by Karina Bashir
The law helps establish legitimacy and inform societal norms—a role that becomes particularly pronounced in the field of psychedelics. Lingering stigma from the War on Drugs, despite the promising scientific potential of psychedelics, hinders the growth of the psychedelic industry and its public acceptance. The public’s trepidation is reflected in a recent survey conducted by the Berkeley Center for the Science of Psychedelics (“BCSP”) in 2023.
By Jonathan Perez-Reyzin
Within the psychedelic legal landscape, the U.S. Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use.
But for many working in drug policy, medicalization is not the exclusive goal. Indeed, there have been calls for legalization of psychedelics for non-medical use — and we are seeing an early attempt at such a model in Oregon.
These efforts are not yet reaching the federal level, but it’s only a matter of time before the legalization of psychedelics and other currently illegal drugs for adult recreational use becomes a federal question, as is already occurring with marijuana. And despite the FDA’s widely recognized role in medicine, few have considered the role the FDA would play in a federal regulatory regime for the non-medical use of drugs, even though it already does regulate at least one recreational substance legal for recreational use: tobacco.
We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). Through regular contributions to Bill of Health, as well as workshops and other projects, POPLAR affiliated researchers will share their expertise and perspectives on developments in psychedelics law and policy. We look forward to learning from and sharing their insights with our audiences. Keep an eye out for their bylines!
By Sarah Hashkes
When we talk about microdosing psychedelics, it’s important we have a mutual understanding of its definition to be able to conduct accurate research, promote regulations, and educate the wider population. This article will look at three main questions and ambiguities regarding the term “microdosing psychedelics” and suggest a definition that would help promote coherence in the field.
By Troy Sims
The Biden Administration has the opportunity to be the first administration to rid our legal system of cannabis regulation chaos.
State laws governing medical or recreational cannabis conflict with federal regulations, leaving cannabis consumers, businesses, and the lawyers representing them caught in the middle.
Guidance documents from the Department of Justice (DOJ) are an often-overlooked source of complexity and confusion in the cannabis industry. The Biden administration should seek to reconcile state and federal cannabis law.
By Chloe Reichel
On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.
The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.
In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.
Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.
In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.
By Dustin Marlan
In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.
But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.
This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.
By Xinyuan Chen, Mackenzie Bullard, Christy Duan, Jamilah R. George, Terence Ching, Stephanie Kilpatrick, Jordan Sloshower, and Monnica Williams
In the last two decades, researchers have started to reexamine psychedelics for their therapeutic potential. Though initial results seem promising, the research has a significant shortcoming: the lack of racial and ethnic diversity among research teams and study participants.
In the 1960s, psychedelic substances such as LSD, psilocybin, and mescaline were a major part of American counterculture. Less well-known is that, concurrently, researchers were studying potential therapeutic uses of these mind-altering substances. Unfortunately, psychedelics were classified as Schedule I drugs in 1970, halting research into their therapeutic benefits.
The recent renaissance of psychedelic research shows these substances have significant capabilities for treating anxiety, depression, posttraumatic stress disorder (PTSD), and substance use disorders. But these promising results are limited in their applicability: an analysis from 2018 showed that 82.3% of all study participants in psychedelic trials internationally were non-Hispanic Whites, and only 2.5% were African-American.
By Manoj Doss
As a psychedelic researcher, I find myself increasingly frustrated by the tendency of the field to make lofty claims about the drugs that stray from the realities and limitations of the data.
For example, psychedelic research that uses neuroimaging employs measures of brain function that are, in fact, quite crude. Typically, one signal in a brain scan can mean many things (amygdala activation can occur when one is scared, happy, observing something salient, etc.).
For this reason, cognitive neuroscientists typically constrain mental activity using behavioral tasks in order to make more educated inferences regarding what is happening in the mind. Yet for some reason, psychedelic scientists believe they can infer mental function from the activity of a few tripping brains under task-free conditions. That is, participants are essentially doing whatever they want in the scanner, making the number of possible inferences one could make nearly infinite. And worse, they base their claims on outdated Freudian theory.
By Sam S.B. Shonkoff
If there is one thing that the critical study of religion unveils, it is that every enchanting and revelatory movement in human history — without exception, no matter how luminous the auras — is nonetheless human.
Psychedelics are no exception.
These substances are making a lot of brain scientists and policymakers talk about mysticism. And how could they not? A rapidly expanding body of data confirms that historically sacramental elements can induce altered states of consciousness with significant healing powers.
In contrast to today’s more conventional psychopharmacological techniques, which require regular doses to maintain chemical changes in the body, it appears that psychedelic medicines operate precisely by means of transformative experiences, the effects of which can last for months, if not years. Scholars and psychonauts alike can hardly account for these phenomena without recourse to the lexicon of religious studies.
And yet, strangely, scholars of religion have been largely absent from this discourse.