A cannabis research company in Rhode Island is calling on the federal court to force the federal government to approve the company’s applications to cultivate and import cannabis for medical research.
MMJ International, a company that hopes to develop and sell cannabis-based medications, claims that the United States Drug Enforcement Administration has been dragging its feet on an approval, missing the 90-day deadline for the agency to take any action on the requests.
“As of the filing of this petition and complaint, it has been over three years since the process commenced and the operation is currently at a standstill,” said the 19-page complaint that was filed April 8 in the U.S. District Court of Rhode Island. “Countless patients who have been affected by Multiple Sclerosis and Huntington’s Disease and are waiting on the potentially life-restoring treatments associated with the development of these pharmaceuticals.”
[Download MMJ International’s complaint.]
For years, the DEA has exclusively allowed the University of Mississippi to produce cannabis for research purposes, but the cultivation site has developed a reputation for generating low-quality cannabis compared to what is legally available in states that have legalized adult use.
“Amongst the research community it has been a long recognized fact that the Marihuana produced by the University of Mississippi was insufficient and of low quality for pharmaceutical research and development,” said the complaint.
The DEA updated its guidance on cannabis research in 2016, to allow more facilities to apply for approval to grow cannabis for research purposes. This shift, which was announced in the final year of Barack Obama’s presidency, was slowed when Donald Trump took office the following year.
More recently, the DEA announced on May 14, 2021 that it would prioritize application reviews for those prospective cultivators.
MMJ International applied for a permit to research cannabis, along with applications for cultivation and importing on Dec. 27, 2018, according to the complaint.
The DEA granted the permit to import cannabis from Canada, so that Catalant Pharma Solutions could process that material into a soft gel capsule to treat Multiple Sclerosis and Huntington’s Disease. MMJ International announced a year ago that it had completed production of those capsules, but the company continues to wait for DEA approval to start clinical trials with the capsules.
Meanwhile, MMJ International has also been awaiting approval for bulk cultivation of its proprietary cannabis strains.
“MMJ Cultivation (an MMJ International subsidiary) applied for a DEA bulk manufacturing registration specifically because they cannot import the specific Marihuana plant strains/genetics that are required for the cultivation and development of the botanical pharmaceuticals according to the Botanical Drug Development Guidance published by the FDA in 2016,” said the complaint. “As such, MMJ cannot move forward with API development because they are still awaiting approval from the DEA on their Bulk Manufacturing registration and cultivation approval”
Federal inspectors visited the company’s planned cultivation facility on Oct. 24, 2021. By the end of January, 2022 the DEA had granted MMJ Labs with a permit to conduct their research, but the company remains without an approved source of cannabis with which to conduct that research.
As of Jan. 22, the DEA failed to meet the 90-day deadline for a determination following a final inspection.
“Not surprisingly, that date has also come and gone and DEA appears to be no closer to a final determination. As such, it is MMJ’s contention that something must be done to escalate this matter, hence this Petition and Complaint.”
In terms of legal precedent, this case would not necessarily change the national landscape, especially since the U.S. legislature is currently working on a bi-partisan cannabis research bill that would allow DEA-approved labs to obtain their research cannabis from dispensaries in states where cannabis is legal.
The defendants include Attorney General Merrick Garland, the United States Drug Enforcement Administration and several members of DEA leadership. A spokesperson for the DEA did not respond to a request for comment by publication.
