On Friday, a federal court blocked an attempt by the Oregon Health Authority (OHA) to end a psychedelics-related lawsuit. The plaintiffs seek OHA’s support to provide in-home psilocybin access for people with disabilities.

Oregon’s psilocybin services program opened in the summer of 2023. Voters approved Measure 109, the Oregon Psilocybin Services Act, in November of 2020. For two years, OHA drafted rules to govern the resulting program, with input from the Oregon Psilocybin Advisory Board. Since the program opened in 2023, state-licensed facilitators have administered psilocybin to clients only at regulated facilities called service centers.

One year ago, four plaintiffs (Jay Cusker, Alison Grayson, Kathryn Kloos, and Yolanda Suarez) sued OHA in federal court. The plaintiffs had previously asked OHA to develop a process for bringing in-home psilocybin services to people with disabilities who could not visit service centers. The plaintiffs believed this process would constitute a reasonable accommodation under the Americans with Disabilities Act (ADA).

OHA disagreed. The agency said plaintiffs’ request would expand the scope of Oregon’s Psilocybin Services Act. State attorneys argued that “there is no legal pathway to make accommodations for psilocybin to be consumed outside of a licensed service center,” and “the [Oregon Psilocybin Services Act] would need to be amended for accommodations to be permitted.” OHA’s denial of the plaintiffs’ request prompted the ongoing lawsuit, Cusker, et al. v. OHA.

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Last September, OHA’s attorneys filed a motion to have the case dismissed (for lack of subject matter jurisdiction and plaintiffs’ failure to state a claim). The agency made peculiar arguments in support of its motion. First, OHA argued that the federal court lacked jurisdiction to decide the case because plaintiffs were asking OHA to violate federal law. OHA said psilocybin is a Schedule I controlled hallucinogen under the federal Controlled Substances Act. And it’s a federal crime to produce, possess, or distribute a Schedule I drug. Consequently, according to OHA, the plaintiffs’ request for in-home psilocybin services was federally illegal, and a federal court could not require the agency to violate federal law.

That argument is intriguing. Since psilocybin is a Schedule I drug (as OHA points out), one might argue that its entire psilocybin program violates federal law. If allowing facilitators to provide psilocybin in people’s homes violates the federal Controlled Substances Act, then allowing similar conduct in service centers might violate federal law as well.

OHA also argued that the plaintiffs’ request would violate state law—the Oregon Controlled Substances Act (a state version of the federal law)—because dispensing psilocybin outside a service center violates this Act.

The plaintiffs relied on a Hawaii case called Crowder, which involved a quarantine for dogs arriving in the state. Hawaii enforced the law against visually-impaired people with service animals. The U.S. Court of Appeals for the Ninth Circuit found that separating people from their service dogs violated the ADA. The court did not accept Hawaii’s claim that state law should control the outcome. Relying on this case, the federal court in Oregon rejected OHA’s attempt to place the state’s controlled substances act above the federal ADA.

A case involving access to marijuana dispensaries also bolstered the plaintiffs’ case. In Smith v. 116 S Market LLC, the plaintiff claimed that a marijuana dispensary violated the ADA by failing to provide compliant parking spaces for people with disabilities. A district court ordered the dispensary to provide the spaces and an accessible route to its property. Like OHA, the property owner said the court could not order the accommodation because it would force the defendant to facilitate access to a federally-illegal Schedule I substance (in this case, marijuana). The Ninth Circuit ruled for the plaintiff. It said the district court’s order to make the property accessible did not force the owner to facilitate marijuana distribution; it merely required ADA compliance (by providing equal access for people with disabilities).

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In the current psilocybin dispute, Cusker et al., the district court viewed Smith as analogous. Instead of asking OHA to expand the scope of the Oregon Psilocybin Services Act, much like Smith’s plaintiff, Cusker’s were merely requesting equal access for people with disabilities. Consequently, their request, and a court order requiring it, would not violate federal or state controlled substance laws.

Attorney Kathryn Tucker serves on the plaintiffs’ legal team. She told me that before filing their legal claim, her clients approached OHA to request a reasonable accommodation. “We also filed an official tort claim notice before filing suit,” said Tucker. “The agency had ample opportunity to avoid litigation but opted not to.”

Disability access to psilocybin services also came up during OHA’s two-year rule making period (from 2021 - 2022). Some members of the Oregon Psilocybin Advisory Board urged OHA to create access for people with disabilities, for whom it would be burdensome to visit a service center.

OHA declined to address the issue through rule making. As it claimed in Cusker, OHA said it lacks authority under the state psilocybin law to allow in-home facilitation. But that’s not entirely clear.

Oregon’s Psilocybin Services Act granted OHA broad discretionary powers. For instance, in addition to authorizing OHA to license psilocybin facilitators and service centers, the Act allowed the agency to regulate psilocybin services “for other purposes as deemed necessary or appropriate by the authority.” The Act prohibited construing its text to “exempt a person from a federal law,” which arguably includes the Americans with Disabilities Act. It gave OHA unstated, implied powers “necessary or proper” to carry out its functions. Furthermore, it prohibited OHA from refusing to perform duties by claiming that certain conduct is illegal under federal law . In other words, OHA had flexibility to interpret the psilocybin act in a manner consistent with ADA requirements.

Similar issues emerged in Colorado. The state’s natural medicine advisory board raised concerns about in-home access for people with disabilities. The Department of Regulatory Agencies (DORA), Colorado’s OHA equivalent, initially entertained the possibility. It seemed like DORA and its advisory board might adopt rules to allow flexible in-home services. However, shortly before finalizing the rules, DORA proposed an amendment to limit home services to people requiring palliative care. That would exclude other individuals, such as people with physical impairments or conditions such as severe post-traumatic stress disorder or social anxiety disorder.

Cusker could set an important precedent. Outside Oregon, people with disabilities could sue state agencies for similar ADA accommodations. Lawmakers drafting psychedelic legal reforms might put disability access at the heart of their bills.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and a visiting fellowat the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek. Follow him on LinkedIn and Bluesky.

Updated May 22, 2025 with additional details on the Church of Gaia, its attorneys, and their legal strategy.

A psychedelic church has reported receiving the first religious exemption to the Controlled Substances Act (CSA) without filing a lawsuit against the Drug Enforcement Administration (DEA).

The Church of Gaia, based in Spokane, Washington, views ayahuasca as a religious sacrament, as do several Indigenous communities of South America’s Amazon basin. Prior to consuming ayahuasca, practitioners brew the tea by combining Psychotria viridis and Banisteriopsis caapi, plants native to the Amazon.

Lawyers Pat Donahue and Taylor Loyden of Terrapin Legal advised the Church of Gaia during its DEA petition process. Attorney John Rapp provided legal guidance. Their client, the church’s founder Connor Mize, chose to pursue an unorthodox legal strategy—the church vowed to suspend its use of ayahuasca while awaiting DEA’s decision. According to Rapp, “Gaia’s the first DEA petitioner to suspend practice—a moving show of lawful intent.”

Technically, DEA has long provided a path for religious groups to receive CSA exemptions under the Religious Freedom Restoration Act (RFRA). Congress enacted RFRA in 1993, shortly after the infamous 1990 Supreme Court case Employment Division of Oregon v. Smith.

Al Smith was fired from his job for participating in peyote ceremonies held by the Native American Church. When Smith applied for unemployment benefits, the state denied his application. Oregon claimed Smith was ineligible because he was fired for violating the state’s criminal drug law. Smith sued, challenging the constitutionality of Oregon’s law, which had restricted his religious freedom.

Although lower courts ruled for Smith, he lost after the U.S. Supreme Court heard his case. In a famous opinion, Justice Antonin Scalia wrote that Smith should not prevail because Oregon’s law did not target religious practice. It was a law of general applicability. In other words, it applied equally to everyone, religious and secular.

The Smith case shocked religious communities. Prior Supreme Court opinions were deeply skeptical when government actions substantial burdened religious practice. Before Smith, such actions had to meet strict scrutiny, the most demanding legal standard, to survive constitutional challenges. But after Smith, courts could presume that government burdens on religious practice were constitutional, if they were neutral and did not target religion. In response, a broad coalition lobbied Congress to strengthen federal protections for religion, even against neutral laws. Congress enacted RFRA in 1993.

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In theory, RFRA exemptions to CSA regulations would allow religious communities to import, store, dispense, and consume Schedule I controlled substances that are central to their spiritual practices. However, until recently, no churches had received a RFRA exemption without suing DEA. Even then, only a few succeeded.

In the 2006 Supreme Court case Gonzales v. UDV, a group named O Centro Espírita Beneficente União do Vegetal (UDV) won a RFRA exemption. The victory allowed the UDV to import ayahuasca from Brazil. In 2009, a U.S. District Court handed a similar exemption to an Oregon branch of the Santo Daime Church.

Other RFRA petitions languished on DEA’s desk. According to the U.S. Government Accountability Office (GAO), DEA received twenty four petitions in the eight-year period from 2016 to 2024. None were granted. After waiting for years, some groups withdrew their petitions.

In early 2024, GAO published a report urging DEA to improve its religious exemption process for psilocybin-producing mushrooms and other controlled substances. Around that time, the Church of the Eagle and the Condor settled a lawsuit with DEA. The settlement provided the RFRA exemption sought by the church. But it came at the cost of having to wage a legal battle against DEA.

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The Church of Gaia appears to have received the first RFRA exemption granted through the petition process, without litigation. On Thursday, it published a press release announcing the outcome of its DEA petition. According to the church, “Gaia’s religious traditions are rooted in deep spiritual beliefs, and its sacramental practices will be conducted in a respectful and structured setting. In accordance with their agreement with the DEA, the church is required to adhere to stringent security protocols.”

Does this outcome reflect a new era for religious exemptions at DEA following GAO’s report calling for reform? Did the church’s success result from its abstinence from ayahuasca and effective negotiating by its legal team? Perhaps a combination of factors? Time will tell if other legal teams can obtain similar results for their clients.

One thing appears certain—interest in religious use of psychedelics appears to be growing. New psychedelic churches frequently emerge. Even established religious groups, including Christians, Jews, and Muslims, are integrating psychedelics into ceremonial practices.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and a visiting fellowat the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek. Follow him on LinkedIn and Bluesky.

In a new paper, Separation of Drug Scheduling Powers, forthcoming in the Yale Law Journal Forum, I analyze the roles of federal agencies in drug scheduling. This complex administrative process determines which drugs are dangerous or addictive enough to require strict regulation. The Controlled Substances Act (CSA) of 1970 provides criteria for determining which drugs should be controlled, and which of five tiers or schedules they should fall into (where Schedule I substances are the most strictly regulated and Schedule V the least).

It is commonly believed that the Drug Enforcement Administration (DEA) is responsible for drug scheduling determinations, while the Department of Health and Human Services (HHS) plays only an advisory role. However, my analysis of the CSA text, structure, purpose, and history suggests otherwise. The Secretary of HHS, currently Robert F. Kennedy Jr., has more scheduling power than is commonly acknowledged. The Secretary can block and constrain DEA scheduling proposals. However, since 1970, HHS has frequently minimized its drug scheduling role, and DEA has effectively assumed scientific decision-making authority meant for public health officials.

President Nixon submitted the first CSA draft to Congress in 1969. In a series of hearings held then and the following year, Congress debated Nixon’s version and subsequent Senate and House drafts. Nixon wanted the U.S. Attorney General in charge of drug control. But that choice concerned physicians, medical researchers, public health officials, and members of Congress. They worried that placing the nation’s highest law enforcement official in charge of drug scheduling would prevent researchers from studying controlled drugs and block doctors from prescribing them.

Health experts from leading hospitals, medical schools, and healthcare associations urged Congress to place scheduling power in the Secretary’s hands. Congress heard and addressed their concerns. According to Representative Rogers speaking on the House Floor, “[T]he scientific community and medical community of this Nation were greatly upset over the fact that scientific and medical decisions in the Senate bill were entered in the [DOJ], with the [AG] having the responsibility to make scientific and medical determinations which were not in the competency of that Department. Rogers said Congress had changed that, so that the Secretary “will determine scientific and medical decisions. This is a most important change.”

Congress effectively reached a compromise, dividing scheduling authority between the law enforcement and public health officials. The Secretary would make scientific and medical judgements regarding drug scheduling, and the Attorney General would make non-scientific, law enforcement decisions (today, the Attorney General delegates drug scheduling authority to DEA, and HHS delegates many responsibilities to the FDA).

In 1970, Representative Springer highlighted this division of scheduling authority. “Let us also make a definite point of the fact that purely enforcement responsibilities are placed with [DOJ],” he said, whereas “medical and scientific judgments necessary to drug control are left where they properly should lie [with the Secretary].”

Federal officials acknowledged this division of labor for at least ten years. But by 1984, when DEA proposed classifying MDMA as a Schedule I drug, the separation of drug scheduling powers created by Congress was largely overlooked.

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In Grinspoon v. DEA, decided by the U.S. Court of Appeals for the First Circuit in 1986, Harvard Medical School professor Lester Grinspoon challenged the DEA proposal to schedule MDMA. He and other medical experts argued that categorizing MDMA as Schedule I was unwarranted and would impede scientific research. Judges of the First Circuit were not persuaded. And the DEA successfully placed MDMA in Schedule I, an outcome that impeded scientific research on MDMA for decades.

Notably, in Grinspoon, the court underestimated HHS’s role in drug scheduling, but the agency did as well. Instead of performing a scientific and medical evaluation and developing scheduling recommendations, HHS “simply rubber-stamped” DEA’s analysis, according to the court. Furthermore, FDA failed to send HHS information that might have undermined DEA’s proposal. Nevertheless, the court concluded that these failures amounted to nothing more than harmless error because DEA need not follow the Secretary’s recommendations. But Congress, the CSA, and the U.S. Supreme Court say otherwise.

The CSA requires HHS to draft scientific and medical recommendations that include whether a drug should be controlled, and if so, the appropriate schedule to which it should be added. Importantly, the CSA binds DEA to those recommendations, which is consistent with numerous statements made during 1970 congressional hearings. As health experts and members of Congress repeatedly said, it would be inappropriate for law enforcement officials to make scientific or medical judgements. Accordingly, those decisions are the exclusive domain of the Secretary. And consequently, DEA should be bound to them, as required by the CSA. Justice Kennedy seemingly agreed in the only U.S. Supreme Court opinion to address this statutory division of power, Gonzales v. Oregon (2006).

Gonzales was not about drug scheduling. But the Court considered whether the U.S. Attorney General could make scientific or medical decisions. After Oregon legalized physician-assisted suicide, the Attorney General threatened to revoke the DEA licenses of doctors who prescribed drugs for this purpose. Although FDA had approved the drugs for other uses, prescribing them for euthanasia was an unapproved, off label use.

Justice Kennedy analyzed the text and structure of the CSA, as well as its legislative history. He concluded that “the Attorney General does not have the sole delegated authority under the CSA. He must instead share it with, and in some respects defer to, the Secretary, whose functions are likewise delineated and confined by the statute.”

Kennedy quoted the Congressional Record of 1974. “All decisions of a medical nature are to be made by the Secretary.” In contrast, the Attorney General makes law enforcement decisions, for instance, judgments regarding the security of stocks of controlled drugs and the maintenance of required records. Furthermore, the CSA’s structure “conveys unwillingness to cede medical judgments to an executive official who lacks medical expertise.”

