Monday, 10 August 2026 06:40 PM
Company Update
WASHINGTON, D.C. / ACCESS Newswire / August 10, 2026 / MMJ International Holdings, Inc. ("MMJ") today responded to a recurring and consequential mischaracterization of its pharmaceutical development program: the suggestion that MMJ has "no product."
That characterization confuses regulatory authorization with physical reality.
MMJ has a product.
It has been formulated. It has been manufactured. It has been packaged. It has undergone analytical and stability work.
What MMJ does not have is permission from the federal government to advance that investigational product into the clinical studies necessary to determine whether it is safe and effective and, ultimately, whether it can be approved for patients.
After more than eight years of pursuing the federal pathway and more than $10 million in documented investment, that distinction matters.
Manufactured Capsules Are Not a Prototype
MMJ's pharmaceutical development program did not stop at a laboratory formulation.
The company evaluated multiple prototype formulations before selecting a standardized botanical cannabinoid soft-gelatin capsule containing 5 mg cannabidiol (CBD) and 2.5 mg tetrahydrocannabinol (THC) per capsule.
In May 2022, MMJ completed manufacture of its finished capsules of the selected formulation with Catalent Pharma Solutions, a global contract development and manufacturing organization serving the pharmaceutical industry.
The resulting investigational product is a defined finished dosage form manufactured for pharmaceutical development.
It is not an idea.
It is not a business plan.
And thousands of manufactured capsules are not merely a prototype.
MMJ Chose the Federal Pharmaceutical Path
MMJ made a deliberate decision years ago: if cannabinoids were going to be developed as medicines for serious neurological diseases, the company would pursue them through the federal pharmaceutical regulatory system.
That meant accepting the expense, delay and scientific scrutiny that come with FDA drug development and DEA controlled-substance regulation.
MMJ's regulatory and development history includes:
Two FDA Investigational New Drug programs, including IND 137754 for Huntington's disease and IND 140712 for multiple sclerosis;
FDA Orphan Drug Designation for Huntington's disease;
Pharmaceutical formulation and manufacturing development;
Stability and analytical testing;
A DEA Schedule I analytical registration held by MMJ BioPharma Labs following federal inspection and approval of required security, recordkeeping and diversion-control measures; and
A DEA bulk-manufacturer registration application submitted by MMJ BioPharma Cultivation on December 27, 2018, which remains unresolved more than seven years later.
MMJ followed the system Washington said pharmaceutical cannabinoid developers were supposed to follow.
And MMJ is still waiting.
What MMJ Does Not Claim
MMJ's investigational products are not FDA-approved drugs.
They are not commercially available.
They cannot lawfully be marketed to patients.
Both IND programs remain subject to FDA clinical hold. Clinical trials necessary to establish safety and efficacy have not been completed. MMJ makes no claim that its investigational products have been proven safe or effective.
Those limitations are stated plainly because they expose the central contradiction.
MMJ did not evade the federal system to reach the market faster.
MMJ submitted itself to that system - and remains trapped inside it.
The Federal Compliance Paradox
While MMJ has spent years navigating FDA and DEA requirements, state-licensed marijuana operators have sold precisely dosed, orally administered cannabinoid capsules, tablets and related products for therapeutic use without obtaining FDA approval for those products.
Some formulations occupy strikingly similar territory to the dosage forms MMJ spent years developing under federal pharmaceutical controls.
Yet recent federal policy has moved toward providing substantial regulatory and economic benefits to portions of the state-licensed cannabis industry.
That raises a question Washington can no longer avoid:
What message does the federal government send when the company that followed the federal pharmaceutical pathway remains blocked while businesses that operated outside that pathway receive new federal advantages?
For MMJ, this is no longer an abstract cannabis-policy debate.
It is about competition, investment, pharmaceutical development and whether compliance with federal law has economic value.
"We were told that if cannabinoids were going to become legitimate medicines, there was a federal pathway: FDA, DEA, pharmaceutical manufacturing, chemistry, stability, clinical trials and scientific evidence," said Duane Boise, Chief Executive Officer of MMJ International Holdings. "We followed it. We spent the money. We underwent the inspections. We made the submissions. And we manufactured thousands of finished capsules."
Boise continued:
"So when anyone says MMJ has ‘no product,' they are confusing the absence of government permission with the absence of a pharmaceutical product. The capsules exist. They were manufactured. What MMJ does not have is permission to complete the process Washington required us to follow."
MMJ is Not Asking Washington for a Shortcut
MMJ is not asking FDA to waive clinical trials.
It is not asking DEA to abandon controlled-substance safeguards.
It is not asking the federal government to assume that its investigational drug is safe or effective.
MMJ is asking for something considerably simpler:
A Federal Court Decision.
After more than seven years of waiting on its DEA manufacturing application and years of pharmaceutical development under FDA oversight, MMJ believes federal regulators must decide whether companies that comply with federal drug-development requirements will be permitted to complete the pathway those same agencies established.
"We are not asking Washington to lower the standard for MMJ," Boise said. "We are asking Washington to explain why that standard appears to apply most severely to the company that actually followed it."
For MMJ, the question facing federal policymakers is becoming increasingly difficult to ignore:
If following federal law leaves a pharmaceutical developer frozen for eight years while companies that bypassed the federal drug-approval pathway receive expanding economic and regulatory advantages, what exactly was the incentive to follow the law?
MMJ intends to continue pursuing its rights through the appropriate administrative and judicial processes.
About MMJ International Holdings, Inc.
MMJ International Holdings, Inc., through its subsidiaries MMJ BioPharma Cultivation, Inc. and MMJ BioPharma Labs, Inc., is developing pharmaceutical-grade cannabinoid drug candidates through the FDA botanical drug development framework, with investigational programs directed toward Huntington's disease and multiple sclerosis.
CONTACT:
Madison Hisey
[email protected]
203-231-8583
Regulatory Notice
MMJ's cannabinoid product candidates are investigational and have not been approved by the U.S. Food and Drug Administration. The company's IND programs remain subject to FDA clinical hold, and the clinical trials required to establish safety and efficacy have not been completed. Nothing in this release should be interpreted as representing that MMJ's investigational products are FDA approved, commercially available, or proven safe or effective.
SOURCE: MMJ International Holdings