Two things are happening in Brazil at once. The Federal Public Prosecutor's Office in Acre has recommended that CONAD and Anvisa spend two years rebuilding the rules for ayahuasca and DMT — including the explicit possibility of removing DMT's criminal treatment in favour of an administrative regime. Meanwhile psilocybin and psilocin sit on List F2 of Portaria SVS/MS 344/1998, with no legal medical or recreational use, and mushroom growers are being prosecuted as traffickers. Brazil also produced the first controlled trial of a psychedelic in treatment-resistant depression (Palhano-Fontes et al., Psychological Medicine, 2018, n=29, ayahuasca — not psilocybin) and cannot prescribe the result. In the US, psilocybin cleared two Phase 3 trials on company toplines with a placebo-adjusted effect of 3.6 to 3.8 MADRS points, got two FDA priority vouchers, and is still Schedule I federally — while the biggest cheque in the sector, Lilly's up-to-$3.8bn AtaiBeckley deal, was written for 5-MeO-DMT.
The short answer
Brazil's ayahuasca rulebook is genuinely in play: prosecutors in Acre have asked CONAD and Anvisa to reopen it, and CONAD's plenary is reportedly scheduled to take it up on 11–12 November 2026. Psilocybin is not part of that request and remains prohibited.
Chacruna's piece frames this as a Global South political moment, timed to Brazil's 25 October runoff. The election frame is real — Flávio Bolsonaro took 47.0% of valid votes to Lula's 45.2% in the first round on 4 October, abstention hit 21.08%, the highest since 1998, and runoff polling is contradictory and inside the margin (Vox Brasil has Lula 51–49; Ipespe/Abrapel and Instituto Veritá have Flávio 51–49). Only the TSE count is official.
But the drug-policy stakes do not need the election to be interesting, and most of the broader political claims circulating around this story are outside what we can verify or what PsyBear covers. Here is the part that is documented:
- Federal prosecutors have formally recommended a two-year rewrite of the ayahuasca and DMT framework.
- Neither recommendation mentions psilocybin or mushrooms.
- Psilocybin and psilocin are on Brazil's prohibited-psychotropics list, and enforcement against growers is active, not theoretical.
- The best early human evidence on an ayahuasca-type intervention came out of a Brazilian university — and remains a single small trial.
What the Acre prosecutors actually asked for
Two recommendations, published 4 September 2026, asking CONAD to review DMT's criminal framing and Anvisa to update its place in the Portaria 344/1998 schedules — both with mandatory consultation of Indigenous peoples and ayahuasca religions. Neither body has publicly responded.
The MPF unit in Acre, through prosecutors Lucas Costa Almeida Dias and Luidgi Merlo Paiva dos Santos, issued recommendations published on 4 September 2026: https://www.mpf.mp.br/o-mpf/unidades/pr-ac/noticias/mpf-recomenda-revisao-das-regras-sobre-uso-da-ayahuasca-no-brasil
To CONAD (the national drug policy council): create a two-year working group to hear Indigenous communities and ayahuasca religions, set objective parameters for production, circulation and use, and review the legal framing of DMT "with the possibility of removing its criminal incidence and adopting a predominantly administrative regime."
To Anvisa (the health regulator): a parallel two-year working group to update how DMT is handled in the Portaria SVS/MS 344/1998 schedules for religious, spiritual and therapeutic use, again with prior consultation of Indigenous peoples.
