Update DEA Hearing July 6: Harvard Expert Testifies State Dispensary Cannabis Does Not Meet Pharmaceutical Standards
DOJ Says the Controlled Substances Act Protects Legitimate Scientific Research. MMJ Says the Government Should Start Treating It That Way.
"The government cannot tell companies to spend years following the FDA's scientific pathway, then dismiss those same efforts as a 'pocketbook interest' when they seek equal treatment under the law. We didn't build a market-we built a medicine." stated Duane Boise, President & CEO, MMJ International Holdings
WASHINGTON, DC, July 6, 2026 (Newswire.com) - MMJ International Holdings, Inc. (MMJIH), together with MMJ BioPharma Cultivation, Inc. and MMJ BioPharma Labs, Inc., today responded to the Department of Justice's recent filing before the U.S. Court of Appeals for the District of Columbia Circuit while highlighting testimony presented Monday during the Drug Enforcement Administration's marijuana rescheduling hearing.
In opposing MMJ's appellate motion for a stay pending review, DOJ argued that the Controlled Substances Act was enacted to protect:
"...the American public and scientists and medical practitioners seeking legitimate access to controlled substances for research and patient treatment."
According to MMJ, that description mirrors the company's activities over the past eight years.
MMJ currently maintains:
two active FDA Investigational New Drug (IND) applications for Huntington's disease and multiple sclerosis;
an FDA Orphan Drug Designation;
a DEA Schedule I analytical laboratory registration through MMJ BioPharma Labs, Inc.;
Manufactured soft gel capsules
a DEA bulk manufacturing application filed in December 2018 through MMJ BioPharma Cultivation, Inc.; and
an ongoing federally regulated pharmaceutical development program pursuing multiple cannabinoid medicines under FDA oversight.
"DOJ describes the very entities Congress intended to protect under the Controlled Substances Act-scientists seeking legitimate access to controlled substances for research and patient treatment. That is precisely what MMJ has spent nearly eight years doing," said Duane Boise, President and CEO of MMJ International Holdings. "Yet in the same brief, DOJ characterizes our interests as merely a 'pocketbook interest.' We respectfully disagree. Our interest is developing federally approved medicines for patients suffering from Huntington's disease and multiple sclerosis."
DOJ's Standing Argument
DOJ argues that MMJ lacks competitor standing because it does not yet have an FDA approved product on the market.
MMJ responds that FDA regulated drug development necessarily requires manufacturing investigational medicines long before commercial approval.
According to MMJ, its investigational cannabinoid soft gelatin capsules have already been:
manufactured under pharmaceutical standards;
analytically characterized;
subjected to stability testing;
incorporated into FDA Investigational New Drug submissions; and
prepared for clinical development.
MMJ argues that the remaining obstacle is its pending DEA bulk manufacturing registration, which is required to cultivate pharmaceutical grade cannabis for FDA authorized clinical research and has remained pending since 2018.
"You cannot conduct FDA clinical trials without first manufacturing the investigational medicine,"Boise said. "Our pharmaceutical products exist. They have been manufactured, tested, characterized and submitted to FDA as part of our IND program. The issue is not whether MMJ has a product. The issue is that our DEA cultivation application has remained unresolved for nearly eight years while the government now argues that the resulting delay defeats our standing."
Harvard Expert Describes FDA Standards for Medicine
Monday's DEA administrative hearing also featured testimony from Dr. Bertha Madras, Professor of Psychobiology at Harvard Medical School, researcher at McLean Hospital, former White House drug policy advisor, former member of the World Health Organization's Expert Committee on Drug Dependence, and author of hundreds of scientific publications.
According to the hearing testimony, Dr. Madras explained the scientific principles underlying FDA botanical drug development, including:
defined chemical composition;
purity;
contaminant controls;
validated manufacturing;
batch-to-batch consistency;
fixed dosing;
stability testing; and
randomized, double-blind clinical trials demonstrating safety and efficacy.
According to MMJ's account of the hearing, Dr. Madras testified that products sold through state marijuana dispensaries generally are not developed under these pharmaceutical standards and expressed concerns regarding inconsistent product composition, contaminant controls, clinical evidence, and non-medical personnel making product recommendations to patients.
MMJ further notes that, according to its representatives present at the hearing, several objections raised during Dr. Madras' testimony were overruled by the Administrative Law Judge, allowing the testimony to proceed.
One Scientific Standard
MMJ says the juxtaposition between DOJ's appellate position and the testimony presented before DEA highlights the central issue raised in its litigation.
"Everything Dr. Madras described as necessary for a medicine-defined chemistry, purity, stability, batch-to-batch consistency, validated manufacturing and controlled clinical trials-is exactly what MMJ has spent years building under FDA oversight," Boise said. "We are not asking for special treatment. We are asking the federal government to apply one scientific standard to everyone. If the FDA pathway remains the gold standard for proving a medicine is safe and effective, then companies that followed that pathway should not be placed at a competitive disadvantage compared to companies that did not."
The Question Before the Court
MMJ maintains that the D.C. Circuit is being asked to resolve important questions concerning constitutional structure, administrative procedure, and equal application of federal law-not whether cannabinoid medicines should be developed.
"This case is about whether the government will consistently apply the scientific standards it has required for decades," Boise concluded. "Congress established the FDA and DEA pathways to protect patients through evidence, quality, and rigorous science. Those standards should be applied equally to every company seeking to develop cannabinoid medicines."
About MMJ
MMJ International Holdings, Inc. is a privately held pharmaceutical development company focused on cannabinoid-based investigational medicines for Huntington's disease and multiple sclerosis.
MMJ BioPharma Cultivation, Inc. has pursued a DEA bulk manufacturing registration since 2018 to cultivate pharmaceutical-grade cannabis for federally authorized research.
MMJ BioPharma Labs, Inc. operates a DEA Schedule I analytical laboratory supporting pharmaceutical cannabinoid research and FDA drug development.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
Source: MMJ International Holdings
