Marijuana Rescheduling In Peril: AMA Demands FDA Scientific Standards As GAO Report Exposes Malaise
Marijuana Rescheduling In Peril: AMA Demands FDA Scientific Standards As GAO Report Exposes Malaise
MMJ International Holdings CEO Duane Boise Says "The American Medical Association October 28 Letter and Congressional Watchdog's GAO Findings Raise Fundamental Questions About Federal rescheduling and Authorization of Non-FDA-Approved Marijuana Products".
WASHINGTON, D.C. / ACCESS Newswire / November 2, 2026 / MMJ International Holdings, Inc. today called attention to two significant developments that raise serious questions about the scientific and regulatory foundation of the federal government's marijuana rescheduling initiative: a new American Medical Association (AMA) letter urging the Food and Drug Administration (FDA) to preserve rigorous drug-approval standards for botanical products, including cannabis, and a Government Accountability Office (GAO) report documenting significant deficiencies in the procedures used by the FDA and Drug Enforcement Administration (DEA) to evaluate and schedule controlled substances.
The developments arrive as the federal government implements its April 2026 marijuana rescheduling order and expands DEA registration opportunities for state-licensed medical marijuana businesses.
MMJ believes the central question is unavoidable: How can the federal government expand regulatory recognition of state medical marijuana products while the nation's leading physicians' organization insists that cannabis products marketed as treatments must meet established FDA scientific standards?
AMERICAN MEDICAL ASSOCIATION: CANNABIS IS NOT EXEMPT FROM DRUG-APPROVAL SCIENCE
In an October 28, 2026 letter to FDA Deputy Commissioner Grace R. Graham, the American Medical Association urged the agency to maintain rigorous, evidence-based requirements for botanical drug products, including cannabis.
In its October 30 announcement, the AMA warned against allowing popularity, anecdotal medical claims or commercial pressures to substitute for controlled clinical trials and appropriate regulatory oversight.
The AMA emphasized the importance of establishing safety and efficacy before botanical products are marketed or prescribed to treat medical conditions.
AMA President Willie Underwood III, MD, MSc, MPH, warned:
"Calling something 'natural' doesn't make it safe."
For MMJ International Holdings, the AMA's position reinforces a fundamental principle: A state medical marijuana license is not a substitute for FDA evidence demonstrating that a particular drug product is safe, effective, consistently manufactured and appropriate for its claimed medical use.
GAO REPORT: FEDERAL DRUG-SCHEDULING PROCEDURES LACK CRITICAL WRITTEN STANDARDS
The AMA's warning follows the September 23, 2026 release of GAO Report GAO-26-108623, Drug Scheduling: While DEA Decisions Have Aligned with Recent HHS Recommendations, Both Need Comprehensive Policies.
The independent congressional watchdog identified substantial gaps in the federal drug-scheduling process.
Among its findings:
- DEA lacks comprehensive policies identifying roles, responsibilities and procedures for scheduling evaluations.
- FDA lacks written policies specifying how personnel should conduct certain scheduling evaluations and develop recommendations.
- FDA's procedures do not adequately specify the criteria and process for determining a substance's potential for abuse, including comparisons with other controlled substances.
- The FDA-NIH memorandum governing coordination of drug-scheduling recommendations is more than four decades old and does not reflect current procedures and organizational responsibilities.
GAO recommended corrective action by DEA, FDA and NIH. The agencies concurred with those recommendations.
The report did not conclude that marijuana rescheduling was unlawful. MMJ contends, however, that the documented procedural gaps raise questions that must be addressed when the government defends the scientific and administrative foundation of its marijuana scheduling decisions.
"The American Medical Association has now reinforced what MMJ has been saying for years: marijuana products marketed to treat disease must be evaluated under rigorous FDA scientific standards," said Duane Boise, President and Chief Executive Officer of MMJ International Holdings.
