The Drug Enforcement Administration (DEA) has again cited the federal government’s revised standard for determining whether a substance has an accepted medical use, explicitly referencing the Justice Department’s 2024 legal opinion supporting marijuana rescheduling in a new Federal Register notice published October 14.
The reference appears in a 36-page DEA notice concerning the proposed temporary placement of two kratom-related substances, 7-hydroxymitragynine and mitragynine pseudoindoxyl, into Schedule I of the Controlled Substances Act when their concentrations exceed specified thresholds.
Although the notice does not directly address the pending marijuana rescheduling proceedings, it discusses the same legal framework used by the Department of Health and Human Services (HHS) to determine that marijuana has a currently accepted medical use, a central justification for moving it from Schedule I to Schedule III.
In a footnote discussing Schedule I classification, DEA outlines its longstanding five-part test for determining whether a substance has an accepted medical use, including requirements for adequate safety studies, demonstrated effectiveness and acceptance by qualified experts.
The agency then describes an additional two-part test developed by HHS, which considers whether a substance is widely used medically under state-authorized programs and whether credible scientific evidence supports at least one of those medical uses.
DEA specifically references the April 11, 2024, opinion from the Justice Department’s Office of Legal Counsel, which concluded that the HHS approach was legally sufficient to establish accepted medical use even when a substance does not satisfy DEA’s traditional five-part test.
That opinion was central to the federal government’s subsequent proposal to move marijuana to Schedule III. HHS applied the two-part approach to marijuana, citing widespread medical use under state programs and scientific evidence supporting its use for pain, nausea and vomiting, and anorexia associated with medical conditions.
The October 14 document applies the framework to different substances, concluding that the available evidence does not establish widespread, medically recognized use of 7-hydroxymitragynine or mitragynine pseudoindoxyl. As a result, DEA says the two-part test is not satisfied for those substances.
The discussion is notable because DEA references the revised medical-use framework in a separate scheduling proceeding more than two years after the Justice Department issued its opinion.
The 2024 Justice Department opinion found that DEA’s traditional approach to accepted medical use was too restrictive because it failed to adequately account for widespread clinical experience under state-authorized medical programs.
The opinion also established that while HHS’s overall scheduling recommendation does not bind DEA, the agency must give significant deference to the department’s underlying scientific and medical determinations throughout the rulemaking process.
In its October 14 notice, DEA further acknowledges that temporary Schedule I scheduling under federal law does not require the agency to determine whether a substance has an accepted medical use, although it nevertheless discusses the medical-use question for the kratom-related substances.
The newly published notice concerns DEA’s intention to issue a revised temporary scheduling order following an October 8 recommendation from HHS establishing new concentration thresholds. It provides the required 30-day notice before the agency may issue the order.
