In Spite of Trump's Marijuana Executive Order, FDA Hemp and Marijuana Botanical Guidance Will Prevail

FDA Law-Not Hemp, Marijuana Politics-Will Decide the Future of Cannabinoid Medicine.

Why "Full-Spectrum CBD" Narratives Are Collapsing-and Why MMJ International Holdings DRUG Development Strategy Was Right All Along" stated Duane Boise, CEO MMJ International Holdings.

WASHINGTON, DC / ACCESS Newswire / December 29, 2025 / While Congress has dismantled the intoxicating hemp market and federal agencies move to realign cannabis policy with medical science, a long-standing truth is finally unavoidable: there are no shortcuts to cannabinoid medicine development under U.S. law.

For nearly a decade, headlines, op-eds, and trade press promoted the idea that hemp-derived or "full-spectrum" CBD products could evolve into federally recognized medicine without complying with the Food, Drug, and Cosmetic Act. That theory has now collapsed-legally, scientifically, and legislatively.

What remains standing is the pathway that MMJ International Holdings chose in 2018: FDA-regulated botanical drug development under full DEA and FDA oversight.

The Era of Fake News Is Over-The Era of Statute Has Begun

Recent federal legislation and appropriations language have fundamentally altered the cannabinoid landscape:

• Hemp is now defined by total THC, not delta-9 alone

• Synthetic and semi-synthetic cannabinoids are banned

• Commercially viable "full-spectrum CBD" products are effectively eliminated

• A 12-month implementation clock is already running

No executive order, press release, or lobbying campaign can override enacted law. The consumer CBD category-marketed for years as "wellness"-is being legislated out of existence.

This is not politics. It is statutory enforcement.

Why the "Full-Spectrum CBD" Argument Was Always Legally Wrong

Under FDA law:

• CBD isolate is excluded from dietary supplements due to the Epidiolex precedent

• Full-spectrum CBD products fail FDA requirements for:

  • Batch-to-batch reproducibility

  • Defined Active Pharmaceutical Ingredient (API)

  • Chemistry, Manufacturing & Controls (CMC)

  • Stability and identity validation

There is no pathway for consumer CBD-hemp-derived or otherwise-to Medicare eligibility, insurance reimbursement, or federal medical recognition without completing the same botanical drug process required of every other medicine.

That process is long by design.

And MMJ completed it.

MMJ's Seven-Year Record: Process, Not Promotion

MMJ did not chase loopholes. It followed federal law.

Over seven years, MMJ completed what most of the industry avoided:

• FDA Orphan Drug Designation (Huntington's Disease)

• FDA IND-authorized clinical programs (Huntington's & Multiple Sclerosis)

• Defined botanical raw material and controlled chemovar

• Reproducible extraction and formulation

• Stability testing under ICH conditions

• Pharmaceutical GMP manufacturing

• Finished soft-gel capsule dosage forms

• DEA Schedule I research compliance

MMJ now has two fully developed drug candidates-MMJ-001 and MMJ-002-ready for FDA clinical advancement.

This is not theoretical science.
This is finished pharmaceutical work.

The Central Contradiction: FDA Success, DEA Paralysis

Despite meeting FDA standards, MMJ remains stalled by one unresolved step: DEA issuance of a bulk manufacturing registration.

That delay is no longer defensible.

The Department of Justice has formally conceded that the DEA's Administrative Law Judge system-used to stall MMJ's application-was unconstitutional. No lawful evidentiary hearing ever occurred. No valid final decision exists.

Meanwhile, federal courts are openly questioning years-long DEA inaction in parallel Schedule I cases, signaling that patience with administrative delay is wearing thin.

For patients with Huntington's Disease and Multiple Sclerosis, this is not a paperwork issue-it is the denial of timely access to potential therapies that have already cleared scientific scrutiny.

Two Futures Remain-Only One Is Medicine

The United States now has only two lawful cannabinoid futures:

FDA-Approved Botanical Drugs

• Prescription only

• Insurance eligible

• Federally lawful

• Scalable globally

This is MMJ's lane.

State-Legal Cannabis Markets

• Politically vulnerable

• Federally non-medical

• Excluded from insurance and federal programs

The former "third lane"-over-the-counter hemp CBD-does not survive under current law.

Why the Fake News Persists-and Why It Will End

Misinformation thrives in regulatory gray zones.
Those zones are closing.

When hemp products disappear from shelves, when banks refuse accounts, when insurers deny coverage, and when FDA approvals-not headlines-define medicine, the narratives will stop.

MMJ did the hard work while others wrote op-eds.

Congress has now confirmed: the shortcut era is over.

The Final Word

This is not about ideology, access rhetoric, or market nostalgia.
It is about federal drug law.

You cannot:

• Backdoor cannabis through hemp

• Bypass FDA science

• Claim medicine without trials

• Ignore botanical drug standards

MMJ followed the law when it was unpopular to do so.
That path is now the only path left.

BUCKLE UP!!

MMJ is represented by attorney Megan Sheehan.

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

SOURCE: MMJ International Holdings