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Drew Kriete -Paper: FROM COUNTER-CULTURE TOWARDS OVER THE COUNTER THE LEGALIZATION OF PSILOCYBIN MUSHROOMS: WHAT A LONG, STRANGE TRIP IT’S BEEN…… 

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Author

Drew Kriete is a third-year J.D. Candidate at California Western School of Law. Drew is he co-chair of the Psychedelic Committee and the class representative for the Cannabis Law Student Society.

He writes…..I am very passionate about promoting the history and proven therapeutic benefits of cannabis, psilocybin, and other natural medicines. I am eager to deepen my ties with the psychedelic legal community so that I may become more involved in policy discussions and help plant-based businesses navigate through cumbersome legal processes.

 

 

Drew Kriete

J.D. Candidate 2023

CALIFORNIA WESTERN

SCHOOL  of  LAW | SAN DIEGO

 

 

FROM COUNTER-CULTURE TOWARDS OVER THE COUNTER

THE LEGALIZATION OF PSILOCYBIN MUSHROOMS: WHAT A LONG, STRANGE TRIP ITS BEEN

 

  • INTRODUCTION
  • PART I: BACKGROUND
  • WHAT PSILOCYBIN DOES TO PEOPLE 
  • WHAT PSILOCYBIN MEANS TO CULTURE AND HISTORY
  • PART II: THE LEGAL STATUS OF PSILOCYBIN AND CONFLICTS BETWEEN LEVELS OF  GOVERNMENTS
  • PART III: RECENT STATE DEVELOPMENTS 
  • WHAT MAY CHANGE THROUGH LEGALIZATION AND DECRIMINALIZATION
  • CRITICISMS AND POSSIBLE SOLUTIONS
  • CONCLUSION

 

INTRODUCTION 

“‘Magic mushrooms’ for PTSD therapy? Vets help sway conservatives.”1 “‘Magic  mushroom’ psychedelic may help heavy drinkers quit.”2 “Psychedelic Treatment with Psilocybin  Relieves Major Depression, Study Shows.”3 Recent headlines such as these have brought  psilocybin mushrooms and the use of other entheogens as a therapeutic tool to the forefront of scientific research and popular culture. Entheogens are “psychoactive, hallucinogenic  substance[s] or preparation[s] especially when derived from plants or fungi and used in religious,  spiritual, or ritualistic contexts.”4 One entheogen receiving the most attention is psychedelic  mushrooms, commonly known as ‘magic mushrooms,’ ‘mushrooms,’ or ‘shrooms.’5 Over 200  species of hallucinogenic fungi have been recorded.6 The most common come from the genus  Psilocybe.7 Psilocybe cubensis (“Gold Caps”) and psilocybe semilanceata (“Liberty Caps”) have  become the most distributed and recognizable species.8 

These mushrooms have been featured in movies and television,9 as well as scientific  studies.10 Yet many people, even those who consider themselves experienced “psychonauts” (a  person who uses altered states induced by substances to “explore human experience and  existence”),11 may not know or understand the history and legal background behind psilocybin mushrooms. 

While psilocybin remains illegal federally, some states and large cities have begun to  relax their laws concerning mushrooms and other plant-based entheogens.12 Psilocybin  mushrooms have been legalized in Oregon and Colorado with service centers opening in the near  future.13 Bills to decriminalize, investigate, or ease restrictions are active in Florida, Georgia,  Hawaii, Iowa, Kansas, Maryland, Massachusetts, Missouri, New Jersey, New York, Oklahoma,  Rhode Island, Vermont, Virginia, and Washington.14 Notable cities that have decriminalized  psilocybin include Denver, Oakland, San Francisco, Seattle, Detroit, Ann Arbor, Cambridge, and  a growing list of others.15  

This article will examine psilocybin mushrooms: what they have come to mean to our  culture, their evolving history, an argument in support of change in their legal status, and a  description of what may change through decriminalization or legalization. Part I will examine  psilocybin mushrooms, their cultural background, the effects of psilocybin, and what the  developing history has come to mean to our culture. Part II examines the legal status of  psilocybin and conflicts between various levels of United States government, using  developments in cannabis as a comparison. This includes a discussion of Constitutional law and  preemption. Part III examines recent state level developments, primarily in Oregon and  Colorado, but also briefly examines a few countries besides the United States, as well as  criticisms to legalization and possible solutions. 

PART I: BACKGROUND 

WHAT PSILOCYBIN DOES TO PEOPLE 

Psilocybin is a naturally occurring hallucinogenic compound found in a variety of  mushroom species.16 Psilocybin mushrooms have “slender stems topped by caps with dark gills  on the underside.”17 Psilocybin is typically consumed through ingestion, as a brewed tea or  paired with other food products, and is later broken down into psilocin through  dephosphorylation in the digestive system.18 Psilocin is a pharmacologically active compound,  structurally similar to the neurotransmitter serotonin, that alters mood, perception, and  cognition.19 Serotonin has a causal association with mental and physical health.20 This is why the  “first-line pharmaceutical treatment” for depression is typically a Selective Serotonin Reuptake  Inhibitor (SSRI).21 SSRIs alter behavior and mood by influencing the amount of serotonin in the  brain.22 However, it has been hypothesized and demonstrated that “in line with SSRIs and  ketamine . . . psychedelics enhance molecular and cellular neuroplasticity.”23 Neuroplasticity is defined as “the brain’s ability to change throughout life” and it “consists of changes in cell  structure, structural plasticity, and changes in the efficacy of synaptic transmission.”24 

Examples of typical effects of psilocybin (or psilocin) include distorted thinking, visual  alteration, and distortion, as well as a feeling of spiritual awakening.25 Stanislav Grof, a  psychedelic research psychiatrist, has described psychedelics as “non-specific catalysts and  amplifiers of the psyche.”26 While most psilocybin users experience euphoric alterations in  mood, some may experience panic or dysphoria.27 It has been stated that “[t]he nature of the [psychedelic] experience depends almost entirely on set and setting.”28 Set refers to the personal  mindset and expectations before and during the experience, while setting refers to environmental  factors.29 However, “survey data on challenging experiences from recreational psilocybin users  suggest even highly challenging experiences can be associated with increased well-being and  perceived benefits in retrospect.”30 Despite a public perception that psychedelic substances are  dangerous, they are physiologically one of the safest.31 

The effects and duration of psilocybin can vary based on the size of the dose and potency  of the mushroom.32 For usual varieties (P. cubensis and P. semilanceata) of dry mushrooms: a  microdose is less than 0.25 g; a low dose is between 0.25 and 1 g; an average dose is between 1  and 2.5 g; a high dose is between 2.5 and 5 g; and a very high dose would be more than 5 g. For  pure psilocybin: a microdose is less than 4 mg; a low dose is between 4 and 8 mg; an average  dose is between 6 and 20 mg; a high dose is between 20 and 35 mg; and a very high dose is over  35 mg. 33 The duration of the experience depends on the dose, but the effects generally last 4 to 6  hours.34 

Microdosing has become a popular way to consume psilocybin mushrooms.35 Microdosing involves taking a sub-hallucinogenic amount.36 It is seen as a relatively safe method  of use that can relieve the potential for psychological risks.37 However, as one article notes,  microdosing has many associated benefits and challenges.38 Some benefits of microdosing  include improved mood, creativity, and decreased social anxiety; conversely, challenges of  microdosing include illegality, discomfort, impaired mood, and increased anxiety.39 The illegal  status leads to negative social stigma, the consumption of too much or too little (due to potency  or dosage), substance availability, and cost.40 Overall, the positive or negative effects of  microdosing are similar to taking larger doses and largely depend on the individual.41 

WHAT PSILOCYBIN MEANS TO CULTURE AND HISTORY 

Human consumption of hallucinogenic mushrooms has been well documented,  particularly in pre-Columbian Mesoamerican societies.42 Its ritual use there is thought to be at  least 3,500 years old.43 The religious ceremonies were further documented in the 16th century by  Spanish historians as they explored the new world.44 Similar shamanistic rituals have also been  documented in indigenous Siberian and East Indian cultures.45 This is also comparable to the  ritual use of peyote in religious ceremonies by indigenous Native Americans.  

