DEA opens comment period for cannabis rescheduling

The agency's proposal could reschedule marijuana, but FDA approval would still be required for medical use.

The Drug Enforcement Administration formally published its proposal to remove marijuana from Schedule I of the Controlled Substances Act and reclassify it as a Schedule III drug, marking the first time the agency has initiated rescheduling proceedings for cannabis.

In a Tuesday notice of proposed rulemaking published in the Federal Register, the DEA said the Department of Health and Human Services recommended that marijuana be moved to Schedule III because:

  • It has a lower potential for abuse than Schedule I and II substances
  • It has accepted medical use.
  • It leads to limited physical or psychological dependence compared to harder drugs.

The agency is seeking public comments on the proposed rescheduling until July 22 and will consider requests for a hearing submitted by June 20. The DEA is specifically soliciting comments on the practical consequences of rescheduling cannabis under the Controlled Substances Act and other relevant statutory frameworks.

If adopted, the change would ease certain regulatory controls on cannabis, though it would remain illegal under federal law unless Congress decides to make legislative changes.

The DEA’s proposal kicks off a high-stakes rulemaking process that will ultimately determine whether marijuana is removed from the most restrictive category of drugs after being listed there for more than 50 years. The outcome could reshape the U.S. cannabis industry that has grown substantially in recent years, largely under state laws that conflict with the federal prohibition.

The notice cites a 2023 recommendation from the Department of Health and Human Services that cannabis has a currently accepted medical use specifically for the treatment of anorexia related to a medical condition, nausea and vomiting (e.g., chemotherapy-induced), and pain.

According to the National Survey on Drug Use and Health, in 2022 an estimated 61.9 million people aged 12 and older (22%) had used marijuana in the past year, and 42.3 million (15%) used it in the past month, the DEA notice said.

If rescheduled, the notice states that drugs containing cannabis would still need FDA approval to be legally marketed unless an investigational new drug application is in effect.

The notice also outlines how rescheduling to Schedule III would still allow the DEA to meet U.S. obligations under international drug control treaties, though some additional regulatory action may be needed.

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Adam Jackson

Adam Jackson writes about the cannabis industry for the Green Market Report. He previously covered the Missouri Statehouse for the Columbia Missourian and has written for the Missouri Independent. He most recently covered retail, restaurants and other consumer companies for Bloomberg Business News. You can find him on Twitter at @adam_sjackson and email him at adam.jackson@crain.com.


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