Arizona Tribune - MMJ International Holdings Seeks Injunction to Halt CMS CBD Program

WASHINGTON, DC / ACCESS Newswire / April 13, 2026 / MMJ International Holdings, Inc. (MMJIH), a pharmaceutical cannabinoid developer advancing therapies for Huntington's disease and Multiple Sclerosis, today issued a strong warning regarding the legality and safety implications of the Centers for Medicare & Medicaid Services' (CMS) newly launched Substance Access Beneficiary Engagement Incentive (BEI) program - a federal initiative now under challenge in the U.S. District Court for the District of Columbia.

The lawsuit alleges CMS created a federally supported cannabinoid access pathway for Medicare beneficiaries without required rule making, without public notice, and without FDA clinical validation standards, raising serious constitutional and administrative law concerns.

MMJ International Holdings has joined additional plaintiffs in the litigation following the filing of a motion for preliminary injunction seeking to halt implementation of the BEI while the court reviews its legality.

A Federal Healthcare Experiment Without Scientific Safeguards

At issue is CMS's decision to allow participating healthcare organizations to discuss and furnish hemp-derived cannabinoid products containing up to 0.3% delta-9 THC to Medicare beneficiaries under an Innovation Center demonstration model.

According to the complaint and supporting filings, CMS implemented the BEI without notice-and-comment rulemaking required under the Administrative Procedure Act, despite the program's clear policy consequences for national cannabinoid access and reimbursement expectations.

Even more troubling, CMS's own April 2025 rulemaking stated that cannabis products were not eligible for Medicare beneficiary coverage, making the BEI a direct reversal of federal policy without explanation or procedural safeguards.

"This program creates a fast lane for retail-grade cannabinoid access while companies pursuing FDA approval continue to follow the law," said Duane Boise, CEO of MMJ International Holdings.
"That is not healthcare policy. That is regulatory improvisation."

Plaintiffs Warn Seniors Are Being Used as Policy Guinea Pigs

Court filings supporting the preliminary injunction warn that the BEI model effectively authorizes distribution of hemp-derived THC-containing products to Medicare beneficiaries without FDA drug approval, without clinical trial evidence, and without public safety analysis tailored to elderly populations.

The lawsuit states plainly:

CMS is treating America's seniors like laboratory subjects in a nationwide cannabinoid access experiment.

MMJ International Holdings argues that such policy shortcuts threaten to weaken the scientific framework that protects patients and ensures therapies are reproducible, safe, and clinically validated.

CMS Created a Cannabinoid Access Policy Without Congressional Authorization

The lawsuit raises fundamental constitutional questions about agency authority.

Plaintiffs argue CMS:

• bypassed required Administrative Procedure Act rulemaking

• reversed its own prior cannabis coverage position

• created a reimbursement-adjacent cannabinoid access pathway outside FDA authority

• imposed economic injury on companies pursuing lawful pharmaceutical development

The filings further assert violations of Fifth Amendment due process and equal protection guarantees affecting regulated therapeutic developers that followed the FDA pathway in reliance on longstanding federal policy expectations.

"This case is about whether agencies can change national drug-access policy without transparency, without science, and without Congress," Boise said.

A Direct Threat to the FDA Botanical Drug Development Framework

MMJ International Holdings has spent nearly a decade advancing standardized cannabinoid therapies through the FDA's botanical drug pathway, including:

• Investigational New Drug (IND) clinical programs

• Orphan Drug Designation for Huntington's disease

• DEA Schedule I analytical registration

• pharmaceutical-grade cannabinoid soft-gel dosage manufacturing

The BEI model risks undermining incentives for companies pursuing validated therapies for serious neurological conditions by allowing federally supported access to non-approved cannabinoid products outside the clinical trial system.

"For companies that followed the rules, this program changes the rules midstream," Boise said.
"That is exactly what administrative law is supposed to prevent."

Preliminary Injunction Could Halt Program Nationwide

The federal court has scheduled expedited briefing and a preliminary injunction hearing to determine whether CMS exceeded its statutory authority when launching the BEI model.

Plaintiffs argue the balance of equities strongly favors preserving the pre-BEI regulatory framework while the court evaluates whether CMS acted lawfully.

If granted, the injunction would pause the federal pilot program and reaffirm that cannabinoid therapies entering Medicare policy must first meet FDA clinical validation standards.

Why MMJ International Holdings Believes the Case Will Prevail

According to MMJ International Holdings, the litigation rests on a straightforward legal principle:

Federal agencies cannot rewrite national healthcare access policy without following federal rulemaking law.

"The Administrative Procedure Act exists for a reason," Boise said.
"When agencies bypass transparency, bypass science, and bypass public input, courts step in. That is exactly what this case is about."

About MMJ International Holdings

MMJ International Holdings, Inc. is a U.S.-based pharmaceutical company developing cannabinoid therapies for Huntington's disease and multiple sclerosis through the FDA botanical drug pathway. Through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, the company is advancing standardized cannabinoid medicines designed to meet rigorous federal regulatory standards for clinical use.

Madison Hisey
[email protected]
203-231-85832

SOURCE: MMJ International Holdings

View the original press release on ACCESS Newswire

W.Stewart--AT