"You cannot responsibly introduce products into a Medicare population when their chemistry is not fully defined and their safety cannot be established. This is not a policy debate-it's a scientific one. MMJ followed the FDA pathway because patients deserve certainty, not guesswork." stated Duane Boise, CEO MMJ International Holdings.

WASHINGTON, D.C. / ACCESS Newswire / May 5, 2026 / A federal judge is now deciding whether to halt a controversial Medicare linked hemp, marijuana CBD program-just as Europe's top scientific authority has delivered a stunning conclusion:

It cannot confirm that a leading CBD product is safe for human consumption.

The finding, issued by the European Food Safety Authority (EFSA)-widely regarded as the European equivalent of the U.S. Food and Drug Administration directly challenges the scientific foundation of the U.S. Centers for Medicare & Medicaid Services (CMS) Substance Access Beneficiary Engagement Incentive (BEI) program.

THE SCIENCE JUST COLLAPSED

In a March 2026 ruling, EFSA evaluated a hemp-derived CBD extract submitted by Charlotte's Web, one of the most established cannabinoid companies in the United States.

After full scientific review, EFSA found:

• 20-30% of the product remains chemically uncharacterized

• No toxicology studies on the actual product being marketed

• No human clinical safety data

• Stability testing conducted on a different formulation

• Unknown allergenic risk

Final determination:

"The safety of the product cannot be established."

AT THE SAME TIME: CMS MOVES INTO THE MEDICARE POPULATION

While global regulators cannot confirm safety, CMS has already launched the BEI program-allowing providers to:

• Discuss hemp, marijuana-derived cannabinoid products

• Furnish them in Medicare linked care settings

This targets Americans over 65, a population that is:

• Managing multiple prescriptions

• More vulnerable to adverse drug interactions

• Largely excluded from cannabinoid safety trials

THE CRITICAL QUESTION: WHAT EXACTLY IS BEING GIVEN TO PATIENTS?

EFSA's findings expose a fundamental problem:

If a leading CBD product cannot be fully defined... what about the rest of the market?

Because BEI suppliers have not submitted:

• FDA Investigational New Drug (IND) applications

• Chemistry, Manufacturing, and Controls (CMC) validation

• Standardized dosing data

• Human safety studies

• Stability testing on final products

They have not even attempted to meet the FDA standards that failed in Europe

THE COURT IS NOW THE BACKSTOP

The U.S. District Court for the District of Columbia is weighing whether to halt the BEI program in:

Smart Approaches to Marijuana (SAM) et al. v. Kennedy
(Case No. 1:26-cv-01081)

At stake:

• Whether CMS bypassed Administrative Procedure Act requirements

• Whether it introduced products without established safety standards

• Whether it created a parallel system outside FDA oversight

THE SCIENCE GAP - AND WHY IT MATTERS

This is not about cannabis policy.

This is about whether medicine is defined by science or by assumption.

DUANE BOISE, CEO - MMJ INTERNATIONAL HOLDINGS

"If the world's leading safety authority cannot confirm what is in a hemp, marijuana derived CBD product or whether it is safe, there is no scientific basis to introduce it into Medicare care. MMJ followed the FDA pathway because patients deserve precision, reproducibility, and accountability-not uncertainty. The BEI program introduces uncertainty into the most vulnerable population."

WHY THIS IS A TURNING POINT

If BEI continues:

• Physicians are forced to evaluate non-standardized products

• Patients may receive chemically undefined mixtures

• Clinical drug development is undermined

• Investor confidence in regulated medicine is damaged

• The line between medicine and supplement collapses

GLOBAL REGULATORS VS. U.S. POLICY

Europe demanded proof-and rejected the product.

The United States is now being asked to decide:

Should access come before evidence?

• Or should science come first?

THE BOTTOM LINE

If safety cannot be established...
why is the product being introduced into Medicare?

ABOUT MMJ INTERNATIONAL HOLDINGS

MMJ International Holdings, Inc. is a U.S.-based biopharmaceutical company developing FDA compliant cannabinoid therapies for Huntington's disease and multiple sclerosis. Through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, MMJ is advancing standardized, pharmaceutical grade cannabinoid drug products under the FDA's botanical drug development framework.

Madison Hisey
MHisey@mmjih.com
203-231-85832

SOURCE: MMJ International Holdings