Both bodies got 30 days to accept or justify refusal, with court action flagged as the fallback. The MPF release cites a public hearing held 28 November 2025 and a 15-year-old IPHAN intangible-heritage process on ayahuasca. The recommendation documents are posted here: https://www.mpf.mp.br/o-mpf/unidades/pr-ac/noticias/recomendacao-conad.pdf and https://www.mpf.mp.br/o-mpf/unidades/pr-ac/noticias/recomendacao-anvisa.pdf
Status: pending, not decided. The 30-day window has closed and we found no CONAD or Anvisa statement of any kind. Reporting by Carlos Minuano in the Psicodelicamente blog at CartaCapital (13 October 2026) says Senad's technical area favoured *partial* acceptance — suggesting equal representation of Indigenous and ayahuasca-religion delegates — and that the call belongs to the CONAD plenary, next meeting 11–12 November 2026: https://www.cartacapital.com.br/blogs/psicodelicamente/quem-vai-escrever-as-novas-regras-dos-psicodelicos/ That date comes from a single source. Treat it as reported, not confirmed.
Worth knowing what is being reopened. Religious ayahuasca use in Brazil rests on CONAD Resolution nº 1 of 25 January 2010, which codified the findings of a multidisciplinary working group created in 2004. It bars commercialisation while allowing transport costs to be covered, and says nothing about export. DMT itself was never descheduled. Religious use has been running on a council resolution, not on legality.
Psilocybin sits on the other side of that line
Psilocybin and psilocin are on List F2 of Annex I to Portaria SVS/MS 344/1998 — prohibited psychotropics, no legal medical or recreational use. The mushrooms are not named in the schedule, which is the basis of a legal argument Brazilian courts have generally rejected.
That molecule-versus-organism gap is not unique to Brazil. The INCB wrote to Dutch health authorities on 13 September 2001 that no plants or natural material containing psilocine or psilocybin are controlled under the 1971 Convention — while noting that criminal cases are decided under *national* law (https://erowid.org/plants/mushrooms/mushrooms_law12.shtml). In the Netherlands that reading eventually favoured defendants. In Brazil it has not.
Enforcement is active. Operação Psicose (Polícia Civil do Distrito Federal, September 2025): nine arrest warrants, roughly 20 search warrants across several states, R$30m in assets frozen, with the main production hub reported near Curitiba. A separate Polícia Federal operation in Belo Horizonte (April 2024) shut down an online mushroom sales site, with the PF stating those involved faced up to 15 years for trafficking.
Two other things people routinely get wrong:
- The STF cannabis ruling does not help. In RE 635.659 (Rel. Gilmar Mendes), the Court held art. 28 of Law 11.343/2006 unconstitutional without reduction of text for cannabis only, setting 40 grams or six female plants as the presumptive user/trafficker parameter. Administrative sanctions survive. Appeals were rejected and the ruling upheld in February 2025. That is decriminalisation, for one plant, and it does not touch psilocybin.
- PEC 45/2023 would push the other way. The "PEC das Drogas" would write criminal liability for possession of any quantity of any illicit drug into the constitution, while barring prison for users. It was authored by then-Senate President Rodrigo Pacheco (PSD-MG) — not by Flávio Bolsonaro, who voted for it and framed it publicly as a rebuke to the STF. It cleared the Senate CCJ 27–4 in March 2024 with Efraim Filho (União-PB) as rapporteur, passed the floor 53–9 and 52–9 in April 2024, and moved to the Chamber of Deputies.
Why thresholds matter: Ipea analysed 5,121 trafficking cases with first-instance terminating decisions in the first half of 2019 and found small cannabis and cocaine quantities predominated — modelling that a 25g cannabis threshold would reclassify 31% of cannabis cases from trafficking to personal use. The same study found the recorded quantities were themselves imprecise, with no clarity on whether packaging was weighed.
Brazil wrote the first controlled trial and cannot prescribe the result
Palhano-Fontes et al. ran the first randomised, placebo-controlled trial of a psychedelic in treatment-resistant depression at UFRN in Natal. It was ayahuasca, not psilocybin, and n=29.
