Smart Approach to Marijuana Files Lawsuit to Block Medicare’s CBD "Shortcut" - MMJ Moves Forward With FDA Drug Development
"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, March 31, 2026 (Newswire.com) - 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 Lawsuit: Challenging "Access Before Evidence"
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.
The MMJ Standard: Why the FDA Pathway Matters
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.
Why MMJ Followed the FDA Pathway:
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.
Follow The Money Trail
"The lawsuit filed by SAM highlights a critical policy failure: the attempt to treat cannabinoids as a political commodity rather than a clinical reality. MMJ followed the FDA pathway because we believe that patients deserve medicine, not experiments. We have done the hard work of stability testing, dose-form validation, and preclinical trial work. By reimbursing unvalidated products, the government is essentially telling companies that scientific rigor is optional. We believe scientific rigor is the only way forward." stated Duane Boise , CEO MMJ International Holdings.
When reimbursement policy moves ahead of scientific validation, the primary beneficiaries are often not patients waiting for clinically tested therapies-but organizations positioned to scale distribution rapidly once federal dollars begin flowing. Transparency regarding the financial and advocacy networks surrounding these developments is essential to ensure national healthcare policy remains grounded in rigorous science rather than profiting.
The Regulatory Crossroads
The April 1 launch of the CMS pilot coincides with a separate White House review of FDA enforcement policies. The contradiction is stark: while one arm of the government seeks to ban high-potency hemp "loopholes," another is preparing to fund them.
MMJ International Holdings remains committed to its mission of providing the first truly validated, FDA-approved botanical cannabinoid medicines for neurological suffering-proving that the highest standard of care is the only standard that matters.
About MMJ International Holdings
MMJ International Holdings is a leading biopharmaceutical company dedicated to the development of plant-derived, FDA-approved cannabinoid medicines. Through its subsidiaries, MMJ BioPharma Cultivation and MMJ BioPharma Labs, the company delivers standardized, reproducible therapeutics for patients with unmet medical needs under full federal oversight.
CONTACT:
Madison Hisey
[email protected]
203-231-85832
SOURCE: MMJ International Holdings
Source: MMJ International Holdings
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