MMJ International Holdings Exposes the Impossible Federal Catch-22 Blocking FDA Regulated Cannabis Medicine. "This is an equation with no solution. To follow the rule is to commit a felony, and to follow the law is to violate the rule. This is the first paradox I've encountered that violates logic and the U.S. criminal code simultaneously." stated Duane Boise, CEO MMJ International Holdings.
WASHINGTON, D.C. / ACCESS Newswire / December 3, 2025 / MMJ International Holdings, a pharmaceutical developer of a fully federally compliant, natural cannabinoid pharmaceutical for Huntington's Disease and Multiple Sclerosis, today released a sharply critical analysis of the Drug Enforcement Administration's marijuana research policies-calling them "mathematically impossible, legally contradictory, and scientifically indefensible."
For seven years, MMJ has been trapped in a bureaucratic paradox that prevents the company from advancing its FDA-authorized clinical program, despite already having:
FDA Orphan Drug Designation
FDA IND programs prepared for Phase 2/3 trials
Fully manufactured GMP softgel capsules
Completed stability data
A DEA Schedule I import authorization
The barrier is not science or safety-but DEA procedure.
A Regulatory Paradox With No Legal Route Forward
To obtain a DEA bulk manufacturing registration for pharmaceutical cannabis, the agency requires applicants to first present a bona fide supply contract with another federally licensed cannabis manufacturer.
But federal law classifies cannabis as a Schedule I drug, making any negotiation, drafting, or agreement involving future cannabis supply a federal trafficking conspiracy.
Meaning:
It is illegal to negotiate the contract DEA demands, and
It is impossible to obtain the license without it.
MMJ International Holdings CEO Duane Boise described the situation plainly:
"This is a regulatory equation with no solution.
To follow the rule is to commit a felony, and to follow the law is to violate the rule.
DEA has created a system where compliance itself is illegal."
Meanwhile, Ultra-Potent THC Products Flourish in Plain Sight
While federally compliant pharmaceutical developers are blocked, state dispensaries nationwide openly sell high-potency THC concentrates, many reaching high levels of THC. These products:
Remain federally illegal under the Controlled Substances Act
Are linked by peer-reviewed research to psychosis, schizophrenia, and neurological destabilization
Are widely accessible to young adults
Yet MMJ-operating entirely under federal authority-still cannot secure approval for:
Consistent, stabilized pharmaceutical softgel capsules
Produced under GMP standards
Using natural full-spectrum cannabis extracts
Intended exclusively for FDA-supervised human clinical trials
Boise added:
"If the goal is to reduce psychosis, violence, and public health harm, the priority should be regulating ultra-potent THC-not blocking standardized pharmaceutical capsules for Huntington's patients."
A System Officially Declared Unconstitutional
In 2025, the U.S. Department of Justice formally acknowledged that the DEA's Administrative Law Judge (ALJ) system-the tribunal required to adjudicate MMJ's case-was "unconstitutional from the start."
As a result:
MMJ never received a lawful evidentiary hearing
The company's 2018 application remains in limbo
There is no functional mechanism to resolve the case without decisive administrative action
Boise characterized the situation as:
"Seven years of delay, despite full compliance, fully manufactured medicine, and FDA readiness.
This is not regulation-it is regulatory entropy."
The Human Cost Behind the Bureaucracy
The satire underscores a deadly serious problem:
Huntington's Disease patients experience chorea-violent involuntary movements that destroy independence and quality of life
MMJ's treatment has FDA Orphan Drug Designation
The medicine is manufactured and ready
The only barrier is one agency's procedural loop
Boise stressed:
"Every day of DEA delay is another day patients go without hope.
We built real medicine-standardized, federally legal medicine-yet we are blocked while dangerous products flourish unchecked."
MMJ Calls for Immediate Federal Action
MMJ International Holdings urges the federal government and DEA Administrator Terrance Cole to:
Resolve MMJ's application immediately under the Administrative Procedure Act
End the Catch-22 that makes compliance legally impossible
Prioritize pharmaceutical-grade cannabinoid medicine over unregulated high-potency THC
Align federal policy with science, public health, and international treaty obligations
Boise concluded:
"The universe is complicated-federal cannabis policy doesn't have to be.
Medicine should not be illegal while illegality is treated as medicine."
About MMJ International Holdings
MMJ International Holdings is a U.S.-based pharmaceutical company developing FDA-regulated, natural cannabinoid medicines. MMJ's subsidiaries-MMJ BioPharma Labs and MMJ BioPharma Cultivation-hold federal designations, IND programs, and DEA licensure for pharmaceutical research targeting Huntington's Disease and Multiple Sclerosis.
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/president-trump-fixing-dea-marijuana-policy-defies-logic-law-and-scie-1114273
