Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market

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.

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United States Capitol Building - Washington, DC.

Psychedelic Policy on the Federal Level: Key Takeaways from a Petrie-Flom Center Panel

By James R. Jolin

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates.

The conversation was situated against the backdrop of the “psychedelics renaissance” in the United States, which has been fueled by a wave of local and state legislation reducing or eliminating the criminal penalties associated with these substances.

Though many localities have made significant strides in addressing the legal questions surrounding psychedelic substances such as psilocybin and dimethyltryptamine (DMT), federal policymakers have not pursued similar initiatives.

Suggestions and considerations for federal psychedelic policy thus formed the substance of the discussion among the panelists:

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Person examining psilocybin mushrooms in lab.

Microdosing Under the Oregon Psilocybin Services Act: A Definite Maybe

By Dave Kopilak

In November 2020, Oregon voters passed the Oregon Psilocybin Services Act (the “Act”), of which I was the primary drafter. This piece of legislation legalizes and regulates the manufacturing of psilocybin products and the provision of psilocybin services under Oregon law. The manufacture, sale, and use of psilocybin products under the Act will continue to be illegal under federal law.

The Oregon Health Authority (OHA) is the state agency that will regulate the program. The Act provides for a two-year program development period that began on January 1, 2021 and that will end on December 31, 2022. The OHA is currently engaged in the rulemaking process and will adopt final rules by no later than December 31, 2022. The OHA will begin receiving license applications on January 2, 2023, and the first licensed businesses likely will begin operating in the first half of 2023.

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Woman experiencing headache lying in bed in darkened room.

Small Doses of Psychedelics for Cluster Headaches

By Bob Wold

One understudied condition for which small doses of psychedelic substances such as psilocybin may be beneficial is cluster headache.

As founder and executive director of the advocacy group Clusterbusters, I have seen firsthand, as a patient and an activist, that, despite its modest name, cluster is far from “just” a headache. It is a chronic pain condition that lasts “on” and “off” for months or years, often with no hint as to its origin. Estimates suggest that one in 1,000 people – which equates to over 332,000 Americans – suffer from cluster headache.

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A paper figure of a cat that fills the shadow of a lion. 3D illustration.

A Proportionate Response to Microdosing

By James Fadiman

Law and policy around microdosing of psychedelic substances should reflect its proportionally low risks.

“Microdosing” refers to the practice of consuming very low doses of psychedelic substances, about 1/10th to 1/20th of a typical dose, primarily of psilocybin-containing mushrooms or lysergic acid diethylamide (LSD). Doses typically are taken intermittently, over several weeks, and they do not interfere with normal daily activities, unlike the powerful consciousness-altering effects of higher doses.

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pieces of paper with chemical structures, micro dosing concept.

Findings from the Microdose.me Study: A Large Scale Observational Study of Psychedelic Microdosing

By Joseph Rootman

Public uptake of psychedelic microdosing has outpaced research on the practice, which has left gaps in our understanding. In order to help fill some of these gaps in the scientific literature, our clinical psychology research team at the University of British Columbia has launched the Microdose.me study along with a team of international researchers and partners. This symposium contribution provides an overview of our findings to date, and offers suggestions for future microdosing research.

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Human heart with blood vessels. 3d illustration

Safety First: Potential Heart Health Risks of Microdosing

By Kelan Thomas

Given the current evidence for psychedelic “microdosing,” the risks may outweigh the benefits for many people.

This is because there is compelling theoretical evidence to suggest prolonged and repeated microdosing may cause valvular heart disease (VHD), and only weak survey evidence that it provides the benefits microdosers typically seek, such as enhanced cognition, or relief from depression and anxiety.

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Mushrooms, capsules, and dropper bottle.

Restricting Access to Microdosing is Morally Wrong

By Erin Sharoni

Restricting access to microdosing, a low-risk intervention that may alleviate intractable pain, depression, and anxiety — obligatory requirements for human flourishing — is morally wrong.

Psychedelic microdosing involves the administration of a psychedelic substance in sub-perceptual doses — doses small enough not to provoke any intoxicating effects, but that potentially result in favorable physiological or psychological changes. Microdosing has emerged as a promising intervention for enhancing creativity and productivity, boosting mood, alleviating pain, and treating depression and anxiety with minimal risk of harm to the participant or society.

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Businessman's hands typing on laptop keyboard in morning light

Microdosing at Work: Business and Legal Implications

By Vincent Sliwoski

In light of the widespread cultural and business culture adoption of microdosing, private sector employers should reconsider the implications of a blanket prohibition on workplace use of controlled substances.

Microdosing is the practice of ingesting subperceptual amounts of psychedelic drugs, such as psilocybin mushrooms or LSD. People microdose for a variety of reasons. These may include medical reasons, such as the treatment of anxiety, depression or attention disorders; or they may include “performance” reasons, like attempts to increase productivity, creativity or awareness.

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