Ayahuasca and the process of regulation in Brazil and internationally: Implications and challenges

doi:10.1016/j.drugpo.2011.06.006

International Journal of Drug Policy

Volume 23, Issue 2, March 2012, Pages 154-161

https://doi.org/10.1016/j.drugpo.2011.06.006 Get rights and content

Abstract

Background

This paper provides a summary and analysis of the regulation of ayahuasca in Brazil, from its prohibition in the mid-eighties to the recent adoption of CONAD's (Conselho Nacional de Políticas sobre Drogas) 2010 Resolution, which established a set of rules, norms and ethical principles to be applied to religious and ritual uses of ayahuasca. Brazil's regulatory process is used as a starting point to explore emerging international regulatory themes as various nations respond to the global expansion of the Santo Daime and UDV (União do Vegetal) ayahuasca religions.

Methods

The text reviews the primary legislative and court documents, academic literature, as well as solicited expert opinions.

Results

Three prominent themes have emerged internationally. The first concerns the scope of international treaties regarding plant-based psychoactive substances, as well as the responsibilities of individual nations to adhere to said treaties. The second concerns the scope of religious liberty and how to determine religious legitimacy. The final theme addresses the potential dangers of ayahuasca to health and public safety.

Conclusion

Over the past 20 years the Brazilian ayahuasca religions have established a global presence, with congregations in the USA, Canada, Japan, South Africa, Australia, and throughout Europe and Latin America. As a result, many nations are faced with the predicament of balancing the interests of these religious minorities with the international “war on drugs.” The regulatory process applied in Brazil exemplifies a progressive approach, one which considered issues of anthropology and involved representatives of ayahuasca religions, and which provided a degree of deference to the principle of religious liberty. The Brazilian process has influenced judicial and administrative decisions internationally, and stands as a model worthy of further consideration.

Section snippets

History of ayahuasca regulation in Brazil

Ayahuasca is a psychoactive beverage generally composed of two plants, Banisteriopsis caapi and Psychotria viridis, the latter of which contains DMT (n,n-dimethyltryptamine), a controlled substance in Brazil (Portaria, 1998) and internationally, under the 1971 United Nations Convention on Psychotropic Substances (CPS). Ayahuasca is traditionally used by diverse indigenous populations of the Amazon, and since the 1930s, has been adopted as a sacrament by several syncretic religious groups in

1971 United Nations Convention on Psychotropic Substances

Brazil, like the USA and many other countries, is signatory to the U.N. 1971 Convention on Psychotropic Substances (CPS), which lists DMT as a Schedule I controlled substance. Under the CPS (Art. 32[4]), signatory countries may make reservations for “plants growing wild which contain psychotropic substances from “among those” in Schedule I and which are traditionally used by certain small, clearly determined groups in magical or religious rites.” Only a few countries have made use of this

Defining religion and religious use

In Brazil, whilst there is no definition of religion in the Federal Constitution, nor in any legal statute, the freedom of belief and worship are generally protected (Constituição da República, 1988, Arts. 1°, III, 5°, VI). Providing an appropriate definition of religion is a complex legal and anthropological matter (Hanegraaff, in press, Sandberg, in press, Walsh, 2010, Weingartner, 2006) one which inevitably evokes issues of human rights. Despite a lack of any official Constitutional or

Safety of use

In Brazil, medical scientists were called to participate in the original CONFEN investigations and in the development of CONAD's 2010 Resolution, but the discussion on whether scientific research had managed to “prove” ayahuasca was harmless was not predominant. Instead, Brazil focused on gathering evidence on the effects of ayahuasca through observation, interviews, and anthropological accounts of its use, whilst strongly encouraging further scientific research. This is in contrast to the

Conclusion

In this paper we have attempted to outline the primary issues that have framed the international debate regarding the expansion of the ayahuasca religions. Interpretations of the CPS have varied by country. On one side, the acute focus on particular psychoactive compounds ignores the fact that these compounds are not traditionally used in isolation but in plant-based preparations and in specific contexts. On the other side, whilst the CPS has allowed for some countries to make exceptions for

Conflict of interest statement

None.