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What does all this legal history mean for drug scheduling today? In Separation of Drug Scheduling Powers, I explain how the Secretary of HHS has the power to overrule and constrain DEA when the agency makes drug scheduling proposals. That means RFK Jr. could potentially deschedule controlled substances, removing them from Schedule I and federal control under the CSA.

I argue that the Secretary has two distinct but interrelated powers, which are defined by 21 U.S.C. 811(b). This CSA provision binds DEA to the Secretary’s scientific and medical recommendations. One sentence defines both a powerful drug control veto and a more subtle scheduling veto. The control veto empowers HHS to overrule drug scheduling proposals if it believes a drug should not be controlled. Dr. Brett Giroir, Assistant Secretary for Health during President Trump’s first term, used the control veto to prevent DEA from controlling kratom, a psychoactive plant native to Southeast Asia. Although used infrequently, the control veto is universally accepted. Even DEA and the Grinspoon court would acknowledge its legitimacy.

Rather than overriding DEA, the HHS scheduling veto can constrain DEA’s scheduling options. For instance, if HHS believes that a drug should be controlled rather than removed from all schedules, the Secretary’s recommendation could limit which schedules DEA can select for a substance—DEA lacks statutory authority to select any schedule it likes.

In 1970, Representative Satterfield described the control and scheduling vetoes. First, he referenced the control veto, stating, “I point specifically to the provision which will give the Secretary the power and the authority to prohibit control of a drug which he determines from a medical or scientific standpoint should not be controlled.” Satterfield then described the scheduling veto, claiming, “by the same token,” the Secretary can “prohibit transfer of a drug from one category to another.”

Notice that preventing the transfer a drug from one schedule to another is not something the control veto can achieve. It’s too blunt an instrument for that. If limited to the control veto, the Secretary could only recommend that a substance be removed entirely from federal control to block its transfer to another schedule.

The scheduling veto provides a more nuanced alternative. Because the Secretary’s scientific recommendations must include the appropriate schedule for each drug, and they bind DEA, the recommendations should limit the schedules into which DEA can place a drug. If instead of recommending that kratom remain uncontrolled, HHS had recommended that it be classified as a Schedule III drug, that recommendation should limit DEA to scheduling kratom no higher than Schedule III. In fact, for at least a decade, that appears to have been the custom. In 1980, Frank Vocci, Chief of Drug Abuse at FDA, wrote that DEA can select a lower schedule than recommended by the Secretary but DEA “will not opt to control in a higher schedule.”

Despite Satterfield’s remarks and prior custom, the scheduling veto is more controversial than the control veto. Last year, when Biden’s plan to reschedule marijuana was advancing, HHS and DEA clashed over the portion of CSA text that describes the Secretary’s scientific and medical recommendations. Consistent with the Gonzales opinion, and the CSA text and legislative history, HHS argued that the Secretary’s recommendations bind DEA throughout the scheduling process. In contrast, DEA claimed that once it announced a proposed scheduling rule, such as the proposal to reschedule marijuana, DEA was no longer bound by the Secretary’s recommendations.

The Office of Legal Counsel (OLC) within the Department of Justice sided with DEA. OLC concluded that the Secretary’s recommendations could not bind DEA once it started the rulemaking process. In the forthcoming paper, I explain why OLC’s interpretation is incorrect.

Interestingly, OLC acknowledged that Congress had placed all scientific and medical decisions solely in the Secretary’s hands. Nevertheless, OLC concluded that the Administrative Procedure Act precluded limiting DEA’s scheduling choices once rulemaking started. Specifically, constraining DEA to the Secretary’s conclusions would deprive interested stakeholders of the opportunity to present evidence that might contradict the Secretary’s conclusions (when DEA proposes a scheduling change, it holds a hearing where stakeholders can testify).

DEA has made similar arguments in the past. For instance, in a hearing to schedule the drug carisoprodol, an administrative law judge stated that DEA could not second guess or re-litigate the Secretary’s scientific or medical recommendations. The DEA Administrator overruled the administrative law judge. In doing so, she cited the Administrative Procedure Act, making claims comparable to OLC’s marijuana rescheduling opinion. But DEA and OLC got it wrong.

Concluding that the Secretary’s scientific and medical recommendations do not bind DEA once rulemaking begins contradicts the CSA text, purpose, and history. 21 U.S.C. 811(b) binds DEA to the Secretary’s recommendations without limitation, and the history of the CSA contains substantial evidence that Congress meant for medical judgements to be made by the Secretary alone, as concluded by Justice Kennedy concluded in Gonzales. Allowing law enforcement officials to make scientific judgments undermines the text of the CSA, its purpose, and the intent of Congress.

Numerous unscientific scheduling decisions illustrate what happens when the separation of drug scheduling powers is disrupted. Instead of maintaining access to controlled substances for scientists and medical professionals, the fears expressed by public health experts in 1970 have largely materialized.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and a visiting fellowat the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek. Follow him on LinkedIn and Bluesky.

While scientific and political interest in psychedelics often takes center stage, spiritual use can be overlooked. That may change in 2025. Last year brought delays for the availability of FDA-approved psychedelics such as MDMA and psilocybin, and state legal proposals slowed or experienced setbacks.

Facing high regulatory costs, licensed psilocybin service centers in Oregon have experienced challenges, and some have closed. Colorado psilocybin centers open this year, but their outlook is uncertain given similarly high operating costs. Colorado also faces a $1 billion budget shortfall, which could impact the state’s regulated program.

In the meantime, people increasingly turn to spiritual or religious communities that utilize psychedelics. Colorado recently decriminalized growing, sharing, and consuming certain psychedelic plants and fungi, which allows churches to operate under state law (although their federal legal status is at best unclear, and at worst, clearly illegal).

Psychedelic spirituality is nothing new. Indigenous communities developed it (as well as psychedelic healing). However, lawmakers, researchers, and reporters usually focus on clinical trials and commercializing psychedelic medicines. There are exceptions.

Brian Muraresku’s 2020 New York Times bestseller The Immortality Key prominently featured religious use, exploring its history in Western civilization. Native American communities are working to preserve their longstanding spiritual traditions and natural resources. Some groups, such as the Sacred Garden Community, the Church of the Holy Light of the Queen, and the Church of Ambrosia, have openly discussed psychedelic sacraments for years.

In addition, psychedelic churches have seemingly become more common and visible. Both established and emerging groups maintain public websites and include large numbers of religious practitioners. The academic and practical study of psychedelic religion is also becoming popular.

In 2025, psychedelic researchers and academic programs focus on religious groups and the legal and ethical challenges they face. Last semester, with colleagues at Harvard Law School’s Petrie-Flom Center, I co-founded the project on Psychedelic Use, Law, and Religious Experience (PULSE). Funded by a grant from the Mahindra Humanities Center, the project is part of the Harvard Study of Psychedelics in Society and Culture. PULSE convenes legal and religious scholars and practitioners with diverse perspectives to discuss how law, policy, and ethics affect the religious and spiritual use of psychedelics.

This Valentine’s Day, PULSE will host a free afternoon conference on law and psychedelic religion at Harvard Law School. The public event will feature panels and discussions with law professors, attorneys, religious scholars, and religious practitioners, including PULSE affiliated researchers.

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More details on registration and the lineup of speakers will follow shortly. In the meantime, please mark your calendars (the on-campus conference will run from approximately 1:30 - 5:00 PM Eastern on February 14).

The February PULSE event dovetails with the Psychedelic Intersections 2025 Conference hosted by the Center for the Study of World Religions (CSWR) at Harvard Divinity School. Organized by CSWR staff, including PULSE-affiliated researchers Jeffrey Breau and Paul Gillis-Smith, this year’s Psychedelic Intersections event focuses on Chaplaincy, Plant Medicine, and Aesthetics. PULSE will contribute a panel on law and psychedelic churches to the event’s impressive lineup.

More programming on psychedelic law and religion will follow in March, when the Jules-Rabinowitz Program on Jewish and Israeli Law holds its annual conference. Psychedelics in Monotheistic Traditions: Sacramental Practice and Legal Recognition will run March 5-6. Organized by Professor Noah Feldman and rabbi, professor, and author Jay Michaelson (also a PULSE affiliated researcher), this event will address psychedelic use in Jewish, Christian, and Muslim communities, and related topics.

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Other academic institutions are focusing on psychedelic spirituality in 2025, including Emory’s Center for Psychedelics and Spirituality and UC Berkeley’s Center for the Science of Psychedelics. This year, the increased visibility of psychedelic spirituality might catch the public’s attention, and appear more prominently on the radar of courts, lawmakers, and regulators.

*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and a visiting fellow at the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek. Follow him on LinkedIn and Bluesky.

The campaign to legalize supervised psychedelic use in Massachusetts has failed. Though only 79% of the votes had been counted by 1:39 AM this morning, the votes against Question 4 outnumbered those in favor by nearly 400,000.

When results started rolling in last night at around 9 PM, the votes in favor and against the initiative were nearly even. But the “no” votes accumulated quickly to surpass those in favor, and the gap widened throughout the evening and early morning hours. Opponents declared victory at around 1:00 AM.

The campaign to pass Question 4 launched on July 3, 2023 as Massachusetts for Mental Health Options. It was funded and overseen by the Washington, DC-based New Approach PAC. The PAC had funded successful psychedelic ballot initiatives, including Oregon’s Measure 109 in 2020 and Colorado’s Proposition 122 in 2022.

New Approach previously ran succesful campaigns to legalize marijuana in many U.S. states, including Massachusetts. In 2016, the state legalized adult marijuana use through a ballot initiative that was also named Question 4.

If Question 4 had passed this morning, it would have decriminalized plants and fungi containing five psychedelic substances in December, including psilocybin, psilocin, ibogaine, DMT, and mescaline. Criminal penalties would have been eliminated for their limited cultivation, possession, and sharing.

Question 4 would also have created a state psychedelic agency modeled after the Massachusetts Cannabis Control Commission. The agency would have drafted rules for the resulting psychedelic industry, which would open in 2026. A state psychedelic advisory board would have been formed to make regulatory recommendations to the new agency.

Proponents of Question 4 claimed psychedelics could help address the state’s mental health crisis. However, the ballot initiative was controversial. In March, state lawmakers formed a rare Special Joint Committee on Initiative Petitions. New Approach and its campaign organized a series of panels to inform the Committee. Speakers included doctors, patients, parents, political strategists, and politicians. In its formal report, the Committee raised concerns regarding Question 4 and declined to recommend it to the legislature, which reserves the right to enact ballot initiatives before they reach voters.

In October, the editorial board of the Boston Globe failed to endorse Question 4, citing safety concerns. The Tufts University Center for State Policy (cSPA) published a report on legalizing psychedelic drugs. Among the possible benefits, cSPA found that psilocybin showed promise for treating some mental health conditions. However, it noted that psychedelics also carry risks. “For instance, ibogaine can cause acute cardiac problems.” cSPA concluded that state-regulated psychedelic treatments “would likely be expensive,” and because psychedelic remain federally illegal, “Question 4 could put Massachusetts at risk of a future federal backlash.”

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It’s unclear what led voters to reject Question 4. In Massachusetts, New Approach faced greater opposition than it had in other states. Recent scandals plaguing the Massachusetts Cannabis Control Commission might have contributed to voters’ hesitation.

Nevertheless, the Yes On 4 campaign gained an impressive list of supporters, including actress Eliza Dushku, U.S. Senator Elizabeth Warren, and many doctors, veterans, and researchers from across the country. The campaign produced polished television advertisements and held press conferences outside the State House.

New Approach reportedly chose Massachusetts as the site of its psychedelic campaign due to polling. “After some initial exploration — considering the timeline and our capacity to take this on — we looked at the bigger picture and it became clear that Massachusetts would be a pretty great place to launch a campaign,” said New Approach Policy Director Jared Moffat last year.

Massachusetts was already home to significant grassroots activism. It led the nation for local psychedelic decriminalization. Today, eight Massachusetts cities have decriminalized psychedelics by making them their lowest law enforcement priority.

It is unclear what Question 4’s failure means for the future of psychedelic policy in the state. Due to limitations of the state constitution, no substantially similar ballot initiatives can be filed for two years. It also remains uncertain how this outcome will impact psychedelic policy in other states.

In Massachusetts, lawmakers might pick up the issue, or local psychedelic decriminalization could continue to expand.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a visiting professor of law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an visiting fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

Speakers from Massachusetts, Oregon, and Colorado met Friday to discuss ballot Question 4, including:

Victoria Litman (Moderator), Roger Williams University School of Law

Ashley Troxell, Psyched 4, Colorado

Heidi Venture, Vital Reset Psilocybin Service Center, Hood River, Oregon

James Davis, Bay Staters for Natural Medicine

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR or PULSE at the Petrie-Flom Center at Harvard Law School, Florida State University, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor of Law at Florida State University, senior fellowand project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

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Next week, Massachusetts will decide the fate of ballot Question 4. If voters approve it, the state will decriminalize sharing and home cultivation of several psychedelic plants and fungi. It will create a psychedelic agency like the Massachusetts Cannabis Control Commission and draft rules to govern the supervised use of psychedelics. Polling suggests that voters are split, and many remain undecided. All would benefit from a balanced discussion of this important voter ballot initiative.

Join Psychedelic Week this evening at 8pm Eastern for a 90-minute moderated discussion of Question 4. Register for free to receive the webinar link.

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The conversation will include speakers with a diversity of perspectives on the ballot question, including:

Victoria Litman (Moderator), Roger Williams University School of Law

Graham Moore, Massachusetts for Mental Health Options (withdrawn)

Ashley Troxell, Psyched 4, Colorado

Heidi Venture, Vital Reset Psilocybin Service Center, Hood River, Oregon

James Davis, Bay Staters for Natural Medicine

Jamie Morey, Massachusetts for Mental Health Options, Parents for Plant Medicine (withdrawn)

Free registration at this link.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR or PULSE at the Petrie-Flom Center at Harvard Law School, Florida State University, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor of Law at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

Updated August 12, 2024 with information about a third retracted paper

Yesterday, the journal Psychopharmacology retracted three papers reporting the results of studies conducted by Lykos Therapeutics (previously known as MAPS PBC). The retractions came one day after the FDA declined to approve Lykos’ MDMA-assisted therapy (MDMA-AT) for the treatment of post traumatic stress disorder. In a complete response letter to Lykos’ new drug application, the FDA asked Lykos to perform a third phase 3 clinical trial.

The first retracted paper, published in 2019, is a meta-analysis of six phase 2 clinical trials of Lykos MDMA-AT. It has ten authors, including a chief architect of Lykos’ clinical protocols Michael Mithoefer, his research partner and wife Anne Mithoefer, Lykos chief scientific officer Berra Yazar-Klosinski, Lykos CEO Amy Emerson, and MAPS founder and Lykos executive board member Rick Doblin.

The second retracted paper, published in 2020, reports on a long-term follow up study of six phase 2 clinical trials. It has six authors, including Yazar-Klosinski, Michael Mithoefer, Emerson, and Doblin.

The third retracted paper, published in 2021, reported the results of a study that explored the effects of gradually discontinuing treatment with selective serotonin reuptake inhibitors (SSRIs) prior to receiving treatment with MDMA. Its authors include Allison A. Feduccia, Lisa Jerome, Michael Mithoefer, and Julie Holland.

Independent journalist Sasha Sisko sent Psychopharmacology editors a request for retractions in 2023.