This ritual and cultural history of entheogens appear to lend some credence to what has  become known as the “Stoned Ape theory.” As argued by ethnobotanist Terrance McKenna, the  theory hypothesizes that psilocybin “was involved in the emergence of human self-reflection on  the African grasslands some tens of millennia ago.”46 The theory suggests that early humans  following herds of cattle foraged mushrooms out of cattle dung.47 Through incorporation of  psychoactive chemical compounds into the early human diet, mutations were caused that  “directly influenced the rapid reorganization of the brain’s information-processing capacities.”48 This hypothesis never achieved much academic acclaim due to a lack of scientific evidence.  Although it developed popularity within psychedelic culture and with well-known  mycologists,49(one who studies mycology, the biological study of fungi) such as Paul Stamets.50 Whatever the case, psychedelic mushrooms certainly played a role in the development of human  culture.51 

Psilocybin mushrooms were popularized in the United States through the combination of  shamanistic rituals and academic interest, which helped develop the American psychedelic  counterculture in the 1960s.52 This occurred through R. Gordon Wasson, a banker with J.P.  Morgan, and his wife Dr. Valentina P. Wasson.53 During their marriage, Gordon and Valentina  Wasson explored the various roles mushrooms have in cultures across the world.54 They are  considered to be “the founders of the science of ethnomycology, the study of human uses of and  lore concerning mushrooms and other fungi.”55 

In 1953, the Wassons discovered and pursued “the existence of still active shamanic  mushroom cults in the mountains of the Sierra Mazateca of Oaxacan Mexico.”56 They made  several unsuccessful trips, but their luck changed in 1955.57 Then, in the Oaxacan village of  Huautla de Jiménez they met María Sabina, a curandera (a native healer or shaman), who  performed sacred mushroom rituals called velada.58 Sabina has become colloquially known as  the “Saint Mother of the Mushrooms.”59 The Wassons continued to study and participate in the  rituals, even on expeditions that were unwittingly financed by the CIA and its infamous  psychedelic mind control project MKULTRA.60 The Wassons later published their research in  their first book Mushrooms, Russia, and History in 1957.61 The book was accompanied by a Life  Magazine photo article, Seeking the Magic Mushroom.62 Between these two works, a massive  public interest in psilocybin and psilocybin mushrooms developed. Gordon Wasson also  delivered samples of the mushrooms to Swiss pharmaceutical chemist and LSD discoverer  Albert Hofmann who isolated and synthesized psilocybin in 1957.63 Thereafter, Hofmann’s  pharmaceutical company Sandoz distributed psilocybin to research institutions.64 

The widespread interest in psilocybin reached academic circles, and over a thousand  clinical papers discussing 40,000 psychedelic patients occurred from 1950 through the mid 1960s.65 In 1960, Doctors Timothy Leary and Richard Alpert began the Harvard Psilocybin  Project.66 The project’s aim was to record and document the effect of psilocybin on human  consciousness by using volunteer graduate students.67 However, by 1962, a number of Harvard  faculty claimed the project’s methodology was unconventional, dangerous, and lacked scientific  objectivity.68 These concerns stemmed from poorly controlled conditions, including the use of  psilocybin by the researchers during volunteer studies.69 In 1963, Alpert was fired “after he  administered psilocybin to an undergraduate student off-campus”70 and the project ended that  same year when Leary was also fired.71 Nonetheless, the two went on to become prominent  figures in the psychedelic counterculture of the 1960s.72 Alpert as a modern spiritual leader  under the name Baba Ram Dass and Leary later became famous for his slogan of, “Tune in, Turn  On, Drop Out.”73 Psychedelic use continued to be prevalent during the 1960s, which strongly  influenced youth culture, science, and politics.74 However in 1965, Sandoz ceased to provide  psychedelic drugs for clinical research and access became more difficult.75 

In 1965, Leary was arrested for possession of marijuana in Texas. Through his conviction  and subsequent appeal, he continued to influence national drug laws. In Leary v. United States,  Leary challenged the constitutionality of the Marihuana Tax Act. The act required him to obtain  an order form, “identify himself not only as a transferee of marihuana but as a transferee who  had not registered and paid the occupational tax”, then directed that this information be conveyed  to state and local law enforcement officials on request.76 Leary argued successfully that the act violated his privilege against self-incrimination.77 On October 27, 1970, Congress responded by  repealing the Marihuana Tax Act and passing the Controlled Substance Act (“CSA”). 78 

Psilocybin mushrooms remained legal until the passage of the CSA.79 The legislation was  championed by President Richard M. Nixon who famously stated in a press conference on June  17, 1971 that drug abuse was “public enemy number one.”80 The CSA provides a framework for  scheduling or categorizing substances based on their medical use and potential for abuse, with  Schedule I being the most dangerous and Schedule V being the least.81 Psilocybin was listed as  Schedule I, where it still remains with heroin, quaaludes, and bath salts.82 Therefore, nearly all  psilocybin consumption and research in the U.S. since has been facilitated by illicit means.  

This changed in 2000, when researchers from Johns Hopkins University gained  regulatory approval to resume psychedelic research, albeit with much more scientific scrutiny  than Leary’s Harvard Psilocybin Project.83 Since then, researchers at Johns Hopkins Center for  Psychedelic and Consciousness Research have continued to lead the way in psilocybin research 

as a therapeutic treatment and have published numerous studies on the topic.84 As a therapeutic  tool, psilocybin has been shown to have positive long-term associations with depression and  anxiety, alcohol and cigarette dependence, as well as an “enduring sense of personal meaning  and increased well-being.”85 Further research is being done exploring psilocybin assisted  psychotherapy as a potential treatment for other conditions such as chronic pain, inflammation,  epilepsy, and a variety of serious personality disorders.86 Psilocybin as a therapeutic tool seems  to bridge the gap between shamanistic natural medicine and western medicine. The positive  therapeutic benefits have become primary reasons why support for the legalization of psilocybin  has grown. 

PART II: THE LEGAL STATUS OF PSILOCYBIN AND CONFLICTS BETWEEN LEVELS OF  GOVERNMENTS 

As noted above, psilocybin and psilocybin mushrooms remain a Schedule I drug under  the CSA.87 Schedule I means there is no currently accepted medical use in treatment in the  United States, a lack of accepted safety for use under medical supervision, and a high potential  for abuse.88 “The regulatory scheme is designed to foster the beneficial use of [Schedule II-IV]  medications, to prevent their misuse, and to prohibit entirely the possession or use of substances  listed in Schedule I.”89 

Some researchers have argued for psilocybin rescheduling if it is approved as a  medicine.90 They argue that psilocybin provides therapeutic benefits and the adverse effects are manageable “when administered according to risk management approaches.”91 Researchers have  concluded that placement in Schedule IV would be a more appropriate scheduling.92 Schedule IV  substances have current medical uses and a much lower potential for abuse.93 Psilocybin has  demonstrated both medical uses and a lower potential for abuse,94 as repeated administration  leads to a rapid tolerance development.95 

Under the CSA, scheduling decisions are given to the Attorney General, working with the  U.S. Department of Health and Human Services (“HHS”). 96 The Attorney General has delegated  its authority to the Drug Enforcement Agency (“DEA”) and the HHS has delegated its authority  to the Food and Drug Administration (“FDA”) and the National Institute on Drug Abuse  (“NIDA”).97 Ultimately the DEA is responsible for scheduling decisions and can reject a  rescheduling request after a hearing with an administrative law judge so long as their decision is  not “arbitrary or capricious.”98 They are further responsible for regulating scheduled substances  and those performing medical or scientific research with scheduled substances.99 

In their recent article, authors Karen Luong, Esq. and Kimberly Chew, Esq. describe  many of the legal developments that have occurred in psychedelic therapeutics.100 The FDA  designated psilocybin breakthrough therapy status in 2018 and again in 2019.101 The status  allows the FDA to expedite the review and approval process.102 

One suggested path to psilocybin legalization would be to sue the DEA, though this  would only be successful after the DEA denies a rescheduling petition.103 As seen in Washington v. Barr, a similar strategy with cannabis was not successful as the Plaintiffs did not exhaust  administrative remedies with the DEA prior to filing their lawsuit.104 While not explicitly stated  in the CSA, the court found exhaustion of administrative remedies was consistent with the intent  of Congress.105 However the Second Circuit Court of Appeals also noted and critiqued the  DEA’s “dilatory proceedings.”106 

Currently, the federal penalty for simple possession of a controlled substance, like  psilocybin mushrooms, is up to 1 year in prison and a minimum fine of $1,000, or both.107 A  second conviction is punishable by a minimum of 15 days but not more than 2 years in prison  and a minimum fine of $2,500.108 Subsequent convictions beyond that are punishable by a  minimum of 90 days but not more than 3 years in prison and a minimum fine of $5,000.109 Meanwhile, manufacturing or possession with intent to distribute faces a minimum penalty of 10  years’ imprisonment.110 

