Clear as Mud – An Exploration into the Legal Scope, Meaning, and Use of the Term “Psychedelic” in an Emerging Area of the Law.

By Ryan E. Behren 

Introduction

The use of substances commonly known as “psychedelics” has garnered bipartisan support for the treatment of mental health conditions such as post-traumatic stress disorder (PTSD), major depressive disorder (MDD), and treatment-resistant depression (TRD).  In 2017, 2018, and 2019, the Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation to psilocybin (commonly known as psychedelic mushrooms) for the treatment of MDD[1] and TRD[2] and 3,4-methylenedioxy methamphetamine (MDMA) for the treatment of PTSD.[3]  A Breakthrough Therapy Designation is only given to drugs in which “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”[4] Moreover, many states are studying the possible benefits of these substances,[5] developing pilot programs,[6] and/or decriminalizing  or limiting legal penalties for their use.[7] States like Oregon[8] and Colorado[9] have even gone as far as to legalize psilocybin for  therapeutic use.[10] Despite these efforts, the legal status of these substances remains questionable, at best. Currently, psilocybin and MDMA are classified by the Drug Enforcement Agency (DEA) as a Schedule I controlled substance with “no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse” [11] Such a designation puts these substances into a delicate legal bind.

However, the increasing amount of research, policy efforts, and legislation concerning psychedelics across the United States evidences a young and rapidly growing psychedelic legal field. As psychedelic law continues to develop clarity and consistency in language and terminology become crucial in many respects. Without such clarity and consistency, horizontal and vertical coordination efforts among governmental entities, the accurate interpretation of data when drafting legislation, and consistent application of the law in courts and administrative settings becomes increasingly difficult. Unfortunately, the term “psychedelic” has scarcely been used in the law to describe the substances popularly associated with the term. To make matters worse, when the term has been used in the law, it has been used inconsistently. As such, this article will discuss the past, current, and future meaning, scope, and usage of the term “psychedelic” in the context of federal and state psychedelic law.

Legal Use of the Term “Psychedelics”

When someone says the word “psychedelic,” most people think of lysergic acid diethylamide (LSD) and/or psilocybin mushrooms. However, in the academic, scientific, and policy setting, the word “psychedelics” has often been used interchangeably to describe a variety of different substances. For example, N,N-dimethyltryptamine (DMT), ayahuasca, 3,4-Methylenedioxymethamphetamine (MDMA), and mescaline are only a few of the many substances that one may refer to when using the term “psychedelics.” Despite a lack of commonality in usage, substances categorized as psychedelics generally produce “hallucinogenic effects” [12] in the individual who takes them. Regardless of this commonality, these substances have different risks, uses, and effects on the individuals taking them. With researchers, legislatures, courts, and administrative agencies utilizing the word “psychedelic” in different ways or not at all, it is imperative to take stock and understand just what everyone is talking about.

Federal

Interestingly, the term “psychedelic” has never been used in a federal statute or regulation. Instead, in statutory compilations such as the Controlled Substances Act (CSA) Congress has referred to substances popularly known as “psychedelics” as “hallucinogenic substances.”[13]Notably, neither “hallucinogenic substances” nor “hallucinogenic effects” are defined anywhere in federal statutory or case law.[14]  Additionally, when federal courts have been confronted with cases involving the use of psychedelics the majority of court’s have avoided using the term, instead referring to these substances broadly as “psychotropic substances”[15] or “hallucinogens,”[16] and specifically by each substances chemical designation.[17] Even the few federal courts that have utilized the term “psychedelic” to refer to “hallucinogenic substances” have failed to delineate the scope and usage of the term.[18] Such ambiguity could ultimately cause trepidations for legislatures drafting law and courts applying it.

Although the term “psychedelic” has rarely been used as a legal term to describe “hallucinogenic substances,” in June of 2023, the FDA released a non-binding draft guidance utilizing the term “psychedelic” to refer to certain “hallucinogenic substances.”[19] The draft guidance titled Psychedelic Drugs: Considerations for Clinical Investigations, explained that within the draft guidance “the term psychedelic is used as shorthand to include classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogenssuch as methylenedioxymethamphetamine.”[20] The draft guidance concerned the clinical investigation of these drugs under an Investigational New Drug (IND) Application, an application that allows for the IND to be investigated through clinical trials.[21] Unfortunately, the FDA’s usage of the term does nothing to alleviate any ambiguity. The FDA failed to clarify what distinguishes a psychedelic from a classic psychedelic, or what other than LSD, psilocybin, or MDMA might fall within the scope of the term. Moreover, this definition seemingly conflicts with a post made on the U.S. Department of Veterans Affairs website noting that MDMA is often referred to as a “non-classic psychedelic.” [22] Although psychedelic law is still young, conflicting usage of these terms, especially at the federal level, only creates for ambiguity and risk to all stakeholders.

