Scheduling delegate's final decisions, July 2016
Scheduling medicines and poisons
Part A - Final decisions on matters referred to an expert advisory committee
4. Scheduling proposals referred to the July 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#18)
Red strikethrough textindicates text that has been deleted.
- Green italicised text indicates text that has been added.
Referred scheduling proposal
An application was submitted to amend the Schedule 9 entry for N,N-dimethyltryptamine (DMT) to be for human or therapeutic use except for oral use in liquid form where the concentration of naturally occurring DMT is 0.25 mg/mL or less.
The applicant's proposed amendments to the SUSMP are as follows:
Schedule 9 - Amend Entry
N,N-DIMETHYLTRYPTAMINE (DMT) for human or therapeutic use except for oral use in liquid form where the concentration of naturally occurring DMT is 0.25 mg/mL or less.
The applicant's reasons for the request are that DMP is an entheogen within Hoasca Tea and is a necessary and essential part of the manifestation of the The Beneficient Spiritist Centre Uniao do Vegetal (UDV) religious group. Members of the UDV receive communion through Hoasca tea. It is a sacrament in their religion and orally ingested at UDV ceremonies.
N,N-Dimethyltryptamine is a psychedelic tryptamine alkaloid with an indole ring structure. The substance occurs naturally in plants with hallucinogenic properties. A summary of its chemical properties are described below in Table 4.4 and its structure is shown in Figure 4.4.
Figure 4.4: Structure of N,N-dimethyltryptamine
The basis of this application is that the entheogen Hoasca tea is a sacrament which has been used in religious ceremonies by The Beneficent Spiritist Centre Uniao do Vegetal (UDV) religious society for over 50 years.
- Hoasca is produced by boiling parts of the bark of the plant Banisteriopsis caapi (known as Mariri) which contains B-carboline alkaloids, with the leaves of a companion plant namely, the shrub Psychotria viridis (known as Chacrona). The maceration of the plants takes place during a ceremony called a "preparo";
- The companion plant; Chacrona, contains a substance called DMT. When sections of Mariri are boiled with the leaves of the companion plant, the resulting brew is considered a "union of the plants" and is consumed orally;
- It is believed that the harmala alkaloids contained in the tea, namely harmine, harmaline and tetrahydroharmine, inhibit monoamine oxidase (MAO) in the body that would ordinarily destroy orally administered DMT, making it orally active. If DMT were to be ingested without an MAO inhibitor, the MAO contained in the gastrointestinal tract and liver would metabolise the DMT before it reached the brain. The MAO inhibitor in Hoasca has the effect of delaying this process by inhibiting the enzyme MAO. The scientists Goodman & Gilman (The Pharmacological Basis of Therapeutics, 8th. edition): "DMT is a psychoactive substance with hallucinogenic effects when it's smoked, snorted or injected, but it's inactive when orally ingested"; and
- A number of religious movements use a similar, but not identical substance as a sacrament. Those substances are commonly referred to as Ayahuasca; meaning "vine of the soul" in the language of the Quechua people who are indigenous to the Amazonian regions of Peru and Ecuador. The various sacraments are also referred to as Daime, Vegetal, Caapi, Yagé, Mihi, Dapa, Naterma and Pinde.
Specific questions raised by the delegate
The delegate asked the committee the following questions:
- Is it appropriate to exclude DMT for oral use in liquid form where the concentration of naturally occurring DMT is 0.25 mg/mL or less?
- What is the risk of low concentration DMT?
- If the request is supported how would a strength solution be regulated or should it have a maximum amount of DMT as well?
Current scheduling status
N,N-Dimethyltryptamine (DMT) is currently listed in Schedule 9.
Relevant scheduling history
In June 1967, DMT was placed in a new Schedule 7 entry. In July 1976, the committee recommended numerous hallucinogenic substances be included in a prohibited list. This included DMT.
