"CMS plays an important role in expanding access to healthcare services, but it does not have the legal authority or scientific mandate to approve medicines," said Duane Boise, CEO of MMJ International Holdings.

"In the United States, only the U.S. Food and Drug Administration determines whether a drug is safe, effective, and manufactured to pharmaceutical standards. Reimbursement cannot replace evidence. Coverage is not approval."

WASHINGTON, DC / ACCESS Newswire / March 31, 2026 / MMJ International Holdings, the leading pharmaceutical developer of plant-derived cannabinoid therapeutics, today addressed the filing of a major federal lawsuit by Smart Approaches to Marijuana (SAM) against the Centers for Medicare & Medicaid Services (CMS). The lawsuit, SAM et al. v. Kennedy et al. (Case 1:26-cv-01081), filed in the U.S. District Court for the District of Columbia, seeks to block the April 1 launch of a Medicare pilot program that would reimburse unapproved hemp-derived CBD products.

While MMJ International Holdings is not a party to the litigation, the company stands as a primary example of why the lawsuit's core argument-that science must precede reimbursement-is a matter of national drug safety.

The SAM filing argues that CMS, under the direction of Administrator Dr. Mehmet Oz, has bypassed the Administrative Procedure Act (APA) and violated the Federal Food, Drug, and Cosmetic Act (FDCA) by creating a federal reimbursement track for products that have not been proven safe or effective through the FDA's gold-standard approval process.

The lawsuit contends that the CMS "Substance Access" pilot effectively creates a "shadow medical system" where federal healthcare dollars fund retail-grade supplements as if they were validated pharmaceuticals.

MMJ International Holdings has spent nearly a decade demonstrating that there are no shortcuts to pharmaceutical legitimacy. Unlike the consumer-grade products targeted by the CMS pilot, MMJ's therapeutic candidates (including MMJ-001 and MMJ-002) have been developed strictly within the FDA's Botanical Drug Development framework.

Safety for Vulnerable Populations: Patients with Huntington's Disease and Multiple Sclerosis require precise, reproducible dosing. Retail CBD products often suffer from "potency drift" and contamination-risks that are eliminated through FDA-mandated Chemistry, Manufacturing, and Controls (CMC).

Clinical Reproducibility: MMJ has secured Orphan Drug Designations and IND (Investigational New Drug) authorizations. This ensures that every soft-gel capsule produced is identical in its pharmacokinetic profile, a requirement that non-drug "hemp" products cannot meet.

Federal Compliance: MMJ operates under DEA Schedule I research registrations and GMP (Good Manufacturing Practice) standards, ensuring that its medicine is federally defensible and ready for a post-rescheduling environment.