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Cannabis Campaigners' Guide News Database result:
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US: President Trump Expected to Remove Cannabis Barriers to MMJ Research and Drug Development
Access Newswire Tuesday 25 Nov 2025 And while some biotechnology firms promote preclinical delivery concepts or experimental formulations, MMJ has achieved what no other U.S. company has: A completed, fully manufactured pharmaceutical cannabinoid drug ready for human trials. MMJ's Soft-Gel Capsule: The First Fully Developed Pharmaceutical Cannabinoid Drug Ready for FDA Trials MMJ's investigational product-a natural, full-spectrum cannabis extract formulated in pharmaceutical-grade soft-gel capsules-has completed every scientific and manufacturing requirement necessary for FDA clinical trials. Completed FDA-Required Scientific Milestones Final dosage-form soft-gel capsules manufactured Full identity, purity, potency, and chromatographic characterization Stability testing completed under ICH guidelines Standardized, reproducible botanical API Pharmaceutical GMP manufacturing completed FDA IND programs for Huntington's Disease and Multiple Sclerosis FDA Orphan Drug Designation for Huntington's Disease DEA Schedule I laboratory analytical work completed (MMJ BioPharma Labs) Unlike nutraceuticals, hemp tinctures, powders, or experimental "platform technologies," MMJ's capsule is a true pharmaceutical drug-with completed Chemistry, Manufacturing & Controls (CMC) meeting FDA expectations. The only outstanding requirement is DEA's issuance of MMJ's bulk manufacturer registration to legally supply the drug for clinical trials. President Trump To Remove DEA Final Barrier - Not the Science MMJ's manufacturing application has been pending since December 2018. Federal law requires timely resolution: 21 C.F.R. § 1316.67 - DEA must issue a final order "as soon as practicable." 5 U.S.C. § 555(b) - Agencies must conclude matters "within a reasonable time." Yet, nearly seven years later, no final decision exists. Compounding this, the U.S. Department of Justice has formally conceded that DEA's ALJ tribunal system-formerly used for such cases-was unconstitutional under Article II. As a result: **No lawful evidentiary hearing ever occurred in MMJ's case. No valid ALJ recommendation exists. And no constitutionally compliant final decision has been issued.** Meanwhile, the D.C. Circuit's criticism of DEA's six-year delay in the Iowaska Church case signals judiciary impatience with DEA's repeated inaction-bolstering MMJ's mandamus remedies should delays persist. MMJ Is Years Ahead of Emerging Platforms and Preclinical Entrants As other companies announce new powder systems, emulsion technologies, or theoretical absorption-enhancement platforms, none possess: FDA IND authorization A completed dosage-form drug DEA compliance GMP manufacturing Botanical API validation Long-term stability data Pharmaceutical-grade reproducibility By contrast: MMJ's drug is finished, validated, compliant, and ready for clinical use. Engineered for neurological diseases, MMJ's soft-gel capsule provides: precise dose control stable plasma levels controlled release characteristics patient-friendly oral delivery full-spectrum synergy for CNS therapeutic targets This is exactly what FDA expects from a cannabinoid therapeutic. Others are just beginning where MMJ already stands. A Perfect Regulatory Moment: Hemp Shutdown + Trump Directive + FDA Oversight Federal policy is consolidating around pharmaceutical-grade cannabinoids: Congress has now: Redefined hemp to include total THC Banned synthetic and semi-synthetic cannabinoids Imposed a 4 mg total-THC limit per container Eliminated intoxicating hemp beverages and THCA loopholes President Trump's upcoming cannabinoid directive is expected to prioritize: FDA-regulated cannabinoid drug development DEA-licensed manufacturing Elimination of gray-market THC products Support for federally legal research Protection of patients through pharmaceutical pathways MMJ is already built for this new regulatory era. The rest of the industry must now catch up. CEO Duane Boise: "We Built Real Medicine-The Nation Is Now Catching Up." "MMJ stayed in the federally compliant lane while the rest of the industry ran toward loopholes," said Duane Boise, President & CEO of MMJ International Holdings. "We manufactured a real cannabinoid pharmaceutical-stabilized, standardized, analytically verified, and ready for FDA trials. The only thing missing is the DEA's final signature." Boise continued: The collapse of the hemp derived THC market and the rise of strict federal oversight validate what we built over the last decade. With President Trump's cannabinoid directive approaching, we expect MMJ to be the first company positioned to advance a federally legal cannabis drug into human clinical trials." About MMJ International Holdings, Inc. MMJ International Holdings, Inc. is a U.S. based biopharmaceutical company developing DEA licensed, FDA regulated, plant derived cannabinoid medicines for neurodegenerative diseases. Through its subsidiaries-MMJ BioPharma Cultivation and MMJ BioPharma Labs-MMJ advances proprietary soft-gel cannabinoid formulations for Huntington's Disease and Multiple Sclerosis within the FDA's botanical drug framework. MMJ is represented by Megan E. Sheehan, Esq., Sheehan & Associates Law. Madison Hisey MHisey@mmjih.com 203-231-85832 SOURCE: MMJ International Holding https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/president-trump-expected-to-remove-cannabis-barriers-to-mmj-research-1112125?fbclid=IwY2xjawOWcrBleHRuA2FlbQIxMABicmlkETFsR2d0Q1Bwa29BeUtyeTROc3J0YwZhcHBfaWQQMjIyMDM5MTc4ODIwMDg5MgABHuRKeyyOnHQfhLqJoVNCC8XANym_S4f6koJ67zehiV2U1bTPQcXoi3D9JYqV_aem_l20RYOo67YPDLQMRIe4r6g
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