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According to retraction notices for the first two articles:

“The Editors have retracted this article after they were informed of protocol violations amounting to unethical conduct at the MP4 study site by researchers associated with this project. The authors have subsequently confirmed that they were aware of these violations at the time of submission of this article, but did not disclose this information to the journal or remove data generated by this site from their analysis. Additionally, the authors also did not fully declare a potential competing interest. Several of the authors are affiliated with either the Multidisciplinary Association for Psychedelic Studies (MAPS) or MAPS Public Benefit Corporation (MAPS PBC), a subsidiary that is wholly owned by MAPS. As is stated in the Funding declaration, MAPS fully funded and provided the MDMA that was used in this trial, and MAPS PBC organised the trial.”

Only one co-author, Allison A. Feduccia, the co-founder and CEO of Psychedelic Support, “agrees with this retraction but disagrees with the wording,” states each retraction notice. Feduccia worked for MAPS PBC (now called Lykos) for over five years as a clinical trial leader, clinical data scientist, and senior clinical data scientist.

The first retraction further states, “Michael C. Mithoefer, Lisa Jerome, Anne Mithoefer, Mark Wagner, Berra Yazar-Klosinski, and Rick Doblin disagree with this retraction. Zach Walsh stated that they neither agree nor disagree with this retraction. The remaining authors did not respond to correspondence from the Publisher about this retraction.”

The second retraction states, “Michael C. Mithoefer, Lisa Jerome, Berra Yazar-Klosinski, and Rick Doblin disagree with this retraction. The remaining authors did not respond to correspondence from the Publisher about this retraction.”

Joar Øveraas Halvorsen, associate professor of psychology at the Norwegian University of Science and Technology, posted about the retractions this morning.

This is a developing story, and more details will surely emerge. It is unclear what these retractions could mean for Lykos and the potential third phase 3 trial requested by the FDA.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University, the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an visiting fellow at the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

As I enter the final push to complete my upcoming book on psychedelic law, my activity on Psychedelic Week has slowed. I write to provide an update and assure you that I’ll resume posting more frequently soon.

I want to thank you for your interest in this newsletter. It has been a pleasure to develop, and I have big plans for it after I submit the nearly-completed book.

Recent Events

In addition to completing several academic writing projects, I’ve been fortunate to co-host several psychedelic events at Harvard Law School’s Petrie-Flom Center.

Last week, we hosted our first psychedelic law and policy bootcamp. This four-day event convened over fifty people from all corners of the psychedelic ecosystem. Participants learned from expert lawyers, healthcare professionals, medical researchers, bioethicists, religious scholars, and spiritual leaders. They discussed timely topics such as federal drug scheduling, state psychedelic regulation, psychedelic clinical trials, the commercialization of psychedelic medicines, engaging respectfully with Indigenous communities, religious freedom, and intellectual property rights. The Psychedelics Bootcamp 2024 was made possible by a generous gift from the Gracias Family Foundation.

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In June, the Petrie-Flom Center held its annual academic conference, which focused on the law and policy of psychedelic medicine this year. All sessions are viewable online for free thanks to the Project on Psychedelics Law and Regulation (POPLAR), the Saisei Foundation, Tim Ferriss, Matt Mullenweg, and the Oswald DeN. Cammann Fund at Harvard University.

To launch the annual conference, we held a fireside chat with New York Times-bestselling author Ayelet Waldman, whose 2017 memoir A Really Good Day helped launch the psychedelic renaissance. Other conference sessions addressed psychedelics in medical and therapeutic practice; human rights and constitutional rights; cross-cultural, indigenous, and spiritual use; research, innovation, and patents; and legalization and access, which was divided into part I and part II. Conference speakers are contributing chapters to an edited volume that we will publish with an academic press.

Recent Publications

Last week, I published a JAMA Viewpoint article titled Psychedelic Therapy Scrutinized by FDA Advisory Committee? The full article is available here. It analyzes the June 4 FDA advisory committee meeting on Lykos and its new drug application for MDMA-AT. I discuss the advisory committee votes and what they mean for the future of psychedelic research.

Thank you for your patience while I wrap up the current book project. I look forward to sharing more details about it soon.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University, the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an visiting fellow at the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

*Updated May 15, 2024 with additional information regarding Christine Diindiisi McCleave.

On Wednesday, May 8, Colorado’s Department of Regulatory Agencies (DORA) will hold the first meeting of its Federally Recognized American Tribes and Indigenous Community Working Group. The meeting is scheduled to run from 2 - 5pm Mountain Time.

For the past year, Colorado’s Natural Medicine Advisory Board, which started meeting in April of 2023, advised DORA on rules to implement the Natural Medicine Health Act (NMHA) and Senate Bill 290 (SB-290). In late 2022, Colorado voters approved the NMHA, which decriminalized four psychedelic plants and fungi and set the state’s regulated psychedelic industry in motion. In 2023, the Colorado legislature amended the NMHA by enacting SB-290.

Unlike the Advisory Board, which received significant media coverage when Governor Jared Polis announced its members in January of 2023, the tribal and Indigenous working group was quietly appointed by DORA without publicity.

The working group has been a long time coming. Last May, Polis signed SB-290, requiring DORA to assemble the group. During a summer Advisory Board meeting, DORA official Sam Bahrami said the working group might start meeting as early as August of 2023. However, nine months later, the group still hasn’t convened. Last month, DORA said the selection process for members was ongoing and the group’s first meeting would likely occur on May 8.

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The year-long wait to assemble the working group is notable because SB-290 requires its formation “for the purpose of engaging and creating a dialogue to identify issues related to the commercialization of natural medicine,” including “avoiding the misappropriation and exploitation of the federally recognized tribes and Indigenous people, communities, cultures, and religions.” The law also requires the group to advise DORA on conservation issues regarding psychedelics and best practices to build trust with Indigenous people.

However, DORA recently released final draft rules for a significant portion of its natural medicine program, including rules applicable to Native Americans and other Indigenous communities, such as rules for psychedelic facilitator training and an accelerated licensing path for traditional healers.

Last week, DORA heard final public comments on those rules. The agency will adopt final rules sometime this month and file them with Colorado’s Secretary of State by May 31, 2024.

Because many of DORA’s final draft rules are already written, and will be finalized this month, one might ask what purpose is there for the tribal and Indigenous working group? Is its presence merely symbolic? Perhaps we’ll know more when the group convenes on Wednesday. The meeting agenda includes an orientation, discussion of a work plan and timeline, and planning for the group’s next meeting. The agenda includes no further details.

The working group includes ten people (nine voting members and one non-voting moderator). DORA describes five as residents of Colorado. The other five members live in Arizona, California, Minnesota, New Mexico, and New York. Two participants (Knight and Whiteman) are members of Colorado’s Ute Mountain Ute Tribe. One member (McCleave) represents the Turtle Mountain Anishinaabe (Ojibwe) Nation. Three members (Dayish, Eriacho, and Robbins) represent the Navajo Nation. One member (Guerra) represents Chicano culture and the Coahuiltecan of South Texas and Northeastern Mexico. Another (Allen) is a member of the Sac and Fox Nation of Oklahoma and the Northern Arapaho Tribe.

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Most group members ostensibly represent tribal communities that utilize peyote cactus in ceremonial contexts. Peyote contains mescaline, one of five psychedelic substances encompassed by the NMHA and SB-290. However, both exclude mescaline derived from peyote, which remains criminalized under Colorado law.

At first glance, it appears that only one member (but perhaps two) represents communities that utilize psilocybin mushrooms. Notably absent from the working group are representatives of Indigenous communities who use iboga, an ibogaine-producing plant sacred to practitioners of the African Bwiti religion prevalent in Gabon and surrounding countries.

The working group also appears to lack representation of communities who utilize ayahuasca, which contains dimethyltryptamine and is utilized by Indigenous people in South America and churches throughout the United States.

The apparent absence of people experienced with religious or Indigenous use of ibogaine and dimethyltryptamine is notable because these substances are among the psychedelics DORA has authority to regulate and that Colorado healing centers could potentially dispense. SB-290 amended the NMHA to re-criminalize the sharing of iboga by individuals and communities, which voters had decriminalized by enacting the NMHA. SB-290 also fast-tracked potential regulatory approval of ibogaine, which would allow healing centers to offer it as early as 2025.

SB-290 does not limit the number of members who can serve on the working group, and DORA could appoint additional participants. However, because psilocybin is the only psychedelic certain to be offered by Colorado healing centers next year, the relative lack of representation of psilocybin practitioners suggests that aligning the group’s composition with the substances most likely to be regulated may not have been DORA’s priority.

The Federally Recognized American Tribes and Indigenous Community Working Group includes the following participants:

Tom Allen - Arvada, Colorado  

Tom Allen is a member of the Sac and Fox Nation of Oklahoma and the Northern Arapaho Tribe. Of the newly appointed members, he has the smallest online presence. He serves on the Denver American Indian Commission, which advocates on behalf of the city’s American Indian community.

In 2019, Colorado Public Radio interviewed Allen for an article on the Denver March Pow Wow, a three day exhibition featuring over “1,500 dancers from close to 100 tribes from 38 states and three Canadian provinces.”

Allen told reporters many tribal elders meet at the Pow Wow to create and sell artwork. Since early childhood, Allen has created Native American beadwork, a skill he learned from his father.

“Beadwork is a expression of a Native American, I think, ingenuity and creativity,” said Allen in 2019. “I know when my father taught me to bead, he said there should be some kind of imperfection in it. ‘Cause we believe there's a spirit in what we make, and the imperfection is where that spirit will come out of it.”

Like his father once did, Allen works at the Denver Indian Center, described as “an urban cultural gathering center for the American Indian and Alaska Native community of the Denver Metro area.”

Daniel Castro - Boulder, Colorado

According to an online biography from the University of Colorado, Denver, “Daniel Castro-Kuthoomi (they/them) 44, is an Indigenous Mestizos Kichwa Two Spirits born and raised in Ecuador who has been on the Curanderismo path since the age of 12.”

Castro-Kuthoomi was “under the apprenticeship of Mama Ines and Taita Luis, medicine elders of the Kuyaloma community of Napo-Ecuador, since 2009,” and “is a licensed clinical mental health counselor and provides mental health support to the Colorado community through their private online practice, Decolonial Counseling, LLC.”

Castro is one of five protestors who took the stage during Rick Doblin’s closing remarks at the Psychedelic Science 2023 conference organized by the Multidisciplinary Association for Psychedelic Studies (MAPS).

Sherrill “Tekatsitsikwa Katsi Cook” Barreiro  - Akwesasne, New York

Tekatsitsikwa Katsi Cook is a Wolf Clan Mohawk Native American Midwife. According to Inspire, a Canadian charity that invests in education for First Nations, Inuit and Métis people, Katsi Cook “is a beloved Native woman leader and Elder.” Inspire credits her with spawning “a new generation of Aboriginal midwives.” She reportedly “operationalized the exemption for Aboriginal Midwives under the Ontario Midwifery Act and Regulated Health Professions Act (1994).” That experience could prove helpful as DORA grapples with exemption criteria for Indigenous natural medicine facilitators in Colorado. However, as mentioned above, it remains unclear whether the working group will have input regarding the exemption.

Frank Dayish  - Gallup, New Mexico

Frank Dayish is a two-time vice president of the Navajo Nation, serving from 2002 to 2006. In 2020, he became CEO of the Navajo Housing Authority. In 2022, Dayish launched a bid for the Navajo Nation presidency.

From 1986 to 1995, Dayish served as president of the Native American Church of North America (NACNA). He was a radio operator in the US Marine Corps in the 1970s. Dayish studied business at New Mexico State University before earning a Master of General Administration from the University of Maryland.

Belinda P. Eriacho - Tempe, Arizona

Belinda Eriacho is a Native American healer of Dine’ (Navajo) and Zuni ancestry. After Eriacho and her brother experienced illnesses, she was inspired to become a traditional healer.

Eriacho serves as Native American Engagement Coordinator for the Soundmind Institute, which trains psychedelic facilitators for Oregon’s psilocybin program and operates retreats in Jamaica, Oregon, and Pennsylvania.

Eriacho founded Kaalogii, a company that promotes Native American tradition and education. She earned her MPH from the University of Hawaii and bachelors and master of technology degrees from Arizona State University.

Santiago Ivan Guerra - Colorado Springs, Colorado

Santiago Ivan Guerra is an Associate Professor at Colorado College and Director of the Hulbert Center for Southwest Studies. Guerra teaches courses such as The Drug War, The Southwest: An Introduction, and The Mexican Immigrant Experience.

Guerra received his BA in Chicano Studies from Southwestern University and his MA and PhD in Anthropology from the University of Texas at Auston. From 2006 to 2008, Guerra conducted ethnographic field research studying drug trafficking in rural South Texas.

Terry G. Knight, Sr. - Towaoc, Colorado

Terry G. Knight, Sr. is a U.S. Air Force Veteran and a member of the Ute Mountain Ute Tribe. Described as a spiritual leader of the Tribe, Knight blessed the 2023 inauguration ceremony of Governor Polis.

According to Colorado Preservation, Inc., which honored Knight last year, he has a “long and lasting legacy of cultural preservation serving the Ute Mountain Ute Tribe for more than four decades.”

Christine Diindiisi McCleave (moderator and non-voting participant) - Minneapolis, Minnesota

Christine Diindiisi McCleave, a citizen of the Turtle Mountain Anishinaabe (Ojibwe) Nation, moderates Colorado’s working group and is not a voting member. McCleave describes herself as a scholar and activist. She has “been working in Indian Country at the national level for more than 10 years.” From 2015 - 2022, she was CEO of the National Native American Boarding School Healing Coalition. McCleave is currently vice president of the Psychedelic Society of Minnesota, and she provides Indigenous consulting services through ChristineMcCleave.com.

McCleave holds a bachelor’s degree in communication studies and a master’s in leadership. She is currently a PhD student in Indigenous Studies at the University of Alaska Fairbanks.

Marlena Robbins - Berkeley, California

Marlena Robbins is a member of the Navajo (Diné) Nation pursuing a doctorate in public health at UC Berkeley. According to Robbins, her dissertation “examines the cultural, social, and policy aspects of psilocybin use within Native American communities, highlighting differences between urban and rural perspectives.”

At the Berkeley Center for the Science of Psychedelics (BCSP), Robbins serves as the Indigenous Science Student Fellow. She previously served as a consultant to the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as an expressive art facilitator with a behavioral health organization in Mesa, Arizona. Robbins earned a BS in Criminal Justice & Criminology and an MS in American Indian Studies from Arizona State University.

Darwin Whiteman Jr. - Towaoc, Colorado

Darwin Whiteman, Jr. is a member of the Ute Mountain Ute Tribe. In 2023, he was elected to serve on the Tribe’s governing council. Whiteman ran against eight other candidates to secure one of two available seats.

Since 2010, Whiteman has served as a security consultant and investigator at the Ute Mountain Casino in Towaoc, Colorado. “I want to build on our strengths, listen to the people and strive forward so that everybody benefits,” he said in a victory speech after the election. His policy plans included supporting tribal hemp cultivation, exploring whether the casino should offer sports betting, and reviving a pottery store at Ute Mountain. “Our people make a lot of arts and crafts and need a place to sell those,” said Whiteman. “The pottery store was our first business and has a lot of history, and we need to get it back open.”

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

In 2023, Massachusetts became a battleground for psychedelic policy. Tensions flared between the New Approach PAC and local community groups such as Bay Staters for Natural Medicine, New England Veterans for Plant Medicine, and Parents for Plant Medicine.

For years, these local groups have helped decriminalize psychedelics in nine New England cities, including eight in Massachusetts and one in Maine.

