DEA’s Own Witness Admitted Marijuana Failed the Medical-Use Test-Then the Government Buried It in Silence
The corrected official transcripts are now public. FDA's supervising scientist named who directed the change in
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The corrected official transcripts are now public. FDA’s supervising scientist named who directed the change in standard: the Assistant Secretary for Health – the same office that produced the government’s headline evidence and never sent a witness.
WASHINGTON, D.C. / ACCESS Newswire / August 26, 2026 / The Drug Enforcement Administration has released the corrected official transcripts from all 11 days of its marijuana-rescheduling hearing. MMJ International Holdings, Inc. (“MMJ”) has reviewed them against the Government’s 50-page closing brief.
Buried inside thousands of pages is one admission that cuts through nearly every political argument surrounding Schedule III: Marijuana would not have passed the federal government’s traditional test for an accepted medical use.
First, the Government Tried to Stop the Question
On Day 2, counsel for the opposing parties sought to ask Dr. Dominic Chiapperino-Director of the Controlled Substance Staff at the Food and Drug Administration (FDA) and the official who supervised the eight-factor scientific evaluation underlying the rescheduling proposal-whether marijuana would have passed DEA’s traditional five-part test for accepted medical use.
Government counsel immediately objected: “That is an opinion that would need an expert witness. That is not the witness before the Court today… he cannot testify to the results of something that was never complete.”
Chief Administrative Law Judge Derek C. Julius overruled the objection: “I’ll allow him – I’ll allow you to ask the question, and he can answer if he knows.”
Then Came the Answer
When pressed on whether marijuana could meet the five-part test applied to 127 other drugs during his career, Dr. Chiapperino admitted that the underlying clinical studies were too small to qualify as adequate and well-controlled studies.
As captured in the transcript (Tr. Day 2, 435-436):
Q: “…as someone who has applied the five-factor test 127 times in your career, and who supervised the data that went in – on marijuana that went into the HHS recommendation in 2023 – it’s true, sir, is it not, that marijuana would not have passed the five-factor test that you’ve applied in other instances?”
A: “…the clinical studies that were considered for these indications, I do think they were not large enough to pass an FDA approval as an adequate, well-controlled study…”
A: “So on the basis of the first element alone, without even consideration of the other two, I do believe that it would have been difficult for marijuana to pass the five-part test.”
Q: “Would not have passed, correct?”
A: “Would not have passed. Sure.”
The government’s closing brief cites Dr. Chiapperino 31 times. It does not cite this. By omitting this crucial cross-examination, the government’s legal strategy effectively shields its own evidentiary contradictions from judicial scrutiny.
Who Changed the Standard?
The hearing records reveal who forced the pivot away from traditional pharmaceutical standards.
When Dr. Chiapperino was asked who directed the FDA to abandon the traditional test in favor of a new, less rigorous two-part test, his answer pointed straight to political leadership:
“The Assistant Secretary for Health.”
At the time, the Assistant Secretary for Health-heading the Office of the Assistant Secretary for Health (OASH) within the Department of Health and Human Services (HHS)-was Admiral Rachel L. Levine, M.D. Levine later signed the August 29, 2023 letter formally recommending that marijuana be moved to Schedule III.
While Dr. Chiapperino identified OASH as the directing body, neither Admiral Levine nor any other OASH representative appeared at the DEA hearing to defend how the new test was created, how state-program evidence was weighed, or why traditional standards were bypassed.
OASH delivered its completed Part 1 memorandum-relying heavily on state programs, 30,000+ practitioners, and millions of registered patients-directly to the FDA, leaving Dr. Chiapperino unable to answer cross-examination questions regarding OASH’s methodology. The government shielded its foundational evidence from cross-examination by refusing to send an OASH witness.
DEA’s Own Scientific Review Was Unfinished
The hearing exposed a second major structural flaw in the rulemaking process.
Dr. Luli R. Akinfiresoye, a DEA pharmacologist in the Drug and Chemical Evaluation Section, testified on Day 6 (Tr. pages 1348-1360) that DEA’s eight-factor scientific analysis had not even been completed when the marijuana Notice of Proposed Rulemaking (NPRM) was published in May 2024.
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“The eight-factor analysis was not complete at the time of the NPRM,” she testified. “Data was lacking. We needed more information.”
DEA had to scramble to prepare a subsequent scientific document to fill massive gaps left by the HHS evaluation-including critical data regarding diversion from state marijuana programs. Moving forward with a sweeping rescheduling proposal while admitting essential scientific data was missing highlights an agency rushing to meet a political timeline rather than a factual one.
The MMJ Connection: Compliance vs. Political Convenience
For MMJ International Holdings, Inc., which has spent more than eight years and over $10 million developing standardized cannabinoid medicines (such as its 5 mg CBD / 2.5 mg THC soft-gel capsules) through the rigorous FDA Investigational New Drug (IND) pathway, these revelations expose a profound double standard.
“The government objected to the question, the judge allowed it, and its own FDA witness gave an answer that strikes at the foundation of the Schedule III recommendation,” said Duane Boise, Chief Executive Officer of MMJ International Holdings. “The government cannot rely on the portions of his testimony it likes while pretending the most important admission never happened. They changed the rules, lowered the bar, hid behind un-cross-examined political offices, and rushed a proposal while their own science was incomplete-all to validate a politically favored substance while penalizing companies doing the hard work of traditional drug development.”
The corrected transcripts are available on the DEA’s official marijuana-rescheduling hearing page.
About MMJ International Holdings, Inc.
MMJ International Holdings, Inc. is a privately held pharmaceutical company developing standardized cannabinoid-based investigational medicines through federal pathways administered by the FDA and DEA. MMJ BioPharma Labs holds a DEA Schedule I analytical-laboratory registration. MMJ BioPharma Cultivation has a pending DEA bulk-manufacturing application. MMJ’s investigational programs concern potential treatments for Huntington’s disease and multiple sclerosis.
CONTACT:
Madison Hisey
MMJ International Holdings, Inc.
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
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