In a move that is escalating a years-long dispute into a potential federal court battle, the Drug Enforcement Administration (DEA) faces a significant legal challenge following a ruling by its Chief Administrative Law Judge, John J. Mulrooney II.
Judge Mulrooney recently ruled against MMJ BioPharma Cultivation, a company seeking registration to grow marijuana for federally sanctioned clinical trials. The ruling, which effectively canceled a scheduled hearing, has been sharply criticized as a denial of due process and is setting the stage for a constitutional showdown that could scrutinize the very structure and authority of the DEA’s administrative legal system.
The Seven-Year Pursuit
MMJ BioPharma Cultivation has been engaged in a persistent, seven-year effort to secure a legally sound DEA registration. The company’s objective is specifically focused on cultivating pharmaceutical-grade cannabis strictly for use in clinical trials approved by the Food and Drug Administration (FDA). These trials are conducted under stringent FDA Investigational New Drug (IND) protocols and aim to develop cannabinoid therapies for severe neurological conditions, including Huntington’s Disease and Multiple Sclerosis.
The pursuit highlights the complex federal regulatory landscape surrounding cannabis, even for medical research purposes, and the difficulties researchers face in accessing a consistent, federally compliant supply of the plant necessary for rigorous scientific study.
The Contested Ruling and Due Process Concerns
The ruling in question, issued by Judge John J. Mulrooney II in June 2025, decided the case without conducting a trial. This decision is at the heart of MMJ BioPharma Cultivation’s grievance.
According to criticisms leveled against the ruling, Judge Mulrooney’s decision bypassed critical steps typically required in administrative proceedings. It is alleged that the ruling ignored contested facts presented by the company, failed to address concerns regarding potential ex parte communications (communication with parties outside of the formal proceedings), and disregarded questions about constitutional structure.
Crucially, MMJ BioPharma Cultivation contends it was not formally notified of the pretrial decision before it was issued, adding another layer to the due process concerns.
A denial of a hearing in an administrative process, particularly one seeking a necessary federal registration, is viewed by the company as fundamentally undermining their right to present their case and challenge the agency’s position in a formal setting.
Citing Supreme Court Precedent
centrale to MMJ BioPharma Cultivation’s impending legal challenge is the assertion that Judge Mulrooney’s ruling stands in direct violation of recent and significant Supreme Court precedent. The company specifically cites the rulings in Axon Enterprise, Inc. v. FTC (2023) and Jarkesy v. SEC (2024).
These landmark Supreme Court decisions significantly altered the landscape concerning the authority of federal agencies in internal administrative hearings. They affirmed that regulated entities could bypass agency administrative proceedings and take their constitutional challenges directly to federal court, particularly when questioning the fundamental validity or constitutionality of the agency’s structure or actions.
MMJ BioPharma Cultivation argues that by deciding the case without a hearing and allegedly ignoring fundamental legal and constitutional concerns, the DEA’s administrative process, as demonstrated by this ruling, has become vulnerable to challenges under the principles set forth in Axon and Jarkesy.
The company believes the ruling itself, by denying them a hearing and bypassing standard procedures, solidifies their grounds to seek redress and resolution in the federal court system rather than through the DEA’s internal mechanisms.
Implications for DEA Authority and Future Challenges
MMJ BioPharma Cultivation views Judge Mulrooney’s ruling not as a setback signaling the end of their quest, but potentially as a strategic advantage. By proceeding in this manner, the ruling inadvertently helps preserve a clear record of the alleged constitutional and DEA procedural violations within the administrative process.
This documented record is seen by the company as providing a powerful basis for a subsequent legal challenge in federal court. The expectation is that a federal court would be the appropriate venue to review the due process concerns, the constitutional questions surrounding the administrative ruling, and the specific circumstances of the denial of registration.
The company’s perspective is that this case could bring the DEA’s administrative law judge system itself under intense legal scrutiny. They suggest that the system, in light of recent Supreme Court limitations on agency power in internal hearings, may not survive challenge if it is seen to deny fundamental rights like due process or bypass constitutional questions that the Supreme Court has indicated belong in federal court.
The looming legal battle is poised to be a significant test case, potentially shaping how federal agencies handle applications related to controlled substances, particularly cannabis for research, and redefining the boundaries of their administrative authority when constitutional rights are implicated. For MMJ BioPharma Cultivation, the seven-year wait for registration is transitioning into a high-stakes legal fight in the federal judiciary.