Last year, New Approach, which is based in Washington, DC and led from California, arrived in Massachusetts with a psychedelic ballot initiative modeled after those it funded in Oregon and Colorado. In Massachusetts, the PAC raised $4 million to put its initiative on the 2024 ballot.

But this election year may be challenging for ballot initiatives across the board. Half the Massachusetts initiatives face legal challenges, and all ballot initiatives in the state face increased scrutiny from lawmakers.

In January, leaders of the Massachusetts House and Senate formed a special joint committee to scrutinize each ballot proposal and contemplate alternatives. This eight-member committee includes four lawmakers from each side of the state legislature.

In Massachusetts, lawmakers can decide to enact a ballot initiative as written by proponents before it goes on the ballot and reaches voters. Alternatively, lawmakers can choose to do nothing, allowing voters to decide in November. The legislature can also amend ballot initiatives or adopt substitute proposals.

The joint committee’s creation ensures New Approach’s ballot initiative will be analyzed and considered for modification or substitution.

Last week, Psychedelic Week contacted New Approach and its Massachusetts public relations firm for comment on the committee and possible substitution. But they did not respond.

Things could get interesting on the special committee because Senate President Karen Spilka recently appointed Senator Jason Lewis to participate.

In 2016, Lewis was a vocal critic of the Massachusetts marijuana initiative funded by New Approach (the PAC spent $4.35 million). Lewis chaired the Special Senate Committee on Marijuana, which drafted a 118-page report on how Massachusetts lawmakers should treat cannabis legalization.

The Committee’s conclusions from 2016 apply to New Approach’s psychedelic ballot initiative in 2024. For instance, the report said tax revenues and fees obtained by the Massachusetts marijuana program might be insufficient to cover its expenses, including costs associated with regulation, enforcement, and related services.

Concerns regarding program solvency arose recently in Oregon, where the state’s psilocybin program, supported by New Approach, nearly went bankrupt despite promises it would be self sufficient by 2023. Last year, Oregon regulators required a $3.1 million dollar taxpayer bailout to keep the program alive. They had requested more than twice that sum (over $6.5 million).

Oregon’s financial challenges should concern Lewis and other members of the special committee. The psychedelic program proposed by New Approach’s 2024 ballot initiative would likely be more expensive than Oregon’s. Instead of relying on an existing agency to regulate psychedelics, as Oregon has, it creates a new state psychedelic agency from scratch, which could be far more costly.

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Lewis’s 2016 committee was charged with learning lessons from other states that had legalized marijuana such as Oregon and Colorado. In 2024, the special joint committee on ballot questions will likely study the ongoing rollout of psychedelic markets in other states.

In Oregon, what was promised as a solution to the state’s mental health crisis may be serving mostly affluent tourists from out of state. Further, high psilocybin prices and operating expenses have reportedly driven aspiring Oregon clients and businesses out of the industry and into underground markets.

In addition to studying other states, Lewis’s 2016 cannabis committee was worried about conflicts between the New Approach-funded Massachusetts marijuana law and federal drug laws. “There is considerable uncertainty regarding federal policy toward marijuana, particularly with the impending change in administration after the [2016] presidential election,” says the committee report.

That uncertainty regarding conflicts with federal law, and changing administrations, may be more relevant today regarding state psychedelic programs. Recently, I explained how state-regulated psychedelics are on a collision course with the FDA. The problem is their unprecedented blending of conventional healthcare with schedule I controlled substances, which has no parallel in state medical marijuana programs.

Nevertheless, New Approach and its sister organization the Healing Advocacy Fund appear unconcerned. They ostensibly assume federal agencies have no interest in state-regulated psychedelics, presumably because they have largely tolerated state cannabis industries for years.

Healing Advocacy Fund Senior Advisor Joshua Kappel spoke at a December 23 meeting of Colorado’s Department of Revenue. Kappel works for a cannabis law firm called Vicente, which New Approach paid $10,000 to draft its Massachusetts ballot initiative. He told Colorado regulators they shouldn’t worry about the federal government, claiming cannabis attorneys have dealt with the state and federal conflict associated with medical marijuana for decades.

Psychedelic Week contacted Kappel who responded but declined to offer comment for this article. His December comments seemingly overlook the fact that psychedelic programs established by New Approach ballot initiatives look almost nothing like medical cannabis programs. Instead, they blend psychedelics with conventional healthcare far more than cannabis industries ever have. Accordingly, assumptions that federal agencies will look the other way may be unfounded. Recent scrutiny of state cannabis regulation suggests federal intervention is a legitimate concern.

In December, the Drug Enforcement Administration (DEA) warned Georgia pharmacists not to dispense medical marijuana. Georgia’s unusual cannabis law allows conventional pharmacies to dispense marijuana. In other words, unlike other states, where patients go to dispensaries outside the healthcare system to purchase cannabis, Georgia blends conventional healthcare with cannabis, which remains a schedule I controlled substance. That drew the DEA’s attention and its December warning. Some Georgia pharmacists say the letter persuaded them to postpone or avoid dispensing cannabis.

Because they blend healthcare with schedule I drugs even further than Georgia cannabis, New Approach’s psychedelic proposals could draw greater federal scrutiny. As in Oregon and Colorado, psychedelic facilitators in Massachusetts would monitor people for hours at licensed psilocybin centers. Even Kappel acknowledges it remains unknown what consequences DEA-registered healthcare professionals might face if they actively participate in these programs. Nevertheless, he and New Approach encourage lawmakers to pursue similar therapeutic frameworks in other states, including California and Illinois.

Some states are taking concerns regarding costs and conflicts very seriously. Last year, Minnesota lawmakers formed a psychedelic task force, which analyzes how various approaches to legal reform intersect with federal laws. The task force will draft a report for Minnesota lawmakers on how different approaches might impact accessibility and conflicts with federal before they enact any psychedelic laws. On Thursday, Vermont lawmakers discussed forming a similar work group.

In Massachusetts, with Lewis on the special ballot initiative committee, lawmakers could dissect all facets of New Approach’s proposal, including its potential cost and how it intersects with federal laws. The committee will likely evaluate how possible alternatives, like those from Massachusetts Representative Nicholas Boldyga and Senator Patricia Jehlen, compare to the ballot initiative.

According to Bay Staters for Natural Medicine, voter and lawmaker support for substitution is growing. In a February 29 email to Psychedelic Week, the group said nearly “500 constituents have reached out to their lawmakers over the last month to call for substitution.”

In December, the Select Board of Provincetown, Massachusetts, partially decriminalized psychedelics and recommended replacement of New Approach’s ballot initiative with an alternative from Boldyga or Jehlen. In February, the Medford, Massachusetts City Council made similar resolutions. Bay Stater for Natural Medicine says other towns may soon follow Provincetown and Medford in asking for substitution.

Potential substitution might not be the only obstacle facing New Approach and its initiative. Three of the six current Massachusetts ballot initiatives face court battles.

The Massachusetts Restaurant Association filed suit in the state’s Supreme Judicial Cour, claiming a ballot initiative about the wages of tipped employees violates the state Constitution. The complaint alleges the initiative violates the single subject rule, which requires ballot initiative to address only one topic. Similar claims have been the downfall of previous initiatives.

In 2022, the court blocked an initiative that would have allowed Uber and Lyft to continue treating gig workers as independent contractors. This year, the same initiative resurfaced for the 2024 ballot. However, it again faces claims it violates the single subject rule.

In a third legal battle, the Fiscal Alliance Foundation filed similar complaints regarding an initiative to allow Uber and Lyft drivers to form labor unions and bargain collectively.

New Approach’s psychedelic ballot initiative is among three proposals that currently face no legal opposition. However, that could change. Bay Staters for Natural Medicine says it will explore all options to challenge what it views as the PAC’s unwelcome intrusion in Massachusetts.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

Late Tuesday night, Medford, Massachusetts, home of Tufts University, became the eighth city in the state to decriminalize psychedelic plants and fungi.

In a 6-1 vote, the City Council adopted a “Resolution to Support Adult Access and Education for Plant Medicine,” introduced by Councilors Matt Leming and Anna Callahan.

Councilor Leming, a neuroscience researcher at Massachusetts General Hospital, told Psychedelic Week, “A growing body of scientific research has found plant medicine uniquely beneficial for treating addiction and post-traumatic stress disorder.” Lemming added, “history is riddled with legislative mistakes that occur because all mind-altering substances are criminalized, misunderstood, and treated with fear. This resolution is one step closer to having nuanced and science-backed policy in Massachusetts.”

In adopting the resolution, Medford joins Somerville, Cambridge, Amherst, Northampton, Easthampton, Salem, and Provincetown, which previously deprioritized enforcement of criminal penalties. The vote sets a new national record for Massachusetts, which contains more cities where psychedelics are decriminalized than any other state.

Like the Provincetown Select Board, which took similar action in December, Medford urges state lawmakers to replace a 2024 ballot initiative proposed by the Washington, DC-based New Approach PAC (New Approach) before it reaches Massachusetts voters in November.

At Tuesday’s City Council meeting, it was initially unclear whether the resolution would pass. After Leming and Callahan introduced the proposal, Councilor George Scarpelli expressed concerns. He said that because the resolution involves law enforcement, the Council should send it to a subcommittee for input from the Chief of Police. To that end, Scarpelli moved to send the matter to the Council’s Public Health and Community Safety Committee.

Councilor Kit Collins responded with support for the resolution and suggested that the Council vote that evening without tabling it for further discussion. Like Collins, Councilor Justin Tseng initially expressed comfort voting on the resolution last night. Collins then asked to hear public testimony before the Council voted on Scarpelli’s motion.

The Council heard comments from Medford and Boston area residents, including James Davis, a co-founder of Bay Staters for Natural Medicine (Bay Staters). With a coalition of other regional organizations, Bay Staters has supported local psychedelic decriminalization throughout Massachusetts and New England. Last year, they supported a successful resolution in Portland, Maine, the first in that state.

Most public comments supported the resolution from Lemings and Collins. However, a final speaker expressed concerns regarding distribution of plant-based psychedelics. He also raised a 2023 incident where an airline pilot allegedly ate psilocybin mushrooms days before attempting to seize control of a plane mid-flight.

In response, Councilor Tseng emphasized that the resolution would not legalize distribution or change local drug laws. Instead, Tseng said it would be a policy recommendation from the Council. However, one of the resolution’s sponsors, Councilor Callahan, said she would respect Scarpelli’s and any other colleagues’ desire to gather additional information before voting.

The Council approved Scarpelli’s motion to send the resolution to the Public Health and Community Safety Committee. However, toward the meeting’s conclusion, Councilor Leming introduced an amended version of the resolution, which would request input from the Chief of Police after its passage.

In a Wednesday email to Psychedelic Week, Bay Staters’ Davis praised Leming’s amendment. “We welcome everyone sharing their concerns because that’s how we educate and persuade people,” said Davis. “We welcome conversations with police because we believe officers are benefiting from plant medicine as public servants with their own traumas.”

Upon reconsidering the resolution with Leming’s amendment, the Council approved it in a 6-1 vote. According to a Bay Staters press release (printed below), “the Medford City Council voted to officially designate growing and sharing psilocybin “magic” mushrooms and related psychedelic plants as the lowest priority of law enforcement.”

For comment on the Medford resolution and its call to replace their 2024 ballot initiative, Psychedelic Week emailed the New Approach PAC (New Approach) and the related ballot campaign Massachusetts for Mental Health Options. New Approach referred questions to Jennifer Manley and Emily Oneschuk who represent the campaign.

Psychedelic Week asked Manley and Oneschuk if the campaign would support a substitute bill offered by the legislature if it resembled language drafted by State Representatives Nicholas Boldyga and Patricia Jehlen or formed a work group to study various approaches to psychedelic legalization. Governor Maura Healey proposed a similar work group in November.

Oneschuk said she had “testified in support of the [work group] proposal from Governor Healey to expand research opportunities for psychedelics and their potential benefits for veterans like me.” Oneschuk added, “I strongly believe that we need to work collaboratively to make sure all voices are heard during the campaign.”

Speaking on behalf of the campaign, Manley, said “[b]efore we are able to take a position on whether to support any proposed substitute ballot language, we would like to meet with supporters of that and understand their motivations and concerns.” Manley added, “We are not aware of any substitute language that has been filed in the Massachusetts General Court at this time.”

But within the legislature, plans to scrutinize and potentially substitute all ballot initiatives are heading up. Last month, House and Senate leaders formed a special committee for that purpose. According to a statement from Senate President Karen E. Spilka and Speaker of the House Ronald J. Mariano, the “State Constitution tasks the Legislature with considering each initiative petition, and with giving interested parties the ability to provide feedback on the policy changes being sought at the ballot box.”

To promote open discussion and detailed analysis of each ballot proposal, Spilka and Mariano formed the Special Joint Committee on Initiative Petitions. The committee “is especially equipped to tackle the unique challenges presented by the legal and policy intricacies of the questions this year. The Legislature looks forward to a fair, balanced, and informed public process for the consideration of all initiative petitions.”

It seems Bay Staters, city councilors, and other stakeholders will have opportunities to share their concerns with the Special Joint Committee. One concern relates to the cost of services under the campaign’s proposed ballot initiative.

“This has already been passed in Oregon,” said Leming on Tuesday, referring to New Approach’s 2020 campaign to build and implement Oregon’s psilocybin services program. Leming said, “long story short, it’s made the price of these plant medicines go between one and three thousand dollars.” He urged state lawmakers to provide alternatives. Acting “through elected representatives, would help to decriminalize it and not create this sort of artificial price.”

Bay Staters expressed similar concerns in its press release, claiming New Approach built “a system in Oregon that is widely criticized for its prohibitive costs and the taxpayer bailouts it required.” Last year, the Oregon psilocybin program received $3.1 million from the state to continue operations.

Another concern relates to a new state agency the campaign ballot initiative would create. “We do not want another Cannabis Control Commission debacle,” said Davis in the press release.

In 2023, three top officials of the Massachusetts Cannabis Control Commission were suspended and investigated, including chair Shannon O’Brien. The agency director resigned under somewhat mysterious circumstances. In December, State Senator Michael Moore said, “the agency, is in disarray” and called for an oversight hearing.

“Putting an unelected control commission in charge of drafting rules for psychedelics in Massachusetts is not the best path forward,” said Jamie Morey, who leads Parents for Plant Medicine, “especially after a similar body in Oregon has made treatment ridiculously expensive and out of reach for most who need it.”

On Tuesday, Councilor Leming agreed. An “avenue that is currently being pursued is a signature collection method, which would basically create an unelected commission that if passed in Massachusetts, would add its own regulation to these plant medicines.” He urged the City Council to support efforts by State Representative Jehlen to decriminalize psychedelics.

Yesterday, Leming told Psychedelic Week, “I am proud that Medford is now the eighth city in Massachusetts to support statewide decriminalization.”

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Bay Staters’ full press release is pasted below:

Press Release: Medford Votes to Decriminalize Magic Mushrooms, Calls for Changing the Psychedelic Ballot Question

Medford is the birthplace of the songs "Jingle Bells" and "Over the River and Through the Wood." It has now achieved another—albeit less musical—claim to fame: embracing the benefits of natural psychedelics.

On Tuesday evening, the Medford City Council voted to officially designate growing and sharing psilocybin "magic" mushrooms and related psychedelic plants as the lowest priority of law enforcement. The measure cites the benefits that naturally-occurring psychedelics have for trauma, neurological diseases, and addiction. For its part the Food and Drug Administration classifies psilocybin mushrooms as a“breakthrough therapy” for depression, yet the substance remains illegal federally and statewide.

