"MMJ Argues Federal Government Cannot Reward State Marijuana Operators While Federally Compliant Pharmaceutical Developers Remain Trapped in Regulatory Limbo" stated Duane Boise CEO MMJ International Holdings.
WASHINGTON, DC / ACCESS Newswire / June 1, 2026 / MMJ International Holdings, MMJ BioPharma Cultivation, and MMJ BioPharma Labs, announced today that they have joined a Petition for Review filed in the United States Court of Appeals for the District of Columbia Circuit challenging the Drug Enforcement Administration's marijuana rescheduling order. The petition seeks judicial review of DEA's April 2026 Final Order that moved FDA approved marijuana products and state licensed medical marijuana products to Schedule III while creating an expedited federal registration pathway for state medical marijuana license holders.
The appeal argues that the federal government has created a regulatory double standard that benefits state marijuana operators while disadvantaging companies that followed the federal pharmaceutical pathway.
"For more than seven years, MMJ followed every federal rule," said Duane Boise, President and CEO of MMJ International Holdings. "We pursued FDA Investigational New Drug applications, obtained Orphan Drug Designation, secured a DEA Schedule I laboratory registration, manufactured pharmaceutical soft-gel formulations, and invested millions of dollars developing cannabinoid medicines. Yet our cultivation application remains unresolved while DEA is now creating an expedited pathway for state operators."
According to the petition, MMJ has suffered competitive injury because the Final Order establishes an accelerated registration process for state medical marijuana licensees while federally compliant pharmaceutical developers continue waiting for regulatory action. The filing states that MMJ pursued the federal pharmaceutical pathway from inception, obtaining FDA INDs, Orphan Drug Designation, pharmaceutical formulations, DEA-inspected facilities, and botanical drug development programs under FDA guidance.
THE CENTRAL QUESTION
MMJ believes the case raises a fundamental question:
Why should companies that operated outside the federal Controlled Substances Act receive expedited treatment while federally compliant pharmaceutical developers continue to wait?
The petition challenges the legality of the DEA's Final Order on multiple grounds, including statutory authority, procedural violations, treaty obligations, constitutional concerns, and the creation of what petitioners describe as a novel regulatory framework never authorized by Congress.
THE PATIENTS LEFT BEHIND
MMJ emphasized that the greatest cost of regulatory delay has not been financial.
"The real victims are the patients," Boise continued. "Families affected by Huntington's disease and Multiple Sclerosis have waited years while federal agencies delayed decisions. Every year lost to bureaucracy is a year patients can never recover."
MMJ's pharmaceutical development program includes cannabinoid-based therapies under FDA oversight and an Orphan Drug Designation program for Huntington's disease. The company maintains that it chose the most rigorous scientific pathway available because patients deserve medicines supported by evidence, quality controls, and pharmaceutical manufacturing standards.
DEA UNDER INCREASING SCRUTINY
The filing also highlights MMJ's long-running dispute with DEA over its cultivation registration application and notes prior constitutional challenges involving the agency's administrative adjudication process. The petition specifically references DOJ's prior acknowledgment regarding constitutional concerns involving administrative law judge removal protections.
As the marijuana rescheduling debate moves forward, MMJ believes federal regulators must answer difficult questions regarding equal treatment, competitive fairness, treaty compliance, and the future of federally compliant pharmaceutical developers.
ABOUT MMJ INTERNATIONAL HOLDINGS
MMJ International Holdings, through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, is developing pharmaceutical-grade cannabinoid medicines for Huntington's disease and Multiple Sclerosis through the FDA drug approval pathway. MMJ BioPharma Labs holds a DEA Schedule I analytical laboratory registration, and the company has pursued federal pharmaceutical development, FDA IND programs, and botanical drug research since 2018.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
Related Documents:
- 26-1136_RESCHEDULING CHALLENGE
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/mmj-international-holdings-joins-landmark-d.c.-circuit-challenge-to-d-1172643