Through decriminalization, cities impose a “lowest law enforcement priority” (“LLEP”) and signal their support for both state and federal decriminalization. 111 Although psilocybin has  been decriminalized in a few states and several cities, it is not equivalent to legalization, as  psilocybin and psilocybin mushrooms remain illegal on a federal level, “but prosecuting people  for their possession or use is deprioritized or discouraged.”112 Decriminalization occurs when the  governing authority decides “to not enforce criminal laws relating to the use and possession of  drugs such as psychedelics.” Meanwhile, legalization allows for psilocybin regulation and  taxation, as well as “permission for personal use within parameters set by the government.”113 

Psilocybin services, like cannabis, could create significant tax revenue and business  opportunities when legalized. Since 2018, tax revenue from the legalization of cannabis in  California alone has produced over $4.3 billion.114 

By examining the similar structure inherent in marijuana cases, we can gain great insight  into how the laws legalizing psilocybin will likely unfold. Marijuana or cannabis, like psilocybin,  is also considered a Schedule I drug under the CSA.115 Yet states have legalized both medical  and recreational cannabis use.116 However, these substances create different physiological  responses.117 While cannabis is seen as safer, survey data suggests that psilocybin mushroom use  creates fewer emergency medical responses.118 However, this statistic could be because fewer  people use psilocybin than cannabis. 

Like marijuana, a dichotomy between local and state governments and state and federal  government may emerge. As seen in Ruggles v. Yagong, decriminalization through lowest law  enforcement priority does not necessarily mean complete freedom from criminal charges for  those who use, produce, or distribute.119 In that case, plaintiffs alleged prosecutors and police  continued to use funds to prosecute cannabis offenses in violation of a county code section.120 The county code section prohibited “expending ‘public funds for the investigation, arrest, or  prosecution of any person, [or] the search or seizure of any property’ in a manner inconsistent   with the LLEP.”121 However, the state argued successfully that the county code section was  preempted by state law.122 The Hawaii Supreme Court held that the state attorney general retains  the duty to enforce the penal code, and this duty is “further delegated to county prosecuting  attorneys.”123 Ultimately, LLEP does not guarantee freedom from prosecution. The state attorney  general still has a duty to prosecute violations of the statewide Penal Code.124 

There is another conflict that can emerge between city and state laws. In City of Riverside  v. Inland Empire Patients Health & Wellness Ctr., Inc., the California Supreme Court held that a  city zoning ordinance that labeled medical marijuana facilities as a nuisance was not preempted  by California’s medical marijuana act. 125 Following this precedent, cities could likely prohibit  psilocybin service centers within their borders, despite broader state legalization. 

Besides the potential for conflicts within the state level, there is also potential conflict  between the state and federal government over psilocybin that is like the conflict regarding  marijuana. This conflict concerns preemption and the competing principles of the Supremacy  Clause and the Anti-Commandeering doctrine in the 10th Amendment. The Supremacy Clause  establishes that federal law is “the supreme Law of the Land . . . any Thing in the Constitution or  Laws of any State to the Contrary notwithstanding.”126 Meanwhile, the 10th Amendment gives  the powers, such as the power to police, that the Constitution does not expressly award to the  federal government to the states.127 Preemption occurs “where it is impossible for a private party  to comply with both state and federal law” and where the challenged state law is “an obstacle to  the accomplishment and execution of the full purposes and objectives of Congress.”128 It is an  obstacle if “the purpose of the act cannot otherwise be accomplished.”129 Here, it is not  impossible to comply with both state legalization and the federal CSA, as a person would not  have to consume psilocybin under the state law.  

Next, psilocybin legalization must be analyzed as an obstacle to the purposes of the CSA. Due to a clause in the CSA, its preemptive effect is extremely limited.130 “The CSA explicitly  contemplates a role for the States in regulating controlled substances, as evidenced by its pre emption provision.”131 The provision requires a “positive conflict” between federal and state law  so that the two cannot consistently stand together.132 The Supreme Court has interpreted this as  meaning a state’s decision to simply permit what the federal government prohibits does not  create a “positive conflict” with federal law.133 Therefore, state psilocybin legalization is not  technically preempted under the CSA. 

However, there remains another issue between state and federal governments. According  to the Commerce Clause within the Constitution, Congress has the authority to “make all Laws  which shall be necessary and proper” to “regulate Commerce . . . among the several States.”134 This has been defined by the Supreme Court to include an “economic ‘class of activities’ that  have a substantial effect on interstate commerce.”135 In Gonzales v Raich, Plaintiffs were legally  growing marijuana for their personal use according to California’s medical marijuana laws.136 The Court determined that Congress could, under its commerce power, prohibit marijuana  cultivation and use, even when done in compliance with California law.137 The Court relied on  Wickard v Filburn, a case regarding a farmer’s production of wheat for his personal  consumption.138 The Court stated, “regulation is squarely within Congress’ commerce power  because production of the commodity meant for home consumption, be it wheat or marijuana,  has a substantial effect on supply and demand in the national market for that commodity.”139 The  private cultivation of psilocybin mushrooms will also run into a similar conflict with the  Commerce Clause. 

Yet state laws do not prevent the federal government from enforcing federal laws  against psilocybin users if the federal government chooses to do so.140 In Printz v United  States, the Supreme Court examined the anti-commandeering rule.141 “The Federal Government  may neither issue directives requiring the States to address particular problems, nor command the  States’ officers, or those of their political subdivisions, to administer or enforce a federal  regulatory program.”142 This means that the federal government can create regulations, but the  federal government must also enforce them through their own agents.143 

However as Robert Mikos notes in his article, On the Limits of Supremacy: Medical  Marijuana and the States’ Overlooked Power to Legalize Federal Crime, “Raich did not stop (or  even slow) state legalization campaigns.”144 Mikos further explains that “state laws and most  related regulations have not been – and, more interestingly, cannot be – preempted by Congress,  given constraints imposed on Congress’s preemption power by the anti-commandeering rule,  properly understood.”145 Therefore, in his view, states can effectively legalize federal crimes.146 The Supreme Court has interpreted the Constitution to give “power to Congress to  regulate individuals, not States.”147 The Constitution allows Congress to regulate interstate  commerce directly but does not authorize Congress to regulate state governments’ regulation of  interstate commerce.148 Congress may still use a variety of incentivizing methods to urge a state  to adopt a program that conforms with federal law.149 One way Congress incentivizes states is to  place conditions on the receipt of federal funds, however the conditions must be related to the  purpose of the funds, among other limitations.150 Another way Congress can incentivize federal  standards is to “offer States the choice of regulating that activity according to federal standards  or having state law pre-empted by federal regulation.”151 

Scott Bloomberg defined this relationship as “Frenemy Federalism.”152 As Bloomberg  explains, “States must implement robust legal and regulatory regimes to, inter alia, keep  marijuana activity from spilling-over into other states. This condition furthers the federal  objective of reducing interstate marijuana activity and functions as a command for states to keep  their markets insular and intrastate.”153 This sort of tense relationship will presumably develop  similarly towards other federally prohibited entheogens, such as psilocybin.154 All of this to say,  the states have the freedom to regulate and allow legal psilocybin therapy or services within their  borders. 

Freedom of religion is another argument that has been used to justify illicit entheogen  use, although with mixed results. The Native American ceremonial use of peyote, another  federally illegal entheogen, has been protected. In Employment Div. v. Smith, the Supreme Court  held that the First Amendment does not protect Native American practitioners who use peyote in  connection with religious ceremonies.155 This raised the important question whether this  religious practice would be protected.156 To protect this important practice, Congress amended  the American Indian Religious Freedom Act, 42 U.S.C. §1996, to include the traditional  ceremonial use of peyote.157 Native American use of psilocybin is not protected, despite Native  sovereignty. While the Native American ritual use of psilocybin was not as common as peyote, a  similar argument for its protection can be made. Mexico already recognizes an exception for indigenous people regarding the prohibition against psilocybin mushrooms.158 

In United States v. Meyers, Meyers argued under the First Amendment and Religious  Freedom Restoration Act (“RFRA”) that he was the founder and Reverend of the Church of  Marijuana.159 Under the RFRA, there are five factors to determine if a belief is a religious belief,  which is protected by the First Amendment, or simply a way of life which does not receive the  same constitutional protections.160 These factors are: (1) Ultimate Ideas, (2) Metaphysical  beliefs, (3) Moral or Ethical System, (4) Comprehensiveness of Beliefs, and (5) Accoutrements  of Religion, such as a prophet, important writings, holidays, gathering places, and other symbols  of a religion.161 After examining these factors, the 10th Circuit Court of Appeals affirmed that  “[m]arijuana’s medical, therapeutic, and social effects are secular, not religious.”162 When  applying this outcome to the religious use of psilocybin, a church of psilocybin would be highly  unlikely to be considered a religion. However, this argument would seem to be much stronger for  Native American ritual use of psilocybin and other entheogens. 

