Sunday, 09 August 2026 01:45 PM
Company Update
With post hearing briefs due August 17 and Administrative Law Judge Derek C. Julius expected to issue a recommendation thereafter, Duane Boise CEO MMJ International Holdings says "the most important question may no longer be whether marijuana reaches Schedule III-but whether the evidentiary record actually supports the government's state licensed marijuana pathway."
WASHINGTON, D.C. / ACCESS Newswire / August 9, 2026 / No one outside the courtroom can know what Administrative Law Judge Derek C. Julius will ultimately recommend following the Drug Enforcement Administration's marijuana rescheduling hearing.
But the hearing transcripts may provide a glimpse into the crystal ball.
With post-hearing briefs due August 17, 2026, and an ALJ recommendation expected at some point thereafter, MMJ International Holdings says the testimony developed during the proceeding has exposed fundamental tensions between the scientific evidence presented at the hearing and the federal government's decision to extend Schedule III treatment to marijuana distributed through qualifying state medical-marijuana programs.
For MMJ, the most consequential question may therefore be larger than whether Judge Julius ultimately recommends Schedule III.
What factual findings will he make to get there?
THE GOVERNMENT'S OWN SCIENTIFIC RECORD MAY BE THE STORY
Among the most significant testimony came from DEA scientist Dr. Luli Akinfiresoye, whose scientific analysis addressed marijuana under DEA's traditional framework for determining whether a substance has a currently accepted medical use.
From MMJ's notes her testimony and analysis raised questions concerning reproducible chemistry, adequate safety information and evidence from adequate and well-controlled studies.
The hearing also developed testimony concerning diversion from state marijuana programs.
Those issues go directly to a fundamental question confronting the ALJ:
Can widespread use of marijuana under state law substitute for the product standardization, safety evidence, controlled clinical evidence and federal regulatory controls ordinarily associated with medicines recognized under federal law?
That question becomes particularly significant because the Attorney General's April 2026 Marijuana Rescheduling Order did not limit Schedule III treatment to FDA-approved cannabinoid medicines.
It also created a separate pathway for marijuana handled pursuant to qualifying state medical-marijuana laws.
A PHYSICIAN "RECOMMENDATION" IS NOT A PRESCRIPTION
The hearing record also highlighted the distinction between physicians recommending marijuana under state programs and physicians prescribing federally approved medicines.
Testimony notes from pain physician Dr. Kenneth Finn addressed questions involving dosing, labeling, medical records, product consistency, safety information and the extent to which physicians actually control or even know the chemical composition of marijuana products ultimately purchased by patients.
That distinction matters.
An FDA-approved medicine ordinarily reaches patients only after its chemistry is characterized, manufacturing is controlled, dosage is established, safety and efficacy are evaluated, labeling is reviewed and federal regulators authorize its use.
State marijuana programs were not constructed around that system.
Yet widespread experience under those programs has become part of the federal government's justification for recognizing marijuana as having accepted medical use.
Judge Julius must now evaluate the evidence supporting that proposition.
THE ALJ COULD CREATE A PROBLEM EVEN WHILE RECOMMENDING SCHEDULE III
The most important part of the forthcoming recommendation may not be the words "Schedule I" or "Schedule III."
It may be the factual findings underneath them.
Judge Julius could theoretically recommend Schedule III while simultaneously finding significant deficiencies involving product consistency, chemistry, controlled efficacy evidence, physician supervision, safety information or diversion.
That would raise an obvious question:
If the factual record demonstrates those deficiencies, how does that same record justify granting federal Schedule III treatment to an entire category of marijuana products based principally upon state licensure?
That issue could extend well beyond the DEA administrative proceeding.
The Attorney General's April 2026 Rescheduling Order is already under judicial review in the U.S. Court of Appeals for the District of Columbia Circuit, where MMJ is challenging aspects of the federal government's rescheduling framework.
MMJ FOLLOWED THE OTHER PATH
MMJ's position presents a stark contrast.
MMJ has pursued the traditional federal pharmaceutical pathway for cannabinoid medicines.
Its development program has included FDA Investigational New Drug applications, DEA-controlled-substance registrations, pharmaceutical manufacturing, defined cannabinoid formulations, chemistry and manufacturing controls, stability testing and preparations for FDA-regulated clinical development.
MMJ has spent years attempting to satisfy federal requirements before bringing a cannabinoid medicine to patients.
The company argues that the federal government cannot rationally impose those requirements on pharmaceutical developers while simultaneously treating state licensure as a gateway to federal Schedule III status for products that have not undergone comparable FDA review.
"We don't need a crystal ball to see the problem," said Duane Boise, CEO of MMJ International Holdings. "We only need to read the tea leaves. The government's own hearing record will raise serious questions about chemistry, safety, efficacy, diversion and what physicians actually know about the products being recommended under state marijuana programs. Judge Julius now has to reconcile that evidence with a federal policy that grants those same programs a pathway into Schedule III."
Boise continued:
"The real question isn't simply whether the ALJ writes ‘Schedule III' at the end of his recommendation. The question is what he finds along the way. If the factual findings undermine the assumptions supporting the state-license pathway, those findings could become extraordinarily important when the legality of the Rescheduling Order is reviewed by the federal courts."
AUGUST 17 IS THE NEXT MARKER
The parties' post-hearing briefs are due August 17.
After briefing concludes, attention will turn to Judge Julius and his eventual recommended decision.
No one can responsibly predict precisely what that recommendation will say.
But after weeks of sworn testimony, cross-examination and scientific evidence, the administrative record now provides something considerably more valuable than speculation:
Evidence.
And when Judge Julius ultimately writes his recommendation, the cannabis industry may discover that the most consequential portion is not his conclusion.
It may be the findings he makes before he gets there.
About MMJ International Holdings
MMJ International Holdings and its affiliated companies are developing pharmaceutical cannabinoid products through the federal FDA and DEA regulatory pathways. MMJ's development efforts include standardized cannabinoid formulations intended for FDA-regulated clinical investigation and potential prescription-drug approval.
CONTACT:
Madison Hisey
[email protected]
203-231-8583
Editor's Note and Disclaimer: Quotations and characterizations of testimony in this release are based on contemporaneous notes taken during the public administrative hearing before the DEA Administrative Law Judge (Docket No. 2024-6) and have not been verified against the certified hearing transcript. Readers should consult the official transcript, once available, for the authoritative record. MMJ International Holdings and its subsidiaries are active parties in three federal matters: (1) the consolidated marijuana rescheduling appeal, SAM Inc. v. Department of Justice, Nos. 26-1106, 26-1130 & 26-1136 (D.C. Cir.), challenging the Attorney General's April 2026 Schedule III Final Order (91 Fed. Reg. 22714); (2) MMJ BioPharma Cultivation, Inc. v. DEA, federal litigation concerning MMJ's bulk manufacturer registration application; and (3) the appeal challenging the CMS Innovation Center's hemp-derived cannabinoid (BEI) pilot program, also before the D.C. Circuit. The views, interpretations, and opinions expressed are solely those of MMJ, relate to matters in active litigation, and do not represent findings of any tribunal or government agency. Nothing in this release constitutes legal, medical, or investment advice.
SOURCE: MMJ International Holdings