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ACCESSWIRE
MMJ PREPARES DEA MARIJUANA LAWSUIT - DEA VIOLATED PRESIDENTIAL RESEARCH
EXPANSION ACT AND CONGRESSIONAL MANDATES
Read full article
MMJ International Holdings
Wed, August 2, 2023 at 4:00 AM EDT·3 min read
FDA Sanctioned Marijuana Clinical Trials Researcher's Suit Moves To DC Appellate
Court, The DEA is the Epitome Of Ineptitude
WESTERLY, RI / ACCESSWIRE / August 2 2023 / Megan Sheehan, attorney for MMJ
International Holdings, is preparing to file a writ of mandamus in the DC
appellate court as the DEA has not responded to a 7 day demand letter for action
on MMJ's 5 year old application to grow pharmaceutical marijuana to support its
research. MMJ has two FDA investigational drug applications (IND's) to research
its THC-CBD developed soft gelatin capsule in clinical trials for Multiple
Sclerosis and Huntington's disease.
https://storage.googleapis.com/accesswire/media/771672/Image-6-8-23-at-902-PM.jpeg
Megan Sheehan referenced several federal laws in her warning letter to the DEA.
One of the laws she cited was the Controlled Substances Act (CSA), a federal law
that regulates the manufacture, distribution, and possession of certain
substances, including marijuana. Sheehan also referenced the Marijuana and
Cannabidiol Research Expansion Act, which was signed into law in December 2022.
The law directs the DEA, National Institutes of Health (NIH) and other federal
agencies to support research into the potential medical benefits and risks of
cannabis and its derivatives, and includes provisions aimed at removing barriers
to such research.
We will get to it when we get to it? IS THE DEA A ROGUE AGENCY?
In her warning letter, Sheehan argued that the DEA's failure to process MMJ's
bulk manufacturing application for almost five years was a violation of both the
CSA (Controlled Substance Act) and the Marijuana and Cannabidiol Research
Expansion Act (MCREA). She also argued that the DEA's attitude toward the
application, which was reported that they "would get to it when they get to it",
was in violation of DEA policies and procedures.
Duane Boise the companies President has been working to speed up the application
process and had Sheehan file a motion in federal court last year against the
DEA, asking the court to order the agency to process the application. In her
decision Federal Court Judge McElroy said it's "not entirely clear" that the
First Circuit has adopted a ruling from the D.C. Circuit that held that the
court of appeals' exclusive jurisdiction over final decisions extends to cases
concerning delayed determinations and dismissed the suit. But the judge noted
that case law indicates that a remedy exists in the courts of appeals for MMJ's
case, which is reason enough to dismiss without prejudice as the Administrative
Procedure Act and Mandamus Act, thus supporting MMJ's argument.
Story continues
In general, the consequences for violating federal laws and regulations can
include fines, penalties, and other legal sanctions. In this case, if the DEA is
found to have violated the CSA or the Marijuana and Cannabidiol Research
Expansion Act, it is possible that the agency could face legal consequences such
as fines or court-ordered injunctions. It is also possible that the court could
order the DEA to process MMJ's bulk manufacturing application and take other
actions to address the agency's failure to comply with federal law. Boise has
also called on lawmakers to take action to address the DEA's flagrant disregard
of the law.
MMJ THC- CBD DRUG Approval?
MMJ, having completed the manufacturing of its THC ,CBD soft gel capsule is
readying for a FDA anticipated approval to utilize the drug in human clinical
trials. MMJ's clinical trials will provide patient dosing, safety, and efficacy
data to the FDA to prove that cannabis can treat neurological disorders. MMJ
anticipates FDA approval thus making it the first THC-CBD soft gelatin capsule
approved for human consumption in clinical trials.
MMJ is represented by Attorney Megan Sheehan of Rhode Island.
For more information on MMJ, please visit www.mmjih.com.
Contact: MMJ
Madison Hisey
Email: mhisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View source version on accesswire.com:
https://www.accesswire.com/771672/MMJ-Prepares-DEA-Marijuana-Lawsuit--DEA-Violated-Presidential-Research-Expansion-Act-and-Congressional-Mandates
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