"A growing body of scientific research has found plant medicine uniquely beneficial for treating addiction and post-traumatic stress disorder. History is riddled with legislative mistakes that occur because all mind-altering substances are criminalized, misunderstood, and treated with fear. This resolution is one step closer to having nuanced and science-backed policy in Massachusetts," said Medford City Councilor and AI researcher Matt Leming, who presented the measure.

The city joins seven other Massachusetts communities, including Somerville and Cambridge, to pass a measure in partnership with Bay Staters for Natural Medicine, a volunteer group that educates people in the therapeutic use of psychedelics. The community group regularly hosts nature forages, potlucks, and grow trainings to bring people together to learn about psychedelics. Many volunteers, including those who organized for the Medford measure, have used the plant medicines to feel more grounded and inspired to change their lifestyles.

Last month, Provincetown's psychedelics measure called for the state legislature to change a ballot question being pushed by an "out-of-state PAC," according to Boston Globe. The PAC created a system in Oregon that is widely criticized for its prohibitive costs and the taxpayer bailouts it required. Medford joined Provincetown in calling for the ballot question to be changed before going to voters.

"We are grateful for the efforts of our Medford volunteers educating their neighbors to build support for this work. We humbly ask Senator Jehlen, Representative Day, and other state leaders to protect this emerging field of mental health and addiction treatment by changing the ballot question. We do not want another Cannabis Control Commission debacle," said James Davis, a co-founder of Bay Staters and Medford organizer.

"Putting an unelected control commission in charge of drafting rules for psychedelics in Massachusetts is not the best path forward, especially after a similar body in Oregon has made treatment ridiculously expensive and out of reach for most who need it. Our elected legislators, who answer directly to the people they represent, should be the ones making important decisions about these regulations, with affordability and accessibility as their primary goal," remarked Jamie Morey, a leader for the Massachusetts advocacy group Parents for Plant Medicine.

Massachusetts advocates are calling for the ballot question to be changed by the state legislature before going to voters to protect the affordability of future services. They maintain that creating another unelected control entity like the Cannabis Control Commission will give rise to similar controversies, licensing rules that drive up costs, and even the potential of taxpayer bailouts that occured in Oregon. The PAC has not offered a defense of these claims nor distanced itself from the Oregon model.

“This out-of-state PAC created a front group, ‘Massachusetts for Mental Health Options,’ to confuse voters and force through laws that will make it impossible for vets like me to afford this care. This is the same PAC that created a failed system in Oregon and corporatized cannabis here in Massachusetts as well,” said Michael Botelho, the founder of New England Veterans for Plant Medicine who shared with NBC Boston how mushrooms helped him work through combat PTSD.

Advocates see this local education work as a way to support passage of Senator Jehlen's An Act Relative to Plant Medicine, which has enjoyed bipartisan support. The legislature is expected to vote on the bill as well as changes to the ballot question within the next month.

Bay Staters for Natural Medicine: team@baystatersnm.com

New England Veterans for Plant Medicine: leadership@plantmedicinevets.org

Parents for Plant Medicine: parentsforplantmedicine@gmail.com

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

*Updated Feb 7, 2024 with statements from Senator Wiener’s press release.

Early Tuesday morning, California lawmakers unveiled a bill called the Regulated Psychedelic-assisted Therapy Act (SB 1012).

Introduced by Senator Scott Wiener, the bill would legalize supervised, medical use of three psychedelic substances, including psilocybin, psilocin, and 3,4-methylenedioxymethamphetamine (MDMA). Regulators could later add dimethyltryptamine (DMT), mescaline (of non-peyote origin), and psilocybin mushroom-producing fungal spores or mycelia.

All products would be regulated by a new department, the Division of Regulated Psychedelic Substances Control, housed within the California Business, Consumer Services, and Housing Agency.

The division would adopt regulations for psilocybin, psilocin, and MDMA by January 1, 2026. At least two years later, in 2028, the division could adopt regulations for DMT, mescaline, and psilocybin mushroom-producing fungal spores and mycelium, if recommended by an advisory committee.

SB 1012 would create a nine-member professional licensing body, the Board of Regulated Psychedelic Facilitators, by April 1, 2025. It would operate alongside state medical, dental, veterinary, and other professional licensing bodies. The board would license and regulate psychedelic facilitators, who would have the lengthy title regulated psychedelic-assisted therapy facilitators.

Many terms defined by SB 1012 are preceded by the phrase regulated psychedelic-assisted therapy. Senator Wiener likely wants to distinguish this bill from his previous attempts to decriminalize psychedelics, through SB 58 and SB 519.

In September, both houses of the California Legislature approved Wiener’s SB 58, making it the first state legislature to enact a psychedelic decriminalization bill. Previously, decriminalization had only been approved by voter ballot initiative. However, Governor Gavin Newsom vetoed SB 58 in October.

According to Newsom, “California should immediately begin work to set up regulated treatment guidelines - replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses.” He said SB 58 “would decriminalize possession prior to these guidelines going into place, and I cannot sign it.”

SB 1012 delivers on Wiener’s promise to fulfill Newsom’s request for a medical framework. Compared to psychedelic laws of Oregon and Colorado, which legalize whole plants and fungi and exclude synthetic products, SB 1012 appears oriented toward pharmaceutical development. Initially, it would legalize only psychedelic chemicals rather than plants and fungi that produce them. It seems that only psilocybin mushroom-producing spores and mycelia could be added, but not before 2028, and their inclusion isn’t guaranteed.

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Wiener’s bill would be the first to regulate the supervised use of MDMA. But it’s unclear where MDMA would be synthesize if SB 1012 is enacted. Two months ago, the California-based drug company Lykos Therapeutics (formerly known as MAPS PBA) submitted a new drug application to the Food and Drug Administration (FDA), seeking approval to market MDMA for treating post-traumatic stress disorder. Its proprietary formulation could receive FDA approval this year.

In addition to forming a new agency division and professional licensing board, Wiener’s SB 1012 would form a committee to advise these bodies on regulating MDMA and other substances.

Notably, SB 1012 is the first psychedelic law to address potential conflicts of interest among officials drafting industry rules. A board candidate is disqualified “if the person or the person’s immediate family owns an economic interest in a college, school, or institution engaged in regulated psychedelic-assisted therapy education. It defines “immediate family” as one’s spouse, domestic partner, parent, child, or child’s spouse or domestic partner.

This policy may be a response to undisclosed conflicts of interest in Oregon. In 2022, Tom Eckert resigned as chair of the Oregon Psilocybin Advisory Board when journalists alleged he was abusing his board position to make rules governing his psychedelic training business, and that of his romantic partner Rachel Aidan, who was CEO of the Synthesis Institute.

Though the addition of language regarding conflicts of interest is an improvement over Oregon and Colorado laws, SB 1012 overlooks the potential conflicts of advisory committee members. Further, the exclusions it raises focus only on economic interests in training programs, excluding other psychedelic businesses, such as product manufacturers, administration centers, and testing labs. Some members of Colorado’s natural medicine advisory board have such financial interests, which often go undisclosed.

How else does SB 1012 compare to the psychedelic programs of Oregon and Colorado? Wiener’s bill is a conglomeration of features from each state but appears more heavily influenced by Colorado’s Natural Medicine Health Act and Senate Bill 290, which overhauled the Act last year.

SB 1012 rejects the term clients adopted in Oregon in favor of participants as used in Colorado. Instead of service centers or healing centers, Wiener’s bill describes psychedelic-assisted therapy clinics or centers. Similar linguistic inconsistencies have caused confusion among regulators and advisory boards, and California’s addition of new terminology adds complexity.

Like Colorado’s law, SB 1012 creates the possibility for psychedelic administration at other approved locations, potentially including people’s homes, which is prohibited in Oregon. In theory, that could increase accessible for people with disabilities and those who have difficulty traveling to licensed facilities. However, the prospect of home administration has been a thorny issue for Colorado’s natural medicine advisory board, with some members pushing for heavy oversight or excluding it from the program.

Both Oregon and Colorado define psychedelic services to include three distinct sessions (preparation, administration, and integration). Colorado requires at least one integration session, where facilitators and participants meet to discuss participants’ psychedelic experience. Integration sessions are optional in Oregon and need only be offered by facilitators.

In addition to requiring integration, SB 1012 provides a more detailed definition of the process. In California, integration would consist of “counseling” provided by facilitators or others trained in “postpsychedelic support” to help participants “ground themselves and feel oriented, better understand their psychedelic experience, and apply insights from their experience to healthy behavioral change in their daily life.”

SB 1012 adds additional required elements to the definition of psychedelic services, including a safety screen prior to administration and follow up sessions. Follow ups are meetings between participants and facilitators up to 36 hours after administration “to assess well-being, screen for adverse reactions and, if needed, make referrals to needed care, additional psychosocial support, or other interventions.”

Compared to past legislation, Wiener’s bill includes unprecedented detail regarding data collection from participants. It describes expansive reporting of de-identified data to “comprehensively measure its success, safety, quality, impact on individuals’ well-being and public health, including adverse events experienced during, immediately after, or after the passage of time with information about substance, dosage, and other contextual information.”

I’ve previously described ethical and legal concerns regarding state-mandated data collection about substance use that remains federally illegal. Oregon’s psilocybin law originally included robust protections for client confidentiality. Under most circumstances, no client information could leave service centers. However, a 2023 legislative amendment allowed aggregated data reporting to the state, and subsequent rules required it for all clients. Reporting only limited, aggregated data provides some protection for clients. By comparison, the expansive reporting of de-identified data under Wiener’s bill is much riskier, with greater potential for clients to be re-identified. See Broken Promises of Privacy: Responding to the Surprising Failures of Anonymization on the shortcomings of de-identification, including the ease with which it is reversed.

Another key departure from Oregon’s law is SB 1012’s lack of boundaries between conventional healthcare and psychedelic services. Oregon prohibits medical use of psilocybin. Service centers and facilitators cannot make medical claims, they are prohibited from diagnosing or treating health conditions, and they cannot operate within licensed healthcare facilities. The New Approach PAC (New Approach), which commissioned its drafting, also wrote Colorado’s law, where it removed these limitations. This week, New Approach’s sister organization, the Healing Advocacy Fund, praised removal of the restrictions, which are absent from Wiener’s SB 1012 and a 2024 Massachusetts ballot initiative that is also supported by New Approach.

Blending psychedelics with conventional healthcare before their approval by the U.S. Food and Drug Administration (FDA) is a growing state-level trend. But it creates significant legal challenges for regulators, facilitators, and business operators. With FDA-approved psychedelics like MDMA and psilocybin on the horizon, laws like SB 1012 increasing put state-regulated psychedelics on a collision course with FDA.

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There are others unresolved implications. Healthcare facilities that receive federal funding from Medicare or Medicaid prohibit Schedule I controlled substances like medical marijuana from their premises. They will likely do the same for psychedelics. Making therapeutic claims about psychedelics or advertising them as therapies likely violates the federal Food, Drug, and Cosmetic Act. In recent years, the FDA has sent many warning letters to cannabis product manufacturers making therapeutic claims.

Medical professionals licensed by the Drug Enforcement Administration (DEA) may be hesitant to enter state psychedelic industries out of fear of losing their licenses. In December the DEA warned Georgia pharmacies not to dispense medical marijuana. By making cannabis available through pharmacies, Georgia blends conventional healthcare with Schedule I controlled substances, more than any other state. Typically, medical professionals have little or no involvement with cannabis. But Georgia’s unconventional approach caught the DEA’s attention. The agency could find emerging state psychedelic laws equally problematic.

In addition to these legal complexities, the social benefits of supervised psychedelic use remain unclear. During the campaign to pass Oregon’s psychedelic law, supporters said it would address the state’s mental health crisis. However, after opening last summer, the program largely serves tourists from out of state. Few Oregonians can afford its high prices, which range from $1,500 to $3,500 for a single, standard dose of psilocybin. Many turn instead to unregulated, underground psychedelic markets.

SB 1012 makes similar promises. It says “California’s current approach to mental health has failed to fulfill its promise. Californians deserve more tools to address mental health issues.” In a Tuesday press release, Wiener wrote, “We know psychedelic therapy saves lives, and safe and controlled access to these innovative treatments will be transformative for so many Californians seeking relief from mental health and addiction challenges.” Can Wiener deliver on that promise? Will his proposal deliver transformative mental health change or primarily create a psychedelic tourism industry? Could it be financially viable, or would it become a financial burden on the state?

In addition to being cost prohibitive for clients, the economic future of Oregon’s psilocybin program is uncertain. Though promised as being self-sufficient by 2023, it cost Oregon taxpayers $3.1 million last year (in addition to millions spent on its two-year development period). California is a different, and much larger, market than Oregon. Nevertheless, important lessons could be learned from Oregon’s financial challenges.

Unlike the proposed Massachusetts program, which would implement a tax on psychedelic sales, SB 1012 would rely on revenue from business license fees and financial penalties assessed by regulators. A similar arrangement prompted the Oregon Health Authority to set license fees high, in hopes of covering its expenses. Service centers pay $10,000 a year and most facilitators pay $2,000. Due to these and other financial barriers, potential operators have abandoned their plans to enter the Oregon market (or gone out of business), reducing program revenue.

Other choices by the drafters of Oregon’s law left potential program revenue off the table. They chose to exempt facilitator training programs from annual licensing. Even a modest fee could have boosted program funds.

Like the original version of Colorado’s law, Wiener’s SB 1012 allows private donors to fund the state psychedelic program. That could help compensate for a budget shortfall, but it might also allow drug companies and other interested parties to make financial contributions, raising ethical concerns regarding a potential quid pro quo.

SB 1012 contains other unique features worth exploring further, and the bill will likely undergo significant change as it makes its way through legislative committees. Follow Psychedelic Week for more news regarding Senator Wiener’s therapeutic bill.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School and the Florida Bar Health Law Section Professor at the Florida State University College of Law. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

*Updated Jan 26, 2024, incorporating comments the Massachusetts ballot campaign sent to Psychedelic Week shortly after publication.

This November, Massachusetts voters may have the opportunity to accept or reject a ballot initiative called the Natural Psychedelic Substances Act.

The thirty-seven-page proposal is multifaceted. One part would legalize the supervised use of five psychedelics. Another would reduce criminal penalties for growing and consuming plants and fungi that contain them. But the lengthy proposal has other features that are often overlooked.

In a series of articles, I’ll analyze sections of the ballot initiative. Today, I discuss the new state agency it would create to regulate psychedelics in Massachusetts, the Natural Psychedelic Substances Commission.

Creating a new agency from scratch is no small task. It requires substantial funding, personnel, and other resources. In 2018, Massachusetts formed the Cannabis Control Commission (cannabis commission). Five years later, its annual expenses exceeded $15 million, and the agency had been plagued by controversy.

In 2023, three top officials were suspended and investigated, including chair Shannon O’Brien, and the agency director resigned. In December, State Senator Michael Moore said, “the agency, is in disarray” and called for an oversight hearing,

The Natural Psychedelic Substances Act is positioned to replicate the costs and controversies of the cannabis commission by forming a similar agency for psychedelics. But the proposal’s appearance on the November ballot is not guaranteed. In Massachusetts, the legislature can choose to enact an initiative as written by proponents, which eliminates it from the ballot. Alternatively, lawmakers can propose a substitute bill, or they can do nothing, and then voters could decide the original initiative’s fate.

At the very least, given the embarrassment caused by the state cannabis commission, lawmakers might consider striking the proposed agency from the ballot initiative. But there’s much more they could do to set Massachusetts psychedelic policy on course.