National Drugs and Poisons Schedule Committee: June 2010
The NDPSC considered the scheduling of entheogenic substances (psychoactive substances used in a religious, shamanic or spiritual context) used in a religious, shamanic or spiritual context. Entheogens are used to supplement various practices for healing and transcendence, including in meditation, psychonautics, art projects, and psychedelic therapy. Historically, entheogens were mostly derived from plant sources, however there now exist many synthetic substances with similar psychoactive properties. Examples of traditional entheogens were included ayahuasca and acacia (both containing N,N-dimethyltryptamine [DMT]), cannabis, and kava.
Members of the NDPSC recalled the 2007 Hanes v Human Rights and Equal Opportunity Commission (HREOC) and Commonwealth of Australia legal proceedings, where the November 2001 NDPSC decision to include Salvia divinorum in Schedule 9 was challenged. The applicant in these proceedings claimed that the committee's action manifested a restriction on his human rights to access Salvia divinorum as part of the practice of his spiritual beliefs.
The judgement upheld the committee's action, noting that the Schedule 9 decision was based upon considerations of public health and safety and that the manifestation of one's religion or belief may be subject to limitations prescribed by law and which are necessary to protect public health and safety.
Members noted that a majority of substances with potential entheogenic uses were included in Schedules 4, 8 and 9.
It was generally agreed that in scheduling a substance, the committee gives extensive consideration to the substance's risk profile and potential use patterns prior to making a decision. Members agreed that the use of a substance in an entheogenic context would not diminish a substance's potential associated risk to public health.
The committee further noted that the 2007 Hanes v HREOC and the Commonwealth decision confirmed that the committee could schedule entheogenic substances in order to protect public health and safety.
In June 2010, the committee agreed that the current scheduling of entheogenic substances remained appropriate.
Pre-meeting public submissions
Fifteen (15) public submissions were received.
All 15 submissions supported the proposal. The main points were that federal regulation required the allowance for religious/spiritual use of DMT under a controlled safe environment, that the current scheduling places restrictions on religious freedoms and that there are potential medical benefits.
The public submissions are available on the TGA website.
Summary of ACMS advice to the delegate
The committee advised that the current scheduling for DMT remained appropriate.
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the committee included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance.
The reasons for the advice comprised the following:
- The proposed use of naturally occurring DMT at low concentrations is for religious purposes as an entheogen. However, managing safety risks within this context is not clear;
- Toxicity - the evidence is not clear for low doses. At high concentrations DMT has been reported to have marked psychotropic responses as well as common physical effects such as diarrhoea and vomiting;
- There is a lack of safety data regarding consumption of low doses of naturally occurring DMT at concentrations of than 0.25mg/mL used in a religious context. It is unlikely that psychoactive effects occur with DMT in the absence of harmaline alkaloids of which concentrations probably need to be approximately 2%;
- The potential interaction with other foods and common medicines (such as SSRI antidepressants) presents a significant risk that needs further investigation. To what extent that they are problematic at low concentrations is unclear. Further safety studies are required for low dose toxicity;
- No information was provided on how brewing the tea would ensure levels of DMT would not exceed 0.25%. International evidence suggests levels of 0.25% would be exceeded;
- Potential for abuse has been reported and is likely to be similar to other compounds such as mescaline, peyote etc. Risks of dependence are unknown when used at low concentrations;
- DMT and harmala alkaloids should be considered as entheogens together in the same application; and
- It is unclear that the proposed use justifies the public health risks of this substance.
The delegate considered the following in regards to this proposal:
- Scheduling proposal;
- Public submissions received;
- ACMS advice;
- Section 52E of the Therapeutic Goods Act 1989;
- Scheduling Policy Framework (SPF 2015); and
- Other relevant information.
