WASHINGTON, DC / ACCESS Newswire / October 29, 2025 / In a rapidly evolving cannabis biopharmaceutical landscape, MMJ International Holdings stands as a pioneer that has spent nearly a decade advancing an FDA regulated, pharmaceutical grade pathway for cannabinoid based therapeutics.

Duane Boise, President & CEO of MMJ International Holdings
A Pharmaceutical Approach in a Fast-Maturing Market
The momentum toward scientifically validated plant medicines continues to accelerate.
Recent institutional financings - such as Cybin Inc.'s $175 million raise backed by OrbiMed, Venrock, Point72, and Deep Track Capital - demonstrate Wall Street's growing appetite for regulated botanical therapeutics.
MMJ's vertically integrated model - MMJ BioPharma Cultivation , MMJ BioPharma Labs , and MMJ International Holdings - ensures control from seed to softgel, guaranteeing pharmaceutical-grade quality, purity, and reproducibility.
MMJ's Regulatory Milestones
Drug Candidate |
Indication |
Key Regulatory Milestones |
Status |
|---|---|---|---|
MMJ-002 |
Huntington's Disease (HD) |
• FDA Orphan Drug Designation • IND application accepted |
Phase II trials pending |
MMJ-001 |
Multiple Sclerosis (MS) |
• IND application filed |
Phase II trials pending |
Distinct Advantages:
Natural vs. Synthetic: MMJ's THC/CBD softgels harness the entourage effect, unlike synthetic isolates such as Marinol.
Standardization & Precision: Every capsule meets Good Manufacturing Practice (GMP) standards for reproducible dosing and purity.
Vertical Integration: MMJ controls cultivation, extraction, and formulation to maintain full traceability and pharmaceutical consistency.
DEA Regulatory Bottlenecks - and a Turning Point in Washington
For years, MMJ BioPharma Cultivation has faced a seven-year delay in obtaining DEA bulk-manufacturing registration, trapped in a legal paradox that required a "bona fide supply agreement" before a license could be issued - an impossible demand under federal law.
This bureaucratic Catch-22 has obstructed FDA-approved science, delayed critical treatments, and cost American patients years of progress.
But change is underway.
Amid the recent federal government shutdown and restructuring, several thousand entrenched bureaucrats - including within the DEA's Diversion Division - have been dismissed, clearing the pathway for accountability and reform across federal agencies.
These reforms create an unprecedented opportunity for agencies like the DEA to modernize their processes, remove conflicts of interest, and finally enable companies like MMJ International Holdings to fulfill the scientific mandate Congress envisioned when it authorized Schedule I research decades ago.
"With Washington finally cleaning house, we now have a real opportunity to restore science-based policy," Boise said. "Thousands of redundant bureaucratic positions have been eliminated, including within the DEA Diversion Division - creating a pathway for lawful, transparent reform. Patients have waited long enough."
Patient and Economic Impact
For patients suffering from Huntington's disease and multiple sclerosis, each delay means continued dependence on ineffective therapies.
Analysts project the global cannabinoid-pharmaceutical market will exceed $50 billion by 2030, but unless reforms translate into timely DEA licensing, the U.S. risks forfeiting that leadership to European and Asian manufacturers.
The success of GW Pharmaceuticals' Epidiolex®, a plant-derived CBD drug that achieved nearly $1 billion in annual sales, proves that the market rewards compliant science.
MMJ International Holdings aims to replicate this success through its FDA-accepted INDs, Orphan Drug Designations, and GMP infrastructure ready for immediate scale-up once the DEA fulfills its statutory duties.
Call to Action: President Trump & DEA Administrator Terry Cole
MMJ International Holdings calls on President Donald J. Trump and DEA Administrator Terry Cole to ensure the agency completes this reform by:
Issuing DEA bulk-manufacturing registrations before supply-agreement requirements;
Eliminating outdated bureaucratic barriers that contradict FDA research protocols; and
Restoring patient access and U.S. competitiveness through a unified, lawful framework.
"The science is ready, the patients are waiting, and the bureaucracy is finally being cleared out," Boise emphasized. "Now it's time for leadership."
About MMJ International Holdings
MMJ International Holdings Inc. is a U.S.-based biopharmaceutical company dedicated to developing FDA-approved, cannabinoid-derived medicines for rare and chronic diseases. Its subsidiaries - MMJ BioPharma Cultivation and MMJ BioPharma Labs - operate within DEA and FDA frameworks to produce standardized, pharmaceutical-grade formulations for neurological and chronic conditions.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
mhisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire