Researchers Ask Federal Court To Block DEA From Banning Two Psychedelics Under ‘Unconstitutional’ Administrative Process

Researchers are asking a federal court to block the Drug Enforcement Administration (DEA) from proceeding in its attempt to ban two psychedelics, arguing that the agency’s administrative approach to the proposed scheduling is unconstitutional.

Panacea Plant Sciences (PPS) filed a complaint and request for injunctive relief against DEA in the U.S. District Court for the Western District of Washington last week.

The legal challenge focuses on the agency’s recent scheduling of an administrative hearing to receive expert input on its controversial plans to classify 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) as Schedule I drugs under the Controlled Substances Act (CSA).

The filing doesn’t speak to the merits of the scheduling proposal—an issue that psychedelics researchers have previously addressed in public comment. Rather, PPS is contesting the administrative hearing process that’s preceding final rulemaking, arguing that DEA’s reliance on administrative law judges (ALJs) to settle such arbitration is unconstitutional based on U.S. Supreme Court precedent.

PPS said that because the Supreme Court has held that ALJs are considered “inferior officers,” current statutory removal protections unconstitutionally insulate them from executive control under Article II of the Constitution. That means DEA should not be permitted to subject researchers to an administrative hearing concerning the psychedelic scheduling proposal, the filing says.

“The hearing and scheduling poses a significant threat to the company,” it says. “PPS conducts research and development on medical technologies which include the use of DOI or DOC for development and as products themselves. Currently, DOI and DOC are not controlled.”

“Under the Controlled Substances Act (CSA) and its implementing regulations, PPS will be required to turn over to law enforcement or destroy our stock of DOI and DOC which means the rule-making acts as an effective taking of property,” the document says.

“As a result, when PPS received the hearing notice from DEA, it was faced with a stark choice: either default and lose automatically or defend itself against the DEA’s attempts to schedule DOI and DOC and its use of an ALJ-overseen adjudication,” it continues. “PPS is thus compelled to participate in the DEA’s adjudicatory proceedings.”

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DEA Agrees To Hold Hearing On Proposed Ban Of Two Psychedelics Amid Pushback From Researchers

The Drug Enforcement Administration (DEA) has scheduled an administrative hearing to get additional feedback from experts about its renewed push to ban two psychedelics after abandoning its original scheduling proposal in 2022.

More than a year after DEA announced its intent to classify 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) as Schedule I drugs under the Controlled Substances Act (CSA), the agency has agreed to hold a hearing before issuing a final rule.

DEA Administrator Anne Milgram signed off on the hearing notice on Thursday. It says that the agency’s administrative law judge will convene the meeting on June 10, at the request of three interested parties, including Panacea Plant Sciences, which had filed a motion contesting the proposed scheduling action last year.

Panacea Plant Sciences founder and CEO David Heldreth told Marijuana Moment on Monday that the company is “prepared to fight the DEA attempt to schedule DOI & DOC.”

“Beyond the scheduling attempt, we believe the DEA administrative law judges and system are unconstitutional,” he said, arguing that there’s legal precedent based on prior Supreme Court rulings. “We expect to file federal challenges to the ALJ prior to the hearing.”

In its notice about the psychedelics ban last year, DEA said its arguments about the merits of the scheduling action remained the same as in its prior abandoned ban attempt. It is maintaining that DOI and DOC hold high abuse potential with no established medical value. But it also notably described a change in the process to request an administrative hearing, which left some with the impression that the agency was deliberately complicating the procedure in the face of likely challenges from the psychedelics research community.

But, ultimately, DEA accepted the multiple requests for a hearing.

“Upon review of the requests for hearings, I have authorized a hearing, and direct the Chief Administrative Law Judge to assign the matter to an Administrative Law Judge who will complete all prehearing procedures, conduct a due process hearing…and issue a recommended decision for the Agency’s review and action,” Milgram said.

A DEA spokesperson told Marijuana Moment on Monday that they expect the notice to be posted on the online docket on Tuesday.

DEA backed down off its original proposed ban of the psychedelics following challenges from Panacea and researchers from Emory University. It remains to be seen how the agency will navigate the scheduling issue following the hearing with experts.

DEA separately withdrew from a proposal to ban five different tryptamine psychedelics in 2022 amid sizable pushback from the research and advocacy communities.

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GOP Senators Tell DEA To Reject Marijuana Rescheduling, Arguing It Would Violate International Treaties

Three Republican senators are urging the Drug Enforcement Administration (DEA) to reject the top federal health agency’s marijuana rescheduling recommendation, arguing that it would put the U.S. out of compliance with international treaty obligations and make it harder to ensure that other countries continue to enforce drug laws, “including for deadly narcotics like fentanyl.”

In a letter sent to DEA Administrator Anne Milgram on Wednesday, Sens. Mitt Romney (R-UT), James Risch (R-ID) and Pete Ricketts (R-NE) said the agency should adhere to precedent and decline to move cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA), as the U.S. Department of Health and Human Services (HHS) has advised.

“Any effort to reschedule marijuana must be based on proven facts and scientific evidence—not the favored policy of a particular administration—and account for our treaty obligations,” the Senate Foreign Relations Committee members wrote.

“Marijuana is controlled under the Single Convention—which is not surprising given its known dangers and health risks—and the United Nation’s International Narcotics Control Board (INCB) has fiercely criticized efforts to legalize marijuana in other countries as a violation of the treaty,” they said.

The letter notes that the Senate ratified the Single Convention that contains drug policy mandates for member states in an unanimous vote in 1967. And they pointed out that DEA has previously cited international treaty obligations in denying past rescheduling petitions.

“It is important that the DEA continues to follow the law and abide by our treaty commitments,” they said, listing a series of questions they’re asking the agency to answer.

For example, the senators asked if DEA still considers it necessary to keep marijuana in either Schedule I or Schedule II to comply with the Single Convention, as it concluded under the Obama administration.

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After 17 Years, Feds Stop Trying To Imprison a Licensed Medical Marijuana Provider

Seventeen years ago, the federal government raided Charlie Lynch’s medical marijuana dispensary in Morro Bay, California, and charged him with five drug felonies. Lynch, whose business complied with state and local regulations, has been fighting to stay out of prison ever since, and last month he finally won that battle.

The Department of Justice (DOJ), which had been insisting since the first iPhone was released that Lynch should be incarcerated for at least five years, suddenly agreed to a deal that will spare him that punishment and erase his criminal record. The case, which proceeded on autopilot even as marijuana prohibition collapsed in one state after another, is a vivid reminder that the unjust, massively unpopular policy persists at the federal level thanks to presidential and congressional inertia.

Lynch, a software developer who lived in San Luis Obispo County, started mulling a new line of work after he obtained a doctor’s recommendation for marijuana to treat his cluster headaches and found there were no nearby dispensaries that could supply his medicine. He conferred with a lawyer, local officials, and even the Drug Enforcement Administration (DEA) before opening Central Coast Compassionate Caregivers in downtown Morro Bay in April 2006.

California had legalized medical marijuana a decade earlier, and Lynch’s business was licensed, aboveboard, and legitimate as far as the city and state were concerned. The mayor, the city attorney, and city council members attended the grand opening ceremony, where the mayor posed for a photo shaking Lynch’s hand.

None of that mattered to the DEA, which raided the dispensary in March 2007, at which point it had been openly serving patients for a year. During Lynch’s 2008 trial in Los Angeles, he was not allowed to discuss the nature of his business, which was irrelevant under federal law.

“We all felt Mr. Lynch intended well,” the jury forewoman told the Los Angeles Times. “But under the parameters we were given for the federal law, we didn’t have a choice.”

At sentencing, U.S. District Judge George Wu considered details the jury was not allowed to hear, including the purpose of Lynch’s business, his extensive efforts to comply with state regulations, and the “scrupulous record-keeping” that enabled him to do that even as it facilitated his federal prosecution. Noting that Lynch had no prior criminal convictions and deeming him neither a typical drug dealer nor a serious threat to public safety, Wu sentenced him to a year and a day in federal prison.

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DEA Failed To Explain Rejection Of Psilocybin Waiver To Treat Cancer Patients, Federal Appeals Court Challenge Says

Lawyers for a doctor in Washington State seeking to legally use psilocybin for end-of-life care argue in a new federal appeals court filing that the Drug Enforcement Administration (DEA) failed to explain a key decision when it denied him access to the psychedelic. They’re asking judges to reverse that move, calling it arbitrary and capricious, and order the government to review the matter anew.

