State Licensed Marijuana Operators Will Face Long Delays for DEA Federal Registrations
WASHINGTON, D.C. / ACCESS Newswire / October 17, 2026 / MMJ International Holdings, a pharmaceutical development company pursuing FDA regulated cannabinoid medicines for Huntington’s disease and multiple sclerosis, today explained why it is challenging the federal government’s April 2026 marijuana rescheduling order in the U.S. Court of Appeals for the District of Columbia Circuit.
The explanation follows public remarks by former Drug Enforcement Administration official Matthew Strait, who said during a recent regulatory webinar that DEA should not be issuing registrations to state licensed marijuana businesses while legal challenges to the new framework remain unresolved.
“My opinion is there should be a healthy dose of expectation management here, because I don’t think it would be wise for DEA to issue any registrations,” Strait said. He also said DEA had issued “zero” registrations under the new framework at the time of the discussion. The webinar was hosted by attorney Jason Adelstone of Harris Sliwoski and included Gillian Schauer, executive director of the Cannabis Regulators Association (CANNRA). Strait’s remarks reflect his personal views, not an official agency position.
MMJ Is Not Challenging Whether Marijuana Can Be Medicine. It Is Challenging How the Government Got Here.
MMJ’s challenge does not ask the court to decide whether cannabinoids have medical value. MMJ has spent years and more than $10 million pursuing that question through the only process federal law recognizes: FDA clinical development under DEA oversight.
MMJ’s challenge rests on four points:
- The order bypassed the process Congress required. Under the Controlled Substances Act, rescheduling a drug requires a scientific and medical evaluation and formal rulemaking on the record. DEA’s own formal hearing on marijuana rescheduling ran from June 29 to July 15, 2026. It has not produced even a recommended decision, and the proceeding is currently stayed. Yet the April order had already moved state-licensed medical marijuana into Schedule III.
- The order lets a state license substitute for federal standards. Pharmaceutical developers must prove product consistency, stability, manufacturing controls and clinical evidence before their medicines reach patients. The April order gives Schedule III treatment to products distributed through state medical programs that were never required to meet those standards.
- The government’s own evidence undercuts the order. At the DEA hearing, Dr. Dominic Chiapperino, an FDA official called by the government, agreed on cross-examination that marijuana is “not a single chemical with a consistent and reproducible chemical profile or predictable and consistent clinical effects.” A DEA pharmacologist, testifying under restrictions DEA imposed to limit her cross-examination, stated that marijuana is a complex substance that needed a five part evaluation.
- Treaty obligations still apply. The United States is bound by the Single Convention on Narcotic Drugs, which imposes specific controls on cannabis cultivation, manufacture and distribution. MMJ’s position is that a framework built around existing state markets does not satisfy those obligations.
Why Registrations Should Wait
- The framework’s legality is unresolved. Petitioners in the D.C. Circuit challenge whether the rescheduling order complies with the Controlled Substances Act, meaning registrations issued under a disputed framework would rest on precarious ground.
- Undoing registrations would be slow, burdensome and expensive. Revoking a DEA registration generally requires an order to show cause and an opportunity for a hearing; if the court vacates the order later, DEA would face cumbersome, case-by-case revocation proceedings across numerous state operators.
- Businesses and regulators need certainty, not reversals. Operators who build compliance programs, supply chains, and financing around a federal registration that may later be withdrawn face severe disruption, as do the state regulators overseeing them.
- The litigation will take time. With briefing schedules underway, a ruling on the merits is months away, leaving any registration issued in the interim legally exposed.
Pending litigation does not automatically bar DEA from acting. But issuing consequential registrations before the courts decide whether the framework is lawful invites exactly the disruption the government says it wants to avoid.
What MMJ Has Built
MMJ’s drug product is a finished medicine: a standardized THC/CBD soft-gelatin capsule in final dosage form, reproducible and stable, manufactured for eventual use in clinical trials through a pharmaceutical manufacturing partner. The company holds FDA Investigational New Drug applications for its Huntington’s disease and multiple sclerosis programs and an FDA Orphan Drug Designation for its Huntington’s disease program. Through the IND process, MMJ is seeking to demonstrate the safety and efficacy of its investigational medicines.
Statement from Duane Boise, President and CEO
“We are not anti-marijuana. We are anti-bad science and anti-fake process.”
“MMJ has spent years doing what federal law requires: building a standardized medicine, documenting its manufacture, and submitting it to FDA review. We did that because patients with Huntington’s disease and multiple sclerosis deserve medicines backed by evidence, not marketing.”
“The April order treats a state license as a substitute for that work. A company that never ran a clinical trial, never validated its manufacturing and never proved its product is consistent from batch to batch now receives federal treatment that the law reserves for drugs with accepted medical use. That is not reform. It is a shortcut, and it devalues the pathway every legitimate drug developer has to follow.”
“Matthew Strait is right that expectations need to be managed. If DEA issues registrations and the court then vacates this framework, the agency will have to unwind them one proceeding at a time. Waiting for the court to rule is not obstruction. It is common sense.”
“The Controlled Substances Act is not optional. We are asking the court to require the government to follow it.”
About the Litigation
MMJ International Holdings is among the petitioners in consolidated proceedings in the U.S. Court of Appeals for the D.C. Circuit challenging the federal marijuana rescheduling order published at 91 Fed. Reg. 22,714. The challenges remain pending, and the validity of the framework is a matter for the court to decide.
About MMJ International Holdings
MMJ International Holdings is a pharmaceutical development company focused on investigational cannabinoid medicines for serious neurological disorders, including Huntington’s disease and multiple sclerosis. The company pursues FDA-regulated clinical development and federal controlled-substance compliance to advance standardized cannabinoid therapies.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-85832
SOURCE: MMJ International Holdings
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