References (82)

E. MacRae
Santo Daime and Santa Maria: The licit ritual use of ayahuasca and the illicit use of cannabis in a Brazilian Amazonian religion
International Journal of Drug Policy
(1998)
Acórdão do Tribunal Regional Federal da 2ª Região do Rio de Janeiro: Habeas Corpus, 2002.02.01.023079-1 [Appellate...
Arrêté du 20 avril, 2005 modifiant l’arrêté du 22 février 1990 fixant la liste des substances classées comme...
Bourgogne, G. (in press). One hundred days of ayahuasca in France: The story of a legal decision. In B.C. Labate & H....
Bressane, R. (2010, Oct. 22). Xamãs urbanos [Urban Shamans]. Revista Alfa. São Paulo,...
J. Bronfman
The extraordinary case of the United States versus the União do Vegetal Church
R.K. Bullis
The “Vine of The Soul” vs. the Controlled Substances Act: Implications of the hoasca case
Journal of Psychoactive Drugs
(2008)
Carroll, S. (2010, Nov. 6). Colombian healer held as a dealer in Houston cell: Arrest of ‘medicine man’ puts drug in...
Church of the Holy Light of the Queen v. Mukasey, 615 F. Supp. 2d 1210 (D. Or....
Constitución Española [Spanish Constitution]. (1978, Oct....

Constituição da República Federativa do Brasil [Federal Constitution of the [Federative Republic of Brazil]. (1988,...

Convention on Psychotropic Substances. (1971), entry into force August 16, 1976, 1019 U.N.T.S....

Cour d’appel de Paris, 10ème chambre (2005) section B, dossier n° 04/01888. Arrêt du 13 janvier 2005 [Court of Appeal...

H. Espíndola

Tombamento da ayahuasca: Indígenas reivindicam participação no projeto que está no Iphan (Safeguarding ayahuasca as an intangible heritage: Indians demand participation in the Brazilian National Historical and Artistic Heritage Institute Project)

Notícias do Ministério da Cultura. O dia-a-dia da Cultura

(2010, Aug. 27)

European Convention on Human Rights. (1950), entry into force 3 Sept. 1953, Europ. T.S. No....

K. Feeney

The legal bases for religious peyote use

K. Feeney

Gonzales v. O Centro Espirita Beneficente União Do Vegetal (2006)

Fotiou, E. (2010). From medicine men to day trippers: Shamanic tourism in Iquitos, Peru. Doctoral Dissertation in...

Gonzales v. O Centro Espíria Beneficiente União do Vegetal, 546 U.S. 418....

Goulart, S. L. (2004). Contrastes e continuidades em uma tradição Amazônica: As religiões da ayahuasca [Contrasts and...

Guam v. Guerrero, 290 F.3d 1210 (9th Cir....

Haber, R. The Santo Daime road to seeking religious freedom in the USA. In B. C. Labate & H. Jungaberle (Eds.), The...

Hanegraaff, W. J.. Ayahuasca groups and networks in the Netherlands: A challenge to the study of contemporary religion....

Juzgado Central de Instrucción, número 3 de Madrid (Oct. 10, 2000), T.S.J.,...

B.C. Labate

A reinvenção do uso da ayahuasca nos centros urbanos (The reinvention of the use of ayahuasca in urban centers)

(2004)

B.C. Labate

Dimensões legais éticas e políticas da expansão do consumo da ayahuasca

Labate, B. C. (2011a). Ayahuasca mamamcuna merci beacoup: diversificação e internationalização do vegetalismo...

B.C. Labate

Consumption of ayahuasca by children and pregnant women: Medical controversies and religious perspectives

Journal of Psychoactive Drugs

(2011)

B.C. Labate et al.

The expansion of the field of research on ayahuasca: Some reflections about the ayahuasca track at the 2010 MAPS “Psychedelic Science in the 21st Century” conference

International Journal of Drug Policy

(2010)

The light from the forest: The ritual use of ayahuasca in Brazil

Fieldwork in Religion

(2006)

B.C. Labate et al.

Ayahuasca religions: A comprehensive bibliography and critical essays

(2009)

Leary v. United States, 383 F. 2d 859 (5th Cir....

Lei No. 11.343 [Law No. 11.343]. (Aug. 23, 2006). D.O.U....

Ley Orgánica de Libertad Religiosa [Organic Law of Religious Liberty], B.O.E. (1980),...

Ley Orgánica del Código Penal [Organic Law of the Penal Code], B.O.E....

C. Long

Religious freedom and Indian rights

(2000)

López-Pavillard, S. & Casas, D. Santo Daime in Spain: A religion with a psychoactive sacrament. In: B. C. Labate & H....

