AS WRITTEN DEA MISSION:
Prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.
Duane Boise MMJ's CEO mentioned that "Thomas Prevoznik DEA Diversion DEPUTY ADMINISTRATOR 's adamant unwillingness to utilize his critical thinking faculties or examine his colossal stubbornness is captive to his unwarranted certainties which are holding him objectivity hostage". The DEA's continued obstruction risks not only legal defeat but also reputational harm as patients await life-saving therapies.
WASHINGTON, DC / ACCESS Newswire / March 22, 2025 / MMJ International Holdings (MMJ) is advancing cannabis-based therapies through the FDA's clinical trial process, which underscores the scientific validity of its research and highlights the DEA's contradictory posture under current law. Here's a clarification of the facts and their implications:
1. MMJ's FDA-Approved Clinical Trials
MMJ has initiated Investigational New Drug (IND) applicationswith the FDA for two cannabis-derived drug candidates:
Oral Gel Capsules for Huntington's Disease: MMJ is developing a THC/CBD-based gel capsule targeting motor and cognitive symptoms of Huntington's, a rare neurodegenerative disorder with no cure.
Oral Gel Capsules for Multiple Sclerosis (MS): A second candidate aims to address spasticity and pain in MS patients.
Status:
The FDA is in the process of approving MMJ's INDs, allowing the company to proceed with Phase 2 clinical trials.
These trials are designed to evaluate safety, dosing, and efficacy, with results potentially paving the way for a FDA pharmaceutical approval.
2. Significance of FDA Engagement
Scientific Validation: The FDA's acceptance of MMJ's INDs reflects its recognition of cannabis's therapeutic potential, contradicting the DEA's Schedule I claim that marijuana has "no accepted medical use."
Regulatory Milestone: FDA-approved trials are a prerequisite for bringing any drug to market, positioning MMJ's candidates as legitimate pharmaceutical developments.
3. The DEA's Contradictory Role
Despite MMJ's FDA progress, the DEA's capricious and arbitrary delays create barriers:
Research-Grade Cannabis Access: MMJ requires DEA approval to cultivate or import cannabis for its trials. The agency's sluggish processing of cultivation applications (mandated by the Medical Marijuana and Cannabidiol Research Expansion Act directly hinders MMJ's ability to proceed.
Catch-22: The DEA claims more research is needed to justify rescheduling, yet its delays obstruct the very research required.
4. Legal and Policy Implications
MMJ's FDA-backed trials strengthen its case against the DEA in two key ways:
Undermining Schedule I's "No Medical Use" Claim:
The FDA's involvement demonstrates federal acknowledgment of cannabis's medical potential, eroding the DEA's justification for Schedule I.
In August 2023, HHS recommended rescheduling marijuana to Schedule III based on similar scientific evidence.
APA Violations:
The DEA's delays in processing MMJ's cultivation application could be ruled "unreasonably delayed" agency action under the Administrative Procedure Act (APA), as seen in prior cases (Scottsdale Research Institute v. DEA, 2021).
5. Broader Context
Right to Try Act: Terminal patients have the legal right to access investigational drugs like MMJ's candidates, but DEA obstruction limits this access.
Executive Priorities: Both the Biden and Trump administrations endorsed expanding cannabis research, yet the DEA's inertia conflicts with these directives.
Moving forward
MMJ International Holdings' FDA-approved clinical trials are a powerful rebuttal to the DEA's Schedule I classification and bureaucratic delays. By advancing rigorous, federally sanctioned research, MMJ is:
Validating Cannabis's Medical Utility: Directly challenging the DEA's "no accepted medical use" designation.
Exposing Regulatory Hypocrisy: The DEA's failure to facilitate MMJ's research-despite Congress's mandates and FDA collaboration-highlights the DEA's systemic dysfunction.
Key Takeaway: MMJ's scientific progress, backed by the FDA, strengthens the legal and moral imperative for the DEA to comply with federal research laws and accelerate approval of MMJ's API Bulk Manufacturing Registration. The DEA's continued obstruction risks not only legal defeat but also reputational harm as patients await life-saving therapies.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
media@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
Related Documents:
- DEA MISSION
View the original press release on ACCESS Newswire
