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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LSD Microdosing. Small or micro doses of LSD drug cut from a tab, presented on a finger.

A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation

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.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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Cannabis in clear glass jars.

The Biden Administration Should Resolve Cannabis Regulation Chaos

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.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

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.

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Kratom leaves and capsules.

A Sensible, Evidence-Based Proposal for Kratom Reform

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.

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Healthcare concept of professional psychologist doctor consult in psychotherapy session or counsel diagnosis health.

The Case for Non-Police Response to Behavioral Health Crises

By Jennifer J. Carroll and Taleed El-Sabawi

People who use drugs continue to die at staggering rates, due not only to overdose from contaminated drug supply, but also due to our persistent reliance on the carceral system to respond to behavioral health crises.

This approach stems from the state-sanctioned violence of the War on Drugs. It takes various forms, including the use of police officers as first responders to behavioral health crises (including welfare checks), the excessive police use of force, and the use of potentially lethal restraint methods to subdue agitated persons. It also manifests in police officers’ use of jail cells as tools for forced “detox” believing that coerced withdrawal while in custody will reduce overdose risk or help someone “go clean” (it very clearly does not).

Evidence-based alternatives to police response for behavioral health crises exist. However, despite being both feasible and effective, these alternatives to police intervention remain the exception, rather than the rule.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

The Myth of Psychedelic Exceptionalism

By Dustin Marlan

The “latest frontier” in drug law reform is the loosening of legal restrictions on psychedelics, such as psilocybin, ayahuasca, and ibogaine. But not all drug reform advocates are thrilled about this development.

Some are concerned that singling out psychedelics for legalization or decriminalization perpetuates the stigma surrounding other illegal drugs. Most prominently, Dr. Carl L. Hart, professor of neuroscience and psychology at Columbia University argues that all drugs “interact on receptors in the brain to produce their effects… we shouldn’t be treating some drugs as if they’re special while others are somehow evil.”

“Psychedelic exceptionalism” describes an ideology that claims psychedelics should be privileged for reform, but other purportedly more harmful drugs, like heroin and cocaine, should remain prohibited. As journalist Madison Margolin frames the question, “Should psychedelics be treated so differently from other drugs, given that any substance may have the power to soothe or scorch the human psyche, and body too?”

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