Former DEA Administrator Sounds Alarm on Drug Safety as Federal Marijuana Rescheduling Faces Critical November 5 Deadline
Former DEA Administrator Sounds Alarm on Drug Safety as Federal Marijuana Rescheduling Faces Critical November 5 Deadline
MMJ's CMS Beneficiary Incentive Case Is on Appeal Before the U.S. Court of Appeals for the D.C. Circuit
WASHINGTON, D.C. / ACCESS Newswire / November 4, 2026 / MMJ International Holdings, Inc. ("MMJ"), a pharmaceutical cannabinoid developer pursuing FDA regulated investigational medicines, today highlighted a growing convergence of concerns over federal cannabinoid policy as former Drug Enforcement Administration Administrator Asa Hutchinson warned of the public-health dangers associated with inadequately regulated intoxicating products.
Hutchinson's November 4 commentary in The Washington Times, titled Reagan's Drug Policy Still Matters, comes just one day before a critical November 5 deadline for supplemental reply briefs in the DEA's marijuana rescheduling proceedings before Chief Administrative Law Judge Derek C. Julius.
The developments follow an October 28 letter from the American Medical Association (AMA) urging rigorous FDA scientific standards for botanical drug products and a September 23 Government Accountability Office (GAO) report identifying deficiencies in federal drug-scheduling procedures.
MMJ believes these developments raise a fundamental question: How can the federal government expand recognition of cannabinoid products as medical products without consistently addressing scientific evidence, pharmaceutical quality, patient safety and applicable federal law?
FORMER DEA ADMINISTRATOR ASA HUTCHINSON: LIVES REMAIN AT RISK
In his November 4 commentary, Hutchinson, who previously served as DEA Administrator, governor of Arkansas and a federal prosecutor, warned that federal policy has allowed a commercial market for intoxicating hemp-derived products to develop without adequate safeguards.
Hutchinson described concerns involving chemically converted cannabinoids, inconsistent age verification, product contamination, misleading consumer perceptions of government oversight and the risks of organized criminal activity.
His commentary specifically addressed intoxicating hemp products, including delta-8 and other cannabinoid derivatives, rather than the separate legal framework governing state medical marijuana.
Nevertheless, MMJ believes his warning illustrates a broader principle: The commercialization of intoxicating cannabinoid products should not outpace the development of appropriate scientific and public-health protections.
Hutchinson's commentary does not address MMJ's litigation or endorse the company's legal positions.
AMERICAN MEDICAL ASSOCIATION CALLS FOR SCIENTIFIC ACCOUNTABILITY
On October 28, 2026, the American Medical Association submitted a letter to FDA Deputy Commissioner Grace R. Graham concerning the agency's initiative, Advancing Development of Botanical Drug Products.
The AMA urged FDA to preserve rigorous scientific standards when evaluating botanical products, including cannabis.
MMJ believes the AMA's position reinforces the importance of distinguishing FDA-reviewed investigational medicines from cannabinoid products marketed under other regulatory frameworks.
State authorization to sell marijuana for medical purposes does not, by itself, establish FDA approval of a drug's safety or effectiveness.
For patients suffering from serious neurological diseases, MMJ maintains that reliable dosing, chemical characterization, product consistency and scientifically supported treatment claims are essential.
NOVEMBER 5: DEA RESCHEDULING HEARING REACHES CRITICAL BRIEFING DEADLINE
On October 22, DEA Chief Administrative Law Judge Derek C. Julius admitted the September 23 GAO report into the administrative record of the marijuana rescheduling proceeding.
Although Julius denied requests to reopen the hearing for additional discovery and testimony, he authorized supplemental briefing addressing the significance of GAO's findings.
Initial supplemental briefs were due October 29. Optional reply briefs are due Thursday, November 5, 2026.
The judge directed the parties to address two central questions:
- What evidentiary weight, if any, should be assigned to the GAO report?
- Are the deficiencies in written drug-scheduling procedures identified by GAO sufficiently substantial to undermine the broader scheduling process or specifically affect the pending marijuana rescheduling proposal?