E. MacRae

The religious uses of licit and illicit psychoactive substances in a branch of the Santo Daime Religion

The light from the forest: The ritual use of ayahuasca in Brazil

Fieldwork in Religion

(2006)

E. MacRae

A elaboração das políticas públicas brasileiras em relação ao uso religioso da ayahuasca

E. MacRae

The development of Brazilian public policies on the religious use of ayahuasca

Cited by (91)

Emotion regulation effects of Ayahuasca in experienced subjects during implicit aversive stimulation: An fMRI study
2024, Journal of Ethnopharmacology
Ayahuasca is a beverage used in Amazonian traditional medicine and it has been part of the human experience for millennia as well as other different psychoactive plants. Although Ayahuasca has been proposed as potentially therapeutic as an anxiolytic and antidepressant, whilst no studies have been carried out so far investigating their direct effect on brain emotional processing.
This study aimed to measure the emotional acute effect of Ayahuasca on brain response to implicit aversive stimulation using a face recognition task in functional magnetic resonance imaging (fMRI).
Nineteen male experienced Ayahuasca users participated in this study in two fMRI sessions before and after 50 min of the Ayahuasca ingestion. Subjects were presented with pictures of neutral (A) and aversive (B) (fearful or disgusted) faces from the Pictures of Facial Affect Series. Subjects were instructed to identify the gender of the faces (gender discrimination task) while the emotional content was implicit. Subjective mood states were also evaluated before Ayahuasca intake and after the second fMRI session, using a visual analogue mood scale (VAMS).
During the aversive stimuli, the activity in the bilateral amygdala was attenuated by Ayahuasca (qFDR<0.05). Furthermore, in an exploratory analysis of the effects after intake, Ayahuasca enhances the activation in the insular cortex bilaterally, as well as in the right dorsolateral prefrontal cortex (qFDR<0.05). In the psychometric VAMS scale, subjects reported attenuation of both anxiety and mental sedation (p < 0.01) during acute effects.
Together, all reported results including neuroimaging, behavioral data and psychometric self-report suggest that Ayahuasca can promote an emotion regulation mechanism in response to aversive stimuli with corresponding improved cognition including reduced anxiety and mental sedation.
The current state of ayahuasca research in animal models: A systematic review
2023, Progress in Neuro-Psychopharmacology and Biological Psychiatry
The psychedelic brew ayahuasca is increasingly being investigated for its therapeutic potential. Animal models are essential to investigate the pharmacological effects of ayahuasca since they can control important factors influencing it, such as the set and setting.
Review and summarise data available on ayahuasca research using animal models.
We systematically searched five databases (PubMed, Web of Science, EMBASE, LILACS and PsycInfo) for peer-reviewed studies in English, Portuguese or Spanish published up to July 2022. The search strategy included ayahuasca- and animal model-related terms adapted from the SYRCLE search syntax.
We identified 32 studies investigating ayahuasca effects on toxicological, behavioural and (neuro)biological parameters in rodents, primates and zebrafish. Toxicological results show that ayahuasca is safe at ceremonial-based doses but toxic at high doses. Behavioural results indicate an antidepressant effect and a potential to reduce the reward effects of ethanol and amphetamines, while the anxiety-related outcomes are yet inconclusive; also, ayahuasca can influence locomotor activity, highlighting the importance of controlling the analysis for locomotion when using tasks depending on it. Neurobiological results show that ayahuasca affects brain structures involved in memory, emotion and learning and that other neuropathways, besides the serotonergic action, are important in modulating its effects. Conclusions: Studies using animal models indicate that ayahuasca is toxicologically safe in ceremonial-comparable doses and indicates a therapeutic potential for depression and substance use disorder while not supporting an anxiolytic effect. Essential gaps in the ayahuasca field can still be sufficed using animal models.
Ayahuasca's therapeutic potential: What we know – and what not
2023, European Neuropsychopharmacology
The therapeutic potential of the psychedelic brew ayahuasca has been investigated in preclinical and clinical studies. Currently, the most consistent evidence refers to depression. However, various studies suggest that ayahuasca may comprise therapeutic benefits in other health conditions. This narrative review provides a comprehensive, up-to-date overview of ayahuasca's therapeutic effects in diverse clinical conditions in human (clinical, cross-sectional, observational, and qualitative) and preclinical (animal and in vitro) studies. In addition to summarizing and discussing the most commonly studied conditions, such as depression, anxiety, and substance use disorders (SUD), we also examine less frequently studied psychiatric, neurological, and physical conditions. Moreover, we discuss evidence from epidemiological studies on the impact of regular, long-term ayahuasca use on health and psychosocial outcomes. Overall, evidence for depression and SUD is more consistent, with numerous and diverse studies. However, a growing body of evidence suggests that other conditions equally relevant to public health might be promising targets for ayahuasca's therapeutic effects. This includes preliminary studies indicating potential for grief, eating disorders, posttraumatic stress disorder, personality disorders, Parkinson's and Alzheimer's disease, and severe physical illnesses (e.g., cancer, chronic conditions). Moreover, preliminary evidence in long-term ayahuasca users does not suggest detrimental effects but possible benefits for individual and collective health. In light of the emerging evidence of psychedelic drugs as therapeutic agents, it is essential to further investigate in rigorous designs the therapeutic potential of ayahuasca in conditions other than depression.
Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines
2022, Neuropharmacology
Citation Excerpt :