"At the same time, the Government Accountability Office has exposed serious deficiencies in the written procedures federal agencies use to make controlled-substance scheduling decisions."
"You cannot have two standards of medicine in the United States-one requiring years of FDA-regulated research, clinical trials and pharmaceutical quality controls, and another allowing commercial products to be promoted as medicine without demonstrating the same scientific evidence," Boise said.
"MMJ is not opposed to medical marijuana. We are opposed to bypassing science, weakening patient protections and calling products medicine without requiring the evidence that American patients deserve."
FEDERAL MARIJUANA REGISTRATIONS RAISE A NEW QUESTION
The Attorney General's April 28, 2026 rescheduling order created an expedited federal registration framework for qualifying state-licensed medical marijuana operators.
MMJ believes implementation of that framework raises important questions about the relationship between DEA registration, FDA drug-approval requirements and federal obligations under the 1961 Single Convention on Narcotic Drugs.
DEA registration under the Controlled Substances Act does not itself constitute FDA approval of a drug's safety or effectiveness.
MMJ contends that expanding federal recognition of state medical marijuana commerce without resolving these distinctions risks creating regulatory uncertainty, potential patient-safety concerns and economic injury to pharmaceutical developers that have invested in the FDA-regulated pathway.
These issues are particularly important where cannabis products are represented or marketed as treatments for serious diseases.
MMJ HAS PURSUED THE FDA PATHWAY
Unlike companies relying solely on state medical marijuana licensing, MMJ International Holdings has pursued federal investigational drug development involving cannabinoid-based pharmaceutical products.
Its development programs include:
Huntington's Disease - FDA IND 137754
Multiple Sclerosis - FDA IND 140712
MMJ has also received orphan drug designation for its cannabinoid development program targeting Huntington's disease.
The company previously completed manufacture of approximately 50,000 pharmaceutical soft-gel capsules containing standardized amounts of cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), as part of its development efforts.
MMJ BioPharma Cultivation, Inc., an affiliated company, submitted a DEA bulk-manufacturer registration application on December 27, 2018.
On October 6, 2026, DEA formally withdrew its Order to Show Cause seeking denial of that application. On October 16, 2026, Administrative Law Judge Angela J. Miranda terminated the administrative proceeding.
DEA stated that its Regulatory Section would notify MMJ of its eligibility for the requested registration. The application remains subject to DEA's regulatory determination.
MMJ CALLS FOR SCIENTIFIC ACCOUNTABILITY
MMJ believes the AMA letter and GAO report should prompt federal policymakers, physicians, investors and regulators to examine whether the nation's medical marijuana framework adequately distinguishes state-authorized cannabis commerce from FDA-reviewed pharmaceutical medicine.
The company calls for transparent scientific evaluation, meaningful product-quality standards, consistent regulatory oversight and adherence to applicable federal law.
"The question is not whether cannabis may have therapeutic value," Boise concluded.
"The question is whether the government will require credible evidence of safety, effectiveness and reproducible pharmaceutical quality before allowing products to be treated as medicine. The AMA is demanding science. GAO is demanding procedures. MMJ is demanding accountability."
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 entities, MMJ has pursued FDA investigational drug programs, pharmaceutical formulation development and federal controlled-substance research and manufacturing authorizations.
The company's objective is to advance cannabinoid medicines through established scientific, regulatory and pharmaceutical development pathways.
CONTACT:
Madison Hisey
[email protected]
203-231-8583
SOURCE DOCUMENTS
American Medical Association: October 28, 2026 letter to FDA Deputy Commissioner Grace R. Graham, concerning FDA Docket FDA-2026-N-9550, Advancing Development of Botanical Drug Products.
American Medical Association: October 30, 2026, AMA Urges FDA to Pursue Safety Standards for Botanical Products.
U.S. Government Accountability Office: GAO-26-108623, September 23, 2026.
https://www.gao.gov/products/gao-26-108623
SOURCE: MMJ International Holdings
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J.Morris--RTC
