DEA Has Published the Evidence Against Marijuana Rescheduling

As Judge Derek Julius prepares his recommendation and Dr. Heidi Overton awaits Senate confirmation, the federal government's own findings expose the contradiction between the AG's rescheduling order, state acceptance and pharmaceutical science.

DEA Said Cannabis Labeling Is "Not Controlled and Often Significantly Inaccurate." The Next FDA Commissioner Inherits the Consequences.

WASHINGTON, D.C. / ACCESS Newswire / August 21, 2026 / MMJ International Holdings, Inc. ("MMJ") today called on Dr. Heidi Overton, President Trump's nominee to serve as Commissioner of the U.S. Food and Drug Administration, to confront the widening divide between the scientific standards FDA imposes on investigational medicines and those applied to cannabis products sold to patients and consumers.

The central question is no longer whether the cannabis marketplace has a quality control problem. The federal government has already documented it.

What DEA published

In its 2025 National Drug Threat Assessment, DEA reported that THC potency continues to rise and remains "largely unregulated in states where marijuana has been legalized."

DEA further warned:

"Product labeling is not controlled and is often significantly inaccurate, putting consumers-especially children who may accidentally consume THC edibles because of their misleading packaging-in greater jeopardy than they are likely aware of."

The assessment also describes illicit cultivation and trafficking networks operating in states with legal cannabis markets. According to DEA, some criminal grow sites use pesticides and fertilizers containing chemicals banned in the United States, while traffickers exploit state-by-state differences in plant limits, registration requirements and enforcement.

DEA also reported that some operators obtain licenses through falsified means, exceed legal production limits and launder proceeds through registered marijuana cultivation operations using straw owners.

DEA's assessment primarily concerns illicit marijuana trafficking. It does not establish that every product sold through a state-licensed dispensary is mislabeled or contaminated.

It does establish something the federal government can no longer ignore: state legalization has not prevented uncontrolled potency, misleading packaging, unlawful diversion, falsified licensing or inaccurate labeling.

The public-health consequences are measurable

The dangers associated with uncontrolled potency, accidental ingestion and uncertain labeling are not theoretical.

Connecticut's Poison Control Center recorded 668 cannabis-related calls involving minors beginning in 2019, including 280 involving children under six, 110 involving children ages six through eleven and 278 involving those ages twelve through seventeen.

In Michigan, more than 400 children under six were treated in emergency departments for marijuana ingestion between 2020 and 2022. Approximately 80 were admitted to critical-care units.

North Carolina recorded 3,542 cannabis-related emergency-department visits in 2025, including 1,424 involving people age 24 and younger.

In October 2024, a Wisconsin restaurant sharing a commercial kitchen with a licensed manufacturer of hemp-derived THC edibles mistakenly used THC-infused oil in food served to unsuspecting customers. The Centers for Disease Control and Prevention identified at least 85 people with symptoms consistent with THC intoxication. Twenty-eight went to emergency departments, and three were hospitalized overnight.

These figures involve cannabis exposure, intoxication and related conditions, including cannabinoid hyperemesis syndrome. They do not establish that every case involved contamination, mislabeling or a product purchased from a licensed dispensary.

But they expose the practical problem facing emergency physicians: the product's origin, strength, ingredients and actual dose frequently remain unknown.

"The emergency department has become the quality-control function for a marketplace that often cannot tell a physician what the patient consumed or in what quantity," said Duane Boise, Chief Executive Officer of MMJ International Holdings. "That is the predictable consequence of distributing intoxicating products without reproducible chemistry, controlled dosing and validated manufacturing."

Massachusetts demonstrates that licensing is not enough

Massachusetts shows why the problem cannot be dismissed as solely an illicit-market issue.

In 2025, the Massachusetts Cannabis Control Commission issued public-health advisories concerning marijuana flower and pre-rolls that had passed required compliance testing but were later identified as contaminated or potentially contaminated with yeast, mold and, in certain products, coliforms above state limits.

The affected products had been distributed through licensed adult-use Marijuana Retailers and Medical Marijuana Treatment Centers.

The Commission subsequently suspended the license of Assured Testing Laboratories while investigating allegedly inaccurate contaminant-testing results. Its August 2025 advisory identified products connected to 544 laboratory samples that had previously failed total yeast-and-mold testing.

The Commission did not conclude that every listed product caused illness, nor did it establish that every potentially affected product was contaminated.

What it did establish was serious enough: products moved through licensed businesses, state-mandated testing and seed-to-sale tracking before regulators determined that the original compliance results could not be trusted.