Evidence tier: small human RCT. Published online in *Psychological Medicine* on 15 June 2018: parallel-arm, double-blind, placebo-controlled, single dose. MADRS scores were significantly lower in the ayahuasca arm at days 1–2 (p=0.04) and day 7 (p<0.0001). Day-7 response was 64% versus 27% (p=0.04). Day-7 remission was 36% versus 7% — p=0.054, a trend, not a result. https://www.cambridge.org/core/journals/psychological-medicine/article/rapid-antidepressant-effects-of-the-psychedelic-ayahuasca-in-treatmentresistant-depression-a-randomized-placebocontrolled-trial/E67A8A4BBE4F5F14DE8552DB9A0CBC97
Twenty-nine people, one site, one dose. That is a real, well-run, hypothesis-strengthening trial and it is not a licence to treat anyone. It is also the only peer-reviewed controlled Brazilian psychedelic trial we were able to verify. We could not verify a Brazilian psilocybin clinical programme, so we are not claiming one exists.
What the US did in the same twelve months
An executive order, two FDA priority vouchers for psilocybin, two positive Phase 3 toplines with modest effect sizes, and a multi-billion-dollar acquisition of a drug that is not psilocybin. Nothing was rescheduled.
Executive Order 14401, signed 18 April 2026, directs FDA to issue National Priority Vouchers to qualifying psychedelics holding Breakthrough Therapy designation, directs FDA and DEA to build a Right to Try pathway including ibogaine compounds with Schedule I handling authorisations, and directs HHS to set aside at least $50m via ARPA-H to partner with states running psychedelic programmes. It reschedules nothing. Psilocybin and ibogaine remain Schedule I federally: https://www.presidency.ucsb.edu/documents/executive-order-14401-accelerating-medical-treatments-for-serious-mental-illness A *JAMA* commentary argues it mostly repackages existing authority and may only moderately accelerate research and review.
FDA's 24 April 2026 announcement confirmed three vouchers — psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, methylone for PTSD — without naming the companies. RAPS reporting, via a person familiar, identifies Compass Pathways, Usona Institute and Transcend Therapeutics; Usona said the voucher cuts review to roughly one to two months but "does not alter scientific or regulatory standards," and had not yet filed. Democratic members of Congress have asked whether vouchers are going to politically favoured companies. The same FDA release allowed a Phase 1 noribogaine study (DemeRx NB) in alcohol use disorder to proceed and said flatly that IND clearance "does not mean the drug has been approved or found to be safe or effective."
The Phase 3 numbers, read honestly. Compass's 17 February 2026 press release — company topline, not peer-reviewed, references listed as "data on file" — reported Week 6 placebo-adjusted MADRS differences of -3.6 in COMP005 (258 dosed) and -3.8 versus 1mg in COMP006 (581 dosed), both p<0.001. The headline "clinically meaningful reduction" figures (25% and 39%) use a ≥25% MADRS cut, not the conventional ≥50% response threshold. Statistically significant; clinically modest. Safety: 11 serious adverse events in 8 participants (5%) in the COMP005 25mg arm, 6 in 6 (2%) in COMP006 Part A, suicidal-ideation SAE rate under 1%, and one suicidal-behaviour SAE — in the 1mg arm. The earlier Phase 2b (NCT03775200) is the reason to keep watching: suicidal ideation, suicidal behaviour and intentional self-injury SAEs occurred more often in the 25mg arm, three 25mg patients had suicidal behaviour and all were non-responders, and 10 of 14 such events happened at least a week after dosing. Compass's 52-week Part C data (~13-point MADRS reduction from baseline) is open-label with no placebo arm.
And the money went elsewhere. Eli Lilly's AtaiBeckley deal, announced 16 July 2026 — $6.75/share, ~26% premium, ~$2.8bn upfront, up to ~$3.8bn with CVRs — is built around BPL-003, mebufotenin (5-MeO-DMT), intranasal, entering Phase 3 in TRD with Phase 3 results expected early 2029. Phase 2b at 12mg showed an 11.1-point MADRS drop against 5.8 points on a 0.3mg low-dose active control. The rest of the pipeline is MDMA- and DMT-based. For scale: Otsuka paid $700m for Transcend, and J&J's Spravato booked nearly $1.1bn in the first half of 2026. The largest bet in the sector is not on psilocybin.
