American Marconi Wireless News - Feds Move To Axe Key DEA Marijuana Rules Clearing the Way for MMJ's FDA Compliant HD and MS Trials

"Trump's Deregulatory Mandate Is Finally Driving DEA Marijuana Policy Reform," states Duane Boise, CEO of MMJ BioPharma Cultivation.

Under President Trump's Executive Order 14192 ("Unleashing Prosperity Through Deregulation"), DOJ's notice eliminates several DEA proposals long cited as "in process".

WASHINGTON, DC / ACCESS Newswire / September 11, 2025 / In a sweeping deregulatory action, the U.S. Department of Justice today withdrew 16 pending rulemakings and 38 projected rules , including multiple Drug Enforcement Administration (DEA) initiatives touching medical marijuana research and manufacturing. For MMJ International Holdings, MMJ BioPharma Cultivation, and MMJ BioPharma Labs , the message is unmistakable: there are no more DEA procedural fig leaves to delay legitimate, FDA compliant science.

Under President Trump's Executive Order 14192 ("Unleashing Prosperity Through Deregulation") , DOJ's notice eliminates several DEA proposals long cited as "in process" most notably:

• Medical Marijuana and Cannabidiol Research Expansion: RIN 1117-AB83

• Amendments to DEA Hearing Regulations:RIN 1117-AB50

• Analytical Labs and Hemp: RIN 1117-AB77:

• Revision of Application for Manufacturing Quota: RIN 1117-AB86

For patients with Huntington's disease and Multiple Sclerosis, and for researchers awaiting a consistent federal framework, the withdrawal cuts both ways: it removes DEA's "rulemaking pending" excuse but it also signals no near term regulatory relief from the agency itself. Decisions must now be made under existing law.

"This DOJ notice proves what we've said for years: the DEA kept MMJ and other companies in limbo by pointing to phantom rulemakings. Those rules will be withdrawn. There are no more excuses," said Duane Boise , President & CEO of MMJ BioPharma. "Administrator Terry Cole can approve our registration today under the Controlled Substances Act and let science move forward. The longer he waits, the more patients suffer."

Seven Years, Two Orphan Drug Designations, and a DEA Maze

MMJ applied for DEA registration in 2018 to produce pharmaceutical-grade cannabis for FDA-authorized clinical trials targeting Huntington's disease and Multiple Sclerosis. The company secured FDA Orphan Drug Designations , built a DEA-spec facility , and passed inspections - yet remains stalled by administrative gamesmanship MMJ and allies describe as "unconstitutional, shifting, and retaliatory."

The withdrawal of RIN 1117-AB50 (DEA Hearing Regulations) is particularly salient following Supreme Court rulings (e.g., Axon and Jarkesy ) and DOJ's own admissions regarding ALJ insulation. With AB50 now off the agenda, the DEA cannot credibly claim imminent reform of its in-house tribunals - leaving the status quo both un-reformed and constitutionally suspect.

What DOJ's Withdrawal Means Now

1) Potentially No more "we're waiting on a rule."
DEA will lose the shield of pending rule-making. Applications like MMJ's must be decided under the current Controlled Substances Act and existing regulations - promptly and on the record.

2) Pathways narrow-so decisions matter more.
With RIN 1117-AB83 (the Medical Marijuana and CBD Research Expansion) withdrawn, the agency is not implementing the streamlined timelines, electronic processes, or supply safeguards many researchers hoped for. That places greater urgency on direct administrative decisions by DEA leadership and potential congressional or FDA oversight .

3) The pattern problem is bigger than MMJ.
MMJ is aware of other companies that suffered unfair treatment, misrepresentations, and apparent intentional obstruction - including registrants that never grew, or operations left idle and bankrupt while compliant science was sidelined. Today's withdrawal highlights years of mission drift and mismanagement .

"If cannabis is 'too dangerous' to research here, why is the VA seeking to import it from overseas?" Boise added. "American patients and veterans deserve U.S. made, FDA regulated medicine - not bureaucratic delay."

What Administrator Terry Cole Must Do

1. Approve MMJ's Registration Now.
   MMJ has met DEA and FDA standards. No new rule is required to act.

2. Publish Clear, Consistent Guidance Under Existing Law.
   End moving goalposts - particularly around "bona fide supply agreements" and quota justifications.

3. Clean Up the Hearing Process.
   In light of constitutional rulings and the abandonment of AB50, provide a transparent pathway that respects Article III oversight where appropriate.

4. Establish Timely, Public Decision Milestones.
   Even without AB83, Administrator Cole can impose internal deadlines that honor congressional intent to expedite research and ensure adequate supply .

Patients Can't Wait

• Huntington's disease is a progressive, fatal neurodegenerative disorder with no cure and limited symptomatic relief.

• Multiple Sclerosis causes irreversible nerve damage and long-term disability.

• FDA-compliant cannabis medicines - such as MMJ's soft-gel formulations - could address spasticity, pain, and neuroinflammation under rigorous clinical controls.

"This isn't about dispensaries or Big Weed - it's about real, prescription grade medicine," Boise said. "Congress passed the Research Expansion Act in 2022 for a reason. It's time for DEA to respect the law's intent and stop blocking clinical progress."

About MMJ BioPharma

MMJ BioPharma is developing FDA-regulated cannabinoid therapeutics for Huntington's disease (MMJ-002) and Multiple Sclerosis (MMJ-001) , each with FDA Orphan Drug Designation . MMJ's pharmaceutical soft-gel capsules are manufactured to cGMP standards. The company is pursuing a fully compliant U.S. pathway and maintains international partnerships for botanical supply and EU distribution .

MMJ is represented by attorney Megan Sheehan .

CONTACT:
Madison Hisey
[email protected]
203-231-8583

SOURCE: MMJ International Holdings

View the original press release on ACCESS Newswire

T.Ward--AMWN