PART III: RECENT STATE DEVELOPMENTS  

With the passage of voter approved Measure 109 in 2021, Oregon became the first state  to legalize psilocybin and psilocybin mushroom services.163 Measure 109 “allow[s] the  manufacture, delivery, and administration of psilocybin at supervised, licensed facilities . . .  under the supervision of a licensed psilocybin service facilitator.”164 These psilocybin services  will use the most common species, Psilocybe cubensis.165 Further, the services will require a  preparation session at least 24 hours before the administration session.166 The maximum dosage  is 50 mg of psilocybin,167 and the amount consumed determines the duration of the  administration session.168 The services will be available for individuals or groups and can be held indoors or outdoors.169 The amount consumed also determines the facilitator to group size ratio, and a maximum dose requires a one-on-one session.170 Finally, the services must offer an  integration session after psilocybin administration to help with a client’s potential need for  support or community resources.171 

By using the term “service providers,” the law effectively allows for both quasi-medical  and recreational facilitated use. These facilitators will have to undergo extensive education and  training on adverse behavioral reactions and adverse medical reactions.172 Multiple companies  have been given approval to train facilitators for therapeutic psychedelic trips.173 The two-year  period to develop the policies, procedures, and infrastructure ends December 30, 2022.174 The  administrative rules also permit licenses to manufacturers to extract psilocybin and create edible  psilocybin products.175 This will certainly attract additional investments and businesses into this  expanding market. 

Service providers open doors in Oregon on January 1, 2023, and psilocybin proponents  see this as the first step in a larger legalization movement. However, feelings within Oregon  remain mixed towards psilocybin, as several rural counties in November 2022 voted against  having psilocybin manufacturing and service centers within their borders.176 

As the next step in the legalization movement, Colorado voters also passed a psilocybin  legalization ballot measure in November 2022.177 The measure was similar to Oregon’s but more  expansive. It both defines psilocybin as a “natural medicine” and decriminalizes adult (21+)  personal use, possession, growth, and transport of natural medicines.178 Colorado Proposition  122 entitled “Access to Natural Medicine” mirrors Oregon’s measure closely, but describes its  facilities as “licensed healing centers to administer natural medicine services.” This will also  allow for the expansion into other natural medicines, such as dimethyltryptamine (“DMT”),  Ibogaine, and mescaline (excluding peyote, lophophora williamsii) after June 1, 2026, if  recommended by the Natural Medicine advisory board. The Colorado Department of Regulatory  Agencies will adopt rules and begin accepting applications for facilitators by September 30,  2024.179 

WHAT MAY CHANGE THROUGH LEGALIZATION AND DECRIMINALIZATION 

Currently, there is already a large community that has formed underneath the prohibition  of entheogens or natural medicines. These communities already offer and engage in facilitated  trips. Some facilitators are oriented towards life coaching and personal growth while others aim  to treat veterans with severe post-traumatic stress disorder. Either way, these groups aim to use  psilocybin and other natural medicines as a tool to guide others through their various traumas  and mental health issues. The strategies developed by underground facilitators have been  incorporated into the current legalization models as facilitators have been made a part of the  Oregon Psilocybin Advisory Board. 

One area that has already been impacted by psilocybin research is the financial  markets.180 There is a growing and expanded market interest in the investment potential for  clinical drugs and businesses.181 This can be clearly seen in the fact that companies actively  engaging in psychedelic research are being traded on the New York Stock Exchange.182 The  psychedelic substance market is projected to grow from $4.75 billion in 2020 to $10.75 billion by 2027.183 

While this is not a complete list of the countries addressing psilocybin decriminalization  or legalization, the economic growth of psilocybin is largely due to the status of psilocybin in western countries. Countries such as Canada, Jamaica, Brazil, Spain, Portugal and the  Netherlands, where psilocybin or psilocybin mushroom research and recreational use have fewer  barriers, continue to help propel psilocybin into mainstream culture. 

In Canada, psilocybin is currently available medically through a special access program  and healthcare provider.184 In Brazil, according to the Brazilian Controlled Drugs and Substances  Act, psilocybin mushrooms are not named as controlled substances185 and can be ordered online  or in retail shops.186 Further both Portugal and Spain have decriminalized drugs for personal  use.187 

In Jamaica, psilocybin is not listed on the Jamaica’s Dangerous Drugs Act as a controlled  substance and, in fact, the nation has never prohibited psilocybin mushrooms.188 Various retreats have already commodified the psilocybin experience and provide a possible model to follow.189 Psilocybin research centers are also active in Jamaica.190 

Finally, while psychedelic mushrooms have been illegal in the Netherlands since 2008,191 psilocybin containing sclerotia, or truffles, are legal. While truffles are not botanically  mushrooms, they are a part of the same organism.192 In response, several retreats and research  organizations have emerged there as well.193 The most well-known, Synthesis, plans to open a  retreat in Oregon that boasts 124 acres of property.194 

CRITICISMS AND POSSIBLE SOLUTIONS 

However, not all psychedelic enthusiasts are excited about the current plans to legalize psilocybin and a list of criticisms have developed. One criticism is that the current formulation  will primarily benefit corporations and those with previous capital.195 This has been an issue seen  in the cannabis market. There are a limited number of licenses available, and alcohol and tobacco  companies are buying large interests in cannabis businesses.196 Logically, it seems  pharmaceutical companies will do the same, and a battle over patent rights has already begun.197 Those who are currently facilitating illegally may also be unable to compete with larger  operations and will be pushed out of the market. This criticism can seemingly be addressed by  distributing psilocybin service center and manufacturing licenses in a more equitable way than that in which cannabis licenses were distributed. Service operators in Oregon are even required  to have a social equity plan.198 It also seems important to recognize, protect, and support the  activists who have risked criminal charges to start this movement. 

Another criticism is that people with “treatment resistant depression” and other mental  health disorders will seek psilocybin treatment and potentially exacerbate their conditions.199 With proper training and education for facilitators, they will be able to recognize potential  mental health issues and refuse service to those who may be unstable. Further, the training  facilitators receive will focus on handling adverse medical behaviors and reactions. In Oregon,  this also comes with a duty to contact emergency services if necessary.200 

An obvious criticism is that legalizing psilocybin could influence children and the  perception of substance use.201 To address this issue, it would be best to use some of the tax  revenue from psilocybin service centers for substance abuse and education programs. For  example, in Colorado, marijuana tax revenue goes toward healthcare, education, monitoring  health effects of marijuana use, law enforcement, and substance abuse prevention and  treatment.202 A potential rise in crime rates may also seem like a valid criticism. However, in contrast to what may be popular opinion, an additional benefit to psilocybin use throughout life  is an association with lower odds of criminal arrest.203 

Another criticism is that ketamine treatments may be similarly effective, yet ketamine has  lower risk of adverse effects and is already federally legal. Both substances effect the brain in  similar ways, however ketamine has a more negative effect on body-movement while psilocybin  has a more positive effect.204 Though more testing needs to be done to determine the comparative  efficacy of the two treatments,205 both treatments have scientific merit and should be made  available to the public. Some consumers may view psilocybin as a natural medicine, while  ketamine remains a traditionally western medicine. 

An additional important criticism is that this may take away from the cultural and  spiritual significance of the indigenous ritual use of psilocybin and other plant medicines.206 In a  recent article, critics Alnoor Ladha & Rene Suša suggest that decriminalization is superior to legalization in the sense that decriminalization “allow[s] those who work in support and  cultivation of these plants to do so without legal recourse and without the machinery of the  corporate-state nexus underwriting the extraction and expansion of psychedelics.”207 They  suggest less profit driven business models could be accomplished through worker-owned  cooperatives and gifting circles.208 They also suggest a form of reparations could be  appropriate.209 Western forms of psilocybin therapy and a more indigenous or shamanistic  approaches do not have to be mutually exclusive. Under future legalization, psilocybin services  will naturally adapt and cater to their customers or markets. Although various standards will be  established, legalization will not mean uniform services across different providers. Native  American tribes should be encouraged to join this process and share their culture in this way if they so desire. However, in line with this criticism, the commercialization of psilocybin will  inevitably affect and alter the cultural spirituality behind mushroom use. 

