TGA is inviting comments and submissions on changes to the poisons standard

[Strontium Dawg]

https://www.tga.gov.au/consultation-invitation/consultation-proposed-amendments-poisons-standard-july-2016-medicines

Pay close attention to the proposed change to scheduling of nn-dmt, if you are interested in that type of thing.

This could be a huge step in a positive direction paving the way for usage in a religious context.

[-RC-]

I can understand that, due to the hugely increased interest in aya, this might be a goer, but given we have huge amounts of naturally, NATIVELY occuring 4-HO-DMT every wet season, surely sacramental use of mushrooms should be considered as well.

In the sense that neither the caapi, nor psychotrias are native. Yes I am aware that we have shitloads of acacias, but mushies outnumber them a billion to one in our country surely?

[theuserformallyknownasd00d]

That's pretty crazy..! 

[FragmentedSanity]

The use of DMT for religious purposes sounds promising, and a step in the right direction...

But am i the only one worried by the idea of a new schedule (10).

I mean its an explosive that causes weightloss and lots if nasty side effets, like death and cataracts, so sure, dont sell it over the counter.  But does it really need a new schedule. Isnt s9 already just  plain banned?  What on earth is s10 gojng to be?

[-RC-]

Punishable by death?

Apparently in ancient India the consumption of ANY mushroom was considered to be as morally wrong as killing a Brahmin...

[Slocombe]

 

The use of DMT for religious purposes sounds promising, and a step in the right direction...

But am i the only one worried by the idea of a new schedule (10).

I mean its an explosive that causes weightloss and lots if nasty side effets, like death and cataracts, so sure, dont sell it over the counter.  But does it really need a new schedule. Isnt s9 already just  plain banned?  What on earth is s10 gojng to be?

Makes no sense to me , couldn't they just put it [DNP] in s7?

Edited April 20, 2016 by Slocombe

[Torsten]

On 19/04/2016 at 11:47 PM, FragmentedSanity said:

But am i the only one worried by the idea of a new schedule (10).

 What on earth is s10 gojng to be?

 

I think you misread the proposal for 2,4-DINITROPHENOL . It is not proposing a new 'schedule', but a new 'schedule entry'.

Schedule 10 already exists. It used to be appendix C.  A simply glance at the SUSMP over the last year or so would tell you so.

[Torsten]

Here are my comments that I wrote about the application (and the commentary that followed) earlier in the week in response to the emails circulating by the people involved. Apologies if it jumps all over the place a bit in a point by point fashion. The position of the point does not indicate importance as i was simply working through various emails step by step.

 

1) I am not sure what the application is trying to achieve. The TGA schedules are not a law. They are merely recommendations to the states which have ultimate control over the schedules under the state health acts. At best the proposal could provide for a federal guide, but I very much doubt the states will simply go along with it. Having some state based ministerial support would have been crucial for this.

 

2) There were suggestions that the TGA is taking this seriously simply because they tabled it. They did not decide on this process. All applications to the TGA have to be considered and decided upon by the delegate. By making the application they have no choice but to process it. There have been frivolous/ridiculous/unwinnable applications in the past, so the mere acceptance means nothing and we should not read anything into that.

 

3) (deleted: not applicable to this forum)

 

4) Religious use is a meaningless term in australia. Any incorporated association (ie 5 or more people) can call itself a religion and gains the legal status of one - which in australia also means nearly nothing, ie there is no status unless you are dealing with constitutional matters. 5 stoner friends that incorporate as an association have the same legal status as the UdV.

 

5) There seems to be a lot of talk about DMT, but none about harmaline. Harmaline is far more legally restricted in australia than DMT (in terms of quantity). In NSW for example it has a dosage unit of just 30 micrograms, ie the same as LSD, which the scheduling was modelled on. Any talk of ayahuasca tea should have been based on harmaline as this is the primary ingredient. This was likely an oversight as it follows the pattern used by the UdV to legalise ayahuasca overseas, but neglects to address the australian situation.

