"The government cannot tell pharmaceutical companies to follow the rules for eight years, then reward everyone who didn't. That's not reform-it's arbitrary government." - Duane Boise CEO MMJ International Holdings.
WASHINGTON, D.C. / ACCESS Newswire / July 15, 2026 / MMJ International Holdings, together with its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, has asked the U.S. Court of Appeals for the D.C. Circuit to stay the Attorney General's Marijuana Rescheduling Order, 91 Fed. Reg. 22714 (Apr. 28, 2026), which transferred state-licensed marijuana products from Schedule I to Schedule III of the Controlled Substances Act without HHS scientific review, without notice and comment, and without requiring a single applicant to meet the federal pharmaceutical standards Congress built into the law. MMJ's court filing presents the D.C. Circuit with a simple question: can the government reward companies that bypassed federal law while punishing the one company that followed it?
MMJ Has Completed Manufacturing Its Product
Critics of MMJ's standing should read the record. MMJ has completed manufacturing of its standardized botanical cannabinoid drug product: a soft-gelatin capsule containing precisely 5 mg of CBD and 2.5 mg of THC, selected after rigorous evaluation of several prototype formulations. The finished product was developed through pharmaceutical grade formulation and stability studies with Catalent Pharmaceutical, analytical testing with a certified lab, and full chemistry, manufacturing, and controls (CMC) characterization - produced under the only lawful federal pathway that exists: the FDA botanical drug development framework.
This is not a concept or a pitch deck. It is a finished, precisely dosed pharmaceutical product supported by two Investigational New Drug applications - IND ---754 for multiple sclerosis and IND ---712 for Huntington's disease - an orphan-drug designation, and a DEA-inspected Schedule I analytical laboratory. The only things standing between MMJ's medicine and patients are FDA clinical holds and a DEA bulk manufacturing application that has sat unresolved since December 27, 2018 - more than seven years of federal silence in the face of full compliance.
The Standing Question, Answered
Commentators have questioned whether MMJ can show a concrete injury. The supplemental declaration of CEO Duane Boise filed with the court answers them. The Rescheduling Order confers Schedule III legitimacy - and Section 280E tax relief worth millions - on state-licensed operators selling the very same product format MMJ manufactures. Trulieve's Momenta gelcaps, Cresco's Remedi capsules, Verano's Avexia tablets, and TerrAscend's Ilera capsules are all precisely dosed oral cannabinoid products marketed for therapeutic use. None has an FDA-reviewed IND. None has clinical-trial data. None has undergone CMC review or demonstrated controlled formulation and stability. Yet each now receives federal Schedule III treatment, while MMJ's federally compliant product remains locked out of the market by the very agencies that created the rule.
The harm is not theoretical. In February 2026, a long-time investor who had committed approximately $1 million declined further investment, citing the regulatory uncertainty created by the rescheduling actions. MMJ's planned capital markets raise with Seaport Global Securities has been materially impaired as institutional investors ask the obvious question: why are Schedule III benefits flowing to state operators while the one federally compliant applicant is still waiting? That is competitive injury, financial injury, and procedural injury - MMJ was denied any opportunity to comment on a rescheduling rule that redefined its market overnight.
The Merits: NORML v. DEA Controls
On the merits, the D.C. Circuit's own precedent decides this case. In NORML v. DEA (1977), the court held that 21 U.S.C. § 811(d)(1) cannot be used by the Attorney General to unilaterally reschedule a substance while bypassing the medical and scientific determination of HHS and the notice-and-comment rulemaking required by §§ 811(a) and (b). That is precisely what the April 2026 Order did. The Order also imposed new regulatory requirements - registration frameworks, quota treatment, finished-product rules - that never went through notice and comment as the Administrative Procedure Act requires. A court cannot let an agency accomplish by fiat what Congress required it to do by process.
A Stay Preserves the Status Quo - and the Rule of Law
The stay factors favor petitioners. The likelihood of success on the merits is strong under binding circuit precedent. The irreparable harm to MMJ is ongoing: every week the Order stands, state operators consolidate federally sanctioned market share - including an NYSE uplisting already announced - while MMJ's eight years and more than $10 million of federal compliance investment are stripped of the competitive distinction they were meant to secure. The government, by contrast, loses nothing from a pause. Marijuana sat in Schedule I for over five decades; the public interest is not harmed by requiring the government to reschedule it lawfully.
MOVING FORWARD
MMJ is opposed to lawless rescheduling. The company built its business on the premise that federal law means what it says: DEA registration, FDA review, clinical trials, and manufacturing controls are the price of bringing a cannabinoid medicine to patients. MMJ paid that price in full - and completed its product. If the Rescheduling Order stands as written, the message to every drug developer in America is that compliance is for suckers. The D.C. Circuit should stay the Order, and the government should finish what it started: act on MMJ's registration, lift the clinical holds, and let a lawful medicine be used in trials for the patients with Huntington's disease and multiple sclerosis who are still waiting.
About MMJ International Holdings, Inc.
MMJ International Holdings, Inc. is a pharmaceutical company developing proprietary cannabinoid-based medicines through the FDA drug approval process for Huntington's disease and multiple sclerosis. The company and its affiliates maintain DEA registrations and are pursuing federal approvals under the Controlled Substances Act and the Food, Drug, and Cosmetic Act.
Media Contact
Madison Hisey
MMJ International Holdings, Inc.
mhisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/mmj-will-stay-marijuana-rescheduling-why-the-d.c.-circuit-should-halt-1191493
