Two Models of Legalization of Psychedelic Substances: Reasons for Concern

This opinion paper (2021) raises concerns over the two concurrent models of legalizing the possession, personal use, and noncommercial sharing of psychedelics in California and clinical use in Oregon. In light of cautionary precedents involving the commercialization of ketamine and cannabis, their chief concern is that non–evidence-based marketing strategies founded on one-sided enthusiasm for the benefits of psychedelics may supplant evidence-based practices, thereby putting vulnerable populations at risk of their potential side effects that have not been studied outside of the clinical population.


“In 1973, the federal government classified psychedelics as schedule I substances, rendering possession illegal, even for research purposes except under tightly regulated circumstances. Although these restrictions have hindered research on the therapeutic uses of psychedelics for decades, recent studies have brought increasing attention and enthusiasm to the potential benefits of psychedelic treatment.1 Accompanying this revival of psychedelic research have been initiatives by states and localities to legalize psychedelic possession and use. Two of the most ambitious measures, in Oregon and California, take different paths to legalization. This Viewpoint reviews these initiatives and the concerns they raise by looking to the cautionary precedents involving the legalization and commercialization of other controlled substances.”

Authors: William R Smith & Paul S Appelbaum


The federal government classified psychedelics as schedule I substances in 1973, but recent studies have shown promising results. Several states have taken measures to legalize psychedelic possession and use.

Models of Psychedelic Legalization

Oregon became the first state to legalize psilocybin through a November 2020 ballot initiative, and created a psilocybin advisory board to guide the state in implementing clinical psilocybin regulation and licensure for treatment.

California Senate bill 519 would legalize the possession, personal use, and noncommercial sharing of psychedelics by adults, and a ballot initiative with similar goals is being prepared for 2022.

of Psychedelic Agents

Although some studies have shown promising effects on depression, suicidality, substance use, and posttraumatic stress disorder, most of the research has been limited by small sample sizes and difficulties with blinding.

Serotonergic psychedelics, such as psilocybin, are distinguished from other substances that are sometimes called psychedelics and included in these legalization measures, such as MDMA. The neurobiological mechanisms of neither class are fully understood, although the “mystical experiences” are critical to the clinical benefits of both classes.

Psilocybin users reported having challenging experiences, putting themselves or others at risk, and becoming violent. Ten percent reported symptoms lasting more than 1 year, but other studies found no relationship.

The Diverse Roots of Psychedelic Advocacy

The push for legalization of psychedelics is driven by the confluence of at least 4 factors, including popular media, concern about the adverse effects of the criminalization of substance use, and the prospect of commercialization and resulting tax revenue.

Although the therapeutic potential and positive effects of decriminalization are important considerations, advocates tend to give limited attention to countervailing concerns. If legalization is followed by commercialization, vulnerable populations may have unprecedented access to these substances.

Lessons From Legalization and Commercialization of Drugs

Commercial interests encourage the perception that marijuana poses less psychiatric risk and offers greater benefit than the evidence suggests.

Although the results of cannabis legalization are debated, they are mixed. The prevalence of psychosis and consequent hospitalization have increased in states that have legalized cannabis, and the proportion of patients with concomitant cannabis use disorder has also increased.

Alternatively, even with strictly clinical use of psilocybin, non-evidence-based marketing may supplant evidence-based practice, as with the proliferation of for-profit chains of ketamine clinics.

Due Care in Psychedelic Legalization

Psychedelics have therapeutic benefits, but rapid legalization and commercialization may short-circuit prudent legal reforms. Deprioritizing enforcement of laws against psychedelic possession may limit risks, but may obscure potential harms.