CONCLUSION 

While there are valid criticisms, the benefits of psilocybin legalization appear to outweigh the potential costs. However, there remains much to be determined in this burgeoning and controversial field. As demonstrated above, there are a variety of reasons psilocybin should  be legalized. Psilocybin has proven therapeutic benefits and market appeal that could influence  the overall direction of our culture. 

From ancient cultures to the modern era, psilocybin mushrooms and other entheogens  have greatly impacted human culture and creativity. While it is impossible to say for certain  where the future of psilocybin is headed, the renewed and continued interest will impact many  parts of our culture and society. Nonetheless, it will impact financial markets and the way  natural-plant medicines are socially viewed. It will also introduce new therapeutics, challenging  209 Id. legal issues, and potentially even recreational use. Although, as with cannabis, more scientific  research is clearly warranted in this mushrooming field.

 

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13 Id. 

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17 DEA, supra note 5. 

18 MEYLERS, supra note 16. 

19 Id. 

20 Simon N. Young, How to increase serotonin in the human brain without drugs, 32 J. OF PSYCHIATRY & NEUROSCIENCE 6, 394-9 (2007), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2077351/.

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23 Cato M. H. de Vos et al., Psychedelics and Neuroplasticity: A Systematic Review Unraveling the Biological  Underpinnings of Psychedelics, FRONTIERS (Sept. 10, 2021),  

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24 Id. 

25 Kathleen Davis, What are magic mushrooms and psilocybin?, MED. NEWS TODAY (Oct. 3, 2021),  https://www.medicalnewstoday.com/articles/308850#risks. 

26 STANISLAV GROF, LSD PSYCHOTHERAPY (4th ed. 2008). 

27 MEYLERS, supra note 16. 

28 TIMOTHY LEARY ET AL., THE PSYCHEDELIC EXPERIENCE: MANUAL BASED ON THE TIBETAN BOOK OF THE DEAD 11 (1964). 

29 Id.

30 Albert Garcia-Romeu et al., Optimal dosing for psilocybin pharmacotherapy: Considering weight-adjusted and  fixed dosing approaches, 35 J. OF PSYCHOPHARMACOLOGY 4, 353-361 (2021),  

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31 David E. Nichols, Psychedelics, 68 PHARMACOLOGICAL REV. 2, 264-355 (2016),  

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4813425/. 

32 Psilocybin Mushrooms: Basic Info, ICEERS, https://www.iceers.org/psilocybin-mushrooms-basic-info/. 33 Id. 

34 Id. 

35 Peter Grinspoon, The popularity of microdosing of psychedelics: What does the science say?, HARV. HEALTH PUB. (Sept. 19, 2022), https://www.health.harvard.edu/blog/the-popularity-of-microdosing-of-psychedelics-what-does the-science-say-202209192819. 

36 Thomas Anderson et al., Psychedelic microdosing benefits and challenges: an empirical codebook, 16 HARM  REDUCTION J. 43 (Jul. 10, 2019), https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-019- 0308-4. 

37 Id. 

38 Id.

39 Id. 

40 Id. 

41 Id. 

42 F.J. Carod-Artal, Hallucinogenic drugs in pre-Columbian Mesoamerican cultures, 30 NEUROLOGÍA 1, 42-49 (Dec. 2, 2014), sciencedirect.com/science/article/pii/S2173580814001527. 

43 Id. 

44 Carod-Artal, supra note 42; see also Harri Nyburg, Religious use of hallucinogenic fungi: A comparison between  Siberian and Mesoamerican cultures, 32 KARSTENIA 71-80, 73-74 (1992), 

https://www.funga.fi/Karstenia/Karstenia%2032-2%201992-4.pdf. 

46 Terrance McKenna, Food of the Gods, 58 (1992). 

47 Id. at 17.

48 Id. at 19. 

49 Mycology, MERRIAM-WEBSTER, https://www.merriam-webster.com/dictionary/mycology. 50 PAUL STAMETS, PSILOCYBIN MUSHROOMS OF THE WORLD, (1996). 

51 Carod-Artal, supra note 42. 

52 Ahmed Kabil, This Mexican medicine woman hipped America to magic mushrooms, with the help of a bank  executive, TIMELINE (Jan. 4, 2017), https://timeline.com/with-the-help-of-a-bank-executive-this-mexican-medicine woman-hipped-america-to-magic-mushrooms-c41f866bbf37. 

53 Donald H. Pfister, R. Gordon Wasson – 1898-1986, 80 MYCOLOGIA 1, 11-13,  

https://doi.org/10.1080/00275514.1988.12025491. 

54 R. Gordon Wasson, The hallucinogenic fungi of Mexico: an inquiry into the origins of the religious idea among  primitive peoples, 19 BOTANICAL MUSEUM LEAFLETS 7, 137-162, 138 (1961). 

55 McKenna, supra note 46 at 58. 

56 Wasson, supra note 54 at 144; see also McKenna supra note 46 at 58. 

57 Kabil, supra note 52.

58 Wasson, supra note 54 at 144; see also Kabil, supra note 52. 

59 John W. Allen, Maria Sabina Saint Mother of the Mushrooms, 1 ETHNOMYCOLOGICAL J. (Jan. 1997), https://bibliography.maps.org/resources/download/16391. 

60 Kabil, supra note 52; MK Ultra Receipts,  

https://documents.theblackvault.com/documents/mkultra/mkultra4/DOC_0000017457/DOC_0000017457.pdf. 61 R. GORDON WASSON & VALENTINA PAVLOVNA WASSON, MUSHROOMS, RUSSIA AND HISTORY (1957). 62R. Gordon Wasson, Seeking the magic mushroom, LIFE 100 (May 13, 1957). 

63 McKenna supra note 46 at 58. 

64 Henry Lowe et al., The Therapeutic Potential of Psilocybin, 26 MOLECULES 10 (May 15, 2021),  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8156539/#B55-molecules-26-02948. 

65 LESTER GRINSPOON & JAMES B. BAKALAR, PSYCHEDELIC DRUGS RECONSIDERED, 192 (1979). 66 Timothy Leary, HARV. UNIV. DEPT. OF PSYCHOL., https://psychology.fas.harvard.edu/people/timothy-leary.

67 Id.

68 Id. 

69 Id. 

70 Id. 

71 Id. 

72 Id. 

73 Id. 

74 David E. Nichols, Psychedelics, 68 PARMACOL. REV. 2, 264-355 (Apr. 2016),  

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4813425/. 

75 Wayne Hall, Why was early therapeutic research on psychedelic drugs abandoned?, CAMB. UNIV. PRESS (October 21, 2021), https://www.cambridge.org/core/journals/psychological-medicine/article/abs/why-was-early therapeutic-research-on-psychedelic-drugs-abandoned/59F93D11DE21F420465559BBEB99CC14. 76 Leary v. United States, 395 U.S. 6, 16 (1969). 

77 Id. 

78 21 U.S.C. § 801 et seq.

79 Id. 

80 Public Enemy Number One: A Pragmatic Approach to America’s Drug Problem, RICHARD NIXON FOUNDATION (Jun 29, 2016),  

https://www.nixonfoundation.org/2016/06/26404/#:~:text=At%20a%20press%20conference%20on,%E2%80%9Cw ar%20on%20drugs%E2%80%9D%20began. 

81 21 U.S.C. § 801 et seq. 

82 Id. 

83 JOHNS HOPKINS MED., supra note 10. 

84 Id. 

85 Garcia-Romeu, supra note 30. 

86 Lowe, supra note 64.

87 21 U.S.C. § 812. 

88 21 U.S.C. § 801 et seq. 

89 Gonzales v. Raich, 545 U.S. 1, 24 (2005). 

90 Matthew W. Johnson et al., The abuse potential of medical psilocybin according to the 8 factors of the Controlled  Substances Act, 142 NEUROPHARMACOLOGY 143-166 (Nov. 2018), 

https://www.sciencedirect.com/science/article/pii/S0028390818302296?via%3Dihub. 

91 Id. 

92 Id. 

93 21 U.S.C. § 812. 

94 Johnson, supra note 90. 

95 Nichols, supra note 31.

96 21 U.S.C. § 811. 

97 28 C.F.R § 0.100(b). 

98 Americans for Safe Access v Drug Enforcement Admin., 703 F.3d 438, 440 (D.C. Cir. 2013). 99 Kimberly Chew & Karen Luong, Legal Developments in Psychedelic Therapeutics, 34 HEALTH LAWYER 4, 5 (2022). 

