MMJ's position is further fortified by its FDA Orphan Drug Designations for the treatment of Huntington's Disease. These designations are awarded to drugs intended for the safe and effective treatment of rare diseases and provide MMJ with critical incentives, including: Seven Years of Market Exclusivity: Protecting MMJ's innovations upon FDA approval. Tax Credits: Applied to qualified clinical testing expenses. Waived FDA Fees: Significantly reducing the capital barriers to drug commercialization. Accelerated Review: Streamlining the path to provide relief to patients with unmet medical needs.

WASHINGTON, D.C. / ACCESS Newswire / December 22, 2025 / MMJ International Holdings, MMJ BioPharma Cultivation and MMJ BioPharma Labs ("MMJ"), a pioneer in pharmaceutical-grade cannabinoid drug development, today issued a statement following President Donald Trump's historic executive order directing the reclassification of cannabis from Schedule I to Schedule III under the Controlled Substances Act. The order marks a decisive shift in federal policy-formally recognizing cannabis' credible therapeutic value and validating a science-first, FDA-regulated pharmaceutical pathway that MMJ has pursued for years.

For decades, Schedule I classification functioned as a structural barrier to legitimate clinical research, limiting FDA oversight and leaving millions of patients- including nearly one in four U.S. adults living with chronic pain-without access to standardized, federally regulated treatment options. President Trump's action dismantles that barrier and aligns federal drug policy with established medical and clinical reality.

"This executive order is a watershed moment that separates medicine from snake oil," said Duane Boise CEO for MMJ International Holdings. "While much of the industry pursued retail expansion and consumer potency, MMJ committed early to the high barrier pathway of FDA aligned drug development. Schedule III confirms that the future of cannabis lies in validated science, not speculation."

A Strategic Advantage in a Schedule III Landscape

The transition to Schedule III draws a clear line between recreational commerce and pharmaceutical medicine. MMJ enters this new landscape with a substantial strategic advantage, having already completed much of the foundational work required for pharmaceutical legitimacy, including:

• Advanced Formulation - Development of a proprietary, pharmaceutical-grade soft-gel capsule

• Scientific Validation - Completion of comprehensive stability testing and chromatography

• Clinical Readiness - Advancement of FDA-authorized clinical programs targeting chronic pain and neurological disorders

This infrastructure positions MMJ to move immediately as regulatory friction eases.

Focus Shifts to DOJ Implementation

With federal policy now clarified, attention turns to the U.S. Department of Justice and Attorney General Pamela Bondi, whose actions will determine the speed at which lawful, FDA-authorized cannabinoid research proceeds. MMJ's prior constitutional challenges to the DEA's administrative process-challenges that resulted in DOJ acknowledgments of fundamental defects in the former framework-underscore the importance of prompt, science-driven implementation.

MMJ urges the Department of Justice to ensure that FDA-authorized programs advance without further delay so patients can access safe, consistent, and reproducible medicines under federal oversight.

A New Standard for Investors

As institutional capital evaluates the implications of Schedule III, the distinction between speculative cannabis retail and regulated cannabinoid medicine has never been clearer. MMJ's early and sustained investment in pharmaceutical manufacturing, clinical validation, and regulatory compliance offers investors exposure to what is now unmistakably a healthcare sector.

"The federal government has caught up to the strategy MMJ has pursued since its inception," the company added. "The question is no longer whether cannabis has medical value, but how quickly pharmaceutical-grade solutions can reach patients."

About MMJ International Holdings

MMJ International Holdings is a biopharmaceutical company focused on the FDA-authorized development of cannabinoid-based medicines. Through its subsidiaries, the company advances pharmaceutical-grade, reproducible final dosage forms supported by clinical trials and high-standard manufacturing for the treatment of chronic pain and neurological disorders.

MMJ is represented by attorney Megan Sheehan.

CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583

SOURCE: MMJ International Holdings