"Medicare patients should not become the testing ground for cannabinoid products that have not undergone the rigorous FDA drug development process required to establish safety, efficacy, manufacturing consistency and appropriate dosing," says Duane Boise CEO of MMJ International Holdings.

WASHINGTON, DC / ACCESS Newswire / August 11, 2026 / MMJ International Holdings, Inc. ("MMJ") today called on Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz and CMS to explain why the federal government is expanding access to hemp derived cannabinoid products for Medicare beneficiaries when those commercial products have not undergone the rigorous FDA drug-development process required of pharmaceutical medicines.

The question has taken on new urgency following Administrator Oz's August 2026 letter to members of the United States Senate urging lawmakers to preserve access to hemp-derived CBD products through Medicare-related programs.

According to the Administrator, CMS has taken "historic action" to expand access to full-spectrum CBD and has created mechanisms allowing certain participating healthcare entities to furnish eligible hemp products to patients.

Oz separately told senators that CMS had "expanded the ability of Medicare Advantage plans to offer hemp-derived CBD products through special supplemental benefits for the chronically ill."

MMJ believes the public deserves to understand exactly what that means - and what scientific standards these products were required to satisfy before CMS facilitated their availability to elderly, disabled and chronically ill Medicare beneficiaries.

These Are Not FDA-Approved Cannabinoid Drugs

The hemp-derived CBD products contemplated by these CMS initiatives should not be confused with FDA-approved pharmaceutical cannabinoid medicines.

Commercial full-spectrum hemp products have not, merely by qualifying for the CMS initiatives, undergone the FDA New Drug Application approval process required to establish the safety and efficacy of a prescription drug for a particular disease or condition.

They have not received FDA approval based on adequate and well controlled clinical trials simply because they satisfy CMS eligibility requirements.

And CMS eligibility does not transform a commercial hemp supplement into an FDA approved medicine.

That distinction becomes particularly important when the target population includes seniors, individuals with disabilities, cancer patients, people with seizure disorders and chronically ill Medicare beneficiaries.

MMJ believes those patients deserve more scientific scrutiny - not less.

Europe Just Demonstrated Why the Scientific Questions Matter

On March 30, 2026, the European Food Safety Authority ("EFSA") published a scientific opinion concerning a carbon-dioxide extract from Cannabis sativa L. submitted by Charlotte's Web, Inc. for authorization as a novel food.

The application proposed use of the hemp extract in food supplements.

EFSA did not conclude that the submitted product was safe under the proposed conditions of use.

Instead, the scientific panel found that a substantial proportion of the hemp extract remained uncharacterized.

EFSA also determined that stability and toxicological studies submitted by the applicant had been conducted using material produced through a different extraction process from the CO₂ extract actually under review, potentially producing different compositions.

EFSA concluded that the absence of adequate stability information and toxicological studies using a representative test material prevented the panel from completing the safety assessment.

The conclusion was direct:

The safety of the novel food under the proposed conditions of use could not be established.

That does not mean EFSA concluded that Charlotte's Web products are dangerous.

It means something equally important for federal health policy:

The available evidence was insufficient for European food-safety scientists to establish the safety of the specific hemp extract submitted for authorization.

MMJ Asks: Why Should Medicare Patients Receive a Lower Evidentiary Standard?

MMJ believes the EFSA findings expose a fundamental contradiction in current U.S. cannabinoid policy.

When MMJ seeks to develop a cannabinoid medicine for Huntington's disease or multiple sclerosis, the company must proceed through FDA Investigational New Drug requirements, chemistry and manufacturing controls, analytical characterization, stability testing, toxicology, clinical protocols and ultimately controlled clinical trials designed to establish safety and efficacy.

Yet CMS is facilitating access to commercial hemp-derived cannabinoid products for chronically ill Medicare beneficiaries without those products first obtaining FDA drug approval for the diseases or symptoms for which patients may use them.

"Why are we lowering the scientific standard precisely when we are dealing with some of the most medically vulnerable patients in America?" said Duane Boise, Chief Executive Officer of MMJ International Holdings. "Europe examined a Charlotte's Web hemp extract and could not establish its safety because important portions of the material were uncharacterized and the supporting stability and toxicology evidence was inadequate for the product actually being evaluated. That should cause American health officials to ask more questions, not fewer."

"Political Pressure Cannot Substitute for Scientific Evidence"

MMJ also questioned why Administrator Oz is personally lobbying Congress to preserve access to these products while fundamental scientific and regulatory questions remain unresolved.