 

6) Expressing the percentage of DMT as mg in liquid isn't going to sit well with the TGA and makes little sense. There is the technical contradiction that you need to be in possession of the herbs first before making the tea, so the exemption must apply to the herbs themselves. Unless of course the intent is to create an exemption only for the UdV who want to import their brew from brazil 'ready made'. So this exemption would not favour independent practitioners. This was not well thought through.

 

7) There is a lot of discussion about moving towards a licensing system. Licensing [if any] will be determined by the TGA.  However, if you are looking at licensing then you are not really looking at recheduling, so I wonder if the applicants have gone about this the right way as they are two separate processes. The only S9 exemption [besides research] I know of is a cultural exemption issued under the health act for the import, distribution and possession of cathinone containing plant material, ie Catha edulis. This had nothing to do with scheduling, but is simply an exemption. Despite this being a nationally available scheme as far as the TGA is concerned, most states have shut it down. I think only Vic and NSW still allow khat permits.

 

8) Much has been made of the religious aspect. 'religious purposes' was a big issue in the USA and some other countries, but has little meaning in Oz. Our federal constitution only guarantees that the federal government can't make laws that discriminate on the basis of religion, but it does not have any control over state law [which is what the TGA schedules are empowered by]. A constitutional scholar friend of mine tells me that a TGA ruling against the proposal is not an infringement of the constitution. There may be recourse under state charters, but so far nothing like that has been successful. I have been saying for years that state support is needed to make progress on this because ultimately these are all state law matters. I think the federal approach is a waste of time unless there is a plan on launching a constitutional challenge in the Northern Territory or ACT. The hopeful view of translating religious freedom exemptions to australia is not likely to be of any merit.

 

9) My friends in law enforcement policy tell me that DMT is very much on the agenda - and not in a good way. The TGA will toe the line of the federal drugs council [whatever the name is escapes me right now] which is focussing to come down harder on DMT rather than to weaken their stance. The TGA has no interest or incentive to buck the trend.

I am not going to waste any time on making a submission as I do not see any chance of voluntary rescheduling (ie without a court case). And even if I was wrong then rescheduling by the TGA achieves nothing in practical terms. I see the only viable options for progress on this issue via the victorian charter or a federal constitutional case. I also do not see any level of government doing this voluntarily - like so many progressive policies this needs to be imposed by a court.

 

Just to be clear, the illegality of dmt containing plant material was never a grey area. It is only unclear in the minds of those who wish it wasn't and who do not understand the law. There is no legal distinction between isolated DMT and non-isolated DMT. Again, this is a distinction only made by those who do not understand the law. There are plenty of legal precedents for there not being a distinction, eg in regards to ephedra/ephedrine, khat/cathinone, harmala/harmaline, iboga/ibogaine, etc. Simply wishing there was a distinction because ayahuasca is special in your mind does not make it so.

 

I initially thought this application was intentionally naive and non-sensical as to provoke the TGA into an assured rejection which would then form the basis of a constitutional challenge. ie the only merit I saw in this application was as a court case trigger to have the law changed from the bench rather than from the regulator. But i have been assured by constitutional experts that a TGA rejection does not produce such a constitutional challenge trigger. Hence I see no merit in this application and in fact find it very damaging as it will draw attention to something that is on a knife edge of being even more restricted [ie the actual plants getting banned], which will have a negative impact on all non-UdV users .

 

One assured outcome at least is that the TGA will finally lay any naive concepts of legality to rest. Their response will be very detailed in the way it will outline both federal and state laws that apply to ayahuasca, so that in future all these deluded individuals can simply be pointed to the TGA record of reason to set them straight. It will also mean that naivety based on ambiguity will no longer be a defence, so anyone involved in the process, in making submissions, and in commenting publicy should not expect any leniency if they do find themselves busted one day. This obviously applies most clearly to the applicant who will have no claim of grey area misunderstandings once the decision is made. I wonder if they considered that a pointless application will actually make their sourcing problems more difficult?

