Psychedelic Regulation Beyond the Controlled Substances Act: A Three-Dimensional Framework for Characterizing Policy Options

Legality is a complex dimension that broadly outlines the conditions of production, distribution, and use that can be undertaken with or without penalty. Treating legality as a continuum acknowledges the variability that can be seen in controlled substance policies and their implementation. As Schedule I drugs, the DEA has deemed many psychedelics to have no currently accepted medical use and only a specific set of legal uses (e.g., research [1, 11]). Nevertheless, some municipalities have directed their law enforcement agencies to deprioritize enforcement of laws prohibiting psychedelics (de facto legalization), while some states have passed laws that allow certain additional uses of psychedelics within their borders (de jure legalization). Though federal law generally preempts conflicting state laws, the 10th Amendment prevents the federal government from commanding states to create laws or to use state officers to enforce federal laws, creating a gray zone of legality when states decide not to criminalize conduct that offends federal law, as is currently the case with cannabis regulation in many states (12). Ultimately, the de facto legality of psychedelic uses will be informed by legal precedent and the selective enforcement of local, state, and federal statutes.

Therapeutic intention refers to the extent to which a policy frames psychedelic use as intended either for medical intervention (i.e., for the treatment of a diagnosed health condition) or for healing (i.e., ameliorating suffering, including spiritual suffering). For example, FDA-regulated therapies for biomedical diagnoses (e.g., treatment of severe alcohol use disorder) fall on the high end of this spectrum, policies that support use for psycho-spiritual practices focused on ‘aligning energetic imbalances’ or generically ‘healing trauma’ would fall in the middle ranges, while decriminalization or legislation supporting recreational use solely for aesthetics, fun, or to enhance creativity, are on the low end.

Structure refers to the degree of organization guiding psychedelic use within a particular context. This may be developed informally, through social norms, or formally, through explicit rules or systems (e.g., regulatory bodies, screening practices, permissions to administer psychedelics, and established care practices). Structure directly influences both set and setting and therefore likely has significant impacts on the outcomes of the diverse forms of psychedelic use (9, 10).

The following examples illustrate how different psychedelic uses fit into these three domains.

The growing interest in psychedelics coupled with municipal and state efforts to liberalize psychedelic regulation prompts consideration of a wide and complex range of potential policy options. Developing a framework for characterizing policies across multiple dimensions can provide a mechanism for analyzing these policies without minimizing their complexity. Here we proposed a three-dimensional framework that contextualizes psychedelic uses by their degree of legality, therapeutic intention, and structure, and briefly reviewed current non-federally regulated policy options and how they can be examined through this framework.

The intention of this framework is to offer a new conceptualization for comparing and discussing the variety of psychedelic regulatory policies. Empirical study is needed to examine the utility of this framework and its limitations in practice. Nevertheless, we hope the consideration of this framework will lead to more nuanced approaches to examining the real complexities of the United States’ psychedelic regulatory policies currently in effect or in development. Future work might compare the impact of different policies with respect to these domains: legality (criminalization, deterrence, stigma); therapeutic intention (safety, therapeutic outcomes, healthcare utilization); and structure (implementation, feasibility, accessibility). These dimensions might be further explored through subdimensions. For example, one aspect of therapeutic intention is the level of therapeutic specificity, or the degree to which psychedelic use is meant to address a precise, diagnosable problem (e.g., seeking remission of an individual’s PTSD diagnosis versus generally increasing self-awareness).

This framework can also guide efforts for future public health campaigns, specifically identifying strategies for mitigating risk and enhancing safety. For clinicians, evaluation of these policies’ health outcomes is highly relevant, particularly as some therapeutic uses will occur outside of conventional healthcare settings. Finally, conducting ongoing evaluations of policies and selecting meaningful outcome measures will be necessary for making any future comparisons and determining which regulatory options are best suited for maximizing safety and societal benefits.

Utilizing a multi-dimensional framework to consider psychedelic policy options beyond the federal CSA is a critical first step in understanding the complex landscape of psychedelic uses in both medicalized and community settings.