Duane Boise stated "In a September 3rd letter to DEA Terry Cole, that the Administrative Procedure Act requires agencies to act "within a reasonable time." If no decision is issued soon, MMJ will pursue all available remedies in federal appeals court to the supreme court if necessary".
WASHINGTON, DC / ACCESS Newswire / September 4, 2025 / Newly confirmed DEA Administrator Terrance "Terry" Cole faces a defining first decision: Will he break from the DEA's long history of obstructing medical cannabis research, or will he side with entrenched bureaucrats accused of stifling science and patient care?
At the center of this test is MMJ BioPharma Cultivation, Inc., a company that has spent more than seven years seeking DEA approval to cultivate pharmaceutical grade cannabis for FDA authorized clinical trials in Huntington's disease and Multiple Sclerosis. Despite earning FDA Orphan Drug Designations and passing multiple DEA inspections, MMJ remains stuck in what company officials describe as a "Kafkaesque regulatory trap."
The Stakes: Patients, Law, and Science
MMJ's application has become a flashpoint for systemic failures inside the DEA:
Unconstitutional Process: MMJ was subjected to an in-house tribunal system later ruled unconstitutional by the Supreme Court in Axon v. FTC and Jarkesy v. SEC.
Retroactive Rulemaking: DEA imposed new "bona fide supply agreement" requirements years after MMJ first applied in 2018.
Excessive Delays: More than 2,300 days have passed without resolution-far beyond the 60-day timeline mandated under the Medical Marijuana and Cannabidiol Research Expansion Act.
While bureaucrats stall, patients with devastating neurological conditions remain without access to investigational therapies. "Every day of delay is a day of suffering," said Duane Boise, CEO of MMJ International Holdings. "This isn't just bad governance-it's a moral failure."
Cole's Decision: Reform or Regression
Administrator Cole, sworn in this summer, has two options:
Side with the Old Guard - Uphold the DEA ALJ's denial, reinforcing the agency's reputation as hostile to science.
Grant MMJ's License - Break from the past, align the DEA with patients, Congress, and modern medicine, and allow FDA-regulated research to proceed.
In a September 3rd letter, MMJ's counsel reminded Administrator Cole that the Administrative Procedure Act requires federal agencies to act "within a reasonable time." The letter warned that if no decision is issued soon, MMJ will pursue all available legal remedies-up to and including appeals in the federal courts and, if necessary, the U.S. Supreme Court.
Why This Matters Beyond MMJ
Cole's ruling comes at a crossroads for federal marijuana policy:
Rescheduling Momentum: President Trump has signaled openness to moving cannabis to Schedule III, which would expand research and ease restrictions.
Public Pressure: Nearly 70% of Americans support legalization, and trust in DEA leadership is at historic lows.
Congressional Oversight: Lawmakers are increasingly critical of DEA roadblocks to scientific research.
"Administrator Cole has a chance to end the DEA's failed marijuana program," said Boise. "The question is whether he'll step up as a reformer-or just become another defender of the status quo."
About MMJ BioPharma Cultivation, Inc.
MMJ BioPharma Cultivation, a subsidiary of MMJ International Holdings, is advancing FDA compliant, pharmaceutical grade cannabinoid medicines. The company holds FDA Orphan Drug Designations for Huntington's disease and Multiple Sclerosis and has developed soft gel capsule formulations of THC and CBD under GMP standards. MMJ is committed to science, patient care, and full federal compliance in pioneering cannabinoid based therapies.
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:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/dea-marijuana-decision-showtime-mmj-issues-demand-letter-on-dea-1068687