The DEA has argued that the GAO report should receive no weight in determining whether marijuana should be transferred to Schedule III.
Opponents contend that the documented deficiencies raise serious questions about the reliability and consistency of the government's scheduling methodology.
The administrative stay is scheduled to expire when the supplemental briefing period closes on November 5. Julius has not announced a deadline for issuing his recommendation.
His recommendation will not itself constitute a final agency decision.
GAO REPORT EXPOSES GAPS IN FEDERAL DRUG-SCHEDULING PROCEDURES
GAO Report GAO-26-108623, issued September 23, 2026, identified shortcomings in the written policies and procedures used by DEA and FDA in controlled-substance scheduling evaluations.
The report raised concerns regarding the documentation of agency responsibilities, evaluation procedures and standards for assessing potential abuse.
The findings have become part of the administrative record in the marijuana rescheduling proceeding.
MMJ believes the report is especially relevant to questions concerning the government's scientific justification for marijuana scheduling decisions and the need for consistent, reproducible evaluation methods.
GAO did not conclude that the marijuana rescheduling proposal was unlawful. Whether its findings undermine the specific rescheduling proposal remains contested.
MMJ CEO: "THE GOVERNMENT CANNOT HAVE TWO STANDARDS FOR MEDICINE"
"The former Administrator of the DEA is warning about the consequences of inadequately regulated intoxicating products. The American Medical Association is calling for rigorous scientific standards. And the Government Accountability Office has identified deficiencies in the federal government's own drug-scheduling procedures," said Duane Boise, President and Chief Executive Officer of MMJ International Holdings.
"At what point does the federal government recognize that the issue is not whether marijuana has medical potential, but whether products presented as medicine are being evaluated under credible and consistent scientific standards?"
"MMJ has invested years in FDA-regulated pharmaceutical development, analytical testing, standardized formulations and clinical research."
"The government cannot have two standards for medicine-one for pharmaceutical developers following the FDA pathway and another for commercial operators whose products have not undergone FDA drug approval."
"Patients deserve science, not political shortcuts. Investors deserve regulatory consistency. And federal agencies must be accountable for the decisions they make."
MMJ'S CMS CHALLENGE IS NOW ON APPEAL IN THE D.C. CIRCUIT
MMJ International Holdings is also pursuing appellate review of its challenge to the Centers for Medicare & Medicaid Services' Beneficiary Engagement Incentive initiative.
The original action was filed in the U.S. District Court for the District of Columbia as Case No. 1:26-cv-01081.
Following the district court's May 22, 2026 dismissal on standing grounds, MMJ filed an appeal on June 5, 2026.
The case is now pending before the U.S. Court of Appeals for the District of Columbia Circuit, Case No. 26-5205.
MMJ challenges the federal policy framework permitting certain Medicare-affiliated organizations to facilitate access to qualifying hemp-derived products that have not received FDA drug approval.
The company maintains that the program raises important questions concerning federal healthcare policy, patient safety, physician responsibility and the competitive consequences for companies pursuing FDA-regulated pharmaceutical development.
The appeal concerns the district court's standing determination as well as the company's effort to obtain judicial review of its claims. No appellate ruling on the merits has been announced.
MMJ believes Hutchinson's warning about inadequately regulated intoxicating products underscores the importance of examining the safeguards governing cannabinoid access in federal healthcare initiatives.
However, Hutchinson's commentary does not address the CMS program itself.
MMJ ALSO CHALLENGES FEDERAL MARIJUANA RESCHEDULING
Separately, MMJ International Holdings and its affiliated companies are petitioners in consolidated proceedings before the U.S. Court of Appeals for the D.C. Circuit challenging the Attorney General's April 28, 2026 marijuana rescheduling order.
MMJ's petition, Case No. 26-1130, is consolidated with related challenges to the federal order.
The litigation raises questions concerning the Controlled Substances Act, federal administrative-law requirements, international treaty obligations and the legal framework for expedited DEA registration of state-licensed medical marijuana businesses.