The opening brief filed in the U.S. Court of Appeals for the Ninth Circuit last week is the latest development in what’s become a years-long effort by Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute to treat terminally ill cancer patients with psilocybin.

The new action takes aim against DEA’s decision in 2022 to deny Aggarwal’s requests to access psilocybin under state and federal right-to-try (RTT) laws, which give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use.

Washington State adopted a right-to-try law in 2017, and then-President Donald Trump signed the federal Right to Try Act the following year. Dozens of other states have enacted their own right-to-try policies.

Over the years, Aggarwal has presented DEA with multiple proposals in order either to legally cultivate or otherwise obtain psilocybin to treat his patients, arguing that the federal Controlled Substances Act (CSA) must accommodate a path to legally accessing the substance under RTT laws.

“DEA has rejected each request,” the new brief says, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.”

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DEA Slammed Over Post Commemorating Nixon’s Drug War Legacy On First Day Of Black History Month

The Drug Enforcement Administration (DEA) is facing criticism over its decision to commemorate President Richard Nixon’s drug war legacy in a social media post that coincided with the beginning of Black History Month.

DEA’s Throwback Thursday (or TBT) post on X featured a picture of Nixon receiving a “certificate of special honor” from the International Narcotic Enforcement Officers’ Association in December 1970 “in recognition of the outstanding loyalty and contribution to support narcotic law enforcement.”

Advocates blasted the homage as tone-deaf, memorializing a president whose own domestic policy advisor would later disclose that his boss promoted punitive drug laws in large part to target his political “enemies,” namely “the anti-war left and Black people.”

DEA didn’t necessarily endorse or provide commentary beyond sharing the moment in history—but the TBT post quickly incited criticism given the timing in connection to Black History Month.

It was also about six months after the photo of Nixon was taken that he’d infamously declare a war on drugs, fueling a mass incarceration movement that would have racially disparate impacts lasting generations into the modern day.

As the Drug Policy Alliance (DPA) pointed out, 1970 also marked the year that Nixon signed the Controlled Substances Act (CSA), codifying broad drug criminalization in a way that has long empowered DEA and is actively being reviewed by the agency as it weighs a marijuana rescheduling recommendation from the U.S. Department of Health and Human Services (HHS).

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Democrats urge Biden administration to deschedule marijuana

Senate Democrats are putting new pressure on the Biden administration to ease federal restrictions on marijuana in a new letter to the Drug Enforcement Administration on Tuesday as it considers rescheduling cannabis after it was federally classified more than five decades ago.

The Department of Health and Human Services formally recommended in August that the DEA move the drug from Schedule I to Schedule III of the Controlled Substances Act, or CSA, prompting a monthslong review, which continues.

The letter, from 12 senators led by Elizabeth Warren, D-Mass., and John Fetterman, D-Pa., and signed by Majority Leader Chuck Schumer, D-N.Y., goes further.

“The case for removing marijuana from Schedule I is overwhelming. The DEA should do so by removing cannabis from the CSA altogether, rather than simply placing it in a lower schedule,” the senators wrote in the letter, first obtained by NBC News.

Rescheduling the drug or removing it entirely would have significant implications for the marijuana industry and for cannabis users, some of whom consume it for medical purposes.

Since 1971, cannabis has been under Schedule I, the highest classification of the CSA, along with drugs like heroin and LSD, which the government formally considers to have high potential for abuse and no accepted medical use.

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Senators Tell DEA To Fully Legalize Marijuana, Demanding Answers On Rescheduling Process

Twelve senators are calling on the Drug Enforcement Administration (DEA) to fully legalize cannabis and answer questions about the agency’s ongoing scheduling review.

In a letter sent to Attorney General Merrick Garland and DEA Administrator Anne Milgram on Monday, the lawmakers—led by Sens. Elizabeth Warren (D-MA) and John Fetterman (D-PA), along with Senate Majority Leader Chuck Schumer (D-NY) and other champions of marijuana reform—denounced the “devastating impact” and “out of step” policy of prohibition, arguing that cannabis should be fully removed from the Controlled Substances Act (CSA).