I’ve previously described the ballot initiative’s history. A political action committee called the New Approach PAC (New Approach) organized and oversees the ballot campaign, which is called Massachusetts for Mental Health Options. Described by the Boston Globe as “a deep-pocketed, out-of-state PAC,” New Approach is based in Washington, DC, and its leadership resides in California. The group has supported psychedelic initiatives in Oregon, Colorado, California, and several other states, as well as cannabis initiatives across the country. A 501c4 organization called the New Approach Advocacy Fund, which has the same leadership as the similar-sounding PAC, is also involved with the Massachusetts ballot initiative.

Some Massachusetts lawmakers and community groups oppose New Approach’s ballot initiative and urge the legislature to adopt a substitute. The proposed state psychedelic agency is a major point of contention.

Previous psychedelic initiatives, including New Approach proposals in Oregon and Colorado, made existing agencies responsible for regulating psychedelics. In Oregon, a ballot initiative called Measure 109 gave this role to the state health authority. In Colorado, Proposition 122 gave oversight to the Department of Regulatory Agencies (DORA). The Colorado legislature later divided those responsibilities between DORA’s and the Department of Revenue.

If approved by voters, the Natural Psychedelic Substances Act would be the first law to create a state psychedelic agency. Last year, a California ballot campaign attempted to form a $5 billion psychedelic agency. But the campaign disbanded when polling showed a majority of voters (60%) opposed state funding of psychedelic treatments.

Psychedelic Week asked the campaign why it chose to form a new state agency. Jen Manley of the public relations firm Dewey Square said, “each state will do things a little differently when it comes to regulating psychedelics. The Massachusetts initiative creates a new regulatory agency to oversee the program.”

Opponents of the Massachusetts initiative worry forming a new agency, with input from New Approach, could allow the PAC to fill the agency with out-of-state friends from the cannabis and psychedelic industries. Notably, the officials who would run the agency, including five psychedelic commissioners, need not live in Massachusetts. When drafting the initiative, New Approach required only that commissioners move to the Commonwealth within 90 days after being appointed. Opponents fear this weak residency requirement is a backdoor for installing candidates from outside Massachusetts.

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If the initiative reaches the 2024 ballot, and Massachusetts voters approve it, then state officials would appoint the five commissioners. Specifically, the governor, attorney general, and state treasurer would each appoint one commissioner. They would fill the remaining two seats by majority vote. Each commissioner would serve an initial five-year term, which could be renewed for an additional five years.

Manley told Psychedelic Week the initiative “allows the governor, attorney general, and treasurer to appoint regulators who have specific backgrounds and expertise in areas germane to psychedelics.” Further, “[t]he crucial thing we want to see is the psychedelic community working collaboratively with state leaders to ensure that a diverse group of thoughtful experts are appointed to the regulatory agency.”

Though appointment by state officials might appear fair, it can have limitations. In Oregon and Colorado, New Approach agents work closely with government officials, arranging frequent private meetings to influence their decisions. New Approach already has potential political ties in Massachusetts. For instance, Danielle McCourt, who filed its campaign paperwork, was Governor Maura Healey’s finance director for nearly four years.

Psychedelic commission seats could be highly coveted because they are well compensated. One commissioner would serve as chair and be paid $188,911 annually. The remaining four could earn about $141,000 per year, or up to 75% of the chair’s salary. The agency would hire other paid employees, including a powerful executive director appointed by the commissioners. This official would have significant authority and can be thought of as the agency president or CEO. In addition, the director would automatically become chair of the state psychedelic advisory board. This provision is another departure from other states like Oregon and Colorado, where advisory board members appoint their own chair.

According to the initiative, the director would be paid an unknown salary determined by the commissioners. So, technically this salary is unlimited. However, the director of the Massachusetts cannabis commission currently receives $195,000, which gives some indication of what the psychedelic agency director might earn. 

The initiative also requires the director to appoint a chief financial and accounting officer who in turn will hire other employees, including lawyers, consultants, and advisors. When adding everything up, the salaries of commissioners and other agency employees quickly surpass $1 million per year. But the agency will have other expenses.

Past spending of the Massachusetts cannabis commission provides a glimpse of what the psychedelic agency might spend. In 2018, the cannabis commission’s first year, the agency spent $2,237,962. Of this total, $1,143,878 provided wages, salaries, and employee benefits. Other operating costs totaled $1,094,084. However, in its second year, cannabis commission expenses mushroomed to nearly five times its first-year budget. 

In 2019, the cannabis commission spent over $10 million dollars. Employee salaries and benefits were over five and a half times higher than in 2018 ($6,391,903), and other operating expenses tripled ($3,847,128). In subsequent years, commission expenses ballooned further. In 2022, the governor allocated over $15.2 million to the agency.

One might ask whether the expenses of a psychedelic agency would be comparable to those of a cannabis commission. So far, the regulation of state cannabis markets differs from oversight of psychedelic industries. One key difference is that cannabis is sold over the counter at storefronts called dispensaries, and psychedelics are sold at licensed facilities called service centers, where clients remain under supervision while they experience the effects of psychedelic products.

For now, the only operating state psychedelic market is in Oregon. Colorado’s market remains in the planning stages and won’t open until 2025. In Oregon, there are fewer licensed psilocybin businesses than in many state cannabis markets. For example, in Oregon there are over 800 licensed cannabis dispensaries and only 19 licensed psilocybin service centers.

That might lead one to believe that with fewer businesses to regulate, a psychedelic agency might spend less than a cannabis agency. However, regulating psychedelic service centers, and the facilitators who monitor clients at those centers, adds significant cost and complexity.

While budtenders who staff cannabis dispensaries may require little or no training, Oregon psilocybin facilitators must complete at least 120 hours of classroom training and 40 hours of hands-on practicum training. State psychedelic agencies must develop and approve training program curricula, as well as facilitator practice standards and ethical codes, which must then be enforced.

Regulating psychedelic service centers is arguably more complex than regulating cannabis dispensaries. In addition to being retail establishments, where controlled substances are stored and sold, service centers require private spaces for clients to remain under facilitator supervision. Unlike cannabis dispensaries, they must have restrooms for clients and spaces for them to store food and belongings.

Some service centers will allow group preparation and administration sessions, and regulators must make and enforce rules for those sessions and facilities. Requirements for client safety screening protocols and transportation plans must also be drafted and enforced. Because state cannabis markets don’t screen clients, and most require off site consumption, they lack comparable regulatory requirements.

These complexities raise the cost of establishing and overseeing state-regulated psychedelic programs. In Massachusetts, the state psychedelic agency would be responsible for drafting and enforcing these and other rules regarding psychedelic business licensure and operation.

But there could be insufficient funds to compensate for the added regulatory complexity. During the 2020 campaign to pass Oregon’s psilocybin law, proponents estimated the program would cost the state about $3 million per year. New Approach’s campaign promised voters it would pay for itself by 2023 with revenue from business license fees. However, in late 2022, Oregon regulators said the program was nearly out of money. In 2023, they asked state lawmakers for $6.5 million to fund program operations for two years. The legislature gave them less than half, or $3.1 million, and the program’s financial future is uncertain.

Creating and operating a Massachusetts psychedelic agency would likely be more expensive. One reason is that Oregon’s Psilocybin Services program is housed within a preexisting agency. Specifically, it’s based at the Center for Health Protection, within the Oregon Health Authority. Creating a branch within an existing agency allows a program to benefit from shared agency resources, including technology and personnel.

André Ourso leads the Center for Health Protection and played a role in establishing Oregon’s psilocybin program. In 2022, the state paid him $160,000. But in addition to implementing Oregon’s psilocybin program, Ourso spread his time across several divisions within the Center for Health Protection, such as Drinking Water Services and Environmental Public Health. In other words, the Oregon public likely got more for the $160,000 it paid Ourso in 2022 than Massachusetts will derive from psychedelic commissioners who would focus solely on psychedelics.

The Oregon Health Authority also employs at least one official devoted full time to psychedelic regulation. Angela Allbee is Section Manager of Oregon Psilocybin Services. In 2022, the state paid her $135,000, near the low end of what Massachusetts would pay most psychedelic agency commissioners. However, Allbee performs many functions of the proposed five-person Massachusetts commission (and its director), at significantly lower cost. Albee receives support from other staff like policy analyst Jesse Sweet who Oregon paid $106,440 in 2022.

Even with a relatively lean staff and shared agency resources, Oregon Psilocybin Services anticipated spending over $3 million per year and could not remain solvent without an infusion of taxpayer funds. There’s no evidence a Massachusetts program would be more successful or sustainable, especially if it forms a new agency with highly paid employees and a lack of shared infrastructure and resources. Further, unlike Oregon, Massachusetts would regulate several psychedelics, including ibogaine, which raises additional regulatory complexities.

According to the ballot initiative, the Massachusetts psychedelic agency would deposit license revenue and monetary penalties collected into a Natural Psychedelic Substances Regulation Fund. The fund would be bolstered by a fifteen percent tax on psychedelic product sales. The Fund’s primary use would be supporting the agency’s operations.

Using tax revenue to fund regulation is one benefit of the Massachusetts proposal over Oregon and Colorado laws, where regulation must be entirely supported by license fees. However, it is unclear how much revenue a tax could generate. Since psychedelic services last several hours, centers cannot serve the volume of clients that one sees at cannabis dispensaries, and as demonstrated in Oregon, there would be far fewer psychedelic centers than cannabis dispensaries.

Campaign representative Jen Manley confirmed this, telling Psychedelic Week, “the regulation of cannabis is very different from regulating psychedelic facilitators. With cannabis there is a high volume of sales that take place at retail storefronts. The scale of production for psychedelics will be far less than cannabis. It is difficult to say with any precision how much the regulatory structure of the psychedelic program will cost and what the state will collect from fees and taxes related to the program.”

With this lower expected sales volume compared to cannabis, and related uncertainty regarding tax and license revenue, the Massachusetts public could be stuck paying for psychedelic agency costs directly, like Oregonians.

Some opponents of the ballot initiative urge Massachusetts lawmakers to adopt a substitute bill drafted by Representative Nicholas Boldyga. This proposal would give the state Department of Health responsibility for regulating psychedelics. Its supporters include the Provincetown, Massachusetts Select Board, which voted last month to promote a substitute bill. A coalition of community groups also backs the proposal, including Bay Staters for Natural Medicine, New England Veterans for Plant Medicine, Parents for Plant Medicine.

In addition to basing oversight within an existing agency, which could reduce program costs, supporters believe a substitute bill would reduce the chances for New Approach to exert hidden influence. That could be the case. But regardless, Boldyga’s proposal would also streamline regulation for the supervised psilocybin program.

According to Bay Staters’ founder James Davis, psilocybin facilitators would undergo criminal background checks and complete a “very small amount of accredited training that would be approved by the Department of Health.” They would pay $155 biennially, “the same way that licensed counselors do.”

State lawmakers have additional options. They could amend the Natural Psychedelic Substances Act, for instance, by retaining its decriminalization provisions and tabling the supervised use program. They could replace supervised use with a task force to study its ideal design, anticipated cost, and implementation. Governor Healey proposed a psychedelic work group in November.

Massachusetts currently leads the nation in local psychedelic decriminalization. Eight cities in the state have made the enforcement of criminal penalties associated with psychedelics their lowest law enforcement priority. Further, state lawmakers, including Senator Patricia Jehlen, have proposed a decriminalization bill. Retaining the ballot initiative’s decriminalization sections would reflect a growing Massachusetts policy trend. It would also have no associated regulatory costs.

Blindly pursuing the ballot initiative’s supervised use program, while most details remain unresolved, and questions from Oregon unanswered, could be a risky gamble of Massachusetts tax revenue. Last month, state tax revenue was down $82 million from the previous year.

Replacing the initiative with a homegrown blend of decriminalization and policy research could be a good solution. It would marry the proposal from Governor Healey with existing legislative proposals and local reforms enacted across the state from Provincetown, Somerville, and Salem to Amherst, Northampton, and Easthampton.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

Updated Feb 28, 2024: Kevin Matthews reports leaving the Healing Advocacy Fund at the end of October, 2023. However, he resumed working for the Fund on a limited contract basis in mid January.

On Wednesday, January 10, activists with Connecticut for Accessible Psychedelic Medicine (CAPM) will host an online and in person public forum on psilocybin decriminalization.

From 10am - noon Eastern, invited speakers will present their views on psychedelic policy reform, followed by a public comment period from noon to 2pm.

Connecticut residents can register to speak during the afternoon session. The event will occur in person at the state capital in Hartford. It will also be live streamed on the Connecticut Network.

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The morning session will include the following invited speakers:

1. Sarah Gersten, Executive Director of the Last Prisoner Project

2. Larry Norris, PhD, Co-founder and National Organizing Director, Decriminalize Nature

3. Ismail Ali, JD, Policy Director for the Multidisciplinary Association for Psychedelic studies (MAPS)

4. Courtney Barnes, Feldman Legal Associates

5. Mason Marks, MD, JD, Visiting Professor of Law, Harvard Law School; Senior Fellow & Project Lead, Project on Psychedelics Law & Regulation (POPLAR)

6. Peter Grinspoon, MD, Harvard Medical Doctor

7. Erin Doolittle, LMFT Marriage and family therapist

8. Kevin Matthews, Denver Psilocybin Mushroom Policy Review Panel; Helix Consulting

9. Jared Moffat, New Approach PAC

10. Victor Constanza, Samuel Evans, LMSW, and Melissa Keilty, LMSW, Connecticut for Accessible Psychedelic Medicine (CAPM)

Last year, the Connecticut House passed a bill from Representative Steve Stafstrom (D-Bridgeport) to partially decriminalize small amounts of psilocybin mushrooms. The bill would have eliminated the criminal penalty for possessing under half an ounce of mushrooms, replacing it with a $150 fine.

Some activist groups, such as New England Veterans for Plant Medicine and Bay Staters for Natural Medicine, raised concerns that the fine could incentivize law enforcement to increase policing. They claimed it could become a source of revenue like parking and speeding tickets. They’d prefer elimination of criminal and civil penalties, which Colorado implemented last November when voters approved Proposition 122, the Natural Medicine Health Act.

Last June, Bay Staters and over twenty individuals and organizations signed a letter urging Connecticut lawmakers to include cultivation and sharing in their decriminalization bills, which Colorado achieved last year and two Massachusetts bills currently propose. Activists adopted the slogan “no grow, no go” to reflect their position.

Though the Connecticut House approved Stafstrom’s psilocybin decriminalization bill last year in a 86-64 vote, it expired before reaching the Senate for a final vote. Last month, Stafstrom said he would reintroduce the bill in 2024.

Watch tomorrow’s public forum for more perspectives on Connecticut psychedelic policy.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

*Updated February 29, 2024. The Massachusetts psychedelic ballot initiative will be analyzed and considered for possible substitution by a special joint legislative committee on ballot questions.

In 2024, Massachusetts continues to be a psychedelic battleground.

On Wednesday, Bay Staters for Natural Medicine (Bay Staters) sent a press release to Psychedelic Week (reproduced in full below). Minutes earlier, I received a form email from the state ballot campaign, Massachusetts for Mental Health Options, which the DC-based New Approach PAC (New Approach) funds and oversees.

The campaign email said Secretary of State William Galvin had certified 96,277 signatures gathered in support of the PAC-funded initiative, “well over the threshold to move forward in the process of qualification for the 2024 ballot in November.”

“We thank the Secretary and his staff for their service reviewing the nearly 100,000 signatures submitted in support,” said campaign spokesperson Jennifer Manley, “as well as the volunteers and advocates who spent many hours talking to voters around the state.” 

