The following article, originally published in the newspaper Folha de S.Paulo on May 27, was written by Patrícia Villela Marino (lawyer and president of Humanitas360 Institute), Clarice Pires (executive director of Scirama Psychedelic Science), and Bruno Pegoraro (president of Ficus Institute).
Washington has moved on two frontiers where Brazil still inches forward, pushed along by court rulings: medicinal cannabis and therapeutic psychedelics.
This is not about broad legalization or recreational use. The point is more fundamental: acknowledging that health, research, and regulation work better than punitive blindness. On cannabis, the Department of Justice announced that FDA-approved cannabis products and medicinal cannabis products covered by a qualified state license have been placed in Schedule 3.
They leave the most restrictive federal category — where they sat alongside heroin — and move to the tier of Tylenol. The practical change is limited. It does not overturn federal cannabis illegality, nor does it resolve interstate transport, banking, or previously handed-down sentences. Even so, the political signal is significant: the government, on its own initiative, has acknowledged a federal pathway for treatment, research, and clinical information.
On psychedelics, the movement follows a similar logic. The White House issued an executive order to accelerate research and approvals of treatments for severe mental disorders, prioritize substances with FDA Breakthrough Therapy designation, create an access pathway through Right to Try legislation, and direct at least $50 million to state partnerships. The direction is to expand federal research, support clinical trials, and allow access in controlled therapeutic settings.
The first concrete effect has already emerged: the FDA granted Priority Review Vouchers to three therapies in development — two involving psilocybin (a substance found in mushrooms) for treatment-resistant depression, and one involving methylone, related to MDMA, for post-traumatic stress.
Even so, psychedelics remain federally illegal, classified as Schedule 1. The vouchers do not approve medicines; they merely shorten the regulatory review period. Psychedelic products that receive FDA approval may then be eligible for reclassification (where applicable), easing access.
None of this dispenses with caution. Ibogaine (a psychoactive substance) may carry significant cardiac risks, and there are warnings about rushed research and unintended health consequences. Serious regulation is not euphoric liberalization. It means bringing these issues out of clandestinity, improvisation, and moralism and placing them under evidence, protocol, and public accountability.
There is political calculation at play, of course. Veterans who support Donald Trump, podcaster Joe Rogan, and the Make America Healthy Again movement appear as relevant actors in this shift. But motivation does not erase the fact: a conservative government recognized that the punitive paradigm can no longer keep pace with reality. When even this kind of pragmatism pushes drug policy toward public health, Brazil’s progressive omission stops looking like prudence. It becomes irresponsibility.
Brazil does not need to copy the United States. It needs to lift the smokescreen. Medicinal cannabis and psychedelic therapies are not magic shortcuts or niche slogans. They are matters of science, care, citizenship, health oversight, and public policy. As long as we remain locked in penal flat-earthism, patients wait, researchers work under artificial constraints, and regulation advances in fragments and court decisions.
The failure of this paradigm is plain to see. The question is not whether we should import the American model. It is why a country committed to rights, health, and harm reduction accepts falling behind precisely where it should be leading.
(Illustration credits: Nada Hayek/NYT)
