factors including potential for abuse, the state of current scientific knowledge regarding the drug, and what, if any, risk the drug poses to public health. The CSA defines Schedule I substances as having no currently accepted medical use and a high potential for abuse. Schedule III substances, by contrast, have an accepted medical use and less of a potential for abuse than Schedule I drugs, such as Tylenol with codeine, ketamine, and anabolic steroids. The federal government categorized Marijuana as a Schedule I substance upon the passage of the CSA in 1970.

The new marijuana rescheduling executive order comes on the heels of years of scientific and regulatory assessments. In its 2023 recommendation that marijuana be downgraded, the Department of Health and Human Services concluded that medical marijuana has a “currently accepted medical use,” citing a survey of more than 30,000 licensed practitioners. The surveyed practitioners reported recommending marijuana to over 6 million patients in 43 jurisdictions for at least 15 conditions, including pain, anorexia, and chemotherapy‑induced nausea and vomiting. That recommendation, supported by the National Institute on Drug Abuse and the Food and Drug Administration, prompted the Department of Justice to propose moving marijuana to Schedule III in May 2024. The pending rule drew nearly 43,000 public comments, a majority of which supported the move.

The recent executive order, which leaves Congress’s broad grant of authority over federal drug policy intact, would neither decriminalize marijuana nationwide nor override applicable state law. Nor does the order automatically reschedule marijuana—once the Attorney General initiates the rulemaking process, there will be a 30-day public comment period following which experts anticipate litigation from opponents.

Though many have criticized marijuana’s classification among the most dangerous and habit-forming substances, some opponents argue that reclassification would only provide a tax cut to the cannabis industry rather than encouraging increased research. Some drug policy experts emphasize that the move would relieve thousands of state-based cannabis businesses, which historically have paid some of the highest federal taxes of the nation, of much of their federal tax burden. Other experts anticipate a marginal increase of cannabis research contingent on increased federal funding.

In this week’s Saturday Seminar, scholars discuss the impact of rescheduling marijuana on medical research, the cannabis industry, and public health.

• The President has many avenues to move marijuana to a less restrictive schedule under the CSA, and may even have the power to entirely remove the drug from the list of controlled substances , argues Scott Bloomberg of the University of Maine School of Law and his coauthors in an article in the Oklahoma Law Review. The Bloomberg team explains that the CSA’s rescheduling procedure allows the Attorney General the necessary flexibility to reschedule marijuana by modifying the regulatory definitions of “medical use” and “abuse potential.” Bloomberg and his coauthors posit that a modified standard of medical use for plant-based substances, coupled with a shift from a use-centric to harm-centric abuse standard, could allow the President to reschedule, or even deschedule marijuana.
• The CSA should be modified to eliminate the DEA’s authority to schedule substances, broaden participation in scheduling decisions, create new schedules for non-medical use, and impose administrative controls on lobbying and advertising by drug manufacturers, contends Matthew B. Lawrence of Emory University School of Law and David E. Pozen of Columbia Law School in a forthcoming article in the Harvard Law Review. Lawrence and Pozen call for the reassessment of U.S. drug policy, which they argue has fueled mass incarceration, inhibited needed access to drugs, and enabled the opioid crisis. Instead, they recommend a pragmatic regulatory approach that facilitates the democratization of drug policy without entirely removing regulatory oversight.
• In an article in the Fordham Law Review, Robert A. Mikos of Vanderbilt University Law School analyzes how federal drug scheduling rules have made it extraordinarily difficult to change marijuana’s legal status. Mikos explains that under the CSA, the DEA has long treated “currently accepted medical use” as a threshold requirement to move out of Schedule I. Although the Department of Health and Human Services recently adopted an experience-based medical use test to support marijuana’s rescheduling, Mikos argues that this alternative still imposes major political and practical barriers for other drugs. Miko concludes that regulators should reconsider the central role of the currently accepted medical use and instead base scheduling decisions on a drug’s actual risks and benefits.
• Rescheduling of marijuana would offer significant opportunities to researchers, contends Lorraine Collins of the University at Buffalo and several coauthors in an article in the Journal of Studies on Alcohol and Drugs. Collins and her coauthors explain that, currently, researchers can only source cannabis from a single, federally approved source, which makes it impossible to study the full range of commercially-available marijuana products. Clinical research is crucial to evaluating the potential harms and benefits of cannabis, Collins and her team argue, and marijuana’s rescheduling would allow for more thorough investigation. Although Collins and her team conclude that some federal requirements would still apply after rescheduling, barriers to research would decrease and researchers could obtain better insights into cannabis and help inform health policy and clinical practices.
• In an article in the Vanderbilt Law School Faculty Publications, Robert A. Mikos of Vanderbilt University Law School argues that administratively rescheduling marijuana under the CSA is unlikely to produce meaningful reform. Mikos explains that the DEA is not legally required to follow the Department of Health and Human Services’ 2023 recommendation to move marijuana to Schedule III and could reject or later reverse rescheduling. Even if rescheduling occurs, Mikos contends that core restrictions under the CSA and the Food, Drug, and Cosmetic Act would remain, including the ban on interstate sales of drugs without FDA approval. Miko suggests that durable marijuana reform will require congressional legislation rather than relying solely on administrative rescheduling.
• In a recent policy analysis in the Journal of Medicine and Public Health, Tyler Jean of the Sansum Diabetes Research Institute calls for legislators to downgrade marijuana’s Schedule I classification to enable further research on the drug’s potential benefits. Jean traces the criminalization of marijuana in the United States over time, arguing that its 1971 classification was ill-advised. Marijuana’s Schedule I classification makes it difficult to conduct research, Jean explains, and notes that only three institutions are permitted to do so. Jean proposes rescheduling marijuana or temporarily descheduling it to allow researchers to study the drug’s harms and benefits. Once a more detailed understanding of marijuana’s effects is achieved, Jean suggests that the federal government should allow the states to decide how they want to regulate the substance.