For the most part, reports to the TGA are due to inappropriate claims being made about new products. Looking for evidence to disprove these therapeutic claim are not usually required because as part of the submission process to List (ARTG L) a new product on the Therapeutic Goods Register, Sponsors (manufacturers/distributors) must only state that they have in their possession evidence that justifies their claims.
However, there no requirement through legislation, or by process that the TGA is required to cite the evidence to confirm it exists, or indeed to evaluate it for appropriateness. Only for Registered (ARTG R) Products is evidence required to be presented. More on this process can be found at the TGA’s Website,
While we hope that no one would seriously advocate the use of a therapy or medication without good evidence to support it; and while use of a treatment ought to be based on the treatment being proven to work – for some therapeutic products there is no requirement for good evidence to be produced.
The Therapeutic Goods Act 1989 requires that all indications and claims made about therapeutic goods must be capable of substantiation – that is, evidence must be held by sponsors which demonstrates the indications and claims are true, valid and not misleading. Currently, Australian Law allows exceptions to this line of evidence. Product Sponsors may make claims based on “historic” value, rather than a robust body of evidence.
According to the Guidelines for levels and kinds of evidence to support indications and claims, no high-level indications can be made using historical evidence.
High level indications / claims are indications or claims that refer to serious diseases or disorders or which relate to:
- Treatment, cure or management of any disease / disorder / condition;
- Prevention of any disease, disorder or condition;
- Treatment of a specific named vitamin or mineral deficiency diseases.
Because of this, should you wish to report a product or therapy for which you believe there to be no good evidence in support for, you should include evidence that supports your assertion. It is then advised to use sources from medical journals with a reputable standing in the medical community with a robust scientific method, and a strong history of critical peer-review.