"DEA silenced the only FDA-pathway cannabinoid developer at its ALJ hearing. The courts won't." - Duane Boise, CEO, MMJ International Holdings.
WASHINGTON, D.C. / ACCESS Newswire / July 12, 2026 / The most revealing moment of the DEA's marijuana rescheduling process may not have occurred during seven days of testimony in Arlington. It occurred weeks earlier, when the DEA decided who would not be allowed into the hearing room.
The agency excluded MMJ International Holdings-the only company developing botanical cannabinoid medicines through the FDA's formal drug approval process-from participating in a hearing whose central question was whether marijuana has a "currently accepted medical use."
That decision speaks volumes.
For nearly eight years, MMJ has done exactly what Congress envisioned for controlled-substance medicines. It obtained DEA registrations, pursued FDA Investigational New Drug applications, developed standardized botanical soft-gel capsules under pharmaceutical manufacturing standards, generated chemistry, manufacturing and controls (CMC) data, completed stability testing, and invested more than $10 million building a scientific record designed to answer the very questions before the agency.
Yet when MMJ asked to present that evidence, DEA responded that those issues were merely "questions of law."
The irony is difficult to ignore.
Throughout the hearing, witness after witness debated whether marijuana sold through state programs possesses reproducible chemistry, standardized dosing, adequate safety data, physician oversight, or reliable clinical evidence. Those are precisely the subjects MMJ has spent years addressing through the FDA pathway. Rather than hear from the one company that actually undertook that work, DEA limited the proceeding while simultaneously concluding that MMJ's evidence was outside its scope.
Even more striking was the precedent the agency relied upon to justify MMJ's exclusion.
DEA cited its 1999 order rescheduling FDA-approved dronabinol formulated in soft gelatin capsules-a cannabinoid medicine that earned Schedule III status only after completing FDA review.
That is precisely the model MMJ followed.
Instead of bypassing federal regulation, MMJ developed standardized botanical cannabinoid soft-gel capsules through FDA Investigational New Drug programs. The company embraced the same scientific framework that underpinned DEA's own 1999 precedent. Yet under the current rescheduling order, state-licensed products that have never undergone FDA review stand to receive Schedule III treatment, while the company following the historical federal model was denied a seat at the hearing.
The contrast raises an obvious question.
If the hearing's purpose was to determine whether marijuana has a currently accepted medical use under federal law, why exclude the only participant whose business has been built around satisfying the federal standards traditionally used to answer that question?
DEA's answer was procedural.
MMJ's answer will come in court.
The D.C. Circuit is now being asked to review not simply the outcome of the rescheduling order, but the process that produced it. Among the issues before the court are MMJ's arguments concerning statutory procedure, notice and comment, constitutional questions surrounding the administrative process, and the government's interpretation of the Controlled Substances Act.
Whether those arguments ultimately prevail will be decided by the judiciary, not the agency.
But one fact is already part of the record.
When the federal government held a hearing to determine whether marijuana satisfies the scientific requirements for accepted medical use, the only pharmaceutical developer that had spent years attempting to satisfy those requirements through the FDA's drug approval pathway was told its evidence would not be heard.
"The DEA convened a hearing on whether marijuana has an accepted medical use and excluded the one company that actually built the scientific record Congress envisioned," said Duane Boise, Chief Executive Officer of MMJ International Holdings. "If those issues are questions of law, then the D.C. Circuit is exactly where they belong. The voice excluded from the hearing in Arlington will now be heard where it matters most-in federal court."
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/mmj-the-voice-dea-didnt-want-to-hear-from-during-marijuana-rescheduli-1189935