The 1971 UN Convention on Psychotropic Substances, which forms the basis of many national controlled substance laws today, allows individual nations to exempt from regulation the use of certain psychoactive drug-containing plants “which are traditionally used by certain small, clearly determined groups in magical or religious rites” (United Nations, 1971). Various countries (including Brazil, Canada, Mexico, Peru, Portugal, Spain, and the United States) have laws and regulations that permit the ritual and religious uses of psychedelic plants and their derivatives, such as peyote or ayahuasca, within certain social groups (Labate and Feeney, 2012). Despite the many differences between medical and faith-based uses of psychedelics, one common element often found in both contexts is ritual—a clear set of procedures that is reproduced, time and time again, with regards to how a psychedelic session is conducted, how facilitators are expected to act, and how participants are engaged with before, during, and after the session.
There is mounting evidence suggesting psychedelic and entactogen medicines (namely psilocybin and 3,4-methylenedioxymethamphetamine [MDMA]), in conjunction with proper psychosocial support, hold the potential to provide safe, rapid acting, and robust clinical improvements with durable effects. In the US, both psilocybin and MDMA have been granted Breakthrough Therapy designations by the US Food and Drug Administration and may potentially receive full FDA approval with similar regulatory considerations occurring in multiple countries. At the same time, regulatory changes are poised to increase access to legal or decriminalized psychedelic use in various non-medical settings. This review provides a brief discussion on the historical use of psychedelic medicines, the status of the empirical evidence, and numerous significant policy considerations that must be thoughtfully addressed regarding standards-of-practice, consumer protection, engagement of communities, safeguarding access for all, and developing data standards, which supports the responsible, accountable, safe, and ethical uses of these medicines in clinical, faith-based, and other contexts. We provide suggestions for how public health and harm reduction can be supported through a public-private partnership that engages a community of stakeholders from various disciplines in the co-creation and dissemination of best practices and public policies.
This article is part of the Special Issue on ‘Psilocybin Research’.
Metabolomics and integrated network analysis reveal roles of endocannabinoids and large neutral amino acid balance in the ayahuasca experience
2022, Biomedicine and Pharmacotherapy
There has been a renewed interest in the potential use of psychedelics for the treatment of psychiatric conditions. Nevertheless, little is known about the mechanism of action and molecular pathways influenced by ayahuasca use in humans. Therefore, for the first time, our study aims to investigate the human metabolomics signature after consumption of a psychedelic, ayahuasca, and its connection with both the psychedelic-induced subjective effects and the plasma concentrations of ayahuasca alkaloids.
Plasma samples of 23 individuals were collected both before and after ayahuasca consumption. Samples were analysed through targeted metabolomics and further integrated with subjective ratings of the ayahuasca experience (i.e., using the 5-Dimension Altered States of Consciousness Rating Scale [ASC]), and plasma ayahuasca-alkaloids using integrated network analysis. Metabolic pathways enrichment analysis using diffusion algorithms for specific KEGG modules was performed on the metabolic output.
Compared to baseline, the consumption of ayahuasca increased N-acyl-ethanolamine endocannabinoids, decreased 2-acyl-glycerol endocannabinoids, and altered several large-neutral amino acids (LNAAs). Integrated network results indicated that most of the LNAAs were inversely associated with 9 out of the 11 subscales of the ASC, except for tryptophan which was positively associated. Several endocannabinoids and hexosylceramides were directly associated with the ayahuasca alkaloids. Enrichment analysis confirmed dysregulation in several pathways involved in neurotransmission such as serotonin and dopamine synthesis.
In conclusion, a crosstalk between the circulating LNAAs and the subjective effects is suggested, which is independent of the alkaloid concentrations and provides insights into the specific metabolic fingerprint and mechanism of action underlying ayahuasca experiences.
Ayahuasca blocks ethanol preference in an animal model of dependence and shows no acute toxicity
2022, Journal of Ethnopharmacology
Citation Excerpt :
From the late twentieth century, syncretic ayahuasca religions spread from Amazon to all-over Brazilian urban contexts and, following, worldwide (Labate and Jungaberle, 2011). The religious use of ayahuasca has been nationally regulated in Brazil since 2010, including plants cultivation, beverage preparation and transport, as well as a set of rules, norms, and ethical principles to be applied to the use of ayahuasca by religious groups (Labate and Feeney, 2012). The indication of ayahuasca in folk medicine relates to a vast range of medical conditions, in particular mental health (Katchborian-Neto et al., 2020).
Ayahuasca, a psychoactive beverage prepared from Banisteriopsis caapi and Psychotria viridis, is originally used by Amazon-based indigenous and mestizo groups for medicinal and ritualistic purposes. Nowadays, ayahuasca is used in religious and shamanic contexts worldwide, and preliminary evidence from preclinical and observational studies suggests therapeutic effects of ayahuasca for the treatment of substance (including alcohol) use disorders.
To investigate the initial pharmacological profile of ayahuasca and its effects on ethanol rewarding effect using the conditioned place preference (CPP) paradigm in mice.
Ayahuasca beverage was prepared using extracts of B. caapi and P. viridis, and the concentration of active compounds was assessed through high performance liquid chromatography (HPLC). The following behavioral tests were performed after ayahuasca administration: general pharmacological screening (13, 130, or 1300 mg/kg – intraperitoneally – i.p., and 65, 130, 1300, or 2600 mg/kg – via oral – v.o.); acute toxicity test with elevated doses (2600 mg/kg – i.p., and 5000 mg/kg – v.o.); motor activity, motor coordination, and hexobarbital-induced sleeping time potentiation (250, 500, or 750 mg/kg ayahuasca or vehicle – v.o.). For the CPP test, the animals received ayahuasca (500 mg/kg – v.o.) prior to ethanol (1.8 g/kg – i.p.) or vehicle (control group – i.p.) during conditioning sessions.
Ayahuasca treatment presented no significant effect on motor activity, motor coordination, hexobarbital-induced sleeping latency or total sleeping time, and did not evoke signs of severe acute toxicity at elevated oral doses. Ayahuasca pre-treatment successfully inhibited the ethanol-induced CPP and induced CPP when administered alone.
Our results indicate that ayahuasca presents a low-risk acute toxicological profile when administered orally, and presents potential pharmacological properties that could contribute to the treatment of alcohol use disorders.

