"This case has become much larger than marijuana," Duane Boise CEO of MMJ International Holdings stated. “The government is effectively telling the Court that protecting patients through the FDA approval process and protecting the public through workplace drug testing are not interests the Controlled Substances Act was designed to protect. We respectfully disagree. Congress enacted the CSA to protect public health, scientific integrity, and public safety-not to reward those who bypassed the federal system while penalizing those who followed it.”
WASHINGTON, D.C. / ACCESS Newswire / July 3, 2026 / MMJ International Holdings, Inc. (MMJIH), together with its subsidiaries MMJ BioPharma Cultivation, Inc. and MMJ BioPharma Labs, Inc. (collectively "MMJ"), today issued a sharp rebuke of the U.S. Department of Justice (DOJ) following the government's latest filing before the U.S. Court of Appeals for the District of Columbia Circuit. MMJ has been spearheading cannabinoid based clinical research for Huntington's disease and multiple sclerosis. In a high stakes filing before the U.S. Court of Appeals for the District of Columbia Circuit, MMJIH argues that the government's legal strategy effectively turns decades of federal drug policy on its head, suggesting that compliance with federal standards has become a liability rather than a hallmark of legitimacy.
The dispute centers on Attorney General Order No. 6754-2026. In its defense, the DOJ argues that MMJ's interests-and those of the National Drug and Alcohol Screening Association (NDASA)-fall outside the scope of the Controlled Substances Act (CSA). Specifically, the government contends that because MMJ does not yet have an FDA approved product on the market, it lacks standing, and that workplace drug testing infrastructure is not a primary concern of federal drug statute.
This legal maneuvering marks a profound pivot from the established federal paradigm that has long governed American medicine. For decades, the government has mandated a single, rigid pathway for drug development: rigorous FDA oversight, DEA compliance, and years of clinical data collection.
"For eight years, we have done exactly what the government demanded," said Duane Boise, CEO of MMJ International Holdings. "We followed the FDA pathway, complied with the DEA, and invested over millions in drug development for clinical research. Now, the DOJ tells the Court our injuries don't matter because we haven't completed the very process they forced us to navigate."
The Regulatory Paradox: Compliance as a Competitive Disadvantage
MMJ's legal challenge highlights a troubling "regulatory paradox." While federally compliant developers like MMJ remain subject to exhaustive regulatory scrutiny and high costs, the DOJ is simultaneously defending an Order that extends significant federal regulatory and economic benefits to state licensed marijuana businesses that have largely bypassed the FDA approval process.
MMJ maintains that this creates a distorted marketplace. By rewarding entities that ignored the federal pharmaceutical pathway while penalizing those that adhered to it, the government is effectively incentivizing a "wild west" approach to medicine.
"Our government should be encouraging companies that follow the federal rules-not placing them at a competitive disadvantage," Boise said. "MMJ chose the FDA pathway because that's the pathway Congress established to protect patients. If those who bypassed that process receive the same or greater federal benefits, then compliance is no longer being rewarded-it's being penalized."
Undermining Public Safety Infrastructure
The DOJ's filing also seeks to dismiss the concerns of the National Drug and Alcohol Screening Association (NDASA), arguing that Congress did not enact the CSA to provide revenue for drug screeners. MMJ argues this dismissive stance ignores the critical role that testing plays in the broader American public safety infrastructure-including transportation, aviation, and healthcare.
"The government's brief treats workplace drug testing as though it exists simply to generate revenue," Boise noted. "That completely misses the point. Drug testing protects the traveling public, hospital patients, and workers in safety-sensitive occupations. Suggesting these interests fall outside the purpose of the Controlled Substances Act should concern every American."
The D.C. Circuit: A Test for Regulatory Integrity
The consolidated appeals pending before the D.C. Circuit will now determine whether Attorney General Order No. 6754-2026 was lawfully issued and whether the DOJ possesses the authority to create this regulatory framework.
"This case has transcended the debate over marijuana; it is now a fundamental challenge to the integrity of federal regulatory authority," Boise concluded. "By arguing that FDA backed clinical development and workplace safety standards fall outside the intent of the Controlled Substances Act, the government is effectively inviting a 'wild west' outcome where compliance is viewed as a competitive handicap. Congress enacted the CSA to protect public health, scientific integrity, and public safety-not to reward those who bypassed the federal system while punishing those who invested years and millions of dollars to follow it. The Court must decide if the rule of law still applies to those who play by the rules."
About MMJ International Holdings, Inc. MMJ International Holdings, Inc. (MMJIH) is a privately held pharmaceutical company developing cannabinoid-based investigational medicines for Huntington's disease and multiple sclerosis through the U.S. Food and Drug Administration's Investigational New Drug pathway. The company holds two active IND applications, an Orphan Drug Designation, a DEA Schedule I analytical laboratory registration, and has pursued a DEA bulk manufacturing registration since 2018 to cultivate pharmaceutical-grade cannabis for federally authorized clinical research.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
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