"The federal hemp crackdown has created long overdue pharmaceutical clarity. MMJ is now the company advancing a fully compliant cannabinoid drug program under FDA and DEA oversight," noted Duane Boise, CEO MMJ International Holdings. "Drug development allows for no shortcuts. It demands consistency, validation, and adherence to federal law."

WASHINGTON, DC / ACCESS Newswire / November 16, 2025 / As Congress moves decisively to end the era of intoxicating hemp products and synthetic cannabinoids, a new chapter is opening for federally legal cannabis based medicines. With regulatory clarity emerging from the FDA, DEA, and bipartisan state authorities, MMJ International Holdings, Inc. now stands as the U.S. company fully positioned within the federal pharmaceutical pathway for cannabis drug development.

For a decade, MMJ pursued the rigorous FDA and DEA route-while the rest of the market chased loopholes, synthetics, and state-level workarounds. Today, with the hemp market collapsing under federal action, MMJ's no short cut strategy has become the blueprint for the industry's future.

I. Federal Hemp Shutdown Reshapes the Cannabinoid Landscape

In the wake of a sweeping federal appropriations bill, Congress is redefining hemp to include total THC, banning synthetic and semi-synthetic cannabinoids such as Delta-8, THC-O, HHC, THCP, and imposing a 4 mg total THC limit per container.

The result:

• Intoxicating hemp beverages become federally illegal.

• THC gummies, vapes, and "hemp-derived THC" products are eliminated.

• THCA "conversion" flower is reclassified as illegal marijuana.

• Synthetic cannabinoid manufacturers lose federal protection.

Simultaneously, state and federal law enforcement agencies-including the Hillsborough County, Tampa, Florida Sheriff's Office-have begun sweeping raids on convenience stores selling synthetic cannabinoids, THC gummies, and related contraband.

The message is clear: the gray market is over.

II. MMJ Clarifies Its FDA Orphan Drug Designation: Huntington's Disease

MMJ confirmed that its investigational cannabinoid therapeutic has been granted FDA Orphan Drug Designation (ODD) for Huntington's Disease, providing:

• Seven years of marketing exclusivity upon approval

• Tax credits for clinical development

• Waived FDA user fees

• Enhanced regulatory support from the Agency

MMJ is also pursuing FDA IND development for Multiple Sclerosis, though MS does not currently hold orphan designation.

III. Nutraceutical vs. Pharmaceutical: Why Federal Law Favors MMJ's Path

As the federal government dismantles the hemp derived THC industry, MMJ emphasized the critical distinction between nutraceutical supplements and FDA regulated pharmaceutical drugs.

Nutraceuticals

Under DSHEA, nutraceuticals:

• Cannot claim to treat or cure disease

• Do not require clinical trials

• Do not undergo FDA review

• Use food-grade-not pharmaceutical-manufacturing

• Cannot contain Schedule I cannabinoids

• Cannot contain FDA-defined APIs

They are supplements, not medicines.

Pharmaceutical Drugs

Under FDA drug law, pharmaceuticals must:

• Contain a validated Active Pharmaceutical Ingredient (API)

• Demonstrate safety, efficacy, and PK/PD through Phase I-III trials

• Meet pharmaceutical-grade GMP

• Pass FDA's IND → NDA approvals

• Comply with DEA scheduling requirements

Most importantly:

FDA-approved drugs may contain botanical, full-spectrum cannabis extracts if the API is consistent, reproducible, and validated.

This is precisely what MMJ has accomplished.

IV. MMJ's Botanical Drug Platform: The Only Federally Legal Route Forward

MMJ's pharmaceutical program is built on:

• A natural, full-spectrum cannabis API

• Soft-gel capsule formulations that are standardized and reproducible

• DEA Schedule I licensure for analytical and research operations

• FDA-reviewed IND programs for Huntington's Disease and Multiple Sclerosis

• Pharmaceutical GMP manufacturing standards

This botanical drug development model mirrors the FDA pathway used for Epidiolex-but with an important distinction:

Unlike Epidiolex (a CBD isolate), MMJ's investigational drug uses a natural, full-spectrum plant extract standardized as a pharmaceutical grade API.

This gives MMJ a unique scientific and regulatory footprint unavailable to nutraceutical firms, hemp processors, or state cannabis companies.

V. Industry Collapse Validates MMJ's Strategy

State licensed marijuana companies now face extreme legal vulnerability, illustrated by Curaleaf's recent appellate filing arguing that its own cannabis contract is "per se unenforceable" because "federal law makes marijuana illegal."

Simultaneously, Congress, the FDA, and law enforcement are eliminating the hemp loophole altogether.

This leaves MMJ as the U.S. cannabinoid company that has remained fully inside federal law since day one.

VI. The Federal Path Forward

MMJ International Holdings calls on the Administration and DEA leadership to expedite long-delayed pharmaceutical cannabis applications and align federal policy with scientific standards by:

1. Approving MMJ BioPharma Cultivation's registration under the 60-day statutory mandate.

2. Establishing a DEA Medical Research Division to separate pharmaceutical licensing from criminal enforcement priorities.

"The hemp shutdown has created clarity, not chaos," said Duane Boise, President & CEO of MMJ International Holdings. "Federal law finally matches what we have followed for a decade: only pharmaceutical science-not synthetics, loopholes, or shortcuts-can define cannabis medicine."

About MMJ International Holdings

MMJ International Holdings, Inc. is a U.S.-based biopharmaceutical company developing DEA licensed, pharmaceutical grade, plant derived cannabinoid medicines for FDA approval. Its subsidiaries-MMJ BioPharma Cultivation and MMJ BioPharma Labs-advance proprietary soft-gel formulations targeting Huntington's Disease and Multiple Sclerosis under FDA IND oversight.

MMJ is represented by attorney Megan Sheehan.

CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-85832

SOURCE: MMJ International Holdings