According to the email, the ballot proposal “would allow adults 21 years and older to seek regulated access to some natural medicines under the supervision of trained facilitators in licensed therapeutic centers.” However, it makes no mention that the initiative would also allow people 21 and older to cultivate, possess, and use natural psychedelic substances at home or on private property. This home grow option appears in the first sentence of the official ballot summary approved by the state attorney general.

After the New Approach-funded campaign formed in July, it filed two nearly identical versions of its initiative. Version A contained the home grow option, and Version B excluded it. Bay Staters and other activists fought hard for home cultivation, and the campaign eventually pledged to pursue only Version A, which includes cultivation. However, its conspicuous absence from today’s email could say something about the campaign’s priorities.

This afternoon, I texted campaign spokesperson Jared Moffat, who works for New Approach and lives in Sacramento, California. Moffat declined to comment on the absence of home cultivation in the Wednesday email.

The other spokesperson, Jennifer Manly, who works for public relations firm Dewey Square, did not return Psychedelic Week’s voicemail before this article went to press.

New Approach “wants facilitators to pay tens of thousands in licensing fees every year just like in Oregon, making this care expensive for all but the ultra-wealthy,” said Colomba Klenner, a Bay Staters volunteer in the group’s Wednesday press release. In Oregon, where psilocybin services became available last summer, the price for a single dose of psilocybin typically ranges from $1,500 to $3,500, which includes supervision and a pre-administration preparatory session.

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Bay Staters is working with state and local lawmakers to replace New Approach’s ballot initiative with an alternate version. Massachusetts law allows the state legislature to enact or amend an initiative before it appears on the ballot.

“We will substitute the ballot question,” says James Davis, founder of Bay Staters and a former legislative staffer to the Chair of the Massachusetts Joint Committee on Cannabis Policy. Last month, Davis urged the Select Board of Provincetown, Massachusetts to decriminalize psychedelics by declaring the enforcement of criminal penalties its lowest priority. The Select Board adopted his proposal. It also urged state lawmakers to replace New Approach’s initiative.

“This PAC is already well-hated among lawmakers for creating the unelected [Massachusetts] cannabis control commission,” says Davis in Bay Staters’ press release. The cannabis commission “has made our cannabis system one of the most embarrassing, least diverse and most restrictive in the country.”

Bay Staters also says signature gatherers employed by New Approach’s campaign misrepresented the initiative to voters to obtain signatures. They allege the paid canvassers presented themselves as volunteers, misrepresented the initiative as a purely medical proposal, and claimed psychedelic services would be covered by insurance.

During our text exchange on Wednesday, New Approach’s Moffat said he would not comment on Bay Staters’ press release or the group’s allegations.

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Michael Botelho, founder of New England Veterans for Plant Medicine, says Massachusetts voters “deserve to know that ‘Massachusetts for Mental Health Options,’ is a front group for “New Approach PAC” that is shamelessly working to confuse voters and force through laws that will make it impossible for vets like me to afford this care.”

According to Bay Staters’ press release, Noah Heller says Massachusetts should be skeptical of New Approach’s claims. Heller leads Psilocybin Oregon and previously worked in the ketamine therapy space. He initially supported Oregon’s ballot initiative, which was also funded and overseen by New Approach, until he saw how inefficiently it was being rolled out.

“The psilocybin services model sounds great, but has been an epic failure in Oregon,” says Heller. “A single psilocybin session costs $3,500. Psilocybin is federally illegal, which means neither private nor public health insurance can pay for these services. While the campaign may claim that will change soon, the truth is this is highly unlikely to happen. Remember medical cannabis has been legal in some states for almost three decades and that [insurance coverage] has yet to occur.”

The full text of Bay Staters Wednesday press release is reproduced below:

Massachusetts Advocates Secure the Support Necessary to Substitute Psychedelic Ballot Question in the Legislature, Replace it with a more Affordable Alternative

Massachusetts voters may soon have the opportunity to loosen the state’s policies on psilocybin “magic” mushrooms, an illegal psychedelic the U.S. Food and Drug Administration (FDA) designates a “breakthrough therapy” for depression. However, Bay Staters for Natural Medicine, the nonprofit behind six local communities passing measures to end arrests for psilocybin mushrooms, is working to substitute the ballot measure for a new version they hope will keep treatments affordable.

Last month, Provincetown became the seventh community in Massachusetts to declare it will end arrests for growing and sharing psychedelic plants and fungi. The community's measure also explicitly calls for state lawmakers to substitute the ballot question by a “DC-based PAC with language that legalizes plant medicine services in a straightforward manner without an unelected control commission prone to regulatory capture by interests outside our communities.”

“We will substitute the ballot question. This PAC is already well-hated among lawmakers for creating the unelected cannabis control commission, which has made our cannabis system as one of the most embarrassing, least diverse and most restrictive in the country,” said James Davis, founder of Bay Staters and a former legislative staffer to the Chair of the Joint Committee on Cannabis Policy in Massachusetts.

“This PAC wants facilitators to pay tens of thousands in licensing fees every year just like in Oregon, making this care expensive for all but the ultra-wealthy. The PAC’s so-called protections on growing and sharing also amount to little more than hefty fines since a standard grow bag for mushrooms exceeded the limits of the bill,” remarked Colomba Klenner, a Bay Staters for Natural Medicine volunteer and certified facilitator who helps guide safe experiences.

Organizers with Bay Staters for Natural Medicines have video documentation of canvassers for New Approach PAC, the entity funding the ballot question campaign, lying to voters in an effort to get them to sign its petition. In the footage, paid canvassers can be seen making multiple misrepresentations, including claims that they are unpaid volunteers, that the law only applies to medical use, that costs will be covered by insurance, and that the ballot measure is the only way to legalize psychedelic services. The canvassers did not know the name of the organization that had hired them.

“Our residents deserve to know that ‘Massachusetts for Mental Health Options,’ is a front group for “New Approach PAC” that is shamelessly working to confuse voters and force through laws that will make it impossible for vets like me to afford this care. I heard that a veteran resigned from being their spokesperson when they learned the truth.” said Michael Botelho, the founder of New England Veterans for Plant Medicinewho shared with NBC Boston how mushrooms helped him work through PTSD.

Per reporting by WBUR, Massachusetts residents have been working with state lawmakers for substitution if the ballot measure goes forward, including former paid canvassers for New Approach PAC. Ultimately, they want to either outright pass a bill on decriminalization or submit to voters this November a package deal that would create a straightforward path to license facilitators through the Department of Public Health, as that department already does for non-psychedelic licensed counselors.

This substitute will model existing legislation that has gained traction in the state. Senator Jehlen and Representative Sabadosa filed An Act Relative to Plant Medicine, which will allow adults to grow and share modest amounts of psilocybin mushrooms without commercial the psychedelics. Republican and former police officer, Rep. Boldyga, filed a bill with the coalition that would create a simple system to become a licensed facilitator with psilocybin mushrooms.

“This is a call to action for plant medicine advocates to share their powerful stories of healing and hope,” said Representative Boldyga, who supporting the legislative push with his experience in law enforcement. “It’s critical that members of the Judiciary Committee hear from veterans, first responders, clinicians, mental health professionals, and the countless others whose lives have been transformed.”

In September, State House News Service reported on affordability concerns related to the D.C. PAC’s ballot question when the grassroots coalition with Bay Staters presented to nearly 60 state lawmakers and their staffon legislation already before lawmakers. Elected Senators and Representatives on the state’s Judiciary Committee asked how these treatments could be kept affordable. A Massachusetts mom and the wife of an Iraq War veteran, Jamie Morey, made it clear she supports the state bills over the ballot question. “This DC Super PAC is trying to rig our rules and the ballot system to profit off suffering in our communities.”

Noah Heller, an Oregon businessman who previously worked in the ketamine therapy and initially supported the ballot question passed in his state called on Massachusetts voters to be weary of New Approach PAC’s claims. “The psilocybin services model sounds great, but has been an epic failure in Oregon. A single psilocybin session costs $3,500. Psilocybin is federally illegal, which means neither private nor public health insurance can pay for these services. While the campaign may claim that will change soon, the truth is this is highly unlikely to happen. Remember medical cannabis has been legal in some states for almost three decades and that has yet to occur.”

Bay Staters for Natural Medicine: team@baystatersnm.com

New England Veterans for Plant Medicine: leadership@plantmedicinevets.org

Parents for Plant Medicine: parentsforplantmedicine@gmail.com

*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

On Monday, Provincetown became the seventh Massachusetts city to decriminalize psychedelic plants and fungi.

According to a press release sent to Psychedelic Week by Bay Staters for Natural Medicine (Bay Staters), “Provincetown is a traditionally Portuguese community where LGBTQ people from around the world visit in search of community and healing. Now the select board of the town has opened up a new opportunity for the winter season when tourism wanes: psilocybin mushrooms” (the full press release is reproduced below).

Massachusetts leads the nation with a record number of cities where local lawmakers have deprioritized the enforcement of criminal penalties associated with psychedelics. Salem, Massachusetts decriminalized psychedelics in May, on the heels of Cambridge, Somerville, Northampton, Easthampton, and Amherst.

Bay Staters is a community organization that educates people about psychedelic plants and harm reduction. Working with a regional network of groups, including New England Veterans for Plant Medicine and Parents for Plant Medicine, Bay Staters has played a central role in making Massachusetts a bastion of psychedelic decriminalization. In October, Bay Staters partnered with Decriminalize Maine to make Portland the first city in Maine to decriminalize psychedelics.

Bay Staters has worked in New England for years. In 2021, it helped make Somerville the first Massachusetts city to decriminalize. However, this year, the state has become a psychedelic policy battleground. A Washington, DC-based political action committee, the New Approach PAC, clashed with local communities by introducing two psychedelic ballot initiatives in Massachusetts for 2024.

Both initiatives would have created a heavily-regulated program for the supported adult use of five psychedelic substances. Facing public pressure, New Approach recently committed to supporting only Version A, which would allow for limited home cultivation of psychedelic plants and fungi (Version B prohibited home cultivation).

Bay Staters and its New England partners worry about New Approach’s lack of consultation with Massachusetts communities, that the PAC is distracting from locally-developed legislation, and that New Approach will create an expensive psychedelic program that excludes locals while costing taxpayers, clients, and the state more than anticipated.

The PAC funded psychedelic ballot initiatives in Oregon and Colorado, where local communities lodged similar complaints. In Oregon, the Psilocybin Services Act cost taxpayers more than New Approach promised. In 2020, its Oregon campaign told voters the program would become self-sufficient by 2023. However, state regulators overseeing it ran out of money this year, costing taxpayers an extra $3.1 million.

Oregon’s psilocybin program is expensive for individual clients, placing it out of reach for many in the state. A single dose of psilocybin can cost $1,500 - $3,500, which includes an intake session and monitoring by state-licensed facilitators.

The resolution adopted by Provincetown’s Select Board is Bay Staters’ latest collaboration. In addition to deprioritizing the enforcement of criminal penalties, it stands out from previous resolutions by urging state lawmakers to replace New Approach’s 2024 ballot initiative. New Approach did not respond to Psychedelic Week’s request for comment on this story or Provincetown’s call to replace its initiative.

According to Bay Staters founder James Davis, lawmakers have until January to provide a substitute bill. On Monday, Select Board member Erik Borg invited Davis to address the Board.

Davis told the Board, “it's no surprise that the Lancet, the most prestigious medical journal in the world, has found that mushrooms and related plant based psychedelics have the lowest harms of any controlled substance particularly in comparison to the alcohol and cigarettes that we can buy at just about any corner store.” He said, “we have a responsibility to educate the public about these plant medicines, their relative safety, and their relative savings for our communities and the state government as a whole.” Davis added, “law enforcement has tended to agree,” referencing Salem Police Chief Lucas Miller, who endorsed Salem’s successful resolution.

He described proposed substitute bills to replace New Approach’s initiative. “We have two primary pieces of legislation before state lawmakers right now,” Davis said. “One would simply decriminalize growing and sharing non-commercially. That’s sponsored by Senator Jalen (D) and Rep. Sabadosa (D). We also have a bill, H.3605, sponsored by a former police officer and the self-proclaimed most conservative representative in the state, Rep. Boldyga (R), that would create a really simple licensing pathway for someone like Patricia to operate above ground.”

According to Davis, this licensing pathway would require people to “undergo a CORI background check” and complete a “very small amount of accredited training that would be approved by the Department of Health.” Applicants would pay $155 annually, “the same way that licensed counselors do.”

Davis concluded that “by using that simple model, we can ensure that this activity is above ground.” He looked to existing state-regulated programs for justification. “The reason why this is incredibly important is we can learn from the lessons of both Oregon and Colorado, where psilocybin was legalized, but in a way that drove all of that activity underground.”

“In Oregon, it costs tens of thousands of dollars in order to operate as a facilitator every year,” said Davis. Under rules adopted by the Oregon Health Authority last December, psilocybin service centers must pay an annual license fee of $10,000, and psilocybin facilitators pay $2,000 a year. In response to these costs, which are passed on to consumers, many people in Oregon are opting for underground psychedelic sessions.

“People are simply growing, gathering and sharing their own and then finding a guide that they trust to help them with the experience,” said Davis. If that practice was moved above ground, as Bay Staters proposes, “that means that people are going to be paying their taxes, there's more accountability, and most importantly, people who want to try plant medicine will have an alternative way with someone they can trust and someone they know is going to help them have the best experience possible.”

Davis discussed the advisory board that would be installed if voters approve New Approach’s initiative next year. This board, appointed by the Governor, would advise a newly formed psychedelic agency on rules for the state-regulated program. In Oregon and Colorado, New Approach and its funders appear to have influenced board member selection.

Davis told Provincetown’s lawmakers, “I believe that you all, as five elected officials, are better at making these decisions than five unelected officials that will be appointed by a PAC if we're not able to change the ballot measure the voters are currently being tricked into voting on in November 2024.” Davis was referencing reports that canvassers paid by New Approach to collect signatures, necessary to place its initiative on the ballot, were misinforming voters about the proposal.

Two Provincetown Select Board members raised concerns about Bay Staters’ proposal. Leslie Sandberg said she supported the supported use of psychedelics, stating “I know how wonderful they are.” But she prefers use to occur under medical supervision.

Davis responded that medical doctors support Bay Staters’ resolution and the proposal would not preclude medical research or the development of psychedelic therapies. He said the model advanced by New Approach would be unaffordable, even to wealthy individuals. Davis argued that bad outcomes would be reduced if decriminalization occurred, which would increase open dialogue and promote education.

Borg agreed with Davis. “I completely understand Leslie's line of questioning,” said Borg. “But one thing we have to keep in mind is that mushrooms currently exist in Provincetown. They currently exist in the state of Massachusetts, people are doing them recreationally. And I don't think whatever happens here tonight, will persuade anyone to, to stop doing them recreationally or to start doing them recreationally. Psilocybin mushrooms are already here in Provincetown.”

Select Board member Austin Miller asked whether the resolution might exceed the Board’s authority. Davis said that “in other townships where we've worked, we acknowledge that this is a resolution. And so based on that text of the resolution, it's already understood to be an ask of the police department and city employees,” rather than a demand. He added, “I've had a version of this discussion, many times, and we often maintain, because it's a resolution that those changes are not as necessary for what it's worth.”

Board member John Golden said, “to me, this is not gonna change it for the town of Provincetown. This is to make the state legislature look at what we're doing. He added, “I just think that Provincetown has always sort of been at the forefront of whatever and, you know, we just got to move forward . . . Provincetown, this is what we do.”

