WASHINGTON, D.C. / ACCESS Newswire / April 11, 2026 / MMJ International Holdings, Inc. (MMJIH), a leading developer of pharmaceutical-grade cannabinoid therapeutics for Huntington's disease and Multiple Sclerosis, today confirmed that it has moved to join litigation challenging a new federal pilot program that permits discussion and furnishing of hemp-derived cannabinoid products to Medicare beneficiaries without FDA drug approval.
The lawsuit, filed in the U.S. District Court for the District of Columbia, challenges the Centers for Medicare & Medicaid Services' (CMS) newly launched Substance Access Beneficiary Engagement Incentive (BEI) model. The case was originally brought by Smart Approaches to Marijuana and other plaintiffs, who argue the program was implemented without required rulemaking procedures and conflicts with longstanding federal drug-approval safeguards.
MMJ International Holdings and its subsidiaries MMJ BioPharma Labs and MMJ BioPharma Cultivation have moved to participate in the litigation to ensure that federally reimbursed cannabinoid access policies remain anchored to scientific validation through the U.S. Food and Drug Administration's botanical drug pathway.
A Federal Policy Shift Without FDA Approval
The BEI program, launched April 1 through the CMS Innovation Center, allows participating organizations to discuss and furnish hemp-derived cannabinoid products containing no more than 0.3% delta-9 THC for symptom-management purposes.
While CMS has stated the program does not constitute formal Medicare reimbursement coverage, critics argue the model creates a federally supported distribution pathway for products that have not undergone FDA drug approval.
"A federal pilot built on the 0.3% THC loophole is reshaping cannabinoid access policy - without FDA approval, without reimbursement transparency, and without advance market notice," said Duane Boise, CEO of MMJ International Holdings. "Patients deserve clinically validated therapies, not experimental access models funded through federal healthcare infrastructure."
Legal Questions at the Center of the Case
The lawsuit raises three central federal law concerns:
Whether CMS exceeded its authority under the Administrative Procedure Act
Whether the BEI conflicts with the Federal Food, Drug, and Cosmetic Act
Whether the Innovation Center can create access pathways for unapproved cannabinoid products prior to FDA drug validation
Although the court denied an emergency temporary restraining order on March 31, the litigation continues, with a preliminary injunction hearing scheduled for April 20, 2026.
Federal defendants have requested that the hearing be postponed.
Why MMJ International Holdings Is Participating
MMJ International Holdings is currently developing standardized cannabinoid soft-gel capsule therapies under FDA Investigational New Drug (IND) authorization targeting Huntington's disease and multiple sclerosis. The company has followed the federal pharmaceutical pathway for nearly a decade, including:
IND-authorized clinical research
Orphan Drug Designation for Huntington's disease
DEA-licensed analytical laboratory infrastructure
Pharmaceutical-grade botanical formulation development
The company's participation in the lawsuit reflects concerns that federal reimbursement-adjacent cannabinoid access programs could undermine the scientific framework required for drug safety and efficacy evaluation.
"When federal healthcare programs begin supporting cannabinoid products outside the FDA pathway, they risk creating a shadow approval system," Boise added. "That is not how medicine in the United States is supposed to work."
Innovation Model or Regulatory Shortcut?
Supporters of the BEI model argue it expands structured patient access to hemp-derived wellness products for chronic conditions.
Opponents argue it creates a precedent allowing federally supported cannabinoid distribution before clinical validation standards are met.
MMJ International Holdings maintains that cannabinoid therapies intended for symptom treatment in serious neurological diseases should advance through the FDA's botanical drug framework - the same pathway used for every other prescription medicine.
About MMJ International Holdings
MMJ International Holdings, Inc. is a U.S.-based biopharmaceutical company developing pharmaceutical-grade cannabinoid therapies for Huntington's disease and multiple sclerosis. Through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, the company is advancing FDA-regulated botanical drug candidates designed to meet rigorous federal safety, quality, and efficacy standards.
Madison Hisey
MHisey@mmjih.com
203-231-85832
SOURCE: MMJ International Holdings
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