"Massachusetts answers the industry's standard defense," Boise said. "These were not products purchased from a street dealer. They moved through licensed businesses, state-required testing and tracked inventory. The system still failed to identify the problem before products reached consumers and medical patients."

A state compliance test is not FDA review

State cannabis testing generally examines a limited panel that may include cannabinoid potency, selected pesticides, microorganisms, residual solvents and heavy metals. Sampling rules, laboratory methods, contaminant limits and enforcement practices vary among jurisdictions.

Passing a state compliance panel does not establish:

• Complete chemical characterization;

• Reproducibility between manufacturing batches;

• Identification and qualification of impurities;

• Validated manufacturing processes;

• Stability throughout the stated shelf life;

• Consistent absorption and bioavailability;

• Safe and effective dosing;

• Drug-interaction and contraindication risks;

• Adequate toxicology; or

• Evidence from adequate and well-controlled clinical trials.

For an FDA-regulated pharmaceutical, quality is not established merely by testing a sample after production. It must be built into the manufacturing process through qualified raw materials, validated procedures, in-process controls, specifications, stability programs, deviation investigations and documented batch-release requirements.

That is the difference between testing a product and controlling a product.

Federal scientists identified the same deficiency

Post-hearing briefs filed August 17, 2026, in DEA's marijuana-rescheduling proceeding cite testimony addressing the same scientific problem.

According to the briefs, FDA official Dr. Dominic Chiapperino described marijuana as "a variable substance" that does not possess "known and reproducible" chemistry. He reportedly testified that marijuana would not satisfy the first element of DEA's traditional five-part test for determining whether a substance has a currently accepted medical use.

The briefs also describe testimony from DEA pharmacologist Dr. Luli Akinfiresoye that marijuana did not satisfy the five elements of that framework: known and reproducible chemistry, adequate safety studies, adequate and well-controlled efficacy studies, acceptance by qualified experts and widely available scientific evidence.

Those are not abstract technical requirements.

If chemistry is not reproducible, physicians cannot know whether successive batches contain the same constituents in the same concentrations.

If manufacturing has not been validated, a passing result from one sample cannot establish the consistency of an entire production lot.

If adequate safety studies have not been conducted, safe doses, interactions, contraindications and risks to vulnerable populations remain uncertain.

Judge Julius's recommendation will not remain confined to scheduling

The Justice Department's Office of Legal Counsel concluded that HHS could employ a different two-part inquiry for determining whether marijuana has a currently accepted medical use under the Controlled Substances Act.

As the parties await Chief Administrative Law Judge Derek C. Julius's recommendation, the practical consequences cannot be ignored.

Any recommendation that treats state acceptance as an adequate substitute for reproducible chemistry, controlled manufacturing and product-specific scientific evidence would make the next FDA Commissioner's job substantially harder.

It would leave FDA confronting an expanding category of products treated as having a "currently accepted medical use" under the Controlled Substances Act even though the products themselves have never satisfied FDA's requirements for approval as medicine.

"Judge Julius is deciding a scheduling question, but his recommendation will not remain confined to a scheduling chart," Boise said. "If state acceptance is allowed to substitute for pharmaceutical evidence, the next FDA Commissioner will inherit the contradiction: marijuana treated as medicine under one federal law while the products sold as medicine have never passed FDA review."

Judge Julius's recommendation cannot make variable chemistry reproducible, validate an uncontrolled manufacturing process, correct an inaccurate label or supply missing toxicology and clinical evidence.

Whatever legal scheduling framework is ultimately applied, the underlying products remain unchanged.

A legal standard cannot change a product

A scheduling decision cannot:

• Make variable chemistry reproducible;

• Remove microbial contamination;

• Correct an inaccurate label;

• Convert an uncertain dose into a controlled dose;

• Identify undisclosed constituents;

• Create missing toxicology data;

• Validate an inconsistent manufacturing process; or

• Establish clinical efficacy.

Scheduling and FDA approval answer fundamentally different questions.

Scheduling determines how a substance is controlled under the Controlled Substances Act. FDA review determines whether a particular product has been characterized, consistently manufactured and shown to be safe and effective for a specific intended use.

Schedule III status is not FDA approval.

A state cannabis license is not FDA approval.

A laboratory certificate of analysis is not FDA approval.

A recommendation is not a prescription, and state acceptance is not proof that a specific product is safe, effective or consistently manufactured.

MMJ followed the federal pathway

MMJ has spent more than eight years and more than $10 million developing standardized cannabinoid pharmaceutical candidates through federal pathways administered by FDA and DEA.

In May 2022, Catalent Pharma Solutions manufactured 50,000 finished soft-gel capsules for MMJ under controlled pharmaceutical conditions. Each capsule contains a standardized dose of 5 milligrams of CBD and 2.5 milligrams of THC.

MMJ is the sponsor of two INDs involving potential treatments for Huntington's disease and multiple sclerosis. FDA has also granted Orphan Drug Designation to MMJ's Huntington's disease development program.

MMJ's drug candidates remain investigational, are not FDA-approved and remain subject to a Full Clinical Hold. MMJ does not represent that they are safe or effective.

That restriction illustrates the disparity.

FDA has required MMJ to address chemistry, manufacturing, impurities, stability, toxicology, dosing and clinical-protocol requirements before a research participant receives a standardized capsule.

Meanwhile, products represented to consumers as "medical" are sold nationwide without undergoing comparable product-specific FDA review.

"MMJ is not asking Dr. Overton to lower FDA's standards," Boise said. "We are asking why the word ‘medical' is permitted to do the work that chemistry, manufacturing controls, toxicology and clinical trials are supposed to do. Calling cannabis medicine does not make it medicine. The evidence must come first."

Questions the Senate should ask

During Dr. Overton's confirmation process, senators should ask:

• Should cannabis products represented as medicine be required to demonstrate known and reproducible chemistry?

• Does any state cannabis-testing program provide protection comparable to FDA-regulated pharmaceutical manufacturing?

• How will FDA address intoxicating-hemp products, chemically modified cannabinoids and high-potency products packaged in candy-like forms?

• What will FDA do about product labeling that DEA has described as "not controlled and often significantly inaccurate"?

• How will FDA respond if marijuana is treated as having a currently accepted medical use under the Controlled Substances Act while products sold as medicine remain unapproved by FDA?

• Will product-specific scientific evidence-or state licensing and political pressure-determine what the federal government recognizes as medicine?

The issue is not whether every cannabis product is contaminated or mislabeled.

The issue is whether the federal government is prepared to call a product medicine before that product satisfies the scientific requirements that medicine has always been expected to meet.

Judge Julius's recommendation may address scheduling, but Dr. Overton-if confirmed-will inherit the scientific and public-health consequences.

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 FDA and DEA. MMJ is the sponsor of two INDs and has received FDA Orphan Drug Designation for its Huntington's disease program. 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.
[email protected]
203-231-8583

Statement

Quotations from DEA's 2025 National Drug Threat Assessment are drawn from the published report, which primarily addresses illicit drug threats and trafficking. The report does not establish that every product sold through a state-licensed cannabis business is mislabeled or contaminated.

Descriptions of Massachusetts regulatory actions reflect public advisories and enforcement records issued by the Massachusetts Cannabis Control Commission. The Commission did not establish that every potentially affected product was contaminated or that any identified product caused a particular illness or hospitalization.

Poison-control and emergency-department figures reflect published public-health reporting and include cannabis exposure, intoxication, cannabinoid hyperemesis syndrome and related conditions. Hospital treatment following cannabis exposure does not, standing alone, establish contamination, inaccurate labeling, manufacturing failure or involvement by a licensed cannabis business.

Testimony described in this release is attributed to post-hearing briefs filed by designated parties in DEA Docket No. 1362, Hearing Docket No. 26-96, on August 17, 2026, and should be verified against the certified hearing transcript before use in litigation or regulatory submissions. MMJ was not a designated party to the proceeding. Chief Administrative Law Judge Derek C. Julius has not issued his recommendation, and MMJ does not predict its outcome.

Dr. Heidi Overton's nomination remains subject to Senate confirmation. MMJ takes no position on her confirmation.

MMJ's product candidates are investigational, have not been approved by FDA and remain subject to a Full Clinical Hold. No clinical trials have been completed, and no conclusions concerning safety or efficacy may be drawn. There can be no assurance that FDA will lift the clinical hold, that DEA will act on MMJ's pending registration application or that any court or agency will reach a particular result.

MMJ is a petitioner in federal litigation concerning the April 2026 marijuana-rescheduling order and an appellant in litigation concerning a CMS cannabinoid program. No court has ruled on the merits of MMJ's claims, and no outcome is predicted or implied.

Nothing in this release constitutes an offer to sell or a solicitation of an offer to purchase securities.

SOURCE: MMJ International Holdings

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