If you are on an antidepressant, this story is an interaction story
Ayahuasca contains MAO-inhibiting harmala alkaloids. Combining it with an SSRI is the best-documented route to serious serotonin toxicity in this field, and that risk does not wait for a regulatory decision.
Callaway and Grob flagged it in the *Journal of Psychoactive Drugs* in 1998: harmala alkaloids' MAO inhibition plus serotonin reuptake inhibition is a mechanism for severe serotonin toxicity (https://pubmed.ncbi.nlm.nih.gov/9924842/). Malcolm and Thomas's 2021 review in *Psychopharmacology* reached the same conclusion from a wider base, singling out MAOI-containing brews such as ayahuasca as the principal concern when combined with serotonergic drugs.
Computational tier, not clinical: a 2026 PBPK modelling study in *Frontiers in Molecular Biosciences* modelled SSRI effects on DMT and harmine exposure, noting that fluoxetine and paroxetine are strong CYP2D6 inhibitors and concluding that even modest increases in DMT exposure may intensify serotonergic effects in people on antidepressants. That is a model. It is a reason for caution, not a measured outcome.
For psilocybin specifically, the interaction questions people actually face are SSRIs, MAOIs, lithium and benzodiazepines: /guides/psilocybin-drug-interactions, /guides/psilocybin-and-ssris, /guides/psilocybin-and-maois, /guides/psilocybin-and-lithium. Do not stop a prescription on your own to make room for a session — see /guides/psilocybin-vs-ssris and /glossary/ssri-discontinuation-syndrome. Personal or family history of psychosis or bipolar disorder is a screening-out question in clinical protocols, and the Compass suicidality data is the reason screening and post-session support are not optional extras. We do not publish dosing beyond /dosage and /guides/safe-trip.
PsyBear takeaways
A pending ayahuasca rewrite is not psilocybin reform, a Phase 3 win is not an approval, and nothing here makes anything legal where you live.
1. The MPF recommendations are live and unresolved. CONAD and Anvisa were asked in early September 2026 to reopen ayahuasca and DMT. Neither has publicly answered. The 11–12 November plenary date rests on one report. Pending, not decided.
2. Psilocybin was not in the ask. List F2 of Portaria SVS/MS 344/1998 still means no legal medical or recreational psilocybin in Brazil, and the "mushrooms aren't named" argument has generally lost in Brazilian courts. Operação Psicose and the 2024 PF operation show what enforcement looks like in practice.
3. Brazil's own evidence is one small trial. The Palhano-Fontes RCT is 29 people, one dose, ayahuasca. First is not the same as settled.
4. Read the Phase 3 effect size, not the word "Phase 3." A 3.6 to 3.8 point placebo-adjusted MADRS difference, with "clinically meaningful" defined at ≥25% rather than ≥50%, from company press releases citing data on file. No peer-reviewed Phase 3 psilocybin paper exists yet.
5. Federal US law has not moved. EO 14401 and the FDA vouchers accelerate paperwork. Psilocybin remains Schedule I federally. Where legal access exists, it is state-licensed: /legal-status, /legal-status/oregon, /legal-status/colorado.
6. If you are retreat-shopping on the back of this news, check the law yourself. Jamaica's psilocybin status is widely described as unscheduled, but we found no Jamaican government or statutory source confirming it — and reporting suggests checks with Jamaican officials could not establish the position either. "Everyone says it's fine" is not a legal finding. Start at /guides/psychedelic-retreats.
Psilocybin remains Schedule I under US federal law outside licensed state programmes and authorised research, and is on List F2 of the prohibited schedule in Brazil. This article is policy commentary, not medical or legal advice, and not a suggestion to obtain anything from an unlicensed seller. Ayahuasca's MAO-inhibiting alkaloids can interact dangerously with SSRIs and other serotonergic medication. Talk to a clinician who knows your prescriptions.
