What if DEA's Own ALJ Hearing Record Undercuts Marijuana Rescheduling?

The public debate has largely assumed only two possible outcomes - Schedule I or Schedule III. But the record may support a third: Schedule II. More importantly, whichever recommendation Judge Julius makes, the government may have created significant problems for itself.

Based on my personal observations and notes from the hearing, the central question is no longer simply whether marijuana has some medical value.

The more difficult question is this:

What happens if the government's own witnesses established that marijuana would not satisfy DEA's traditional scientific standard for currently accepted medical use?

DEA'S TWO COMPETING SCIENTIFIC STANDARDS

For decades, DEA evaluated currently accepted medical use under a five-part test requiring:

• Known and reproducible chemistry;

• Adequate safety studies;

• Adequate and well-controlled efficacy studies;

• Acceptance by qualified experts; and

• Widely available scientific evidence.

The Department of Health and Human Services reached its 2023 Schedule III recommendation using a new two-part inquiry. That test considers widespread experience under state medical-marijuana programs and whether some credible scientific support exists for at least one medical use.

The Department of Justice's Office of Legal Counsel subsequently concluded that the new two-part test is legally sufficient, even if marijuana cannot satisfy DEA's traditional five-part standard.

But legal permission to use a new test does not erase conflicting scientific evidence.

WHAT IF DEA'S OWN SCIENTIST DISAGREED?

During the hearing, DEA pharmacologist Dr. Luli Akinfiresoye testified concerning the agency's scientific evaluation of marijuana under its traditional five-part test.

Based on my observations of that testimony, Dr. Akinfiresoye concluded that marijuana failed the established requirements involving reproducible chemistry, adequate safety evidence and adequate well-controlled efficacy studies. Her testimony also raised concerns involving diversion from state marijuana systems, product variability and public-health risk.

FDA official Dr. Dominic Chiapperino similarly faced questioning about whether marijuana could satisfy the five-part standard historically used in federal scheduling proceedings.

What if the final record establishes that the government's own scientific witnesses agreed marijuana would not pass that test?

That would not automatically defeat the two-part HHS standard. But it would leave DEA with a serious obligation to explain why it changed methodologies, why the new methodology is scientifically adequate and how the agency reconciles contradictory findings from its own personnel.

A STATE LICENSE DOES NOT CHANGE CHEMISTRY

The hearing also exposed a problem extending beyond the administrative proceeding.

Acting Attorney General Todd Blanche's April 2026 order already transferred state-licensed medical marijuana into Schedule III. That separate order is under review in the U.S. Court of Appeals for the District of Columbia Circuit.

Yet a state license does not make marijuana's chemistry reproducible. It does not create adequate controlled clinical trials. It does not establish standardized dosage, validated manufacturing, stability, bioavailability or predictable drug interactions.

If marijuana lacks reproducible chemistry and sufficient controlled efficacy evidence, those deficiencies do not disappear when the manufacturer receives a state license.

That distinction matters to MMJ International Holdings.

MMJ has spent more than eight years and more than $10 million developing standardized cannabinoid pharmaceutical candidates through the FDA and DEA pathways. MMJ developed a final dosage form containing 5 milligrams of CBD and 2.5 milligrams of THC per soft-gel capsule and had thousand of soft gel capsules manufactured by Catalent Pharma Solutions.

MMJ remains subject to FDA requirements and a Full Clinical Hold because it followed the federal process.

Meanwhile, the Attorney General's order created expedited federal advantages for state operators whose products have not undergone comparable chemistry, manufacturing, stability, safety or efficacy review.

WHAT IF THE JUDGE RECOMMENDS SCHEDULE III?

A Schedule III recommendation would not end the controversy.

DEA would still have to explain:

• Why it abandoned or supplemented its longstanding five-part test;

• Why "mixed" or "inconclusive" evidence became sufficient;

• How evidence involving selected preparations supports the entire category of marijuana;

• How products ranging from low-dose formulations to high-potency concentrates share one accepted medical use;

• Why state-program prevalence substitutes for traditional scientific acceptance; and

• How DEA reconciles Schedule III with contrary conclusions from its own scientific personnel.

Schedule III may remain the government's preferred outcome, but the administrative record could make that result harder-not easier-to defend in court.

WHAT IF THE JUDGE RECOMMENDS SCHEDULE II?

Schedule II may be the overlooked possibility.

Judge Julius could conclude that marijuana has some currently accepted medical use but that its abuse potential, dependence liability, inconsistent chemistry and public-health risks do not support Schedule III.

That result would place the administration in an extraordinary position.

The Attorney General has already moved state-licensed medical marijuana to Schedule III, while the ALJ could recommend Schedule II for the remainder of the same CSA-defined substance.

The government would then have to explain how licensing status-not chemistry, pharmacology or clinical evidence-justifies different federal schedules for materially comparable marijuana.

WHAT IF THE JUDGE RECOMMENDS SCHEDULE I?

A recommendation to retain Schedule I would create an even more direct conflict.

It would mean the hearing record failed to establish one or more findings required for Schedule III, even though the Attorney General had already granted Schedule III treatment to state-licensed marijuana through a separate treaty-based order.

That would strengthen questions already before the D.C. Circuit:

• Did the Attorney General bypass the evidentiary process because the necessary findings could not be made?

• Did the government create a hybrid schedule based on licensing status rather than the characteristics of the substance?

• Did HHS scientifically evaluate the classification Blanche ultimately adopted?

• Were state operators given federal advantages without satisfying standards imposed on federally regulated pharmaceutical developers?

THE RECORD NOW MATTERS MORE THAN THE POLITICS

The ALJ's recommendation will be advisory. DEA Administrator Terrance Cole will retain ultimate administrative authority, and judicial review is likely regardless of the result.

But the hearing was not meaningless.

It created a sworn administrative record. That record may contain admissions the government cannot simply erase because they complicate the preferred policy outcome.

The government may ultimately choose Schedule I, Schedule II or Schedule III. Each outcome now requires an explanation.

If Schedule III is recommended, DEA must reconcile its own scientific conflict.

If Schedule II is recommended, the government must explain why comparable marijuana occupies different schedules based on licensing status.

If Schedule I is retained, the Attorney General's earlier decision to place state-licensed marijuana in Schedule III becomes even more difficult to defend.

Whichever way Judge Julius rules, the government has a great deal of explaining to do.

About MMJ International Holdings

MMJ is a petitioner in pending federal litigation concerning the April 2026 Marijuana Rescheduling Order. No court has ruled on the merits of MMJ's claims. Nothing herein predicts any judicial or administrative outcome or constitutes an offer to sell or solicitation of an offer to purchase any security.

CONTACT:

Madison Hisey