100 Id. at 8. 

101Id.; see also Mason Marks, A Strategy for Rescheduling Psilocybin, SCI. AM. (Oct. 11, 2021),  https://www.scientificamerican.com/article/a-strategy-for-rescheduling-psilocybin/. 

102 Chew, supra note 99. 

103 Marks, supra note 101. 

104 Washington v. Barr, 925 F.3d 109 (2d Cir. 2019).

105 Id. at 116. 

106 Id. at 113. 

107 21 U.S.C. § 844. 

108 Id. 

109 Id. 

110 21 U.S.C. § 841. 

111 Zoe Sottile, San Francisco takes one step closer to decriminalizing plant-based psychedelics, CENT. NEWS  NETWORK (Sept. 10, 2022, 12:21 AM EDT), https://www.cnn.com/2022/09/10/us/san-francisco-decriminalization psychedelics 

trnd/index.html#:~:text=It%20was%20probably%20only%20a,CNN%20affiliate%20KPIX%2DTV%20reported. 112 Makin, supra note 15. 

113 Chew, supra note 99 at 8.

114 Cannabis Tax Revenues, CAL. DEPT. OF TAX AND FEE ADMIN.,  

https://www.cdtfa.ca.gov/dataportal/dataset.htm?url=CannabisTaxRevenues. 

115 21 U.S.C. § 812. 

116 Robert L. Page II et al., Medical Marijuana, Recreational Cannabis, and Cardiovascular Health: A Scientific  Statement From the American Heart Association, 142 CIRCULATION 10 (Aug. 5, 2020),  

https://www.ahajournals.org/doi/10.1161/CIR.0000000000000883. 

117 Frederick S. Barrett et al., “Hallucinations” Following Acute Cannabis Dosing: A Case Report and Comparison  to Other Hallucinogenic Drugs, CANNABIS CANNABINOID RES. (Mar. 1, 2018),  

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5908416/. 

118 Global Drug Survey 2021, GLOB. DRUG SURVEY, https://www.globaldrugsurvey.com/wp content/uploads/2021/12/Report2021_global.pdf. 

119Ruggles v Yagong, 135 Haw. 411 (Haw. 2015). 

120 Id. at 415.

121 Id. at 415. 

122 Id. at 422. 

123 Id. 

124 Id. 

125 City of Riverside v. Inland Empire Patients Health & Wellness Ctr., Inc., 56 Cal. 4th 729 (2013). 126 U.S. CONST., art. 6, cl. 2. 

127 U.S. CONST., art. 1, § 10.

128 Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000). 

129 Savage v. Jones, 225 U.S. 501, 533 (1912). 

130 Scott Bloomberg, Frenemy Federalism, 56 U. RICH. L. REV. 367, 385 (2022). 

131 Gonzales v. Oregon, 546 U.S. 243, 251 (2006). 

132 21 U.S.C. § 903. 

133 Barnett Bank v. Nelson, 517 U.S. 25 (1996). 

134 U.S. CONST., art. 1, § 8. 

135 Gonzales v. Raich, 545 U.S. 1, 17 (2005). 

136 Id.

137 Id. 

138 Wickard v. Filburn, 317 U.S. 111 (1942). 

139 Gonzales, 545 U.S. at 125. 

140Emerald Steel Fabricators, Inc. v. Bureau of Labor & Indus., 230 P.3d 518, 529 (2010). 141 Printz v. United States, 521 U.S. 898 (1997). 

142 Id. at 935. 

143 Id. at 935. 

144Robert Mikos, On the Limits of Supremacy: Medical Marijuana and the States’ Overlooked Power to Legalize  Federal Crime, 62 VAND. L. REV. 1421, 1423 (2009).

145 Id. at 1481-82. 

146 Id. at 1421. 

147 New York v. United States, 505 U.S. 144, 166 (1992). 

148 Id. 

149 Id. 

150 Id. at 167. 

151 Id. 

152 Bloomberg, supra note 130 at 368. 

153 Id. 

154 Id. at 402.

155 Emp’t Div. v. Smith, 494 U.S. 872, 888 (1990). 

156 42 U.S.C § 1996. 

157 Id. 

158 Código Penal Federal [CPF], art. 195 bis, Diario Oficial de la Federación [DOF] 10-1-1994, últimas reformas  DOF 20-08-2009 (Mex.). 

159 United States v. Meyers, 95 F.3d 1475, 1482 (10th Cir. 1996). 

160 Id.

161 Id. at 1483. 

162 Id. at 1484. 

163 Peipert, supra note 12. 

164 Or. Admin. R. 333-333 et seq. 

165 Id. 

166 Id. at 5000. 

167 Id. at 5240. 

168 Id. at 5250. 

169 Id. at 4450. 

170 Id. at 5230.

171 Id. at 5260. 

172 Id. at 1010. 

173 Anthony Effinger, Second Company Says It Has Been Approved to Train Facilitators for Therapeutic Psilocybin  Trips, WILLAMETTE WEEK (October 20, 2022 11:10 AM PDT),  

https://www.wweek.com/news/state/2022/10/20/second-psilocybin-company-says-it-has-been-approved-to facilitate-therapeutic-trips-under-measure-109/. 

174 Or. Admin. R. 333-333 et seq. 

175 Id. at 2110. 

176 Jane Vaughan, Several rural Oregon counties vote against therapeutic use of psilocybin, OPB (Nov. 9, 2022 11:06 AM PST), https://www.opb.org/article/2022/11/09/several-rural-oregon-counties-vote-against therapeutic-use-of-psilocybin/. 

177 Peipert, supra note 12.

178 Col. Rev. Stats. 12 art. 170, § 101 et.al. 

179 Id. 

180 Psychedelic Drugs Market, By Drugs (LSD, Ecstasy, Phencyclidine, GHB, Ketamine, Ayahuasca, Psilocybin),  Route of Administration (Oral, Injectable, Inhalation), Distribution Channel, End-Users, Application and Geography  – Global Forecast to 2026, (December

See https://www.researchandmarkets.com/reports/5240207/psychedelic-drugs-market-by-drugs lsdecstasy?utm_source=GNOM&utm_medium=PressRelease&utm_code=894w6r&utm_campaign=1513085+- +Global+Psychedelic+Drugs+Market+Report+2020%3a+Market+Size+is+Projected+to+Reach+%2410.75+Billion +by+2027&utm_exec=chdo54prd. 

181 Id. 

182 NYSE Stock Quote, CYBIN, https://ir.cybin.com/investors/stock-info/default.aspx#stock-quote. 183 Psychedelic Drugs Markert, supra note 180. 

184 Psilocybin and psilocin (Magic mushrooms), GOVT. OF CANADA, https://www.canada.ca/en/health canada/services/substance-use/controlled-illegal-drugs/magic-mushrooms.html#a33. 

185 Lei No. 11.343, de 23 de Augusto de 2006 (Braz.). 

186 Psychedelic Drug Laws in Brazil, TRIPSITTER (May, 23, 2022), https://tripsitter.com/legal/brazil/. 187 Psilocybin Laws: A Country-by-Country Magic Mushrooms Legal Guide, PSILOCYBIN.NET, https://psilocybin.net/laws/. 

188 Fred Rocafort, Jamaica: Psilocybin Leader, HARRIS BRICKEN (Aug. 19, 2022), 

https://harrisbricken.com/psychlawblog/jamaica-psilocybin-leader/.

189 ATMAN RETREAT, https://atmanretreat.com/. 

190 UWI FST/Field Trip Opens ‘World-First’ Mushroom Research Lab, THE UNIVERSITY OF THE WEST INDIES (Feb  11, 2021), https://www.mona.uwi.edu/fpas/uwi-fstfield-trip-opens-%E2%80%98world-first%E2%80%99- mushroom-research-lab. 

191 Catherine Hornby, Dutch ban on “magic” mushrooms to take effect, REUTERS (Nov. 28, 2008),  https://www.reuters.com/article/us-dutch-mushroom/dutch-ban-on-magic-mushrooms-to-take-effect idUSTRE4AR32R20081128. 

192 Peter de Boer, How Do Sclerotia Magic Truffles Differ from Magic Mushrooms?, TRUFFLE MAGIC (Jun. 27,  2017), https://www.trufflemagic.com/how-do-sclerotia-magic-truffles-differ-from-magic-mushrooms/. 193SYNTHESIS, https://www.synthesisretreat.com/; see also OPEN FOUNDATION, https://open-foundation.org/. 194 Olivia Goldhill, ‘It’s not medical’: Oregon wrestles with how to offer psychedelics outside the health care  system, STAT (Mar. 10, 2022), https://www.statnews.com/2022/03/10/oregon-wrestles-with-offering-psychedelic therapy-outside-health-care-system/. 

