Government Accountability Office Exposes Deficiencies in DEA and FDA Marijuana Rescheduling Procedures Behind Department of Health Human Services Recommendation; Judge Halts Broader Marijuana Rescheduling
WASHINGTON, D.C. / ACCESS Newswire / September 30, 2026 / MMJ International Holdings, Inc. (“MMJ”), a pharmaceutical developer pursuing FDA approval of cannabinoid medicines for Huntington’s disease and multiple sclerosis, today highlighted the September 29 order by DEA Chief Administrative Law Judge Derek C. Julius staying the pending proceeding on broader marijuana rescheduling.
The hearing concluded July 15, and post-hearing briefs were filed August 17. The next anticipated step was the judge’s recommended decision. Instead, the proceeding has been halted while Judge Julius considers a motion to admit a September 23 Government Accountability Office report into the record and allow supplemental briefing.
DEA must respond by October 13, 2026. Other designated participants may also file responses. The proceeding remains stayed pending resolution of the motion.
GAO Documents Two Different Medical-Use Standards
The report, GAO-26-108623, describes DEA’s longstanding five-part test for determining whether a substance without FDA approval has a currently accepted medical use. That test requires:
- Known and reproducible chemistry.
- Adequate safety studies.
- Adequate and well-controlled studies proving efficacy.
- Acceptance by qualified experts.
- Widely available scientific evidence.
Government Accountability Office report also describes the additional two-part framework introduced by HHS in 2023. That framework considers widespread current medical use by licensed practitioners under state-authorized programs and credible scientific support for at least one of those uses.
Department of Health Human Services assessment relied on the two-part framework to recommend marijuana’s placement in Schedule III. As the GAO report explains, the approach permitted a finding of currently accepted medical use even when a substance had neither FDA approval nor satisfaction of DEA’s five-part test.
Court Filings Connects GAO Report to Sworn Testimony
The National Drug & Alcohol Screening Association, DUID Victim Voices, and Kenneth Finn, M.D., jointly requested admission of the report, supplemental briefing, and a hold on the recommended decision and certification of the record until that briefing concludes.
Their motion connects GAO’s discussion of the two frameworks to testimony already presented during the hearing.
According to the motion’s transcript citations, FDA official Dr. David Chiapperino testified that FDA did not complete a five-part medical-use analysis in its marijuana evaluation. He also acknowledged that the second part of the new framework uses a less rigorous evidentiary standard and that marijuana would not have passed the five-part test.
The motion further cites DEA pharmacologist Dr. Luli Akinfiresoye’s testimony questioning the two-part framework’s scientific adequacy because it lacked chemistry, safety, and efficacy requirements.
Those statements are hearing testimony cited by the moving parties, distinct from GAO’s audit findings.
Federal Audit Also Identifies Procedural Gaps
GAO found that DEA lacks comprehensive written policies and procedures directing staff on conducting scheduling evaluations and making scheduling decisions.
The report likewise identified gaps in FDA’s written procedures for conducting eight-factor analyses and developing scheduling recommendations, including criteria for determining a substance’s potential for abuse relative to other substances.
DOJ, including DEA, and HHS concurred with GAO’s report recommendations to address the identified deficiencies.
GAO did not determine which schedule marijuana belongs in. The moving parties argue that its findings are relevant to evaluating the government’s evidence supporting Schedule III.
Expect Significant Additional Delay
“This is a significant interruption at a consequential stage of the proceeding,” said Duane Boise, CEO of MMJ International Holdings. “The hearing was completed, the briefs were filed, and the next anticipated step was a recommendation. Now the judge must address whether a federal audit belongs in the record and whether additional briefing is required. MMJ expects that process to cause significant delays in completing broader rescheduling.”
“The distinction between the two-part and five-part tests matters,” Boise added. “One expressly requires reproducible chemistry, adequate safety studies, and controlled studies proving efficacy. The other permits a medical-use finding through a different evidentiary framework. MMJ believes those differences deserve careful examination before the federal government completes a decision with consequences for patients, researchers, and pharmaceutical developers.”
October 13 is the deadline for responses to the motion, not a date for completing rescheduling. Any supplemental briefing would depend on the judge’s subsequent ruling. The stay order establishes no completion date.
Separate April Order Remains in Effect
The September 29 stay applies to the pending proceeding concerning broader marijuana rescheduling. It does not suspend the separate April 2026 order placing marijuana in FDA-approved products and marijuana subject to qualifying state medical licenses in Schedule III.
About MMJ International Holdings
MMJ International Holdings, Inc., through MMJ BioPharma Cultivation, Inc. and MMJ BioPharma Labs, Inc., develops standardized cannabinoid medicines under FDA Investigational New Drug programs, including an orphan-drug-designated program for Huntington’s disease and a program for multiple sclerosis.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
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