Former DEA, FDA Drug Development, and Public Health Experts Raise Concerns Ahead of June 29 Hearing
WASHINGTON, D.C., June 17, 2026 – As the Drug Enforcement Administration prepares for its June 29 marijuana rescheduling hearing, MMJ International Holdings is drawing attention to a group of former federal officials, pharmaceutical scientists, and public health experts who are challenging the government’s current approach to marijuana rescheduling.
The experts are not politicians, cannabis activists, or industry lobbyists. Their careers have centered on enforcing federal controlled-substance laws, developing FDA-regulated medicines, overseeing pharmaceutical standards, and studying the public health effects of drugs.
“As DEA prepares for the June 29 hearing, MMJ International Holdings is bringing forward the very experts who built, enforced, and understand the federal drug approval system,” said Duane Boise, Chief Executive Officer of MMJ International Holdings.
MMJ International Holdings Questions The Federal Rescheduling Pathway
MMJ International Holdings says the central issue is not whether cannabis may have medical value. The company argues that the larger question is whether federal regulators can create a separate pathway for state marijuana operators while requiring federally compliant pharmaceutical developers to follow stricter FDA and DEA standards.
For years, federal regulators have maintained that companies seeking to manufacture cannabis-derived medicines must comply with the same scientific, manufacturing, and controlled-substance requirements applied to other pharmaceutical developers.
MMJ International Holdings states that it followed that process. The company obtained FDA Investigational New Drug authorizations, secured Orphan Drug Designation, established a DEA-registered analytical laboratory, completed pharmaceutical manufacturing activities, and spent years navigating the DEA registration process.
Former DEA Section Chief Jorge Jimenez Brings Regulatory Experience
Among the experts participating in opposition to the current rescheduling process is Jorge Jimenez, a retired DEA Supervisory Diversion Investigator who spent nearly two decades inside the agency.
Jimenez ultimately served as Section Chief of both the Regulatory Section and the Import/Export Section within DEA Headquarters. During his tenure, he helped oversee controlled-substance registration programs involving bulk manufacturers, importers, exporters, analytical laboratories, and other DEA registrants operating under federal law.
MMJ International Holdings says Jimenez’s experience is especially relevant because he managed the very regulatory programs now at issue in the marijuana rescheduling debate.
Concerns Over Different Standards For State Marijuana Operators
According to MMJ International Holdings, the federal government now appears positioned to create a pathway that may allow state marijuana operators to benefit from rescheduling without requiring the same regulatory foundation demanded of federally compliant applicants.
The company argues that this could represent a departure from long-standing DEA practice. MMJ says companies operating through the federal pharmaceutical system have been required to meet strict standards for registration, manufacturing, testing, documentation, and compliance.
By contrast, many state marijuana products have not gone through FDA drug approval, DEA pharmaceutical registration, validated manufacturing review, or clinical testing required for federally regulated medicines.
Pharmaceutical Standards Remain Central To The Debate
MMJ International Holdings says the distinction between a pharmaceutical cannabis-derived product and a commercial marijuana product is scientific, not political.
Drug products must demonstrate reproducibility, stability, impurity control, validated manufacturing processes, analytical characterization, dose consistency, and clinical evidence. These requirements exist to protect patients, support physician confidence, and preserve the integrity of the drug approval system.
The company argues that federal rescheduling should not blur the line between FDA-regulated medicines and commercial cannabis products that have not met the same standards.
Dr. Elio Mariani Highlights FDA And Manufacturing Requirements
Joining Jimenez is Dr. Elio Mariani, a pharmaceutical scientist with more than 45 years of experience in drug development, FDA regulatory affairs, manufacturing, analytical chemistry, and pharmaceutical commercialization.
Dr. Mariani’s background includes leadership roles responsible for developing more than 100 pharmaceutical products, working with FDA on Investigational New Drug and New Drug Application submissions, and overseeing scientific affairs for publicly traded pharmaceutical companies.
According to MMJ International Holdings, Dr. Mariani’s involvement underscores the scientific concerns behind the company’s position. The company says any product treated as a medicine under federal law should meet the quality, consistency, and evidence standards expected of medicines.