 

Like i said previously, this does not have the hallmarks of a well though out strategy as it misses the intended aim, neglects to be inclusive, fails to consider basic practicalities, and is a carbon copy of the process applied in other countries based on laws not in existence here. In fact, proposals of this nature have been proposed by naive people with no understanding of law for at least 12 years and usually stall once they gain a modicum of an understanding of the legal situation. There is nothing special in this application and it could have been made without any financial outlay by anyone naive enough to ignore the basic realities.

 

 

 

 

 

 

[-RC-]

Very informative. Thanks T.

[folias]

Do we live in North Korea or South Korea?

I honestly can't see Australian courts sending ayahuasca people to jail. Also, if there is a court case, it will give us a chance to publicise this issue further.

This proposed amendment has already gained some media publicity which I will announce here when the time is right :-)

Decriminalisation is the only sensible way forward, and the 1st step there is to decriminalise plants that are used in a context of healing, rather than just recreatioally.

[Yeti101]

Hard to say how the courts would react. 

 

Regarding decriminalisation, remember, the SUSMP is not law. To actually decriminalise anything, you would need to chance the state laws. Would re-scheduling make that easier? Probably. But you could just lobby for amendment to the relevant state laws and leave the TGA to their own devices. 

 

Anyway, I guess we will just have to wait and see how this turns out.

[Yeti101]

Hey @folias - I've done some more reading, and here the situation, as I see it in NSW. (I am not an expert, if you are ever in trouble, get a real lawyer!)

 

In NSW DMT is a specifically a prohibited drug as it's in Schedule 1 of the  NSW DRUG MISUSE AND TRAFFICKING ACT 1985. Getting it off the TGA S9 list won't change that.

 

But, it's also the case that anything on S9, not otherwise specified in the NSW Schedules, is also prohibited under NSW law. For example: 'A person who has in his or her possession a Schedule 9 substance (not being a prohibited drug within the meaning of this Act) is guilty of an offence.' - where 'prohibited drug' is defined as being on NSW Schedule 1. (from section 18B of the NSW act)

 

So, for the legal status of DMT to change in NSW, you would have to change both its listing on the TGA S9 and its listing on the NSW Schedule 1. Either that, or change the NSW law to exempt it from the 'all-other S9s' provision of section 18B.

 

I think. I could be wrong though, and am happy to be corrected. It's just how the situation strikes me as I read the relevant Acts. (Oh yeah, I know how to have a fun Saturday night!)

 

 

[folias]

Scratching your arse is also prohibited in section 5C49.2 of the Porcine Buttock ACT in NSW.

But also, scratching your arse is legal if you happen to be be upside down in an Uber actually using the app at the time, though it may effect your rating on the Uber app, but don't quote me on that!

[ThunderIdeal]

Cant even scratch your arse anymore

 

*shakes head*

 

I wonder what other archaic laws are contained within pig's arse

 

Edited May 29, 2016 by ThunderIdeal
More

[folias]

What happened to the TGA? Did they get scared and go to ground on this issue?

https://www.inverse.com/article/17643-australia-s-debate-on-ayahuasca-and-dmt-legalization-helps-psychedelic-research

[Yeti101]

I think @Marty Achuma said somewhere that the interim decision is scheduled to come out tomorrow. So perhaps we'll have a better idea of what's happening sometime soon.

[waterboy 2.0]

Better stick it here as well.

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; ( the purposes for which a substance is to be used and the extent of use of a substance; © 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; ( the purposes for which a substance is to be used and the extent of use of a substance; © 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.

 

[Strontium Dawg]

I guess it's not really a surprising result considering the current climate. I mean we have Derryn and Pauline in the Senate which hardly suggests a progressive political landscape...not that the two are related.

As for the comments regarding potential for abuse being similar to mescaline and peyote, what does that even mean? I would have thought that puts it into one of the lower strata for abuse potential. 