After replacing one word of Bay Staters’ proposal to address Miller’s concern regarding the Board’s authority, members approved the resolution in a three-to-one vote, with Miller voting against the proposal and Sandberg abstaining.

Provincetown residents praised the Select Board’s decision, citing benefits related to public health, the economy, and social equity. “Our town is now leading the way for affordable access to plant medicine and set an example for our state,” said Anna May Meade, a local author and member of the Visitor’s Services Board who helped lead the effort. “The PAC-funded ballot measure should be changed to reflect what communities across the state have called for.”

Bay Staters says readers can help its educational mission by sharing its messages or making a donation.

Bay Staters’ full press release is reproduced below:

Provincetown Votes to End Arrests for Natural Psychedelics, Calls for State Lawmakers to Rewrite the Ballot Question

Provincetown is a traditionally Portuguese community where LGBTQ people from around the world visit in search of community and healing. Now the select board of the town has opened up a new opportunity for the winter season when tourism wanes: psilocybin mushrooms.

Categorized as a “breakthrough therapy” for depression by the FDA, psilocybin mushrooms and other psychedelic plants will now be the lowest priority for law enforcement in the community by order of the select board. Specifically “investigation and arrest of adults for planting, cultivating” and sharing psychedelic plants and fungi will not be permitted. The measure also calls for town employees to treat the possession of all controlled substances as a public health issue rather than a criminal issue.

The organization behind this measure and the decriminalization of six other communities statewide, Bay Staters for Natural Medicine, emphasized psilocybin’s benefits for alleviating opioid addiction and helping traumatized veterans in its presentation for the select board. Its local volunteers also emphasized the economic and tax benefits. Several advocates plan to open retreat centers where people can have guided experiences with psilocybin and enjoy community ceremonies to have spiritual experiences in a group environment.

“This vote signals Board support of Provincetown to not only stand strong as a community known for its arts, inclusion and celebration but now also as a destination for healing, which could be a boon to our off-season economy,“ says Steven Azar, resident and small business owner in Provincetown. “Decriminalization of plant medicine will result in more public education on the safe use of plant medicine and its therapeutic benefits…,” said Patricia van Dijkhuizen, a resident of Provincetown, certified psychedelic practitioner, and LCSW.

An economic analysis by advocates found that Provincetown could generate an additional $300,000 in revenue and $13.8 million in economic activity every year. In late fall and winter, the model predicts that thousands of additional people each year will visit the town in the off-season to stay at local hotels, visit community stores, and enjoy the town’s cuisine.

“Our town is now leading the way for affordable access to plant medicine and set an example for our state. The PAC-funded ballot measure should be changed to reflect what communities across the state have called for,” said Anna May Meade, a local author and member of the Visitor’s Services Board who helped lead the effort.

The measure also explicitly calls for state lawmakers to change the ballot question that may be presented to Massachusetts voters next fall. Funded by a secretive entity Boston Globe recently described as “a deep-pocketed, out-of-state PAC,” the ballot question has come under fire for copying the model it created in Oregon where treatments with psilocybin mushrooms often cost thousands of dollars.

“Local communities are asking their elected officials, like Senator Cyr, to substitute the ballot question so that future psychedelic services can be affordable. Even upper middle class families will be excluded from this life-changing care if we create another unelected control commission instead of legislating,” said James Davis, the founder of Bay Staters for Natural Medicine and author of the measures.

Advocates point out that a state representative and former police officer, Representative Boldyga, has filed legislation to legalize psychedelics by creating a simple process by which people can get training and licensing to be guides. For many, this calls into question the motives of the PAC that filed the ballot question and underscores the necessity of substituting so voters are not misled.

“The PAC swooped in uninvited and hired an army of canvassers to lie to voters. If our state lawmakers lack the backbone to substitute the ballot question, then they will be letting veterans like me die and forfeiting our democracy to dark money,” said Michael Botelho, the founder of New England Veterans for Plant Medicine who shared with NBC Boston how mushrooms helped him work through combat PTSD.

*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

Psychedelic Week has created a customized version of ChatGPT called Newsie: Psychedelic Week’s AI newsgathering chatbot, to summarize news from the psychedelic ecosystem for the past seven days. Users can select one of several pre-written search options or input personalized questions or search instructions (unfortunately, access to customized GPTs like Newsie is limited to ChatGPT Plus subscribers, which could change in the future).

2023 was a pivotal year for artificial intelligence (AI). Leading chatbot developer OpenAI publicly released ChatGPT, its take on large language models (LLMs), in November of 2022. But LLM technology really hit its stride in early 2023, when OpenAI improved the platform by releasing ChatGPT Plus in February and ChatGPT 4 in March. These developments made ChatGPT a household name and one of the fastest growing apps of all time.

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Earlier this month, OpenAI released its latest version, ChatGPT 4 Turbo. The update allows ChatGPT Plus subscribers to create customized “GPTs” and automate a variety of tasks. For instance, GPTs can search the internet, analyze documents, create images, and engage users in conversation. But what makes customized GPTs so interesting and useful is the ability to train them on unique data (such as uploaded images or documents) and provide specialized instructions. These updates can make customized GPTs more focused and effective than OpenAI’s public release version. 

As you will quickly learn from using them, Newsie and other GPTs can be informative, entertaining, and sometimes very impressive. But they’re far from perfect (and unlikely to replace psychedelic journalists anytime soon). Perhaps with ChatGPT version 5.0?

While entrepreneurs and consumers embrace AI chatbots, OpenAI and its competitors work to integrate them into many industries, such as healthcare. My academic colleague Claudia Haupt and I have written about potential medical applications and risks in two articles for the Journal of the American Medical Association (JAMA): AI-Generated Medical Advice—GPT and Beyond and AI Chatbots, Health Privacy, and Challenges to HIPAA Compliance.

To address AI risks, the Biden Administration published a fact sheet in July on its efforts to secure voluntary commitments from leading AI companies to mitigate concerns regarding safety, privacy, security, and transparency. While AI-related norms and regulations take shape, consumers should exercise caution and skepticism when using chatbots, which can provide inconsistent and inaccurate results. Newsie is instructed to provide links to references that support its responses. However, the quality of those references can vary considerably.

Since its inception, Psychedelic Week has used AI to create images to accompany its stories. OpenAI’s DALL-E 4 created the image above, depicting a humanoid robot “newsie” in a futuristic version of New York City. Customized GPTs can utilize DALL-E to produce images in addition to searching the internet and analyzing uploaded information.

If you have access to ChatGPT Plus and can try Newsie, please let me know what you think of its results. What roles do you think AI should play in newsgathering and reporting?

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

This week, the Oregon Health Authority (OHA) is receiving public comments on new draft rules for the state’s psilocybin industry. The OHA published an original set of rules last December to implement Measure 109 (the Oregon Psilocybin Services Act), which voters approved in November 2020.

Psilocybin businesses and facilitators licensed earlier this year are operating under the OHA’s original rules. The recently proposed updates make numerous “technical fixes” and implement Senate Bill 303 (SB 303), a psilocybin data collection bill the legislature enacted in May.

On Wednesday and Thursday of this week, the OHA’s psilocybin services division held online public listening sessions to receive feedback on the proposed rules. The agency held a third and final hearing this morning. The OHA will continue receiving written testimony until Tuesday, November 21st at 5pm Pacific. Readers can submit comments by emailing the agency at publichealth.rules@odhsoha.state.or.us.

Though OHA’s proposed rules include technical fixes in many areas, from psilocybin product manufacturing to facilitator training, the most controversial and widely discussed rules involve SB 303. The bill has a complex history one can read about here, here, and here. Its sponsor, Senator Elizabeth Steiner unveiled SB 303 on January 9, within two weeks of OHA’s publication of its original ruleset in December.

In Wednesday’s public listening session, one of the most frequently discussed topics was the nature of SB 303’s data opt-out provision. OHA’s proposed rules, which will implement the bill, allow clients to opt out of having any data collected under SB 303 from being aggregated or reported to OHA, which would otherwise collect and share that data with Oregon Health & Science University (OHSU).

This issue was discussed repeatedly during several meetings of OHA’s Rules Advisory Committees (RACs) held to discuss early drafts of the proposed rules. Most participants on the RACs interpreted SB 303’s opt out provision to be unrestricted. In other words, once a client opts out, none of the data collected under SB 303 is aggregated by psilocybin service centers or shared with OHA and OHSU.

However, on September 14 , RAC member Heidi Pendergast of the Healing Advocacy Fund surprised other members with a previously unheard interpretation of SB 303. According to Pendergast, the rules should allow clients to opt out of sharing some types of aggregated data with OHA but not others. Several RAC members expressed confusion in response.

At a subsequent RAC meeting on September 20, Erin Williams, an attorney representing Oregon’s Department of Justice (DOJ), said her office had reviewed the issue from a legal perspective. On her interpretation, SB 303 allows clients to opt out of sharing all data collected under the bill. OHA’s current proposed rules reflect this interpretation.

Nevertheless, Pendergast’s minority view resurfaced months later, just before this week’s listening sessions. The Healing Advocacy Fund circulated an email promoting it. “Contact the OHA to let them know that reporting client service averages and adverse events for all clients is critical to understanding and increasing program safety,” said the Fund (emphasis its own).

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At Thursday’s listening session, Pendergast and the Fund’s Sam Chapman reiterated this position. Chapman said a partial opt out had always been the intent of SB 303. To investigate, Psychedelic Week reviewed footage of Oregon House and Senate discussions regarding the bill.

The result is a short video titled The Most Important Thing About Senate Bill 303 (embedded below). Psychedelic Week was unable to find cases where Steiner or the Fund, which lobbied for the bill’s passage, mentioned a partial opt out. In many cases, they described an “overt opt-out option” or clients’ “full authority to opt out.” Several lawmakers emphasized the importance of the opt out prior to voting on SB 303. This raises the question, would the legislature have passed SB 303 without Steiner and Chapman’s repeated reassurances of a complete opt out?

Psychedelic Week also reviewed testimony submitted by Chapman and the Healing Advocacy Fund throughout the legislative process.

On March 22, the Fund submitted the following slides to the Oregon Senate Committee on Health Care. The first slide states, “clients can opt-out from having their information aggregated and passed on for reporting purposes.” The Fund highlighted the statement in yellow and put the words “clients can opt-out” in bold.

The second slide states “clients can opt out of having info passed on to OHA.” The Fund underlined “clients can opt out.”

These slides refer to the -2 amendments to SB 303 sponsored by Senator Steiner. The original bill contained no opt out provision, but the -2 amendments added one, which was viewed by the public, Steiner, and the Healing Advocacy Fund as responsive to privacy concerns.

On February 10, Chapman sent an email to the Fund’s mailing list. “Worth noting up front that the biggest request we heard from the community is for clients to have the ability to opt-out of having their information shared with the OHA, which is now reflected in the new version.”

Days later, on February 22, Chapman submitted testimony to the Senate Committee on Health Care regarding the -2 amendments. “Under the revised version of SB 303, a client may choose to opt-out of having a Service Center provide their aggregate information to the OHA,” Chapman told legislators.

On May 3, Chapman submitted testimony to the House Committee on Behavioral Health & Health Care. In bold text, he says, “clients have full authority to opt-out of having their aggregated information passed along to the Oregon Health Authority.”

*The views expressed on Psychedelic Week do not represent the views of POPLAR at the Petrie-Flom Center at Harvard Law School, Yale Law School, Florida State University College of Law, or any other entity with which the author is associated. Psychedelic Week is an independent project unaffiliated with these programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at the Florida State University College of Law, the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and a visiting fellow at the Information Society Project at Yale Law School. Marks teaches drug law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.

*Updated December 27, 2023.

Today, multiple sources say the Massachusetts psychedelic ballot campaign run by New Approach PAC may have made technical errors while collecting signatures for its 2024 ballot initiative.

To keep the ballot initiative alive, proponents must file 74,574 signatures with election officials before November 22, one week from today (update: according to the campaign, it has collected over 100,000 signatures before the deadline).

Rumor has it the campaign must start from scratch and collect an additional 74,574 signatures. So far, Psychedelic Week has been unable to verify these claims, which should not be taken as fact until they can be confirmed. (update: according to Boston’s WBUR, “state officials [who reviewed the campaign’s signatures] found several "disqualifying marks" on their ballot papers,” and “the campaign printed a labor union logo on their ballot sheets, violating signature-gathering regulations and potentially invalidating thousands of signatures.”

Psychedelic Week contacted New Approach’s Jared Moffat, who oversees the Massachusetts campaign, but did not receive a response before press time. Moffat later offered to send a campaign statement (see below), but he declined to comment on the alleged errors in signature collection or reporting.

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At 12:34 pm Eastern, author Jules Evans posted on X (formerly Twitter), “I hear that New Approach PAC collected the necessary 75,000 signatures for the Massachusetts psychedelic therapy bill, but there's been some error so they have to collect them all again with a week or so to go, hence they're hiring signature gatherers...?”

Evans linked to a job post for campaign signature gatherers, which other sources independently provided to Psychedelic Week.

The posting states, “We’re urgently hiring campaign staff to gather petition signatures from Massachusetts voters to put an important initiative on the ballot in 2024!” and “We are hiring folks to start ASAP and this is a short-term role, with an end date of 11/19.” Instead of paying signature gatherers per signature, which is commonly done to incentivize them, the campaign is offering an hourly wage.

A spokesperson for the campaign declined to tell WBUR how many signatures were affected or comment on the union logo that reportedly appeared on the signature forms. Prior to the revelation that disqualifying marks appeared on the paperwork, the conspiratorially-minded might have wondered whether these rumors could serve as pretext for the campaign to substitute a different version of its ballot initiative.

On September 6, Massachusetts Attorney General Andrea Campbell certified two psychedelic voter ballot petitions submitted by the campaign: 23-13 (Version A) and 23-14 (Version B). Certification means that according to Campbell, the petitions meet the state’s constitutional requirements, and proponents can start collecting signatures.

Petitions Versions A and B are nearly identical. Both would create a regulated program for the non-medical, supported adult use of five psychedelic substances: psilocybin, psilocin, ibogaine, mescaline, and dimethyltryptamine. The petitions have only one difference. Version A would allow people to legally cultivate psychedelics at home, and Petition Version B would not.

After a backlash from local activists who support home cultivation, including Bay Staters for Natural Medicine and New England Veterans for Plant Medicine, New Approach agreed to pursue only Version A, which would allow home cultivation. However, Psychedelic Week has been unable to verify that the 74,574 previously collected were for Version A, and it isn’t clear whether new signatures will be collected for Version A or B.

Within hours of this article’s publication, the public relations firm Dewey Square Group sent a message from the campaign stating, “we are working diligently to ensure we meet the signature threshold to move our petition (Version A) forward in the ballot qualification process.”

It is unclear whether collecting the required signatures within one week is a realistic goal, especially with the Thanksgiving holiday rapidly approaching. However, the campaign statement was optimistic. “We are confident we will have a sufficient number of signatures to qualify.” The statement omitted mention of the alleged signature collection or reporting errors and did not explain why additional signature collection may be necessary.

Stay tuned to Psychedelic Week for further coverage of the Massachusetts campaign and efforts by local activists like Bay Staters to enact psychedelic legislation with state lawmakers.

*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University, or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is a Visiting Professor of Law at Harvard Law School. He is also the Florida Bar Health Law Section Professor at Florida State University, senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and an visiting fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.