"MMJ International Holdings Joins Smart Approaches to Marijuana et al, Federal Challenge to CMS Hemp Program on 4/20: "Botanical Therapies Must Meet FDA Standards-Not Political Timelines" said Duane Boise MMJ International Holdings CEO.

WASHINGTON, D.C. / ACCESS Newswire / April 20, 2026 / On a day traditionally associated with cannabis advocacy, MMJ International Holdings announced its support for litigation aligned with Smart Approaches to Marijuana et al challenging the Centers for Medicare & Medicaid Services' cannabinoid reimbursement framework, warning that federal healthcare dollars should not be used to introduce unvalidated botanical products into the Medicare population.

The company's position is clear:

Botanical therapies must meet reproducibility, safety, and clinical-trial standards before federal adoption.

MMJ International Holdings is supporting the legal effort alongside nationally recognized pain specialist Kenneth Finn, M.D., and constitutional attorney Ilya Shapiro of Burke Law Group, who are raising concerns about the scientific and regulatory implications of introducing hemp derived cannabinoid products into Medicare access pathways without FDA validation.

This Is Not Anti-Cannabis. It Is Pro-Science.

MMJ emphasized that its position is frequently misunderstood by fake news outlets.

This is not opposition to cannabis medicine.

It is opposition to bypassing the regulatory framework that protects patients.

"April 20 has always been a day about access," said Duane Boise, President & CEO of MMJ International Holdings.

"Now it must become a day about standards. Botanical medicines hold enormous promise-but promise alone is not enough. Patients deserve therapies that are reproducible, tested, and safe."

The Hemp Industry Did Not Collapse Because of Regulators

According to MMJ leadership, the tightening regulatory environment facing hemp-derived THC products was predictable-and avoidable.

Across multiple states and now federally, policymakers are responding to:

• escalating THC concentrations in "hemp" consumer products

• lack of reproducible formulations

• absence of stability-controlled dosage forms

• inconsistent labeling accuracy

• absence of controlled clinical trials demonstrating efficacy

These same structural weaknesses are now emerging in parts of the broader marijuana marketplace.

High-potency products without pharmaceutical reproducibility are drawing the same scrutiny that triggered the federal November 12 intoxicating hemp restrictions now approaching implementation.

The lesson is straightforward:

Markets built on loopholes rarely survive contact with federal healthcare policy.

CMS Should Not Introduce Unvalidated Cannabinoids Into the Medicare Population

MMJ's strongest concern centers on the proposed role of Centers for Medicare & Medicaid Services in supporting access to hemp-derived cannabinoid products before FDA approval pathways are completed.

Medicare beneficiaries represent the most medically vulnerable population in the United States.

Introducing non-IND botanical products into that population without:

• reproducibility standards

• stability validation

• pharmacokinetic characterization

• controlled efficacy trials

creates what MMJ describes as a dangerous policy precedent.

"Federal healthcare programs should never become distribution channels for products that have not met the same safety and efficacy requirements as every other medicine," Boise said.

FDA Botanical Drug Guidance Already Defines the Correct Path

The United States does not prohibit plant-based medicines.

It regulates them.

The FDA Botanical Drug Development Guidance requires:

• controlled chemistry

• batch-to-batch consistency

• contaminant testing

• validated dosing

• stability verification

• clinical-trial evidence

Those expectations apply equally to:

cannabinoids
psychedelics
plant-derived neurological therapies
and any future botanical medicines entering federal healthcare systems

MMJ followed that pathway deliberately.

MMJ Chose the Pharmaceutical Route When Others Chose Retail Markets

While much of the cannabinoid sector pursued state-level commercialization strategies, MMJ International Holdings invested in a federal scientific pathway that included:

• FDA Investigational New Drug submission

• standardized cannabinoid soft-gel dosage development

• orphan-drug designation for Huntington's disease

• DEA analytical laboratory registration

• DEA bulk-manufacturing application for clinical supply

This approach reflects a long-term commitment to medical legitimacy rather than short-term market positioning.

A Warning to the Marijuana Industry on 4/20

According to MMJ leadership, the marijuana industry now faces the same crossroads the hemp industry encountered several years ago.

Without:

reproducibility
stability-validated dosage forms
controlled clinical trials
and federal compliance alignment

parts of the sector risk repeating the same regulatory cycle now reshaping hemp.

This is not speculation.

It is already happening.

Why the Lawsuit Matters

By supporting SAM's litigation challenging CMS's cannabinoid-access framework, MMJ International Holdings is reinforcing a simple national principle:

Federal reimbursement should follow science-not precede it.

The company's position is shared by clinicians, regulatory scholars, and constitutional policy experts participating in the legal challenge.

Together, they are asking a straightforward question:

Should taxpayer-funded healthcare programs introduce botanical therapies before those therapies meet FDA drug-development standards?

MMJ International Holdings believes the answer must remain no.

And on this 4/20, the company is reaffirming its commitment to ensuring that the future of cannabinoid medicine is defined not by loopholes-but by evidence.

Madison Hisey
MHisey@mmjih.com
203-231-8583

SOURCE: MMJ International Holdings