Clinical-Stage Pharmaceutical Developer Says Recent Coverage Misses the Real Story: Marijuana Chemistry, Safety, and Scientific Validation
WASHINGTON, D.C. / ACCESS Newswire / May 25, 2026 / MMJ International Holdings, Inc. ("MMJ") today responded to recent media coverage surrounding the challenge to the Centers for Medicare & Medicaid Services' (CMS) Substance Access Beneficiary Engagement Incentive (BEI) program, arguing that the ongoing portrayal of the litigation as a "pro-marijuana versus anti-marijuana" battle fundamentally misunderstands the issues at stake.
According to MMJ, the case has never been about marijuana.
It has always been about science.
This Is Not a Marijuana Debate
Recent industry coverage has repeatedly attempted to place participants in the litigation into simplistic categories of either "pro-marijuana" or "anti-marijuana."
MMJ rejects that characterization entirely.
MMJ International Holdings is a clinical-stage pharmaceutical company focused exclusively on developing cannabinoid-based medicines through the FDA's botanical drug development pathway.
The company has spent nearly a decade and invested millions of dollars developing therapies for Huntington's disease and Multiple Sclerosis under federal regulatory oversight.
MMJ has:
Obtained FDA Investigational New Drug (IND) applications;
Received FDA Orphan Drug Designation;
Imported cannabinoid active pharmaceutical ingredients under federal authorization;
Developed and evaluated multiple formulations;
Selected a final clinical formulation;
Completed GMP scale-up manufacturing of approximately 50,000 soft-gelatin capsules;
Conducted stability testing under FDA and International Council for Harmonisation (ICH) standards;
Generated Chemistry, Manufacturing and Controls (CMC) data;
Submitted data to FDA in accordance with the agency's Botanical Drug Development Guidance;
Obtained a DEA Schedule I analytical laboratory registration.
"MMJ is not anti-marijuana," said Duane Boise, Chief Executive Officer of MMJ International Holdings.
"We are anti-unknown chemistry. We have spent years identifying, characterizing, manufacturing, testing, and stabilizing cannabinoid formulations under FDA standards because patients deserve to know exactly what is in a product, how it was manufactured, whether it is stable, and whether it has been clinically evaluated. This is not a debate about marijuana. It is a debate about scientific standards and patient safety."
The Real Issue: Public Health and Scientific Standards
MMJ emphasized that its participation in the litigation was driven by concerns regarding scientific validation and regulatory consistency-not opposition to cannabinoid therapies.
In fact, MMJ's entire business model is built around the belief that cannabinoids may have significant therapeutic value when developed according to established pharmaceutical standards.
The company notes that recent findings from the European Food Safety Authority (EFSA) illustrate why chemistry, characterization, and safety data remain critical.
EFSA recently concluded that it could not establish the safety of a Charlottes Web hemp extract product due to unresolved toxicological concerns, insufficient characterization, and significant unidentified components within the product.
According to MMJ, those findings demonstrate a broader principle:
The issue is not whether cannabinoids work.
The issue is whether regulators and patients know precisely what is in the product being consumed.
"Europe did not reject cannabinoids," Boise said.
"Europe rejected uncertainty. The EFSA findings highlight exactly why FDA requires chemistry, manufacturing controls, stability testing, and clinical evaluation. Those standards exist to protect patients. They are not bureaucratic obstacles. They are public health safeguards."
The Court Never Addressed the Science
MMJ further noted that the recent dismissal of the challenge to CMS's BEI program was based solely on procedural standing grounds.
The Court did not rule that the program is lawful.
The Court did not determine that the products being furnished are safe.
The Court did not determine that CMS acted within its statutory authority.
The Court did not evaluate whether Medicare beneficiaries should receive cannabinoid products that have not undergone FDA drug approval.
Instead, the Court concluded only that the plaintiffs had not established sufficient standing to proceed.
"The Court never examined the science," Boise stated.
"The Court never evaluated whether these products meet appropriate standards. The Court simply concluded that no one had demonstrated sufficient injury to challenge the program. Those are very different questions."
A Growing Regulatory Contradiction
MMJ also pointed to the approaching implementation of Section 781 of Public Law 119-37, which becomes effective on November 12, 2026.
The legislation imposes strict federal limits on hemp-derived cannabinoid products and is expected to significantly alter portions of the current marketplace.
According to MMJ, this creates an increasingly difficult question for policymakers:
Why is the federal government facilitating access to hemp-derived cannabinoid products through Medicare while simultaneously moving toward stricter federal restrictions on those same categories of products?
That question remains unanswered.
Common Ground on Public Health
MMJ acknowledged that organizations involved in the litigation may hold different views regarding broader marijuana policy.
However, the company emphasized that the coalition shared a common concern regarding public health, scientific validation, and patient safety.
"Organizations can disagree on marijuana policy and still agree that products intended for patients - especially seniors - should be supported by sound science," Boise said.
"We are not fighting against cannabinoids. We are fighting for the standards that ensure cannabinoids are safe, reproducible, and properly understood before they reach vulnerable patient populations. That is not an anti-marijuana position. That is a pro-patient position."
About MMJ International Holdings
MMJ International Holdings, Inc. is a clinical-stage pharmaceutical company developing cannabinoid-based therapies through the FDA's Botanical Drug Development framework. The company has received FDA Orphan Drug Designation, maintains active FDA IND programs, and operates through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, including a DEA-registered Schedule I analytical laboratory. MMJ's mission is to develop scientifically validated cannabinoid medicines that meet the same rigorous standards expected of every other pharmaceutical product.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings, Inc.
Related Documents:
- OPINION
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/mmj-international-holdings-rejects-%22anti-marijuana%22-label-defends-sci-1170322
