Dmaa to be banned 1 august ! - Ausbb

Aek · 11-07-2012, 11:28 AM

The official Ban to take effect is

DMAA TO BE BANNED 1 AUGUST !!!

Any Sales after this date TGA Can Legally Prosecute

Notice under subsection 42ZCZP of the Therapeutic Goods Regulations 1990

A delegate of the Secretary to the Department of Health and Ageing hereby gives notice of the delegate's interim decision under subsection 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations).
This notice provides the interim decision for 1,3-dimethylamylamine (DMAA), the reasons for the decision and invites further submissions from parties who made a valid submission in response to the original invitation for submissions (published on 26 April 2012 at Invitation for public comment - ACMS and ACCS meetings, June 2012).
Further submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date 25 July 2012.
Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate.
Please note that all valid submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework (SPF), issued by the National Coordinating Committee on Therapeutic Goods. The SPF is accessible at NCCTG scheduling policy framework.
Persons making submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred) via the email address provided below. Submissions, preferably in electronic format, should be made to:
Medicines and Poisons Scheduling Secretariat (MDP88)
GPO Box 9848
CANBERRA ACT 2601
email SMP@health.gov.au Facsimile 02 6289 2650
The closing date for further submissions is 25 July 2012.
Table of contents

1,3-dimethylamylamine or 4-methylhexane-2-amine (DMAA)
1,3-dimethylamylamine or 4-methylhexane-2-amine (DMAA) interim decision

Scheduling proposal

The medicines scheduling delegate initiated a proposal to include of 1,3-dimethylamylamine (DMAA) in Schedule 9 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). This was in response to New Zealand's temporary Class Drug Notice of 8 March 2012 advising that DMAA would be classified as a temporary class drug (equivalent to Schedule 9). New Zealand's temporary prohibition of DMAA came into effect on 9 April 2012.
Scheduling status

DMAA is not specifically scheduled in Australia.
Pre-meeting submissions

Six pre-meeting submissions were received. One submission supported the proposed prohibition, noting that DMAA is addictive. The other five submissions did not support the prohibition, indicating that DMAA is safe, effective and has no negative health effects. One submission also suggested that DMAA be regulated rather prohibited.
The redacted public submissions are available at Public submissions on DMAA referred to ACMS#6 (July 2012).
Advisory Committee on Medicines Scheduling (ACMS) discussion

The Committee considered the referral from the medicines scheduling delegate to include 1,3-dimethylamine or 4-methylhexane-2-amine (DMAA) in Schedule 9 of the Standard for the Uniform Scheduling of Medicines and Poisons.
Members deliberated over the proposed scheduling of DMAA and whether it should be included in Schedule 4, Schedule 9 or Appendix C. Members noted that:

There is inadequate evidence to suggest DMAA's toxicological and pharmacological properties warrant a Schedule 9 listing.
DMAA is not listed in either Schedule IV to the United Nations Convention on Narcotic Drugs, 1961 or in Schedule 1 to the United Nations Convention on Psychotropic Substances, 1971.
There is a lack of supporting evidence to reach the conclusion that DMAA needs the same level of control as amphetamine.
DMAA's toxicological properties meet the Appendix C scheduling criteria.

Members agreed that DMAA should be included in Appendix C for the following reasons:

DMAA has no current accepted therapeutic use.
DMAA has a stimulant effect which can induce a psychoactive effect.
DMAA is being actively promoted and used as a party drug as well as a sports supplement.
There is no real evidence of dependence on DMAA.
There are a number of significant adverse events including cardiac, nervous and psychiatric disorders that have been reported with use of DMAA including cerebral haemorrhage and heart attacks.
The potential for misuse and abuse is high.

Delegate's consideration

The delegate considered the following in regards to this proposal:

New Zealand's temporary Class Notice;
International scheduling decisions, including the United States FDA, Canada and United Kingdom;
public submissions received;
ACMS advice;
section 52E of the Therapeutic Goods Act 1989;
scheduling factors1;
other relevant information.

1 Scheduling Policy Framework for Medicines and Chemicals
Delegate's interim decision

The medicines scheduling delegate has made an interim decision to include 1,3-dimethylamylamine in Schedule 9 of the SUSMP. The delegate has also agreed to the inclusion of a cross reference to the index from DMAA to 1,3-dimethylamylamine and 4-methylhexane-2-amine.

The proposed implementation date for this decision is 1 August 2012.

The delegate decided that the relevant matters under section 52E(1) of the Therapeutic Goods Act 1989 include (a) 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, and (e) the potential for abuse of a substance.
In response to safety concerns surrounding the abuse of DMAA and following advice from the ACMS and public consultation, the delegate has made an interim decision to include DMAA in Schedule 9 of the SUSMP. The decision to introduce broader controls on DMAA included the following reasons:

there are no current approved therapeutic uses for DMAA;
there are no benefits but there are significant risks;
there are risks due to DMAA's toxicity;
DMAA presents a high risk of abuse, misuse and illicit use;
reports of adverse events including high blood pressure, psychiatric disorders, cerebral haemorrhage and stroke;
an absence of studies demonstrating the long-term safety of DMAA; and
the wide variability in the potency of the different doses of DMAA.