195 https://www.denverpost.com/2022/09/08/colorado-initiative-58-psychedelics-natural-medicine-health-act mushrooms/. 

196 Ryan Malkin, Why the Alcohol Industry Is Betting Big on Cannabis, SEVENFIFTY DAILY (Mar. 15, 2021),  https://daily.sevenfifty.com/why-the-alcohol-industry-is-betting-big-on-cannabis/; see also David Sabaghi, Why  Cannabis Is Part Of The Future Of Big Tobacco, FORBES (Aug 2, 2021, 07:00 AM EDT),  https://www.forbes.com/sites/dariosabaghi/2021/08/02/cannabis-is-part-of-the-future-of-big tobacco/?sh=5d1e82971ed5.

197 I. Glenn Cohen & Mason Marks, Patents on Psychedelics: The Next Legal Battlefront of Drug Development,  HARV. L. REV. (Feb. 20, 2022), https://harvardlawreview.org/2022/02/patents-on-psychedelics-the-next-legal battlefront-of-drug-development/. 

198 Or. Admin. R. 333-333-4020. 

199 Makin, supra note 15. 

200 Or. Admin. R. 333-333-4700. 

201 Peipert, supra note 12. 

202 Marijuana Tax Revenue and Education, COL. DEPT OF EDUC.,  

https://www.cde.state.co.us/communications/2021marijuanarevenue.

203 Grant M. Jones & Matthew K. Nock, Psilocybin use is associated with lowered odds of crime arrests in US  adults: A replication and extension, 36 J. OF PSYCHOPHARMACOLOGY 1, 66-73 (2022),  

https://nocklab.fas.harvard.edu/files/nocklab/files/02698811211058933.pdf. 

204Adam Wojtas et al., Effect of Psilocybin and Ketamine on Brain Neurotransmitters, Glutamate Receptors, DNA  and Rat Behavior, 23 INT. J. MOLECULAR SCI. 12, 6713 (Jun. 16, 2022), 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9224489/. 

205 Id. 

206 Max Lubbers, Therapists who already incorporate psychedelics in their practice are mixed on Prop 122, COL. PUB. RADIO (Nov. 2, 2022), https://www.cpr.org/2022/11/02/psychedelic-therapy-colorado-prop-122-ballot measure/. 

207 Alnoor Ladha & Rene Suša, Why the “Psychedelic Renaissance” is just Colonialism by Another Name, DOUBLE  BLIND MAGAZINE (Nov. 9, 2022), https://doubleblindmag.com/colonialism-by-another-name/. 208 Id.



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Paper 24 October 2024: Expert recommendations for Germany’s integration of psychedelic-assisted therapy

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Psychedelic-assisted therapy (PAT) is a modality of mental health treatment that merges psychotherapeutic interventions with psychedelic states, often facilitated by substances such as lysergic acid diethylamide (LSD), psilocybin, and 3,4-Methylenedioxy-methamphetamine (MDMA). The latter two being in phase III trials. Whereas MDMA is considered an entactogen that enhances self-awareness and emotional connectivity, psilocybin is a naturally occurring psychedelic compound found in certain mushrooms. Recent research suggests that these and other psychedelics, all small molecules, most with benzene or phenyl rings, uniquely work by reopening a “critical period” in the brain, allowing for new learning within social contexts in a process involving changes in brain plasticity and oxytocin signaling [1]. Despite their classification as a Schedule I drugs under the Controlled Substances Act by the Drug Enforcement Agency (DEA) in the United States, their therapeutic potential has been increasingly recognized, with demands from the public to make them available for those with treatment resistant conditions. These among other developments resulted in MDMA being granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of treatment-resistant PTSD (TR-PTSD) in phase II, (phase III studies were for ‘moderate to severe’ PTSD). Psilocybin (COMP360) and a deuterated psilocybin analogue (CYB003) were granted FDA Breakthrough Therapy designation for treatment resistant depression (TRD) [2,3,4].

Methodologically rigorous clinical research suggests that PAT may offer substantial long-term alleviation of symptoms in patients suffering from psychopathologies such as PTSD, TRD, major depressive disorder (MDD), end of life anxiety, obsessive–compulsive disorder (OCD), substance use disorders (SUD), psychotic conditions, and more [56]. Notably, a single session of substance-assisted therapy has been reported to lead to significant symptom reduction, with some patients achieving remission that can persist for at least twelve months [7]. This enduring effect underscores the potential of psychedelic-assisted therapy in providing therapeutic outcomes that are significantly superior to antidepressant medications such as SSRIs, which often have poor efficacy rates and unwanted side-effects such as agitation, weight gain, sexual performance difficulties, gastrointestinal issues, and other symptoms [18].

In February 2024, Lykos (formerly MAPS PBC) submitted a new drug application (NDA) to the FDA for MDMA (Midomafetamine) capsules in combination with psychotherapy for the treatment of PTSD [9]. Following the submission, a citizen petition was filed, raising concerns about the integrity of the clinical trials. This prompted the FDA to convene an advisory board meeting in June 2024 to review the claims. The petition raised several issues, including alleged bias in the trial design, inadequate sample diversity, insufficient double-blinding, underreporting of adverse events such as sexual misconduct, and confusion regarding the integration of psychotherapy within the study design [10]. Despite the principal view that MDMA trials are sound, and even the FDA’s participation in the creation and oversight of the studies these concerns influenced the FDA’s review process. Subsequently, in August 2024, the FDA issued a final decision rejecting the NDA under the Prescription Drug User Fee Act (PDUFA). It is important to note however that the FDA encouraged ongoing MDMA research and asked for another Phase III trial.

This decision led to additional actions, including the Journal of Psychopharmacology retracting three articles related to the MDMA clinical trials conducted by the MAPS research team and the initiation of an FDA investigation. Lykos has since filed for a reevaluation of their NDA. If approved, MDMA would become the first psychedelic-assisted therapy officially recognized in the United States.

As unexpected as the August 2024 rejection of the application by Lykos for approval of MDMA was for some, the hope based on the phase II studies, remains that either MDMA or psilocybin will within the next two to three years receive a positive evaluation from the FDA although the exact timing remains unknown. Unlike the MDMA trials, where the FDA was initially satisfied with the blinding process prior to the advisory board meeting, Compass’ psilocybin trials were designed to minimize the unblinding caused by psychotropic effects, following the FDA’s advice to their satisfaction until this day.

Lykos and Compass have been the two major companies driving development, and although Lykos has yet to submit a new phase III proposal, Compass continues with their phase III clinical trial. In general enthusiasm in the field for further research continues as there remains a need for novel treatments, and despite the uncertainty, the FDA seems generally favorable toward psychedelic medicine [10].

This paper outlines the current and required infrastructure for the successful integration of PAT, including rescheduling of psychedelic drugs beyond ketamine, accessibility, reimbursement strategies, accreditation of practitioners, ethical considerations and educational requirements. The role of the German government and affiliated agencies is pivotal in shaping this framework, ensuring that the setup not only complies with regulatory standards but also supports the ethical deployment of these therapies.

Moreover, with the European Medicines Agency (EMA) currently deliberating on the integration of psychedelics within the European framework, Germany has a unique opportunity to lead by example, showcasing a meticulous approach to the adoption of psychedelic-assisted therapies and must therefore also prepare to accommodate these innovative treatments [11]. This could serve as a model for other European nations, promoting a harmonized approach to these promising treatments across the continent.

The first half of this paper covers the regulatory environment in Germany, as it is impossible to understand the steps required to make PAT a reality without some in-depth understanding of the country’s unique health care system. The second half of this paper covers the German provision of outpatient mental healthcare and how and where PAT would fit and critically, proposes a training scheme for the education of PAT facilitators.

