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HHS Recommends ‘Replanting’ Marijuana in Schedule III

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On August 29, 2023, the U.S. Department of Health and Human Services delivered its recommendation on marijuana scheduling to the Drug Enforcement Administration. The recommendation comes after President Joe Biden's October 2022 directive for HHS to provide a scheduling recommendation for marijuana to the DEA. Multiple sources have confirmed, HHS recommends marijuana be reclassified as a Schedule III controlled substance. Marijuana is currently classified as a Schedule I drug, the category of which is reserved for drugs with no currently accepted medical use and a high potential for abuse (like LSD and heroin). Schedule III on the other hand is reserved for drugs with a moderate to low potential for physical and psychological dependence (such as Tylenol with codeine, ketamine, anabolic steroids, and testosterone).

HHS’s recommendation was based on an extensive FDA review of scientific data and consideration of the eight factors that determine the control status of a substance. These factors are listed in Section 201 (c), [21 U.S.C. § 811 (c)] of the Controlled Substances Act, under which the U.S. Attorney General must consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules:

(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

Moving forward, the HHS recommendation is not binding, and DEA has the final authority to schedule or reschedule a drug under the Controlled Substances Act. If the DEA ultimately agrees and completes its own research (if any), DEA would go through a formal rulemaking process, including a public comment period, before finalizing the scheduling action with a final rulemaking.

While the possible rescheduling would not decriminalize marijuana, rescheduling could reduce the regulatory burden on drug researchers. Likewise, the rescheduling could allow cannabis businesses to claim tax credits and deductions on income generated by sales of marijuana, which are currently prohibited under the tax code while marijuana is still classified as a Schedule I.

Quarles will continue to monitor updates on this topic. If you have any questions, please contact your local attorney or:

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