Federally Compliant Pharmaceutical Developer Raises Constitutional, Statutory, Treaty, and Competitive Fairness Objections - Reserves Right to Seek Federal Court Review
WASHINGTON, D.C. / ACCESS Newswire / May 26, 2026 / MMJ International Holdings, together with its subsidiaries MMJ BioPharma Cultivation, and MMJ BioPharma Labs, (collectively, "MMJ"), formally announced today that it will file a Notice of Intent to Participate in the Drug Enforcement Administration's (DEA) administrative hearing regarding the proposed rescheduling of marijuana from Schedule I to Schedule III, scheduled for June 29, 2026.
As a federally compliant pharmaceutical developer with long-standing applications for bulk manufacturing of cannabis for FDA-authorized clinical research, MMJ is entering the proceeding as a primary stakeholder to challenge the regulatory framework that threatens the integrity of the U.S. pharmaceutical drug development pipeline - and to ensure that rescheduling adheres to rigorous, science-based, and constitutional standards.
"The Gold Standard - Applied Only to Us"
MMJ has spent nearly a decade and more than $10 million operating within the full federal pharmaceutical registration system: obtaining FDA Investigational New Drug applications, earning FDA Orphan Drug Designation for Huntington's disease and Multiple Sclerosis, building a DEA Schedule I analytical laboratory, and submitting a bulk manufacturing registration application that has remained pending for more than seven years without resolution.
During that same period, state-licensed cannabis operators - operating outside the federal registration system - have seen their products increasingly recognized, reimbursed, and commercially rewarded under the very federal framework MMJ was required to follow.
"MMJ has spent nearly a decade operating within the gold standard of federal pharmaceutical registration, fulfilling every requirement for FDA-authorized clinical trials and DEA compliance," said Duane Boise, CEO of MMJ International Holdings. "As we approach this hearing, our objective is to ensure that federal policy does not sacrifice the safety, reproducibility, and rigorous standards of pharmaceutical-grade medicine in favor of political expediency. The companies that followed the rules deserve to know why the rules only applied to them."
Four Grounds for Participation
Constitutional Integrity
MMJ has raised formal objections regarding the constitutional authority of DEA Administrative Law Judges, citing the Department of Justice's own acknowledgment of concerns regarding presidential supervision and removal protections under Article II of the U.S. Constitution. Citing Lucia v. SEC, Axon Enterprise v. FTC, and SEC v. Jarkesy, MMJ reserves the right to challenge the validity of these proceedings in federal court regardless of the administrative outcome.
Adherence to Loper Bright
Following the Supreme Court's elimination of Chevron deference in Loper Bright Enterprises v. Raimondo, MMJ will challenge any claim that DEA is entitled to judicial deference in interpreting "currently accepted medical use," scheduling criteria, or any other provision of the Controlled Substances Act. MMJ demands that the DEA substantiate its interpretations through strict statutory analysis - not agency convenience.
International Treaty Obligations
MMJ intends to raise the apparent conflict between the proposed Schedule III reclassification and the United States' obligations under the 1961 Single Convention on Narcotic Drugs, as amended. Specifically, MMJ will address how the DEA proposes to satisfy its international treaty obligations while simultaneously permitting a regulatory framework that treats federally compliant pharmaceutical developers and state-licensed cannabis businesses under fundamentally different standards.
Competitive Fairness
MMJ is challenging the arbitrary regulatory advantages currently being conferred upon state-licensed operators that have not undergone the same federal oversight required of pharmaceutical developers. After nearly a decade of compliance, MMJ has a direct and substantial interest in ensuring that the rescheduling proceeding does not further entrench a two-tiered system that rewards regulatory shortcuts while penalizing companies that followed every federal rule.
Not Anti-Marijuana. Pro-Science.
MMJ's participation in the rescheduling hearing should not be mischaracterized as opposition to the medical potential of cannabis. MMJ has staked nearly a decade of investment on the scientific conviction that cannabinoids may hold therapeutic value for patients suffering from Huntington's disease and Multiple Sclerosis. That is precisely why MMJ demands the same scientific rigor for cannabinoid medicines that federal law requires of every other drug.
"This is not just about rescheduling a plant," added Boise. "It is about protecting the future of pharmaceutical-grade cannabinoid medicine. If cannabinoids have medical value - and MMJ believes they do - then they deserve the same scientific standards required of every other medicine. MMJ will continue to push for a federal pathway that recognizes the evidence-based approach we have pioneered."
MMJ expressly reserves all rights to seek judicial review, declaratory relief, and injunctive relief in federal district court, ensuring that the final outcome of the DEA's rescheduling process is held to the highest standard of administrative fairness and constitutional compliance.
About MMJ International Holdings
MMJ International Holdings, Inc. is a pharmaceutical development company focused on cannabinoid-based medicines for serious neurological conditions including Huntington's disease and Multiple Sclerosis. MMJ holds FDA Investigational New Drug applications, FDA Orphan Drug Designation for both conditions, and a DEA Schedule I analytical laboratory registration. The company has invested more than $10 million pursuing the federal pharmaceutical approval pathway and maintains a pending DEA bulk manufacturing registration application filed in 2018.
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/delayed-again-will-marijuana-rescheduling-survive-constitutional-chal-1170713
