From Iowaska Church to MMJ BioPharma Cultivation, Appellate Courts Patience with DEA's Inaction Wears Thin Amid Constitutional Challenges.
Administrator Terrance "Terry" Cole must issue a final order "as soon as practicable." The Administrative Procedure Act likewise requires agencies to "proceed to conclude a matter presented to [them]" within a reasonable time.
WASHINGTON, DC / ACCESS Newswire / November 17, 2025 / A recent hearing in the U.S. Court of Appeals for the D.C. Circuit has put a harsh spotlight on the Drug Enforcement Administration's chronic delays in handling applications involving Schedule I substances-delays that mirror the seven-year limbo faced by MMJ BioPharma Cultivation, Inc., a subsidiary of MMJ International Holdings, Inc.
On Friday, a three judge D.C. Circuit panel hearing In re Iowaska Church of Healing, appellate case No. 25-1140 repeatedly questioned why the DEA has taken more than six years to act on the church's request for a religious exemption to use ayahuasca, a sacramental tea containing DMT, a Schedule I substance.
"There have been a lot of extensive delays here," Judge Gregory Katsas observed, noting that long periods of total inactivity by DEA "are not small numbers" and stressing that the process should be "monthslong, not yearslong.
Judge Bradley Garcia was even more blunt: "I don't know how I can look at this record and think that anyone at DEA was doing anything about this case for the past 15 months".
Those comments echo the experience of MMJ BioPharma Cultivation, whose application to become a DEA-registered bulk manufacturer of marijuana has been pending since 2018.
MMJ's Case: Constitutional Challenge and Continued Delay
In MMJ's matter, the anticipated full evidentiary hearing before a DEA Administrative Law Judge (ALJ) never occurred. Instead, in a significant constitutional concession, the Department of Justice determined that the DEA's administrative law judge system violates the separation of powers principles under Article II of the U.S. Constitution.
The Department of Justice formally announced it would no longer defend the constitutionality of the ALJ removal restrictions in 5 U.S.C. § 7521, acknowledging that the DEA's internal tribunal system was "unconstitutional from the start". This admission followed Supreme Court decisions in Axon v. FTC (2023) and Jarkesy v. SEC (2024), which declared that federal agencies cannot act as prosecutor, judge, and jury within their own tribunals.
Despite this constitutional collapse, MMJ's application remains in regulatory limbo. Under 21 C.F.R. § 1316.67, DEA Administrator Terrance "Terry" Cole must issue a final order "as soon as practicable." The Administrative Procedure Act likewise requires agencies to "proceed to conclude a matter presented to [them]" within a reasonable time.
Yet, nearly seven years after MMJ's initial application, no final decision has been issued.
In a September 3, 2025 letter to Administrator Cole, MMJ's counsel Megan E. Sheehan of Sheehan & Associates Law formally demanded prompt action:
"More than a month has passed since the record was transmitted, and my client has been engaged in this matter with the DEA since first submitting its application in 2018," Sheehan wrote. "Throughout this period, my client has endured ongoing reputational and financial harm stemming both from the unresolved status of this proceeding and, more broadly, from the continued uncertainty surrounding MMJ's licensing".
Sheehan's letter advised DEA that if no decision is issued by January 28, 2026-six months from the date the record was transmitted-MMJ "will have no choice but to consider all available remedies in federal court to ensure that this matter is resolved".
Parallel Paths: Iowaska's Mandamus Roadmap and MMJ's Next Steps
In the Iowaska case, the church is seeking a writ of mandamus-a court order compelling DEA to act-arguing that DEA decisions under the Controlled Substances Act are reviewable exclusively in the courts of appeals under 21 U.S.C. § 877, and because DEA's inaction effectively blocks any final decision, the court must use its authority under the All Writs Act (28 U.S.C. § 1651) to order the agency to finish the job.
The government has now conceded in that case that the D.C. Circuit does have jurisdiction and that the church has no adequate alternative remedy-a legal framework that maps closely onto MMJ's situation.
"What the Iowaska church is now arguing is exactly what we've been living," said Duane Boise, President & CEO of MMJ International Holdings. "DEA's delay isn't neutral; it is outcome by attrition. When judges ask how something becomes a six-year process instead of a six-month process, they are asking the same question we have asked since 2018".
The Bureaucratic Catch-22
MMJ's case has exposed what company officials describe as a "Kafkaesque regulatory trap" within the DEA. The agency requires applicants to present a "bona fide supply agreement" with an authorized buyer before issuing a bulk manufacturing registration.
The fatal flaw? Federal law prohibits any company from signing such an agreement until after it receives that registration. This creates an impossible circular condition that keeps legitimate researchers permanently stuck in limbo while less-qualified entities either sit dormant or operate under restrictive DEA memoranda of understanding that prohibit normal commerce.
"The DEA's own paperwork confirms exactly what we've told Congress and the courts," said Duane Boise. "The DEA has been playing regulator, prosecutor, and market participant all at once. That's not regulation-it's obstruction in uniform. And every day of delay means another day patients go without medicine the FDA has already cleared for human trials".
A Scientifically Ready, Federally Compliant Program Waiting on One Signature
MMJ International Holdings has spent nearly a decade building a fully federally compliant pharmaceutical cannabis platform, including :
FDA Orphan Drug Designation for Huntington's Disease therapy based on a natural, full-spectrum cannabis extract
FDA IND programs for Huntington's Disease and Multiple Sclerosis
DEA Schedule I-licensed analytical laboratory (MMJ BioPharma Labs)
Pharmaceutical GMP manufacturing and soft-gel capsule formulations designed to meet FDA's botanical drug standards
"Our entire program was built around federal law-DEA scheduling, FDA clinical trials, GMP manufacturing," Boise continued. "We did not take the shortcut route of state dispensaries or hemp-derived synthetics. Yet the very agency that should be encouraging this model has left us in regulatory purgatory for seven years".
From Hemp Shutdown to Pharmaceutical Clarity
The timing of DEA's inaction comes as Congress moves to shut down the intoxicating hemp market, ban synthetic cannabinoids, and impose strict limits on total THC content. This regulatory shift confirms that the long-term future of cannabinoids lies in FDA- and DEA-regulated pharmaceutical drug development, not gas-station products or state-only cannabis schemes.
A sweeping federal appropriations bill supported by President Trump and backed by a bipartisan coalition of 39 State Attorneys General would :
Redefine hemp to include total THC content across all variants
Ban synthetic or chemically modified cannabinoids (Delta-8, THC-O, HHC, THCP)
Impose a 4mg total THC cap per container, effectively eliminating intoxicating hemp products
"The D.C. Circuit is already signaling that 'enough is enough' on DEA delay," Boise said. "If our fully tried, fully briefed case continues to sit on someone's desk while patients with Huntington's Disease and Multiple Sclerosis wait for research, we are prepared to seek the same mandamus relief that Iowaska Church is pursuing. At some point, the rule of law has to mean something-even for DEA."
About MMJ International Holdings, Inc.
MMJ International Holdings, Inc. is a U.S.-based biopharmaceutical company developing DEA-licensed, pharmaceutical-grade, plant-derived cannabinoid medicines for FDA approval. Its subsidiaries-MMJ BioPharma Cultivation and MMJ BioPharma Labs-advance proprietary soft-gel formulations targeting Huntington's Disease and Multiple Sclerosis within the FDA's botanical drug framework.
MMJ is represented in DEA matters by Megan E. Sheehan, Esq. of Sheehan & Associates Law.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-85832
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/d.c.-circuit-grills-dea-over-years-long-delays-as-mmj-biopharma-culti-1103207