MMJ believes healthcare policy involving cannabinoid products should be driven by scientific evidence, product characterization and patient safety rather than political or commercial pressure.

"Dr. Oz is the Administrator of CMS. His responsibility should be to Medicare beneficiaries and sound healthcare policy," Boise said. "Political pressure from the hemp industry cannot substitute for toxicology, reproducible chemistry, stability data, controlled manufacturing and clinical evidence. If CMS wants cannabinoid products furnished to chronically ill Medicare beneficiaries, then CMS should explain what scientific evidence it relied upon to conclude that those products are appropriate for that population."

MMJ emphasized that it is not asserting that every hemp-derived CBD product is unsafe.

The issue is whether the federal government has adequate product specific evidence to know.

There is a difference between evidence demonstrating that a product is unsafe and insufficient evidence demonstrating that it is safe.

For MMJ, that distinction is precisely why rigorous pharmaceutical development exists.

Seven Prototypes. One Selected Formulation. Pharmaceutical Development.

MMJ has spent more than eight years and more than $10 million pursuing cannabinoid medicines through the federal pharmaceutical pathway.

MMJ evaluated seven prototype formulations before selecting a standardized cannabinoid soft-gel formulation containing 5 mg cannabidiol and 2.5 mg tetrahydrocannabinol per capsule.

The selected formulation was scaled for production and incorporated into MMJ's Investigational New Drug program.

MMJ's standardized final-dose investigational soft-gel product has been manufactured in collaboration with Catalent Pharma Solutions.

MMJ has also pursued analytical characterization, stability work, FDA IND programs, FDA Orphan Drug Designation and DEA controlled-substance registrations.

And MMJ's product still cannot be marketed.

MMJ's investigational therapies remain subject to FDA clinical hold and have not completed the clinical trials necessary to establish safety or efficacy.

MMJ says that is exactly how a legitimate pharmaceutical system is supposed to work:

Until the evidence exists, the company cannot tell patients that its investigational medicine is proven safe and effective.

What Scientific Standard Did CMS Apply?

MMJ believes CMS should publicly answer several basic questions before expanding cannabinoid access among Medicare beneficiaries:

What product-specific toxicology evidence did CMS review?

What stability data did CMS require?

How does CMS determine whether the chemical composition of one batch is reproducible in another?

What contaminants, impurities and minor cannabinoids must be identified and controlled?

What drug-interaction evidence exists for elderly beneficiaries taking multiple medications?

What clinical evidence supports use of these products for the symptoms and conditions Administrator Oz specifically identified to Congress?

And perhaps most importantly:

Why should a cannabinoid pharmaceutical developer be required to answer those questions before reaching patients while a commercial hemp product can enter a Medicare-related pathway without completing the same FDA drug-development process?

EFSA's Findings Make the Question Impossible to Ignore

EFSA's broader 2026 CBD assessment underscores the uncertainty.

The European regulator established only a provisional safe intake level of approximately 2 mg of CBD per day for a 70-kilogram adult, and that provisional level applies to qualifying formulations containing at least 98% pure CBD under specified conditions.

EFSA specifically identified populations for whom safety could not be established, including people taking medications.

That deserves particular attention in a Medicare population, where medication use is common.

The Charlotte's Web assessment involved a different, full-spectrum-type hemp extract containing CBD and other cannabinoids. EFSA concluded that the safety of that specific novel food under its proposed conditions could not be established.

MMJ believes American policymakers should explain why those scientific uncertainties do not warrant comparable caution here.

MMJ Calls for Transparency Before Expansion

MMJ is calling on CMS to disclose:

1. The scientific and safety criteria used to determine which hemp-derived cannabinoid products qualify for its programs;

2. The evidence CMS relied upon concerning safety, stability, composition, drug interactions and manufacturing consistency;

3. The regulatory mechanism through which CMS expanded Medicare Advantage access to hemp-derived CBD through Special Supplemental Benefits for the Chronically Ill; and

4. Whether FDA reviewed or endorsed the scientific standards CMS is using for cannabinoid products furnished to Medicare beneficiaries.

"We are not anti-marijuana and we are not anti-CBD. We are anti-unknown chemistry," Boise said. "If these products can withstand rigorous scientific evaluation, then demonstrate it. But Medicare beneficiaries should not become the population in which unanswered questions about commercial cannabinoid products are discovered after widespread exposure."

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.

MMJ's cannabinoid product candidates are investigational and have not been approved by the U.S. Food and Drug Administration. Required clinical trials have not been completed, and no conclusions regarding their safety or efficacy should be drawn.

CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583

SOURCE: MMJ International Holdings