For seven years, a critical application to grow cannabis for FDA approved medicine has languished at the Drug Enforcement Administration (DEA), sparking allegations that the agency is in "blatant violation of federal law" and blocking potential treatments for thousands of patients battling Huntington's Disease (HD) and Multiple Sclerosis (MS).

WASHINGTON, DC, AL / ACCESS Newswire / October 6, 2025 / At the center of a growing legal and political firestorm is MMJ BioPharma Cultivation, a pioneering pharmaceutical company that first sought a DEA registration in 2018 to cultivate pharmaceutical-grade cannabis for FDA-approved clinical trials. Despite clear federal law mandating prompt action, the company's application remains stalled - now entering its seventh year of delay.

In 2022, Congress passed the Medical Marijuana and Cannabidiol Research Expansion Act, requiring the DEA to approve such research applications within 60 days. Yet MMJ's request has languished for more than 2,500 days, a delay the company and legal experts call "unlawful, unethical, and catastrophic for patients."

The Human Cost of Bureaucratic Cruelty

The toll of this obstruction is measured not in paperwork, but in people.

"Every year of delay in this type of critical research can cost lives and prolong the suffering of countless individuals," said Duane Boise, President & CEO of MMJ BioPharma Cultivation. "We have the science, the regulatory approvals, and the patients ready to participate - but the DEA's silence has become cruelty disguised as process."

MMJ's parent company, MMJ International Holdings, holds two active Investigational New Drug (IND) applications and FDA Orphan Drug Designations for its proprietary cannabinoid soft-gel formulations targeting Huntington's Disease (HD) and Multiple Sclerosis (MS). These are not theoretical drugs - they are FDA recognized, clinically designed, and ready for trial.

Internal DEA Dysfunction and "Catch-22" Obstruction

Internal DEA communications have revealed a stunning lack of competency and accountability. One agency official admitted, "I know nothing about marijuana," while others imposed contradictory demands - requiring a Bona Fide Supply Agreement that, under law, can only be completed after registration is granted.

Critics say this Kafkaesque loop reflects "a deliberate disregard for patient welfare and a betrayal of the DEA's core mission to ensure adequate medical research supply."

New Leadership Faces a Defining Test

The fate of MMJ's seven-year application now rests with DEA Administrator Terrance "Terry" Cole, who was sworn in on July 23, 2025. A 22-year DEA veteran, Cole's public priorities - focused on cartel enforcement and the opioid crisis - have yet to address the scientific and medical oversight failures plaguing the agency's marijuana research program.

Advocates are calling this Cole's defining test: Will he continue the legacy of prohibitionist bureaucracy, or fulfill Congress's intent to advance legitimate medical research?

Trump Administration Steps In

Recent moves from the Trump Administration have sharply intensified pressure on the DEA. In September 2025, the Department of Justice, acting under President Trump's deregulatory directive, withdrew more than 50 pending DEA rulemakings, including those obstructing medical marijuana research.

"This action stripped the agency of its procedural fig leaves," said Boise. "It forces an imminent decision under existing law - no more excuses, no more hidden rules."

MMJ's counsel has issued a formal demand letter to Administrator Cole, citing the Administrative Procedure Act, which requires federal agencies to act "within a reasonable time." With seven years of delay, MMJ argues the DEA is now in "open defiance of federal law, congressional intent, and moral decency."

A Legal and Political Flashpoint

MMJ's case has become a national litmus test for whether the federal government truly supports medical cannabis reform. The company is preparing to escalate its legal challenge to the federal appellate courts, questioning not only the delay but also the constitutional validity of the DEA's internal adjudication system, which the Department of Justice has already acknowledged as inconsistent with Article II of the Constitution.

For President Trump, the stakes are high.
A swift approval of MMJ's license would send a powerful message that his administration is serious about science-driven reform and fulfilling the campaign promise to "unlock cannabis medicine." Conversely, continued DEA obstruction would expose deep bureaucratic resistance and jeopardize public confidence in the administration's reform agenda.

"Justice Cannot Wait Another Day"

"The clock is now ticking down on Administrator Cole's first real test of leadership," Boise said. "This is not about politics; it's about patients and the rule of law. If President Trump truly wants to put medical science first, he must use his executive power to end the DEA's calculated cruelty. Justice for Huntington's and MS patients cannot wait another day."

About MMJ BioPharma Cultivation

MMJ BioPharma Cultivation, Inc., a subsidiary of MMJ International Holdings, is developing standardized, pharmaceutical grade cannabinoid formulations for FDA regulated clinical trials targeting Huntington's Disease and Multiple Sclerosis. The company operates within DEA and FDA frameworks and maintains international partnerships to ensure global GMP and GDP compliance.

MMJ is represented by attorney Megan Sheehan.

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

SOURCE: MMJ International Holdings