State

At the state level, the scope and usage of the term “psychedelic” has been even more variable. Most states do not utilize the term “psychedelic” in their Controlled Substances Act, instead utilizing the terminology used in the Federal CSA.[23]Moreover, in at least one state, “hallucinogenic substances” and “psychedelic phenethylamines” are distinguished from each other in the states’ CSA.[24] Some state courts have made a similar distinction in case law describing “‘Narcotic drugs’ to include ‘mescaline’ and ‘lysergic acid diethylamide’, as well as other psychedelic or hallucinogenic drugs.”[25]Although common sense would likely lead one to believe that the court is purposely casting a wide net, double usage becomes problematic in a legal environment that is actively referring to these substances in various ways with varying legal effects stemming from each term.

States that have legalized substances such as psilocybin have decided to forgo the use of the word “psychedelic” when drafting legislation. For example, Colorado utilizes the term “Natural Medicine” to mean the substances psilocybin and psilocyn.[26] However, the substances dimethyltryptamine, ibogaine, and mescaline may also be considered “Natural Medicine” under the Colorado statute if approved by the state on or after June 1, 2026.[27] Oregon chose not to utilize the term “psychedelic,” instead using only the term “psilocybin” to mean “psilocybin or psilocin.”[28] This is likely because psilocybin and psilocin were the only substances legalized under the Oregon statutes. However, in the same statutory compilation, the Oregon legislature, when describing qualifications to be on the Oregon Psilocybin Advisory Board, stated that one qualification is “[a] person who has professional experience conducting scientific research regarding the use of psychedelic compounds in clinical therapy.” [29] Notably, it is unclear what “psychedelic compounds” this language is referring to.

Such inconsistency is not limited to states that have legalized these substances but also those that are creating pilot programs to evaluate these substances’ benefits and risks. In a Connecticut statute named “Psychedelic-assisted therapy pilot program,” the legislature chose not to define “psychedelic,” instead explicitly naming and defining the substances that will be used in the program.[30]In other states, terms like “alternative therapies” are used to describe substances commonly known as “psychedelics.”[31]For example, a Maryland Statute implementing a PTSD and Traumatic Brain Injury (TBI) alternative therapy fund defined “Alternative Therapies” to include “psychedelics including 3,4-Methylenedioxymethamphetamine (MDMA), psilocybin, and Ketamine.”[32] Notably, it is unclear from the statute what other substances may be included within the term “psychedelic.”

Looking Ahead

States and the federal government are looking for ways to alleviate a dire mental health crisis currently wreaking havoc across the United States. Positive research on the efficacy of utilizing substances commonly known as “psychedelics” for the treatment of numerous mental health conditions has provided both public and private stakeholders with an overdue sense of hope. This hope is evidenced in the increasing amount of legislation, research, and acknowledgment of “psychedelics” as a means of mental health treatment. As shown above, the term “psychedelic” lacks a concrete meaning in the law. However, the law relies on consistency and clarity of language. In any emerging area of law, it is crucial to ensure that the language of the law accurately reflects the environment, behavior, and things it is intended to regulate. That responsibility becomes even more critical when the law concerns substances that are federally illegal and carry with them long-held stigmas. To complicate matters, substances that are often labeled as psychedelics are usually recognized by their specific chemical designations, or even labeled based on the effects these chemicals have on certain biological receptors. Such designations and effects can be difficult to understand by an individual without a science background. As legislators, policy advocates, researchers, and administrative agencies continue to participate in the creation of a psychedelic legal framework, these actors should keep these aspects in mind.  If not, the law will not accurately reflect a clear and consistent picture of the risks and benefits associated with certain substances, the individuals that certain substances may or may not help, and the broader socio-economic environment in which they are being utilized.

[1] Rich Haridy, Psilocybin for Major Depression Granted Breakthrough Therapy by FDA, New Atlas (Nov. 24, 2019), https://newatlas.com/science/psilocybin-major-depression-mdd-usona-breakthrough-therapy-fda/.

[2] Press Release, Compass Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin therapy for Treatment Resistant Depression, Compass Pathways (Oct. 23, 2018), https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/.

[3] Press Release, FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Therapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials, Multidisciplinary Ass’n for Psychedelic Stud. (Aug. 26, 2017), https://maps.org/news/media/press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd-agrees-on-special-protocol-assessment-for-phase-3-trials/. https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/

[4] Breakthrough Therapy, Drug Enf’t Admin., https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy (last visited April 16, 2024).

[5] See e.g., Joyce E. Cutler, Texas the Latest State to Legalize Psychedelic Medical Research, Bloomberg Law (June 23, 2021), https://news.bloomberglaw.com/health-law-and-business/texas-the-latest-state-to-legalize-psychedelic-medical-research

[6] See e.g., Connecticut Moving Forward with Psychedelic-Assisted Therapy, CBIA (April 7, 2022), https://www.cbia.com/news/issues-policies/connecticut-moving-forward-with-psychedelic-assisted-therapy/.

