TGA rules for supplements
And the words it may use are set by a government list, not by you.
The TGA's own words
That is the opening clause of the TGA's guidance on permitted indications. Most supplements are listed medicines. The sponsor certifies they hold the evidence. Nobody at the TGA reads it before the product goes on sale.
Read the label number
AUST L means listed, with claims from the permitted list and no efficacy assessment. AUST L(A) means the claims were assessed. AUST R means the medicine was individually evaluated. A practice cannot lean on an AUST L number as though the regulator had checked.
Where the words come from
The TGA requires listed medicines to use indications drawn exclusively from a list of pre-approved permitted indications. It is a menu, not a set of principles. If your claim is not on it, phrasing it more carefully does not help.
Banned outright
Stating the amount of a vitamin or mineral as a percentage of the recommended daily intake is a prohibited representation. So is quoting an RDI that is not current and from the NHMRC. The list sits in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990.
The other two
You cannot represent a vitamin product as a substitute for good nutrition or a balanced diet, and you cannot represent it as superior to, or more beneficial in any way than, dietary nutrients. Believing it is true is not a defence. The representation itself is what the rule prohibits.
A test you can apply yourself
The TGA defines a serious form of a condition as one requiring a health professional to diagnose, follow up or treat. Naming one is a restricted representation, and it needs the TGA's prior approval. Only two substance-based exemptions sit in the permitted list: vitamin D with calcium for osteoporosis, and folic acid for neural tube defects.
Cannot be applied for
Prohibited representations cover cancer, sexually transmitted diseases, HIV and AIDS, hepatitis C, and mental illness, along with abortifacient action. You cannot apply to use them. The TGA can permit them in a specific advertisement, but that is granted rather than requested.
Two rulebooks, one page
A registered practitioner selling supplements is inside the TGA rules and the National Law at once, and clearing one tells you nothing about the other. With the claim set by the regulator, everything that sells has to live elsewhere on the page.
Tap below for the five checks worth running this week.