A drug company spent nearly eight years fighting the DEA to make cannabis medicine the hard way. Now that everyone else is getting an easier path, it’s in court trying to undo the whole thing, a move that could send cannabis back to Schedule I for the entire industry.
MMJ International Holdings spent nearly eight years and millions of dollars fighting the DEA for the right to grow cannabis. It sued the agency. Its CEO called the delays “obstruction in uniform.” Now that the federal government has created a new, easier path for state-licensed cannabis businesses, MMJ is in court challenging the rescheduling.
For nearly a decade, it was the kind of company cannabis reformers could point to as a victim of the DEA. It did everything the federal government said to do. It filed drug applications with the FDA, won an Orphan Drug Designation, stood up a DEA-licensed lab, and asked the agency for permission to grow cannabis for clinical trials. Then it waited. And waited. Its application has been pending since December 2018.
The company was furious about it, loudly and for years. Its CEO, Duane Boise, did not mince words about the agency’s conduct. Now that same company is in federal court trying to reverse the rescheduling of marijuana, the first major federal marijuana reform in half a century. If it wins, cannabis could revert to Schedule I, the punishing 280E tax bill could return, and every state operator that just applied for federal relief could be left holding a voided application.
The company that spent the better part of a decade trying to get through the front door is now asking a court to decide whether everyone else should have to use it, too.
The Hard Road
To be fair to MMJ, and the story does not work unless you are, its grievance is real. The company, through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, has chased FDA approval for cannabinoid medicines aimed at Huntington’s disease and multiple sclerosis since 2015. It holds FDA Investigational New Drug (IND) applications and FDA Orphan Drug Designation, and its lab carries a DEA Schedule I analytical registration. This is the expensive, slow, by-the-book pharmaceutical route the federal government has long told cannabis companies was the only legitimate one.
And the DEA stonewalled it. MMJ BioPharma Cultivation applied in December 2018 to become a federally authorized bulk manufacturer of cannabis for those trials. The DEA opened its pre-registration investigation in 2021 and inspected the facility that October. Then nothing. As Cannabis Business Times reported, MMJ sued the agency in 2024 over the delays, accusing it of obstructing legitimate research and running what the company called a “kangaroo court.” MMJ even challenged the constitutionality of the DEA’s in-house judges, and the Justice Department later conceded that the removal protections shielding those judges violate the separation of powers, though that concession did not resolve MMJ’s own stalled application.
On that record, MMJ had a point. A company that did everything right sat in limbo for years while the agency that demanded the rigor refused to act on it.
The Turn
Then the ground shifted. In April 2026, the Trump administration rescheduled state-licensed medical cannabis to Schedule III and opened an expedited DEA registration path for state operators. While MMJ kept pursuing FDA-approved cannabinoid medicines, state-licensed cannabis businesses were suddenly getting federal relief through a faster route, no INDs required.
So, MMJ joined the other side. It is now one of the petitioners in the consolidated challenge to the rescheduling order before the U.S. Court of Appeals for the D.C. Circuit. As Business of Cannabis reported, MMJ filed alongside an addiction recovery clinic, a victims’ group and two doctors, naming President Trump, the Justice Department, the DEA, Acting Attorney General Todd Blanche and DEA Administrator Terrance Cole as defendants. The petitioners are not asking for a tweak. They want the court to stay the order and vacate it entirely.
Read what that means in plain terms. A stay freezes the reform. Vacatur erases it. Cannabis would revert to Schedule I, the 280E tax penalty that costs operators an effective rate far above ordinary businesses would come roaring back, and the DEA applications state companies are racing to file would rest on a legal foundation the court had just voided. A win for MMJ could become a major setback for the state-licensed industry.
The Argument, And the Witnesses
MMJ frames this as principle, not spite. Asked directly whether a company that fought to enter the federal system is now trying to block reform for everyone else, Boise rejected the premise. “That question assumes rescheduling is about helping an industry. It isn’t,” he told High Times. “We don’t oppose legitimate medicine, we oppose lowering the scientific standard for what gets called medicine.” The broader industry, he argued, “has spent years bastardizing the word ‘medicine’” by marketing state products as medical without the reproducible formulations, stability testing and clinical trials the FDA pathway demands. “MMJ chose the harder path because patients deserve medicines backed by science, not marketing.”