Key Takeaways
Two things are happening in Brazil at once. The Federal Public Prosecutor's Office in Acre has recommended that CONAD and Anvisa spend two years rebuilding the rules for ayahuasca and DMT — including the explicit possibility of removing DMT's criminal treatment in favour of an administrative regime. Meanwhile psilocybin and psilocin sit on List F2 of Portaria SVS/MS 344/1998, with no legal medical or recreational use, and mushroom growers are being prosecuted as traffickers. Brazil also produced the first controlled trial of a psychedelic in treatment-resistant depression (Palhano-Fontes et al., Psychological Medicine, 2018, n=29, ayahuasca — not psilocybin) and cannot prescribe the result. In the US, psilocybin cleared two Phase 3 trials on company toplines with a placebo-adjusted effect of 3.6 to 3.8 MADRS points, got two FDA priority vouchers, and is still Schedule I federally — while the biggest cheque in the sector, Lilly's up-to-$3.8bn AtaiBeckley deal, was written for 5-MeO-DMT.
FAQ
- Is ayahuasca legal in Brazil?
- Religious use is permitted under CONAD Resolution nº 1 of 25 January 2010, which set norms based on a multidisciplinary working group created in 2004. It prohibits commercialisation while allowing transport costs to be covered, and does not address export. DMT itself was never descheduled, so religious use rests on a council resolution rather than on the substance being legal.
- Did Brazilian prosecutors ask to decriminalise psilocybin?
- No. The MPF recommendations published on 4 September 2026 ask CONAD to review the legal framing of DMT — including possibly removing its criminal incidence in favour of an administrative regime — and ask Anvisa to update DMT's treatment in the Portaria SVS/MS 344/1998 schedules. Neither document mentions psilocybin or mushrooms.
- What is the legal status of magic mushrooms in Brazil?
- Psilocybin and psilocin are on List F2 of Annex I to Portaria SVS/MS 344/1998, the prohibited-psychotropics list, meaning no legal medical or recreational use. The mushrooms themselves are not named in the schedule, which is the basis of an ongoing legal argument that Brazilian courts have generally rejected. Enforcement is active: Operação Psicose in September 2025 involved nine arrest warrants and R$30m in frozen assets, and a 2024 Polícia Federal operation saw the PF state that those involved faced up to 15 years for trafficking.
- Does the STF cannabis ruling apply to psilocybin?
- No. In RE 635.659 the STF held art. 28 of Law 11.343/2006 unconstitutional without reduction of text for cannabis only, setting 40 grams or six female plants as the presumptive user/trafficker parameter, with administrative sanctions surviving. The ruling was upheld in February 2025. It is decriminalisation for one plant and does not touch psilocybin.
- How strong are the Compass Phase 3 psilocybin results?
- Statistically significant and clinically modest, based on company toplines rather than peer-reviewed publication. The Week 6 placebo-adjusted MADRS difference was -3.6 in COMP005 and -3.8 versus 1mg in COMP006, both p<0.001, and the headline "clinically meaningful reduction" figures use a ≥25% MADRS cut rather than the conventional ≥50% response threshold. The 52-week durability data is open-label with no placebo arm.
- Is it dangerous to combine ayahuasca with an SSRI?
- The risk is documented in the peer-reviewed literature. Callaway and Grob (Journal of Psychoactive Drugs, 1998) described harmala alkaloids' MAO inhibition plus serotonin reuptake inhibition as a route to severe serotonin toxicity, and Malcolm and Thomas (Psychopharmacology, 2021) identified MAOI-containing brews such as ayahuasca as the principal concern when combined with serotonergic drugs. A 2026 PBPK modelling study adds that strong CYP2D6 inhibitors like fluoxetine and paroxetine may increase DMT exposure, though that is a computational model, not a trial.