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Policy analysisAyahuasca and the process of regulation in Brazil and internationally: Implications and challenges

Abstract

Background

Methods

Results

Conclusion

Section snippets

History of ayahuasca regulation in Brazil

1971 United Nations Convention on Psychotropic Substances

Defining religion and religious use

Safety of use

Conclusion

Conflict of interest statement

International Journal of Drug Policy

The extraordinary case of the United States versus the União do Vegetal Church

The “Vine of The Soul” vs. the Controlled Substances Act: Implications of the hoasca case

Journal of Psychoactive Drugs

Tombamento da ayahuasca: Indígenas reivindicam participação no projeto que está no Iphan (Safeguarding ayahuasca as an intangible heritage: Indians demand participation in the Brazilian National Historical and Artistic Heritage Institute Project)

Notícias do Ministério da Cultura. O dia-a-dia da Cultura

The legal bases for religious peyote use

Gonzales v. O Centro Espirita Beneficente União Do Vegetal (2006)

A reinvenção do uso da ayahuasca nos centros urbanos (The reinvention of the use of ayahuasca in urban centers)

Dimensões legais éticas e políticas da expansão do consumo da ayahuasca

Consumption of ayahuasca by children and pregnant women: Medical controversies and religious perspectives

Journal of Psychoactive Drugs

The expansion of the field of research on ayahuasca: Some reflections about the ayahuasca track at the 2010 MAPS “Psychedelic Science in the 21st Century” conference

International Journal of Drug Policy

The light from the forest: The ritual use of ayahuasca in Brazil

Fieldwork in Religion

Ayahuasca religions: A comprehensive bibliography and critical essays

Religious freedom and Indian rights

The religious uses of licit and illicit psychoactive substances in a branch of the Santo Daime Religion

The light from the forest: The ritual use of ayahuasca in Brazil

Fieldwork in Religion

A elaboração das políticas públicas brasileiras em relação ao uso religioso da ayahuasca

The development of Brazilian public policies on the religious use of ayahuasca

Policy analysis
Ayahuasca and the process of regulation in Brazil and internationally: Implications and challenges