Rogue traders: why regulation counts
The tight regulatory regime around thearapeutic goods in Australia, widely regarded as a global benchmark, is working, says the Complementary Healthcare Council.
The Council was responding to recent media coverage of a study into Traditional Chinese Medicine (TCM) products seized by Australian Border Officials, and highlighted the study’s finding as a validation of the regime.
All complementary medicines, including those imported for sale in Australia, must meet regulations set by the TGA. This includes meeting standards around Good Manufacturing Practice (GMP) and ensuring that products are Listed or Registered on the Australian Register of Therapeutic Goods (ARTG).
All ingredients used in listed products must be on the permitted list of ingredients: ingredients which have been evaluated and pre-approved for use and are considered ‘low risk.’
Registered products are considered higher risk, and therefore generally undergo additional individual evaluations.
The 15 TCM products featured in the study conducted by researchers at Murdoch University in Western Australia were seized by Customs as they were found to contain prohibited and undeclared ingredients.
This is the standard process and outcome for products not meeting the stringent regulations put in place by the Government to protect Australian citizens from rogue traders and products, CHC says.
‘The context of this study proves that our regulatory system works,’ says Dr Wendy Morrow, executive director of the CHC.
‘Safety of consumers is the number-one priority of complementary medicine companies manufacturing or importing products into Australia, and this is why we have such regulations in place.’
CHC says consumers must note the difference between complementary medicines which are researched, manufactured, labelled and marketed in line with Australia’s regulatory regime and those which are illegal products.
It is vital that Australian consumers distinguish products that have met regulations and standards from those which have not, it says.
‘The CM Industry continues to educate consumers around identifying appropriately regulated products, in particular highlighting the requirement for an AUST L (Listed) or AUST R (Registered) marking on the label of a product,’ Wendy says.
‘We also persistently highlight the risk associated with buying products online from outside Australia.
‘Consumers need to be aware that products purchased online from overseas have not been subject to Australian regulations and may not meet the high standards we set here.
‘The rogue products featured in this study are just that – rogue,’ she says. ‘They were found to be in breach of Australian laws in addition to TGA regulations, clearly making this an acute case.
‘It is important to understand that these study findings are not representative of products imported legally and should not tarnish an entire industry, especially when the situation has shown the Australian regulatory system to be working as it should.’