Doing so would present a “rare opportunity to shape the new cannabis industry from the ground up, designing a federal regulatory system untainted by the corporate capture that has influenced alcohol and tobacco regulations, and advancing federal cannabis reforms that acknowledge and repair the harms of cannabis criminalization.”

The U.S. Department of Health and Human Services (HHS) has recommended that DEA move marijuana from Schedule I to Schedule III of the CSA following a scientific review that concluded cannabis does have therapeutic applications and is less harmful than other controlled substances on lower schedules. DEA makes the final decision, however, and is not bound by the HHS recommendation.

“While rescheduling to Schedule III would mark a significant step forward, it would not resolve the worst harms of the current system,” the senators’ letter, which was first reported by NBC News, says. “Thus, the DEA should deschedule marijuana altogether.”

The lawmakers acknowledged that incremental rescheduling “would have some important policy benefits,” however, such as eliminating barriers to research and federal employment for medical cannabis patients, as well as allowing state-licensed marijuana businesses to take federal tax deductions that they’re currently barred from utilizing under the Internal Revenue Service (IRS) code known as 280E.

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12 State Attorneys General Tell DEA To Reschedule Marijuana As ‘Public Safety Imperative’

A coalition of 12 Democratic state attorneys general is urging the Drug Enforcement Administration (DEA) to move forward with federal marijuana rescheduling, calling the policy change a “public safety imperative.”

In a letter led by Colorado Attorney General Phil Weiser (D) that was sent to DEA Administrator Anne Milgram on Friday, the top state law enforcement officials said were “encouraged” to see the U.S. Department of Health and Human Services (HHS) recommend moving cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA) “in the interest of public health and safety.”

“For these reasons, we encourage the DEA to implement a final rule rescheduling cannabis to Schedule III based on the Federal Drug Administration’s [sic] scientific and medical conclusions,” they wrote. “We see this as a public safety imperative and write in support of this policy change.”

“As state attorneys general, we have a responsibility to protect consumers and defend public safety,” they said, adding that they remain concerned about the illicit cannabis market, unregulated sales of intoxicating hemp-based cannabinoid products and the “continuing proliferation of dangerous opioids.”

“State-sanctioned cannabis markets provide access to regulated products that are clearly safer to what individuals can buy on the street—and supporting the effective operation of these regulated markets thus fits with our commitment to addressing the opioid crisis and rising overdose deaths,” the officials said.

“The undersigned appreciate that rescheduling to Schedule III will allow the state-regulated cannabis industry to continue to set the standard for legal products and work to eliminate the illicit market and unregulated intoxicating hemp products that currently operate in interstate commerce. Regardless of the policy choices made, demand for these products will continue. Meeting this demand only in a regulated, legal marketplace better protects consumers.”

The letter also notes that tax revenue from regulated cannabis sales is “material,” contributing “billions of dollars” to state coffers. Moving cannabis to Schedule III would further allow licensed businesses to take federal tax deductions after being excluded form the scope of the 280E provision, which would help them “expand their investments into the state programs and focus on public health and safety in collaboration with law enforcements efforts.”

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Why Some Activists Fear Marijuana Rescheduling: Responding To Former FDA Official’s Dismissal Of Our Concerns 

Politico recently published an extensive Q&A with Howard Sklamberg, a former top Food and Drug Administration (FDA) official who currently works at the law firm Arnold and Porter. Many advocates for legalization and restorative justice have concerns about the rescheduling of cannabis to a Schedule III substance—fears that Sklamberg believes are “alarmist and misguided.”

As a longtime advocate, I have to say that I don’t share that view. Honestly, I can’t believe Sklamberg said some of the things that he said—and I think the fears that we have are well-informed, reasoned and practical, if for no other reason than the worrying lack of transparency coming from regulatory agencies since rescheduling was recommended last year. We advocates are not always right, but our track record on drug policy is better than that of the policymakers and regulators who campaigned for, created and continued the so-called war on drugs.

Regulators, elected officials and their surrogates could benefit from hearing and taking seriously the other side: the concerns that advocates have about cannabis rescheduling. I’ve done my best to capture some of them below.

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