MMJ International Holdings Files Formal Challenge To DEA Marijuana Rescheduling As Constitutional, Treaty, And Pharmaceutical Questions Collide

"After Eight Years, Millions invested, FDA INDs, Orphan Drug Designation, DEA Inspections, and a Completed Federal Investigation, MMJ Demands the Government Explain Why Companies That Followed Federal Law Were Left Behind" asked Duane Boise, CEO MMJ International Holdings.

WASHINGTON, D.C. / ACCESS Newswire / May 29, 2026 / MMJ International Holdings, ("MMJ"), together with its subsidiaries MMJ BioPharma Cultivation, and MMJ BioPharma Labs, announced today that it has formally entered the Drug Enforcement Administration's June 29, 2026 marijuana rescheduling hearing with a sweeping legal challenge raising constitutional, treaty, statutory, and pharmaceutical-regulatory objections to the federal government's proposed transfer of marijuana from Schedule I to Schedule III under the Controlled Substances Act.

The filing, submitted through counsel pursuant to 21 U.S.C. § 811(a), formally establishes MMJ as an "interested person" in the proceeding while preserving the company's rights to judicial review and future federal litigation under 21 U.S.C. § 877 and the Administrative Procedure Act.

But the filing does far more than reserve procedural rights.

It forces the federal government to confront a question Washington has spent years avoiding:

What happens to the federally compliant pharmaceutical companies that followed every rule the government said was required?

Eight Years of Compliance. Still Waiting.

MMJ's position is not theoretical.

Since 2018, MMJ has pursued the federal pharmaceutical pathway for cannabinoid medicine through:

• FDA Investigational New Drug ("IND") submissions;

• FDA Orphan Drug Designation for Huntington's disease;

• DEA registration proceedings;

• pharmaceutical formulation and stability testing;

• DEA-inspected laboratory infrastructure;

• analytical characterization and quality-control programs;

• and development of cannabinoid therapeutics targeting Huntington's disease and Multiple Sclerosis.

In December 2018, MMJ BioPharma Cultivation submitted its application to the DEA for registration as a federally authorized bulk manufacturer of marijuana active pharmaceutical ingredient for FDA-authorized clinical trials.

The DEA commenced its mandatory Section 303 pre-registration investigation in June 2021 and concluded the investigation with a final on-site inspection in October 2021.

According to MMJ, all DEA security requirements, diversion controls, and regulatory conditions were fully satisfied evidenced by the DEA issuing a schedule 1 analytical lab registration.

The application remains pending to this day.

Over that same period:

• state-market marijuana businesses expanded nationwide;

• hemp-derived cannabinoid markets exploded commercially;

• and the federal government increasingly normalized cannabinoid commerce outside the FDA pharmaceutical pathway MMJ spent years pursuing.

"We followed the exact federal framework the government told cannabinoid developers was required," said Duane Boise, CEO of MMJ International Holdings. "FDA INDs. Orphan Drug Designation. DEA registrations. Pharmaceutical controls. DEA inspections. Eight years later, the companies that complied with federal law are still waiting while the government increasingly rewards entities operating outside that same framework."

MMJ Raises Six Major Legal Objections

MMJ's filing raises six major objections and issues for the DEA hearing, including:

Treaty Compliance and International Obligations

MMJ challenges whether the proposed Schedule III framework adequately satisfies the United States' obligations under the 1961 Single Convention on Narcotic Drugs while simultaneously permitting state-market expansion outside the federal registration system.

Disposition of Pending DEA Applications

MMJ demands clarification regarding the fate of pending DEA marijuana manufacturer applications submitted under the current Schedule I framework, including MMJ's own application pending since December 2018.

Competitive Injury and Administrative Fairness

MMJ argues the proposed framework risks creating a two-tier regulatory system that advantages companies that bypassed federal pharmaceutical requirements while disadvantaging federally compliant developers who spent years satisfying those same standards.

Post-Loper Bright Statutory Interpretation

Citing the United States Supreme Court's decision in Loper Bright Enterprises v. Raimondo, MMJ objects to any assertion that DEA is entitled to automatic judicial deference regarding statutory interpretation, scheduling criteria, or "currently accepted medical use."

Article II Constitutional Objections

MMJ further asserts that DEA administrative proceedings continue to suffer from serious constitutional defects under Article II of the United States Constitution, citing:

• Lucia v. SEC;

• Axon Enterprise v. FTC;

• and SEC v. Jarkesy.

Reservation of Federal Court Rights

MMJ expressly reserves all rights to pursue declaratory relief, injunctive relief, and judicial review in federal court regardless of the outcome of the DEA proceeding.

"This Is Not Anti-Marijuana. It Is Pro-Science."

MMJ emphasized that its participation in the hearing should not be misconstrued as opposition to cannabinoid medicine.

The company has invested millions in advancing cannabinoid therapeutics through the FDA's botanical drug development framework because it believes cannabinoids may possess significant therapeutic value for serious neurological diseases.

Instead, MMJ argues the federal government cannot simultaneously:

• demand pharmaceutical rigor from federally compliant developers;

• delay compliant applicants for years;

• and increasingly normalize non-FDA pathways for the broader market.

"This is not anti-cannabis," Boise stated. "This is about scientific standards, constitutional process, equal treatment, and whether the federal government still intends to operate under a coherent regulatory framework."

The June 29 Hearing May Become Much Larger Than Marijuana

MMJ stated that the DEA hearing now arrives amid:

• escalating constitutional scrutiny of federal agencies;

• ongoing litigation involving state attorneys general;

• active CMS-related cannabinoid litigation;

• and growing judicial skepticism toward administrative deference following recent Supreme Court rulings.

According to MMJ, the proceeding is no longer simply about marijuana rescheduling.

It is increasingly becoming a test of:

• administrative fairness,

• constitutional limits on agency power,

• treaty compliance,

• and the treatment of companies that pursued the federal pharmaceutical pathway in good faith.

About MMJ International Holdings

MMJ International Holdings, Inc. is a pharmaceutical development company focused on cannabinoid-based medicines for Huntington's disease and Multiple Sclerosis. MMJ maintains FDA Investigational New Drug applications, FDA Orphan Drug Designation, a DEA Schedule I analytical laboratory registration, and ongoing cannabinoid pharmaceutical development programs pursuing the federal FDA botanical drug pathway.

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

SOURCE: MMJ International Holdings