[ThunderIdeal]

Ohhhh that must be why we have stupid drug laws.   Pauline Hanson.

 

 

[-RC-]

1 hour ago, Glaukus said:

 

As for the comments regarding potential for abuse being similar to mescaline and peyote, what does that even mean? I would have thought that puts it into one of the lower strata for abuse potential. 

 

Bad drugs are bad, and they WILL be abused, not used. Right? 

[Strontium Dawg]

1 hour ago, Glaukus said:

1 hour ago, ThunderIdeal said:

Ohhhh that must be why we have stupid drug laws.   Pauline Hanson.

 

 

not that the two are related.

 

[Flux]

More DEA-logic-fuckery...cites 'a lack of evidence for non-toxicity and safety data' (keeps it illegal to research so that no such data can be gathered)

[Tobias Penno]

On 15 September 2016 at 3:49 PM, Responsible Choice said:

 

Bad drugs are bad, and they WILL be abused, not used. Right? 

 

Just thought I'd share some literature with y'all .

 

Santos, dos, R.G. et al., 2016. Antidepressive, anxiolytic, and antiaddictive effects of ayahuasca, psilocybin and lysergic acid diethylamide (LSD): a systematic review of clinical trials published in the last 25 years. Therapeutic Advances in Psychopharmacology, 6(3), pp.193–213.

"Moreover, experimental studies of acute ayahuasca administration to healthy volunteers [Riba et al. 2001, 2003, 2006; dos Santos et al. 2011, 2012; de Araujo et al. 2012; Palhano-Fontes et al. 2015; McKenna and Riba, 2016] and mental health assessments of long-term ayahuasca consumers [Grob et al. 1996; Barbosa et al. 2005, 2009, 2012; da Silveira et al. 2005; Doering- Silveira et al. 2005; Halpern et al. 2008; Fábregas et al. 2010; Bouso et al. 2012, 2015; dos Santos, 2013] suggest that this preparation is quite safe."

 

Also - RE: the comment about potential for abuse being similar to mescaline and peyote.

Firstly - Mescaline is one of the key psychoactive ingredients in Peyote. Secondly - the abuse potential of Mescaline is similar to all of the so-called 'psychedelics'.. it doesn't have one - at least not in the conventional sense of abuse, these drugs are not addictive in the classic neurobiological sense where drugs act on the dopaminamergic system - altering the structure of the reward pathways of the brain. In fact - psychedelic drugs have been repeatedly demonstrated to have a clinically significant effect in helping people with addiction >>> Published recently in the internationally renowned psychiatric journal 'The Lancet'.

 

Ben Sessa, 2014. Turn on and tune in to evidence-based psychedelic research. The Lancet Psychiatry, 2(1), pp.10–12.

"Use of psychedelic drugs for the treatment of addictions has been explored since the 1950s. Indeed, Bill Wilson, the founder of Alcoholics Anonymous, was a keen supporter of LSD therapy. A meta-analysis6 of 

LSD-based therapy for alcoholism in the 1950s and 1960s gathered several heterogeneous studies. None was as methodologically robust as contemporary research studies, but when analysed together they showed a significant effect size. 60 years later, with pharmacological treatments for alcohol and opiate addictions remaining relatively poor,7 researchers are now revisiting psilocybine-assisted psychotherapy for the treatment of alcohol dependency.8 For example, ketamine-assisted psychotherapy yielded positive results in Russia in the 1990s. Evegeny Krupitsky and Alexander Grinenko9 compared 111 patients with alcohol addiction given ketamine-assisted psychotherapy with 100 patients with alcohol addiction given conventional management. 66% of patients given ketamine-assisted psychotherapy remained sober after 1 year, compared with 24% of the control group."

[waterboy 2.0]

I think you have missed some of the sarcasm Tobias

There is no need to attempt to school the guys here.

[folias]

5500 words of my analysis of this issue, including my submission to the TGA.

http://julianpalmerism.com/why-is-dmt-illegal/