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For over 2 decades Americans for Safe Access (ASA) has been advocating for a change in the scheduling of cannabis to recognize its medical use. We are excited to see that the Food & Drug Administration (FDA) incorporated many of our suggestions into their approach to the scheduling process and were able to utilize ASA’s data in reaching their conclusion that cannabis does in fact have accepted medical use.

Background:

In October 2022, President Biden called on Health & Human Services (HHS) & the Department of Justice (DOJ) to conduct a review of the scheduling of Cannabis under the Controlled Substance Act (CSA).

The process of determining the schedule of a substance defined under the CSA requires a medical & scientific review outlined by the “Eight Factor Analysis” & “five-element test” for determining whether the drug has a currently accepted medical use for treatment in the United States. FDA conducts the initial analysis for HHS before handing over their findings & recommendations to the Drug Enforcement Administration (DEA) to inform their review & scheduling determination on behalf of the DOJ.

Over the last 50 years, HHS & DOJ have conducted five scheduling reviews of cannabis, initiated by the petition process defined in the CSA. The last review concluded in 2016 with the DEA issuing the report “Denial of Petition to Initiate Proceedings to Reschedule Marijuana” see Factsheet: 2016 DEA Cannabis Scheduling Denial 

On August 30, 2023, HHS confirmed that it had recommended that cannabis be moved to a Schedule III status to the DEA.  Today, HHS’ report behind that recommendation was made public through a FOIA request:

HHS Report to DEA on Status of Cannabis Scheduling 

ASA's Recommendation to HHS 

What’s next:

The DEA is now performing a review that will include HHS’ findings, their internal application of the “8 Factor Analysis”, & US obligations to scheduling allowances under international drug treaties. Their determination & rationale will be posted to the federal registry accompanied by a timeframe for public comment. At that time, stakeholders can request a hearing to present the DEA with additional information in pursuit of a different outcome. If granted, a non-binding hearing will be conducted by an administrative law judge.

ASA is calling on Congress to adopt a comprehensive approach to cannabis regulations that would include the creation of a new schedule for cannabis & cannabinoids (Schedule VI) & the creation of the Office of Medical Cannabis & Cannabinoids Control (OMC) housed in HHS.

For more information on the impact of cannabis scheduling see:  Factsheet: Rescheduling Cannabis Update

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