Proposed new Schedule entry

Schedule 9 - New entry

1,3-dimethylamylamine
SUSMP Index - New cross-reference entries

DMAA

KungFooGoo · 11-07-2012, 11:50 AM

Pretty sure it's already banned.... BN has posted a few things on it recently.

Aek · 11-07-2012, 12:09 PM

I have more trust in the TGA website over BN, furthermore the DMAA containing products are still being sold as we speak have alook at some of the retail stores that are online.

The official date is the 1st of August if you do not believe me then pick up the phone and call the TGA in Canberra if you want confirmation !!!

Bradders · 11-07-2012, 12:09 PM

Quote:

Originally Posted by KungFooGoo

Pretty sure it's already banned.... BN has posted a few things on it recently.

They were waiting for an official announcement I believe before the stopped selling it.

perceive · 11-07-2012, 12:09 PM

Quote:

Originally Posted by KungFooGoo

Pretty sure it's already banned.... BN has posted a few things on it recently.

I think they posted notice only that is was forthcoming and were still waiting for a date.. They were still selling products with it.. It sounds like this Aug 1 day is when those sales will stop.

coaltrain · 11-07-2012, 12:15 PM

So that's jack3d too?? :'(

TrentZor · 11-07-2012, 12:18 PM

Crap now how am i going to get high at stereosonic this year?..
Better stop the cut now.

Admin · 11-07-2012, 12:24 PM

Quote:

Originally Posted by TrentZor

Crap now how am i going to get high at stereosonic this year?..
Better stop the cut now.

guess you'll just have to go for more harder drugs which will be a lot easier to get lol

cracks me up , they ban it because of the effects etc , but more hardline drugs that screw you up more and screw up the family and community are much easier to get hold of , can score quicker then what it takes to get an ambulance or get a taxi

TrentZor · 11-07-2012, 12:28 PM

in the news today -

Man jailed for 5 years after being busted smuggling in 100kg of Dmaa into the country.

Player · 11-07-2012, 01:48 PM

Thanks aek, i haven't seen/heard about this 100 times before

sarcasm intended..