The D.C. Circuit litigation is separate from the administrative hearing before Judge Julius.
MMJ maintains that the federal government must reconcile the treatment of state-authorized medical marijuana with the legal and scientific requirements governing controlled substances and pharmaceutical development.
MMJ RESPONDS DIRECTLY TO FDA BOTANICAL DRUG INITIATIVE
MMJ has also prepared a formal response to FDA Docket No. FDA-2026-N-9550, Advancing Development of Botanical Drug Products.
Through counsel Connor W. Mighell, the company has addressed the FDA's examination of botanical drug development based on MMJ's experience pursuing investigational cannabinoid medicines.
The submission requests confidential treatment of company-specific technical and regulatory information, including manufacturing, analytical testing, stability and regulatory correspondence.
MMJ believes that standardized chemical composition, consistent product quality and reproducible pharmaceutical development are essential to advancing cannabinoid-based treatments.
MMJ'S FDA INVESTIGATIONAL DRUG PROGRAMS
MMJ International Holdings has pursued FDA-regulated development programs for serious neurological diseases, including:
Huntington's Disease - FDA IND 137754
Multiple Sclerosis - FDA IND 140712
The company has also received FDA orphan drug designation for its cannabinoid development program targeting Huntington's disease.
MMJ previously completed the manufacture of approximately 50,000 standardized pharmaceutical soft-gel capsules containing cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC).
The products remain investigational and have not received FDA approval for commercial marketing.
MMJ BioPharma Cultivation, Inc. also continues to pursue federal bulk-manufacturer registration following DEA's October 2026 withdrawal of its Order to Show Cause and termination of the contested administrative proceeding.
THE QUESTION FACING FEDERAL REGULATORS
As the November 5 rescheduling briefing deadline approaches, MMJ believes federal policymakers must confront several unresolved questions:
- What scientific standards should govern cannabinoid products represented as medicines?
- How should federal regulators account for differences in chemical composition, potency and reproducibility?
- What effect should GAO's documented procedural deficiencies have on the marijuana scheduling analysis?
- How should federal registration and healthcare policies distinguish controlled-substance authorization from FDA drug approval?
- What safeguards are necessary to protect patients while permitting legitimate pharmaceutical research and development?
"Former DEA Administrator Hutchinson is warning about public safety. The AMA is calling for scientific standards. GAO is calling for better procedures," Boise concluded.
"MMJ is asking a simple question: Will the federal government follow the science and apply the law consistently?"
"Medical marijuana policy must ultimately be judged by the evidence, the quality of the products and the protections afforded to American patients."
ABOUT MMJ INTERNATIONAL HOLDINGS, INC.
MMJ International Holdings, Inc. is a biopharmaceutical development company focused on cannabinoid-based investigational medicines for serious neurological diseases, including Huntington's disease and multiple sclerosis.
Through its affiliated companies, MMJ BioPharma Cultivation, Inc. and MMJ BioPharma Labs, Inc., the company has pursued federal controlled-substance manufacturing and analytical research authorizations to support pharmaceutical development.
MMJ is committed to advancing standardized cannabinoid medicines through FDA-regulated scientific and pharmaceutical development pathways.
CONTACT:
Madison Hisey
[email protected]
203-231-8583
SOURCES
The Washington Times - November 4, 2026
Asa Hutchinson, Reagan's Drug Policy Still Matters
https://www.washingtontimes.com/news/2026/nov/4/reagans-drug-policy-still-matters/
American Medical Association - October 28, 2026
Letter concerning FDA's Botanical Drug Development Initiative
U.S. Government Accountability Office - September 23, 2026
GAO-26-108623
https://www.gao.gov/products/gao-26-108623
Drug Enforcement Administration - Marijuana Rescheduling Proceedings
FDA - Docket No. FDA-2026-N-9550
Advancing Development of Botanical Drug Products
SOURCE: MMJ International Holdings
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A.Taylor--RTC