Delegate's interim decision
The delegate notes, and accepts, the ACMS advice and reasons that the current Schedule 9 entry for N,N-dimethyltryptamine remains appropriate. The proposed use of naturally occurring N,N-dimethyltryptamine is for religious purposes at low concentrations as an entheogen. While the evidence of toxicity of N,N-dimethyltryptamine consumption at low concentrations is lacking, at high concentrations N,N-dimethyltryptamine has been reported to have marked psychotropic responses as well as common physical effects such as diarrhoea and vomiting. It is not clear how the safety risks within the religious context will be managed. Furthermore, the potential for abuse has been reported and is likely to be similar to other compounds such as mescaline, peyote etc. Risks of dependence and food interactions are unknown when used at low concentrations. It is unclear that the proposed use justifies the public health risks of this substance.
An implementation date is not relevant given there will be no change to the SUSMP as a result of this interim decision.
The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance.
Public submissions on the interim decision
One (1) submission (the applicant) was received that opposed the interim decision for DMT for the following reasons:
- To managing safety risks associated with the use of DMT as an entheogen and toxicity:
- Cites declaration that Ayahuasca is 'relatively safe'; and considers that DMT at low doses is generally inactive when consumed, in the absence of the harmala alkaloids. Asserts that those alkaloids are not scheduled, questions the relevance to to the safety of the consumption of DMT at concentrations less than 0.25mg/mL;
- States that neither DMT-containing plants (Chacrona or Psychotria Viridis) nor preparations made from these plants are controlled under the 1971 Convention on Psychotropic Substances;
- Proposes that the religious ceremonies are supervised by those with extensive experience with ritual consumption of the DMT-containing tea Hoasca with strict medical guidelines followed for first-time consumers of the tea in a private sessions involving consultation regarding spiritual motivation and health background to identify high risk individuals; and
- Proposes to store Hoasca tea in a locked refrigerator in a secure location to prevent theft and diversion, with the relevant authorities given access to the storage location and records.
- Considers that Hoasca is not addictive, and asserts that there are no references cited in the interim decision document regarding the 'reports of abuse' or evidence that the potential for abuse is 'likely to be similar to mescaline, peyote etc'.
- Refers to overseas legal proceedings and considers this to be an international precedent regarding the legality of DMT-containing plants. States that there are no references cited in the interim decision regarding "international evidence suggests levels of 0.25% would be exceeded".
- The submission asserts that it is not evident how the June 2010 National Drugs and Poisons Schedule Committee (NDPSC) scheduling decision for entheogenic substances was taken into account for the DMT interim decision; or why refusing the religious use of DMT is necessary to protect public health and safety.
- Asserts that the interim decision infringes upon religious freedoms under the Australian Constitution; and states that the importance and necessity of the proposed use to the religion is not apparent in the reasons for the decision. The submitter also proposes to work with the Department of Health and stakeholders to develop further guidelines for the proposed use for religious purposes.
Delegate's final decision
The delegate notes that the submission by the applicant to the interim decision did not raise any new information to alter the interim decision. The use of a substance in an entheogenic context would not diminish a substance's potential associated risk to public health in its use.
The scheduling of a substance for human safety overrides religious purposes. The Schedule 9 decision was based upon considerations of public health and safety and that the manifestation of one’s religion or belief may be subject to limitations prescribed by law and which are necessary to protect public health and safety.
The delegate has confirmed the interim decision and has confirmed that the final decision and reasons for the final decision are in keeping with those for the interim decision.
- Declaration of Charles S. Grob M.D. Gonzales Case No. MP/PDP 09-5300
- Callaway JC1, McKenna DJ, Grob CS, Brito GS, Raymon LP, Poland RE, Andrade EN, Andrade EO and Mash DC, 1999 'Pharmacokinetics of Hoasca alkaloids in healthy humans (pdf,181kb)', J Ethnopharmacol. 65(3), 243-56.
- Abridged Judgement of The District Court of Amsterdam, Case Number 13/067455-99(pdf,31kb); Judgement of Supreme Court of the United States in the case of Gonzalez v O Centro Espirita (pdf,126kb)
- Australian Constitution ACT - SECT 116