Following President Trump's Executive Order, MMJ International Holdings Confirms It Has Final Dose Form, Validated, Reproducible Pharmaceutical Cannabinoid Soft-Gel Capsules Ready for FDA Clinical Trials
MMJ Is One of the Only U.S. Companies Positioned to Immediately Advance Schedule III Medical Cannabis Research Under FDA and DEA Oversight
WASHINGTON, DC / ACCESS Newswire / December 18, 2025 / Following today's White House announcement and Fact Sheet, "President Donald J. Trump Is Increasing Medical Marijuana and Cannabidiol Research," MMJ International Holdings, Inc. confirmed it has completed development of its final dose form pharmaceutical soft-gel cannabinoid capsules. These capsules are validated, reproducible, manufactured to pharmaceutical GMP standards, and are awaiting final FDA authorization for use in federally approved clinical trials.
President Trump's Executive Order directs the Attorney General to expedite the rescheduling of marijuana to Schedule III and instructs HHS to modernize research standards. Critically, the Order acknowledges that the absence of FDA approved, standardized cannabinoid medicines has been a primary barrier to patient care. MMJ International Holdings was built specifically to fill this void.
MMJ Has Achieved What Federal Policy Now Demands
While the majority of the cannabis industry remains fixated on state-legal retail products, MMJ has spent nearly a decade developing true pharmaceutical-grade cannabinoid medicines under federal law. MMJ confirms it has:
Manufactured a final dose form soft-gel capsule containing a standardized, plant-derived cannabinoid active pharmaceutical ingredient (API).
Validated batch-to-batch reproducibility consistent with rigorous FDA pharmaceutical requirements.
Completed formulation, stability, and quality testing required for clinical trial material.
Prepared FDA IND-ready clinical trial supply for immediate use upon Agency authorization.
These capsules are drug-grade formulations designed expressly for FDA-regulated clinical trials-precisely the type of medicine contemplated by the President's Order to provide doctors with adequate prescribing guidance.
Executive Order Confirms the MMJ Model
The White House Fact Sheet recognizes that marijuana has a "currently accepted medical use" and notes that the lack of FDA approval leaves six million registered patients and 30,000 practitioners without standardized guidance. MMJ's pharmaceutical development program directly addresses this deficiency.
With the shift toward Schedule III, federal policy now prioritizes:
FDA-approved drug development
Standardized, reproducible final dose forms
Controlled, non-smoked delivery systems
Rigorous safety and efficacy trials
MMJ already operates entirely within this framework, holding FDA-reviewed IND programs, Orphan Drug Designation for Huntington's Disease, and DEA-licensed laboratory operations.
CEO Perspective: "The Medicine is Ready"
"Today's Executive Order confirms what patients and scientists have long known: cannabis medicine must be studied as medicine," said Duane Boise, President & CEO of MMJ International Holdings. "MMJ has already completed development of a final dose form, validated, reproducible cannabinoid soft-gel capsule suitable for FDA-regulated clinical trials. The science is ready. The medicine is ready. We now await final FDA authorization to move forward and provide a lifeline to patients suffering from Huntington's Disease and Multiple Sclerosis."
About MMJ International Holdings
MMJ International Holdings, Inc. is a U.S.-based biopharmaceutical company developing DEA-licensed, pharmaceutical-grade, plant-derived cannabinoid medicines for FDA approval. Through its subsidiaries, MMJ BioPharma Cultivation and MMJ BioPharma Labs, the company advances standardized final dose form soft-gel capsule formulations targeting serious neurological and medical conditions.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-85832
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/trump-orders-marijuana-research-expansion-mmj-already-has-the-medicin-1119275