"We built real medicine while the industry chased loopholes," said Duane Boise, President and CEO of MMJ International Holdings. "We have a stabilized, standardized, and analytically verified cannabinoid pharmaceutical, ready for clinical trials.

WASHINGTON, DC / ACCESS Newswire / November 25, 2025 / As Congress moves decisively to eliminate intoxicating hemp products and President Trump prepares to announce a national cannabinoid regulatory directive, MMJ International Holdings, Inc. stands alone as one U.S. company with a fully manufactured, validated, federally compliant cannabinoid pharmaceutical drug ready for FDA clinical trials pending final DEA authorization.

With sweeping new federal restrictions-including bans on Delta-8, THC-O, HHC, THCP, and THCA-converted products, plus a strict 4 mg total-THC-per-container cap-the unregulated hemp-derived THC market is collapsing nationwide. This regulatory realignment cements MMJ's decade-long commitment to the FDA pharmaceutical pathway as the new dominant model for cannabinoid development.

And while some biotechnology firms promote preclinical delivery concepts or experimental formulations, MMJ has achieved what no other U.S. company has:

A completed, fully manufactured pharmaceutical cannabinoid drug ready for human trials.

MMJ's Soft-Gel Capsule: The First Fully Developed Pharmaceutical Cannabinoid Drug Ready for FDA Trials

MMJ's investigational product-a natural, full-spectrum cannabis extract formulated in pharmaceutical-grade soft-gel capsules-has completed every scientific and manufacturing requirement necessary for FDA clinical trials.

Completed FDA-Required Scientific Milestones

• Final dosage-form soft-gel capsules manufactured

• Full identity, purity, potency, and chromatographic characterization

• Stability testing completed under ICH guidelines

• Standardized, reproducible botanical API

• Pharmaceutical GMP manufacturing completed

• FDA IND programs for Huntington's Disease and Multiple Sclerosis

• FDA Orphan Drug Designation for Huntington's Disease

• DEA Schedule I laboratory analytical work completed (MMJ BioPharma Labs)

Unlike nutraceuticals, hemp tinctures, powders, or experimental "platform technologies,"
MMJ's capsule is a true pharmaceutical drug-with completed Chemistry, Manufacturing & Controls (CMC) meeting FDA expectations.

The only outstanding requirement is DEA's issuance of MMJ's bulk manufacturer registration to legally supply the drug for clinical trials.

President Trump To Remove DEA Final Barrier - Not the Science

MMJ's manufacturing application has been pending since December 2018.
Federal law requires timely resolution:

• 21 C.F.R. § 1316.67 - DEA must issue a final order "as soon as practicable."

• 5 U.S.C. § 555(b) - Agencies must conclude matters "within a reasonable time."

Yet, nearly seven years later, no final decision exists.

Compounding this, the U.S. Department of Justice has formally conceded that DEA's ALJ tribunal system-formerly used for such cases-was unconstitutional under Article II.
As a result:

**No lawful evidentiary hearing ever occurred in MMJ's case.

No valid ALJ recommendation exists.
And no constitutionally compliant final decision has been issued.**

Meanwhile, the D.C. Circuit's criticism of DEA's six-year delay in the Iowaska Church case signals judiciary impatience with DEA's repeated inaction-bolstering MMJ's mandamus remedies should delays persist.

MMJ Is Years Ahead of Emerging Platforms and Preclinical Entrants

As other companies announce new powder systems, emulsion technologies, or theoretical absorption-enhancement platforms, none possess:

• FDA IND authorization

• A completed dosage-form drug

• DEA compliance

• GMP manufacturing

• Botanical API validation

• Long-term stability data

• Pharmaceutical-grade reproducibility

By contrast:

MMJ's drug is finished, validated, compliant, and ready for clinical use.

Engineered for neurological diseases, MMJ's soft-gel capsule provides:

• precise dose control

• stable plasma levels

• controlled release characteristics

• patient-friendly oral delivery

• full-spectrum synergy for CNS therapeutic targets

This is exactly what FDA expects from a cannabinoid therapeutic.

Others are just beginning where MMJ already stands.

A Perfect Regulatory Moment: Hemp Shutdown + Trump Directive + FDA Oversight

Federal policy is consolidating around pharmaceutical-grade cannabinoids:

Congress has now:

• Redefined hemp to include total THC

• Banned synthetic and semi-synthetic cannabinoids

• Imposed a 4 mg total-THC limit per container

• Eliminated intoxicating hemp beverages and THCA loopholes

President Trump's upcoming cannabinoid directive is expected to prioritize:

• FDA-regulated cannabinoid drug development

• DEA-licensed manufacturing

• Elimination of gray-market THC products

• Support for federally legal research

• Protection of patients through pharmaceutical pathways

MMJ is already built for this new regulatory era.

The rest of the industry must now catch up.

CEO Duane Boise: "We Built Real Medicine-The Nation Is Now Catching Up."

"MMJ stayed in the federally compliant lane while the rest of the industry ran toward loopholes," said Duane Boise, President & CEO of MMJ International Holdings.
"We manufactured a real cannabinoid pharmaceutical-stabilized, standardized, analytically verified, and ready for FDA trials. The only thing missing is the DEA's final signature."

Boise continued:

"The collapse of the hemp derived THC market and the rise of strict federal oversight validate what we built over the last decade. With President Trump's cannabinoid directive approaching, we expect MMJ to be the first company positioned to advance a federally legal cannabis drug into human clinical trials."

About MMJ International Holdings, Inc.

MMJ International Holdings, Inc. is a U.S. based biopharmaceutical company developing DEA licensed, FDA regulated, plant derived cannabinoid medicines for neurodegenerative diseases. Through its subsidiaries-MMJ BioPharma Cultivation and MMJ BioPharma Labs-MMJ advances proprietary soft-gel cannabinoid formulations for Huntington's Disease and Multiple Sclerosis within the FDA's botanical drug framework.

MMJ is represented by Megan E. Sheehan, Esq., Sheehan & Associates Law.

Madison Hisey
MHisey@mmjih.com
203-231-85832

SOURCE: MMJ International Holdings