Historical roots of psychedelics in Germany

Psychedelic research in Germany harkens back to the 1910s and 1920s when the atypical psychedelic MDMA was first synthesized, and pioneering research was being conducted on the properties of mescaline. During this early period, Beringer and colleagues [12] saw in mescaline and similar substances, an opportunity to explore the phenomenology of psychopathology, creating what they described as ‘model psychoses.’ Although problematic in many ways, this stream of research opened up a new dimension of empathy and understanding into the experience of individuals with chronic psychosis [13]. In fact, the research carried out at the University of Heidelberg, culminating in Beringer’s habilitation thesis “Der Meskalinrausch” from 1927, can be considered the first major work in the field of psychedelic psychopharmacology in the West [12]. Another noteworthy event in the history of psychedelic drugs in German-speaking Europe is Albert Hoffman’s accidental discovery of the properties of lysergic acid diethylamide (LSD) on April 19, 1943, which accelerated interest in psychedelic compounds throughout the Western world [14]. In particular, this landmark event led to the widespread experimental use of psychedelics for a diverse range of psychiatric conditions across Europe and North America.

This period of research during the 1950s and 1960s, though short-lived, would later become known as the first wave of psychedelic research [1415]. During this brief moment in history, Betty Eisner, a German-educated American, first described the implementation of low-dose LSD in combination with psychotherapy, making a major contribution in the field which still today remains underrecognized [16]. Margot Cutner, a German psychoanalyst who was leading psychedelic research in England after fleeing from the Nazis, provided some of the first insights on the relevance of the role of the facilitator in psychedelic-assisted therapy (PAT) and the now well-known notion of ‘set and setting’ [16]. Following this, Hanscarl Leuner coined the term “psycholytic therapy” at the University of Göttingen underscoring the drug’s therapeutic potential in a sub-threshold dose range [17]. Despite Leuner and colleagues’ extensive research on LSD being among the most comprehensive bodies of work on the topic to date, it has been largely neglected until recently due to never being published in English [18].

A surprising turn of events occurred when in 1961, the United States passed the seemingly politically motivated US Controlled Substances Act, which resulted in an immediate and indefinite suspension of psychedelic research throughout the U.S. Europe was quick to follow suit, and psychedelics became labeled as potentially dangerous and addictive with no accepted medical use [19]. Subsequently, despite early breakthroughs and extensive research, these restrictions ushered in a prohibition era that would last decades, hampering progress and limiting the exploration of psychedelic compounds throughout the Western world. Germany was no exception, and psychedelic treatments now being championed for their therapeutic potential were outlawed.

Economic burden of treating PTSD and depression in Germany

The economic and human costs of PTSD and depression in Germany highlight an urgent need for more effective interventions [20]. Trauma-related healthcare costs range from 524.5 million to 3.3 billion euros annually [21], while depression adds another 1 to 5.2 billion euros [2223]. Current pharmaceutical treatments, such as serotonin-reuptake inhibitors (SSRI), offer limited efficacy and fail to fully address the needs of individuals with PTSD, depression, or their comorbidities [24].

A recent study of German insurance claims highlighted both the direct and indirect costs of PTSD (ICD-10-GM F43.1) [2021]. PTSD patients typically suffer for about 6 years, with a 50–100% likelihood of comorbid conditions such as major depressive disorder (MDD), panic disorder, and substance use disorder (SUD). Per-patient costs were 43,000 EUR, three times higher than for those without PTSD, driven by increased healthcare utilization, impaired work capacity and reduced quality of life. PTSD also accounts for approximately 200,000 Disability-Adjusted Life Years (DALYs) annually in Germany, a metric that reflects both premature mortality and years lived with disability, quantifying the overall burden of disease [25].

Similarly, depression carries significant economic burdens with indirect costs from labor absenteeism, social benefits, and prevention measures estimated at 10 to 16 billion euros annually, surpassing direct healthcare costs [2627]. Depression accounts for approximately 470,000 DALYs in Germany [28], while globally, PTSD contributes an additional 3 million DALYs, underscoring its substantial public health impact.

In short, PTSD and depression remain conditions with a high unmet need. SSRIs, first introduced in 1988 (fluoxetine), are still the primary pharmaceutical treatment for many psychological disorders, despite their limited efficacy and adverse side effects, including symptom exacerbation and suicidal thoughts [29].

Regulatory landscape

The European Medicines Agency (EMA) grants marketing authorization for new medicines across the EU. The sponsor of the medication submits an application for approval to the EMA following phase III trials, and after EMA approval, marketing authorization is granted, which allows the medication to be sold in all European Union member states. Sponsors then must decide which member states they wish to enter, as, even if the Sponsor has marketing authorization, each EU state has its own rules about how health insurers will be reimbursed for new medications. European member states furthermore have country specific processes and infrastructure around the provision of therapeutic services which are an essential part of PAT.

In Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees both clinical trial approval (pre- and post-EMA approval) and the documentation as well as considerations related to safety, efficacy, and quality, and specific labeling requirements tailored to the German context (Fig. 1).

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https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-06141-3?utm_medium=email&_hsmi=97789529&utm_content=97789529&utm_source=hs_email



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Psychedelics

Jacobin Article: “Nationalize Psychedelics” | Cannabis Law Report

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Here’s the introduction

here were high hopes that MDMA-assisted therapy would be approved by US regulators in 2024. The data showed that the drug-therapy combo significantly reduces post-traumatic stress disorder (PTSD) symptoms, or even eases them completely — despite a strong placebo effect in the trials, which involved well under a thousand participants. When the study data was published in September 2023, the New York Times reported that MDMA-assisted therapy was “inching closer to approval.” But in an August ruling that came as a wake-up call to figures in the nascent psychedelic industry as well as an underlying psychedelic movement made up of a hodgepodge of campaigners, the Food and Drug Administration (FDA) declined to give the green light, citing a lack of convincing clinical evidence and issues with the studies. The FDA requested further data from a new study, which would take several years, marking a significant setback for the prospect of medical psychedelics.

As early as 2026, however, the FDA will likely have another opportunity to approve another psychedelic drug for Americans with depression — psilocybin, which is derived from magic mushrooms — depending on the results of late-stage research. Even if it does pass, the therapy will likely not be immediately covered by insurance and so will remain beyond the reach of most Americans. This reality, plus the fact that psychedelics are meant to make you feel more interconnected (and thus perhaps less likely to want to squeeze profits from your peers), raises an intriguing possibility: that the psychedelics industry could be nationalized for the public good.

“Psychedelics, like pharmaceutical products, are just going to be inaccessible to many, many people,” says Professor Susi Geiger, a patent expert from University College Dublin. Step one to ensuring equitable access, and giving hospitals some respite from the straightjacket that often forces them to pay well over the odds for drugs, is reforming a patent system that enables Big Pharma to hike prices on existing drugs cartel-style thanks to the monopolies they enjoy over their products. To prevent the far-out possibility of Google founder Sergey Brin controlling the price of certain psychedelic therapy protocols, Geiger suggests a complete moratorium on private patents over psychedelics. “That’s the equivalent of nationalizing it at the source and keeping it as a public good.”

The idea may sound utopian and raise more questions than it immediately solves, even if the US patent office got on board and Congress created a European-style semi-socialized health care system, free at the point of use. “How can we trust exclusive access through a national health service when the state has only previously handled access [to psychedelics] through prohibition and religious censorship?” asks Chris Byrnes, a patent attorney at CalyxLaw. Matt Brockmeier, counsel at Antithesis Law, says less charitably: “I don’t trust the federal government — this or any other administration — to oversee something as monumental as our collective consciousness. Their track record is abysmal; they ruin everything they so much as look at because of the influence of special interests, fraud, waste, abuse, outright corruption, and general incompetence.”

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https://jacobin.com/2024/10/psychedelics-nationalization-psilocybin-mdma-therapy



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Canada -Chocolate bricks filled with magic mushrooms seized at Peace Bridge warehouse

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Members of U.S. Customs and Border Protection said they are continuing to investigate after several shipments of chocolate bricks filled with magic mushrooms were found at the Peace Bridge warehouse at the Port of Buffalo, New York.

In a news release, U.S. CBP said officers discovered “multiple commercial shipments” containing psilocybin, the chemical compound found in magic mushrooms, at the warehouse over the past 30 days.

The shipments were coming from Canada to the U.S.

“CBP officers working in the Peace Bridge cargo facility discovered multiple shipments manifested as ‘chocolate and other food preparations,’” the news release read.

“Upon further inspection of these shipments, it was discovered that the chocolate bricks contained psilocybin, a schedule 1 controlled substance.”

The chocolate bricks were “field tested” by officers and the substances tested positive for the “properties of psilocybin.”

According to the release, there were a total of 15 seizures with a weight of about 10 kilograms in the last 30 days.

The estimated street value of the drugs, officers said, is believed to be US$165,000.

https://www.cp24.com/news/canada/2024/10/11/chocolate-bricks-filled-with-magic-mushrooms-seized-at-peace-bridge-warehouse/



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