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Torsten

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mmmm, it's even got that new fresh-as-of-July-2016 smell to it

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@Torsten

When the legislation says things like:

Quote

a)      in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

...

 

does that mean the scheduling only applies to those preparations listed? Or is it a roundabout legalese way of saying "you can have formaldehyde in oral hygiene preparations containing less than 0.1 per cent of free formaldehyde?

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any news on the proposed DMT rescheduling ?

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On 30/08/2016 at 9:40 AM, Flux said:

any news on the proposed DMT rescheduling ?

 

"Please be aware that an interim decision will be published on matters referred to the July 2016 ACMS on the TGA website at the following link 15 September 2016:

https://www.tga.gov.au/scheduling-delegates-interim-decisions-invitations-further-comment

 

Please check the TGA website on this day for the information you are seeking."

 

"The Standard for the Scheduling of Medicines and Poisons (SUSMP) is implemented and enforced through individual State and Territory legislation and therefore you may wish to speak to your state and territory drugs and poisons unit for further information. Their contact details can be found at http://www.tga.gov.au/industry/scheduling-st-contacts.htm# "

 

Whether this succeeds or fails it is still a step in the right direction. If it succeeds it will be up to the States and Territories to how or if it will be implemented. At the moment it sits with the expert advisory committee. I wonder if anyone from here is on this 'expert' committee

 

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No great suprise...

 

EDIT - full link....https://www.tga.gov.au/book-page/14-nn-dimethyltrypamine

 

Quote
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.
Delegate considerations

The delegate considered the following in regards to this application:

  • 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 10 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.

 

Edited by waterboy 2.0
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