Supplement regulation in Australia

Supplements, including probiotics, are usually assessed by the TGA as Listed Products, a designation which ensures formulations are true-to-label and permits more generic health claims without the requirements for rigorous scientific backing. All supplements, including probiotics, might, in theory, request Registered Product status from the TGA, which would allow higher level health claims, but also requires a greater burden of scientific support. In practice very few supplements are Registered Products* and no probiotics are Registered. (Ref)

Yomogi a Listed probiotic treatment for diarrhoea (note its Listing code).

Imodium, a registered medication indicated for diarrhoea. See the tiny R number at the bottom left.

Thus, for TGA Listed products, consumers can be confident the product contains what it says on the label and that it’s safe when taken as directed. However, if a product is Listed rather than Registered, any benefits are less supported by clinical evidence and may be negligible. For a rationale for any benefit we will need to examine the evidence ourselves, or look to collations of evidence, such as those from the WGO.

Products that have passed the TGA assessment process include the TGA number on the label (though sometimes in very small writing), with ‘L’ denoting a Listed Product and ‘R’ a Registered product.

Health claim differences can sometimes be subtle. For instance, Yomagi, a Listed probiotic, makes a few health claims including to “Reduce and relieve diarrhoea and the occurrence of diarrhoea in adults and children”. Imodium is a Registered medicine and claims “Effective relief from the symptoms of diarrhoea, including loose stools, stomach cramping and pain”.

All products that make any health claim should be registered with the TGA but, in the days of online shipping, many are not. You can search for products with the TGA here: Australian Register of Therapeutic Goods (ARTG) or look for the label number on the pack.

*Commonly, vitamins and minerals that have been sold for many years with well clarified benefits in specific groups, such as iron, vitamin D, calcium and folic acid.