The TGA are the gatekeepers of all medicines, drugs, medical devices that are manufactured in Australia or imported for use in Australia. They work under a very strict Code and set of Regulations and Protocols. And so they should.
Up until 2016 TB4 had no status on the TGA databases. It was not registered or listed on the Australian Register of Therapeutic Goods (ARTG), it was not listed on any TGA Schedule which includes all poisons , substances not registered, experimental substances, dangerous goods.
Without going into the complexity of all this can I just repeat myself again that TB4 is not a registered substance anywhere in the world and has therefore not be subjected to a strenuous review by independent scientific and medical experts from Regulators like the TGA (Aust, the FDA (U.S.) and MHRA (UK). Evidence would include clinical trials in Humans. This has not been done
ASADA and the TGA both come under the control of the Health Department (Greg Hunt).
In 2015 an application for the Scheduling of TB4 was submitted by an unnamed applicant citing the reason that TB4 was on the WADA Banned List because it was performance enhancing and for this reason TB4 should Scheduled. The application can be found on the TGA website.
The TGA were clearly concerned about the manner in which TB4 was being advertised, sold and accessed without legitimate purpose (see later). I absolutely support this rationale.
If you read further down the web page the TGA list the reasons why they want to include TB4 on the Schedules List which include limited research data on efficacy, not registered anywhere in the world, experimental substance, concerns on safety etc. Then it claims that the substance is used as a performance and image enhancing agent which, to my mind, is contradictory to the other reasons.
The application contains no visible supporting scientific/medical references for this performance enhancing claim.
In relation to the legitimate concerns of the TGA about the advertising and sale of TB4 it is worth noting that the TGA (Dept of Health) has lodged a claim before the NSW Supreme Court to have an Australian Company (Peptide Clinics) withdraw all products and claims made on their webpage claiming unsubstantiated efficacy about their products. One of these substances is TB4.
I have heard that these claims have been removed but I can’t confirm them as access to the webpage is restricted. I also understand that the case is still before the court because of other illegal practices (issuing of prescriptions).
The TGA have been questioned about the contradiction and although they have acknowledged that the reasons for Scheduling could be viewed as contradictory they say that their statement does not imply performance enhancement. My response was that as the gatekeepers of medicines for Australia their decisions, which become part of the regulatory framework, should not be open to interpretation or question. I have been invited to submit an application to review the Scheduling of TB4 (a bureaucratic nightmare).