[7] Tara Law, Colorado Voted to Decriminalize Psilocybin and Other Psychedelics, Time (Nov. 11, 2022), https://time.com/6232212/colorado-decriminalizes-psychedelics-psilocybin-proposition-122/. See Psychedelic Legalization & Decriminalization Tracker, Psychedelic Alpha, https://psychedelicalpha.com/data/psychedelic-laws (last visited April 16, 2024), for more information about state initiatives concerning psychedelics.

[8] See generally Psilocybin Regulation, Or. R. Stat. T. 37, Ch. 475A (creating a regulated legal framework for the legal use of psilocybin).

[9] See generally Natural Medicine health Act of 2022, Col. Rev. Stat. Ann. § 12-170 (creating a regulated legal framework for the use of psilocybin and potentially other substances).

[10] Some states like Kentucky and Washington have also been studying the use of ibogaine, a naturally occurring psychoactive compound coming from the iboga tree, for the treatment of opioid use disorder. See e.g., Rick Perry et al., The Case for Ibogaine: Kentucky’s Opportunity to Lead in the Fight Against Opioid Addiction, Newsweek (Nov. 8, 2023), https://www.newsweek.com/case-ibogaine-kentuckys-opportunity-lead-fight-against-opioid-addiction-opinion-1841234.

[11] Controlled Substances Act, 21 U.S.C. § 812(c); See Mason Marks & I. Glenn Cohen, Patents on Psychedelics: The Next Legal Battlefront of Drug Development, 135 Harv. L. Rev. F. 212, 213 (2022) (quoting Controlled Substance Schedules, DRUG ENF'T ADMIN., https://www.deadiversion.usdoj.gov/schedules/index.html).

[12] See supra n. 13 and accompanying text for a discussion on the ambiguity regarding the term “hallucinogenic effects”).

[13] See 21 U.S.C. § 812 (describing lysergic acid diethylamide and psilocybin as “hallucinogenic substances”).

[14] See United States v. Way, No. 114CR00101DADBAM1, 2018 WL 5310773 (E.D. Cal. Oct. 25, 2018), aff'd, 804 F. App'x 504 (9th Cir. 2020) (upholding jury determination of substance as an analogue because of its “hallucinogenic effects” based on evidence given through expert testimony).

[15] Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418, 426, 438 (2006) (utilizing the term “psychotropic substances” as used in the 1971 United Nations Convention on Psychotropic Substances when discussing the use of DMT in “hoasca” (commonly known as Ayahuasca)).

[16] See e.g., Id. at 438; United States v. Klecker, 348 F.3d 69, 72 (4th Cir. 2003).

[17] See e.g., United States v. Boot, 25 F.3d 52, 53 (1st Cir. 1994) (referring to lysergic acid diethylamide (LSD) by its specific chemical designation); 21 U.S.C.A. § 812 (designating “hallucinogenic substances” by “specific chemical designation”). Notably, in certain circumstances concerning the religious use of hallucinogenic substances, they have been called “entheogens.” See generally Oklevueha Native Am. Church Of Hawaii, Inc. v. Lynch, 828 F.3d 1012 (9th Cir. 2016).

[18] See e.g., Native Am. Church of New York v. United States, 468 F. Supp. 1247 (S.D.N.Y. 1979), aff'd, 633 F.2d 205 (2d Cir. 1980) (referring to a “hallucinogenic substance” listed in the CSA as a “psychedelic drug”).

[19] U.S. Food & Drug Admin., Psychedelic Drugs: Considerations for Clinical Investigations (2023), https://www.fda.gov/media/169694/download.

[20] Id.

[21] Investigational New Drug (IND) Application, U.S. Food & Drug Admin., https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application (last visited April 16, 2024).

[22] Leslie Morland & Joshua Woolley, Psychedelic-Assisted Therapy for PTSD, U.S. Dept. of Veterans Affairs, https://www.ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp#one (last visited April 16. 2024).

[23] See e.g., N.C. Gen. Stat. Ann. § 90-89(3) (utilizing the term “hallucinogenic substances” to describe chemical designations commonly known as “psychedelics”).

[24] 35 Pa. Stat. Ann. § 780-104(1)(iii), (viii) (West).

[25] State v. Phillips, 190 S.E.2d 433, 434 (Ct. App. N.C. 1972).

[26] Colo. Rev. Stat. Ann. § 12-170-104(12)(a) (West). When ingested, “[p]silocybin is metabolized in the body to the active drug psilocyn, also present in many of the same mushrooms.” Psilocybin, Drug Enf’t Admin., https://www.dea.gov/factsheets/psilocybin (last visited April 16, 2024). Additionally, “psilocyn” and “psilocin” are used interchangeably to describe the same substance.

[27] Colo. Rev. Stat. Ann. § 12-170-104(12)(b)(I)-(III).

[28] Or. Rev. Stat. Ann. § 475A.220(11) (West).

[29] Id. at § 475A.225(1)(f)(i) (West).

[30] Conn. Gen. Stat. Ann. § 17a-484g(a)(1)-(2) (West) (naming MDMA and psilocybin as the substances that will be used in the program).

[31] See e.g., Md. Code Ann., Health-Gen. § 24-2101(b) (West).

[32] Id.