The Department of Health and Human Services (HHS), which includes the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA,) has released the full version of its memorandum to the Drug Enforcement Administration (DEA) detailing its reasonings for its earlier recommendation to reschedule marijuana from Schedule I to Schedule III under the CSA.
The report follows an earlier recommendation from HHS recommending reclassifying marijuana from a Schedule I drug to a Schedule III drug; however, the Fall 2023 announcement did not have the accompanying memorandum with the agency's full research and rationale. Currently, marijuana is scheduled as Schedule I under the CSA, which contains what is considered the most “dangerous and addictive” substances listed under the CSA. The CSA prohibits the manufacture, distribution, dispensation, and possession of Schedule I substances, as these substances are deemed to have no “currently adopted medical use in treatment” and a “high potential for abuse.” 21 USC 812. In contrast, Schedule III substances have “a potential for abuse less than the drugs or other substances in schedules I and II” and have “a currently accepted medical use in treatment in the United States.” 21 USC 812. Schedule III substances also are categorized as having “ moderate or low physical dependence or high psychological dependence.” 21 USC 812.
The report, sent to Anne Milgram of the DEA, includes analysis of the eight factors used to determine scheduling under the CSA, as required under 21 U.S.C. 811(c):
Actual or relative potential for abuse
Scientific evidence of its pharmacological effect
The state of current scientific knowledge regarding the drug or other substance
Its history and current pattern of abuse
The scope, duration, and significance of abuse
What, if any, risk there is to the public health
Its psychic or physiological dependence liability; and
Whether the substance is an immediate precursor of a substance already controlled.
After comprehensively analyzing the eight necessary factors, the agencies must make three findings to develop its official recommendation: the substance’s relative abuse potential compared to other drugs, whether it has a currently accepted medical use (CAMU) in treatment in the United States (or a currently accepted medical use with severe restrictions (21 U.S.C. 812(b)(2)(B)), and its relative safety or ability to produce physical dependence compared to other drugs, as provided under 21 U.S.C. 812(b). For further information on the FDA’s process in giving scheduling recommendations, please see Assessment of Abuse Potential of Drugs: Guidance for Industry.
“After assessing all available preclinical, clinical, and epidemiological data,” the FDA recommended that marijuana be rescheduled from Schedule I into Schedule III of the CSA, based on its three findings:
Marijuana has a potential for abuse less than the drugs or other substances in Schedules I and II
Marijuana has a currently accepted medical use in treatment in the US
Abuse of marijuana may lead to moderate or low physical dependence or high psychological dependence
Twelve state Attorney Generals responded to the earlier recommendations with a letter of support to "encourage the DEA to implement a final rule rescheduling cannabis to Schedule III" following HHS' recommendation. In particular, the state AGs hoped the rescheduling would allow for greater research abilities for state-regulated cannabis industries, expanded investments for regulated cannabis companies, and an enhanced ability to regulate the “illicit market and unregulated hemp-derived cannabinoids” within the states. AGs from Colorado, Illinois, California, Maryland, Connecticut, Massachusetts, Delaware, Oregon, Pennsylvania, Nevada, New Jersey, and Rhode Island signed the letter in support.
Though the recommendation is a historic shift in cannabis policy, “[i]n general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, “guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited.” For rescheduling to occur, DEA must officially adopt the recommendation and undertake a potentially lengthy administrative process of public comments, rulemaking, and review processes.
Industry analysts are hopeful that the DEA will follow the recommendations, resulting in significant changes in marijuana policy in the country. In a 2020 Congressional Hearing titled “Cannabis Policies for the New Decade” by the House Committee on Energy and Commerce, Matthew Strait, Senior Policy Advisor for the DEA, informed the legislative committee that the DEA has “never refused to reschedule a compound after being given a recommendation to do so by the FDA” and that if the FDA recommends rescheduling, the DEA is “bound by the recommendations of the Secretary as it pertains to scientific and medical matters.” 21 USC 811 (b). However, while “binding,” if the Attorney General determines that “all other relevant data” included in the analysis outweighs the scientific and medical data presented, the DEA may reject the recommendation. 21 USC 811 (b).
What comes next will be hard to predict, but DEA is expected to release its decision in the coming months as to whether it will reject the recommendation or move forward with rescheduling.
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