Public Health Concerns Raised By Dr. Bertha Madras
Also participating in opposition filings is Dr. Bertha Madras, a professor at Harvard Medical School and one of the nation’s recognized experts on addiction, neurobiology, and drug policy.
Dr. Madras has raised concerns about the public health consequences of marijuana rescheduling without resolving key questions involving vulnerable populations, youth exposure, dependency risk, psychiatric effects, impaired driving, and long-term neurological impact.
MMJ International Holdings says her participation reinforces the need for DEA to examine marijuana rescheduling through a public health lens, not only through a commercial or political lens.
Expert Opposition Is Not Based On Political Ideology
MMJ International Holdings says the participation of Jimenez, Mariani, and Madras challenges the idea that opposition to marijuana rescheduling is driven only by ideology.
One expert spent his career enforcing federal controlled-substance laws. Another spent decades developing FDA-regulated medicines. Another spent her career studying the neurological and public health effects of drugs.
Their professional backgrounds are different, but MMJ says their concerns point to the same issue: whether federal regulators can bypass the scientific, legal, and regulatory safeguards that have historically governed controlled-substance medicines.
MMJ International Holdings Calls For Regulatory Fairness
MMJ International Holdings argues that the federal government should not penalize companies that followed the lawful FDA and DEA process.
The company says it invested significant time and resources into FDA-authorized research, DEA registration, controlled-substance compliance, analytical laboratory operations, and pharmaceutical manufacturing because those were the standards required by the federal system.
“MMJ International Holdings accepted the burden of operating within the federal framework,” Boise said. “If the government now lowers the bar for others, it undermines the very process it required compliant applicants to follow.”
June 29 Hearing Could Shape Federal Cannabis Policy
As the June 29 DEA hearing approaches, MMJ International Holdings says the issue before the agency is larger than whether marijuana belongs in Schedule III.
The company believes the hearing will test whether federal regulators can change marijuana policy while preserving the safeguards that govern controlled-substance medicines, FDA-regulated drug development, and public health protection.
DEA will not only hear from industry participants or policy advocates. It will also hear from former officials and scientific experts who helped build, enforce, and evaluate the regulatory framework now being challenged.
Implications For Patients, Physicians, Investors, And Policymakers
The MMJ International Holdings says the outcome of the rescheduling process could affect patients, physicians, investors, researchers, and companies operating within the federal pharmaceutical system.
- For patients, the question is whether products presented as medical cannabis will meet consistent safety, quality, and evidence standards.
- For physicians, the question is whether rescheduling will provide scientifically reliable products supported by clinical data.
- For investors and regulated companies, the question is whether federal agencies will apply the same rules to all participants or create uneven standards between federally compliant applicants and state marijuana operators.
- For policymakers, MMJ says the hearing raises a fundamental question about whether cannabis reform can move forward without weakening the drug approval system.
MMJ International Holdings Says Medical Cannabis Must Follow Scientific Standards
MMJ International Holdings says it supports the development of cannabinoid-based medicines through proper federal channels. The company’s position is that cannabis-derived therapies should be evaluated like other pharmaceutical products, with clear evidence, controlled manufacturing, validated testing, and regulatory oversight.
“Patients deserve safe, consistent, scientifically evaluated products,” Boise said. “Physicians deserve products supported by evidence. Companies that followed the law deserve a process that does not penalize compliance.”
About MMJ International Holdings
MMJ International Holdings is a pharmaceutical development company focused on cannabinoid-based medicines developed through federally compliant regulatory pathways. The company has pursued FDA-authorized clinical development, DEA registration, pharmaceutical manufacturing, analytical testing, and controlled-substance compliance as part of its efforts to advance cannabis-derived drug candidates through recognized federal systems.
Forward-Looking Statements
This press release may contain forward-looking statements regarding regulatory proceedings, federal cannabis policy, controlled-substance classification, pharmaceutical development, and MMJ International Holdings’ business and legal positions. Forward-looking statements are based on current expectations and are subject to risks, uncertainties, regulatory developments, administrative outcomes, and other factors that may cause actual results to differ materially. MMJ International Holdings undertakes no obligation to update these statements except as required by law.
Media Contact
Madison Hisey
MMJ International Holdings
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