Reasons for scheduling delegates' interim decisions & invitation for further comment, July 2012
Scheduling of medicines & poisons
10 July 2012
This consultation closed on 25 July 2012
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.
1,3-dimethylamylamine or 4-methylhexane-2-amine (DMAA)
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.
DMAA is not specifically scheduled in Australia.
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).
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.
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.
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.
Schedule 9 - New entry
SUSMP Index - New cross-reference entries
Content last updated: Tuesday, 10 July 2012
Content last reviewed: Tuesday, 10 July 2012
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