That distinction sits at the heart of the dispute, and so does the word itself. MMJ uses “medicine” in its pharmaceutical sense, in reference to products that have completed the FDA approval process. Much of the state-licensed cannabis industry, by contrast, has never argued that dispensary flower is equivalent to an FDA-approved pharmaceutical. It argues the two serve different purposes under different regulatory systems. So, the fight is less about whether pharmaceutical standards matter than whether state medical cannabis should have to become a pharmaceutical product before federal law can acknowledge it at all.
The company’s core claim is a regulatory double standard: it argues the government cannot extend Schedule III benefits to state operators who skipped the FDA pathway while companies that spent years and millions following it remain stuck in limbo. Its filings raise constitutional, statutory and treaty objections, including the argument that the rescheduling order creates a “hybrid schedule” Congress never authorized. On the consequences, a stay that would freeze the relief the whole industry is counting on, Boise was unmoved. If the court finds the order unlawful, he said, “any consequences for tax treatment, registrations, or existing business models would be the legal result of correcting an invalid agency action, not the objective of MMJ’s lawsuit. Our case is about restoring the rule of law, not restoring Schedule I for its own sake.”
To carry the message, MMJ has put forward people with federal pedigrees. In a June 17 announcement, it pointed to Jorge Jimenez, a retired DEA supervisory diversion investigator who once served as a section chief at DEA headquarters overseeing registrations, and Dr. Elio Mariani, a pharmaceutical scientist with decades in drug development. Their pitch is that opposition to rescheduling is not all ideology, that some of it comes from people who built the federal drug approval system. Also cited in the broader opposition is Dr. Bertha Madras, the Harvard Medical School professor and longtime cannabis skeptic who served on President Trump’s 2017 opioid commission, a figure with her own decades-long record on drug policy, not a witness MMJ brought forward.
The Ladder Problem
Here is the tension the company cannot fully escape. For years, MMJ argued that the DEA was the villain, that it ignored science, defied the rule of law and kept medicine from sick patients. Now it is asking a federal court whether anyone else should be allowed to enter through a different door. MMJ says it is a matter of scientific standards and equal treatment. Critics see a company trying to keep everyone else out of a system it spent years trying to enter.
You can read MMJ’s move two ways, and the company would insist on the first. One, it is a consistent demand that the government hold everyone to the same scientific standard, even if that means slowing the whole thing down. Two, it is a company that did the hard work, got beaten by the bureaucracy, and now wants to make sure nobody else gets the prize it was denied. The filings are about standards. The effect, if they succeed, is to pull the ladder up behind it.
Boise rejects the second reading outright. “This isn’t about denying anyone relief. It’s about ensuring that everyone who wants to market products as medicine plays by the same scientific rules,” he said. “Equal treatment doesn’t mean lowering the standard, it means applying the same standard to everyone.”
He also pushed back on the idea that simply granting MMJ its long-stalled DEA license would make the lawsuit go away. The application, filed in 2018, is still pending, and resolving it “would certainly address one part of the harm MMJ has experienced,” he said, but “even if MMJ received its DEA registration tomorrow, the legal questions before the Court would remain.”
That distinction matters. By MMJ’s own account, simply receiving its long-delayed registration would not end the dispute. The company is not only asking to enter the federal system itself. It is asking the court to throw out the easier path the rest of the industry just started using.
The stakes are not abstract, and they are close. The petitioners asked the D.C. Circuit to freeze the rescheduling order while the case plays out. That fight runs parallel to a separate DEA hearing on rescheduling that begins June 29, and there is no fixed deadline for either to resolve. If the court grants a stay, the relief the industry has been counting on, the tax break, the registration path, the first real federal thaw in half a century, stalls while the lawyers argue. There is an irony in that. The company that spent years condemning the DEA for making it wait is now asking a court to make everyone else wait, too.