11-07-2012, 11:28 AM	#1 (permalink)
Aek Junior Member Join Date: Oct 2008 Gender: Posts: 191	Dmaa to be banned 1 august ! The official Ban to take effect is DMAA TO BE BANNED 1 AUGUST !!! Any Sales after this date TGA Can Legally Prosecute Notice under subsection 42ZCZP of the Therapeutic Goods Regulations 1990 A delegate of the Secretary to the Department of Health and Ageing hereby gives notice of the delegate's interim decision under subsection 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations). This notice provides the interim decision for 1,3-dimethylamylamine (DMAA), the reasons for the decision and invites further submissions from parties who made a valid submission in response to the original invitation for submissions (published on 26 April 2012 at Invitation for public comment - ACMS and ACCS meetings, June 2012). Further submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date 25 July 2012. Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate. Please note that all valid submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework (SPF), issued by the National Coordinating Committee on Therapeutic Goods. The SPF is accessible at NCCTG scheduling policy framework. Persons making submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred) via the email address provided below. Submissions, preferably in electronic format, should be made to: Medicines and Poisons Scheduling Secretariat (MDP88) GPO Box 9848 CANBERRA ACT 2601 email SMP@health.gov.au Facsimile 02 6289 2650 The closing date for further submissions is 25 July 2012. Table of contents 1,3-dimethylamylamine or 4-methylhexane-2-amine (DMAA) 1,3-dimethylamylamine or 4-methylhexane-2-amine (DMAA) interim decision Scheduling proposal The medicines scheduling delegate initiated a proposal to include of 1,3-dimethylamylamine (DMAA) in Schedule 9 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). This was in response to New Zealand's temporary Class Drug Notice of 8 March 2012 advising that DMAA would be classified as a temporary class drug (equivalent to Schedule 9). New Zealand's temporary prohibition of DMAA came into effect on 9 April 2012. Scheduling status DMAA is not specifically scheduled in Australia. Pre-meeting submissions Six pre-meeting submissions were received. One submission supported the proposed prohibition, noting that DMAA is addictive. The other five submissions did not support the prohibition, indicating that DMAA is safe, effective and has no negative health effects. One submission also suggested that DMAA be regulated rather prohibited. The redacted public submissions are available at Public submissions on DMAA referred to ACMS#6 (July 2012). Advisory Committee on Medicines Scheduling (ACMS) discussion The Committee considered the referral from the medicines scheduling delegate to include 1,3-dimethylamine or 4-methylhexane-2-amine (DMAA) in Schedule 9 of the Standard for the Uniform Scheduling of Medicines and Poisons. Members deliberated over the proposed scheduling of DMAA and whether it should be included in Schedule 4, Schedule 9 or Appendix C. Members noted that: There is inadequate evidence to suggest DMAA's toxicological and pharmacological properties warrant a Schedule 9 listing. DMAA is not listed in either Schedule IV to the United Nations Convention on Narcotic Drugs, 1961 or in Schedule 1 to the United Nations Convention on Psychotropic Substances, 1971. There is a lack of supporting evidence to reach the conclusion that DMAA needs the same level of control as amphetamine. DMAA's toxicological properties meet the Appendix C scheduling criteria. Members agreed that DMAA should be included in Appendix C for the following reasons: DMAA has no current accepted therapeutic use. DMAA has a stimulant effect which can induce a psychoactive effect. DMAA is being actively promoted and used as a party drug as well as a sports supplement. There is no real evidence of dependence on DMAA. There are a number of significant adverse events including cardiac, nervous and psychiatric disorders that have been reported with use of DMAA including cerebral haemorrhage and heart attacks. The potential for misuse and abuse is high. Delegate's consideration The delegate considered the following in regards to this proposal: New Zealand's temporary Class Notice; International scheduling decisions, including the United States FDA, Canada and United Kingdom; public submissions received; ACMS advice; section 52E of the Therapeutic Goods Act 1989; scheduling factors1; other relevant information. 1 Scheduling Policy Framework for Medicines and Chemicals Delegate's interim decision The medicines scheduling delegate has made an interim decision to include 1,3-dimethylamylamine in Schedule 9 of the SUSMP. The delegate has also agreed to the inclusion of a cross reference to the index from DMAA to 1,3-dimethylamylamine and 4-methylhexane-2-amine. The proposed implementation date for this decision is 1 August 2012. The delegate decided that the relevant matters under section 52E(1) of the Therapeutic Goods Act 1989 include (a) 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, and (e) the potential for abuse of a substance. In response to safety concerns surrounding the abuse of DMAA and following advice from the ACMS and public consultation, the delegate has made an interim decision to include DMAA in Schedule 9 of the SUSMP. The decision to introduce broader controls on DMAA included the following reasons: there are no current approved therapeutic uses for DMAA; there are no benefits but there are significant risks; there are risks due to DMAA's toxicity; DMAA presents a high risk of abuse, misuse and illicit use; reports of adverse events including high blood pressure, psychiatric disorders, cerebral haemorrhage and stroke; an absence of studies demonstrating the long-term safety of DMAA; and the wide variability in the potency of the different doses of DMAA. Proposed new Schedule entry Schedule 9 - New entry 1,3-dimethylamylamine SUSMP Index - New cross-reference entries DMAA Last edited by Aek; 11-07-2012 at 11:31 AM.

11-07-2012, 11:50 AM	#2 (permalink)
KungFooGoo Gangster Join Date: Oct 2011 Location: Perth - NOR Gender: Training Exp:1-2 Years Muscle Goals:Build Muscle Posts: 4,835	Pretty sure it's already banned.... BN has posted a few things on it recently. __________________ Training Log

11-07-2012, 12:15 PM	#6 (permalink)
coaltrain Senior Member Join Date: Feb 2012 Location: Brissy Gender: Posts: 283	So that's jack3d too?? :'( __________________ Eat big, lift big, train big, get a big penis. Proven science

11-07-2012, 12:18 PM	#7 (permalink)
TrentZor Active Member Join Date: Aug 2009 Location: PTC Sydney Gender: Posts: 5,131	Crap now how am i going to get high at stereosonic this year?.. Better stop the cut now. __________________ WWW.PTCSydney.com.au Strength and Conditioning Gym Trent ASCA level 1 Coach - 0421 790 933

11-07-2012, 12:28 PM	#9 (permalink)
TrentZor Active Member Join Date: Aug 2009 Location: PTC Sydney Gender: Posts: 5,131	in the news today - Man jailed for 5 years after being busted smuggling in 100kg of Dmaa into the country. __________________ WWW.PTCSydney.com.au Strength and Conditioning Gym Trent ASCA level 1 Coach - 0421 790 933

11-07-2012, 12:09 PM	#3 (permalink)
Aek Junior Member Join Date: Oct 2008 Gender: Posts: 191	I have more trust in the TGA website over BN, furthermore the DMAA containing products are still being sold as we speak have alook at some of the retail stores that are online. The official date is the 1st of August if you do not believe me then pick up the phone and call the TGA in Canberra if you want confirmation !!!

11-07-2012, 01:48 PM	#10 (permalink)
Player DuffProteinMan Join Date: Jul 2010 Gender: Training Exp:Just Started Muscle Goals:Build Muscle Posts: 7,460	Thanks aek, i haven't seen/heard about this 100 times before sarcasm intended..