ASMI Response to Four Corners Program

17 May 2016

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Statement by the Chief Executive Officer of ASMI, Dr Deon Schoombie


ABC Four Corners program, 'Supplements and Safety - The hidden dangers of vitamins and health supplements' broadcast on 16 May 2016
The episode broadcast on Four Corners was a wholly-US program that examined the use of dietary supplements from a US perspective, but with limited relevance to the situation in Australia.
The fact is that there are significant differences between the way the US and Australia regulate these products.
In Australia, complementary medicines are regulated by the Therapeutic Goods Administration (TGA). This is considered one of the most rigorous systems for regulating supplements in the world, and companies marketing complementary medicines must comply with a range of TGA requirements.
Features of the Australian regulation of complementary medicines include:
 Complementary medicines (e.g. fish oil, vitamins and mineral supplements) are regulated as medicines in Australia and must be manufactured to medicinal standards in TGA approved sites
 The TGA conducts a safety assessment on ingredients in Listed (displaying an AUST L number) complementary medicines
 Complementary medicines must contain the ingredients listed on the label and no other active ingredients, and they must only be produced from ingredients approved as low-risk by the TGA
 The TGA routinely conducts manufacturing site inspections, sampling and testing of products in the market to monitor compliance
 Companies marketing complementary medicines can only make limited claims regarding their effectiveness and are required to hold evidence supporting those claims
 All complementary medicines legally available for sale in Australia must be included on the TGA's publicly accessible database, the Australian Register of Therapeutic Goods (ARTG)
 The TGA maintains a rigorous system for recording, monitoring and responding to adverse events for all medicines, including complementary medicines.
The features of the Australian regulatory environment are very different to those in the US that were featured in the Four Corners program, and they should give Australian consumers a high level of confidence in the safety and efficacy of their medicines.
For ASMI, consumer safety is the highest priority and consumers are reminded to only purchase regulated complementary medicines in Australia from reputable sources, and not from overseas.
Consumers should also follow label instructions and warning statements, they should report any adverse reactions, and should consult with a healthcare professional about possible interactions with other medicines.

The Four Corners program also raised issues in relation to omega-3 fish oil supplements.
The majority of Australian do not eat enough fish, and omega-3 supplements play an important role in helping people to consume adequate marine-sourced omega-3s.
Companies that market fish oil products in Australia must comply with TGA requirements including strict manufacturing standards that maximise the purity of these products.
Australian consumers can be confident that fish oil products available in Australia are of the highest quality as they are required to comply with medicinal manufacturing standards.
As with all medicines, fish oil products must be labelled with an expiry date, and products are required to comply with content standards for the duration of their shelf life.
About ASMI: The Australian Self Medication Industry (ASMI) is the peak body representing sponsors of non-prescription medicines - over-the-counter (OTC) and complementary medicines (CM). ASMI members make up 80 per cent of the $4.5bn Non-Prescription Medicines market. Membership totals 55 companies and ASMI members employ approximately 6,000 people with exports estimated at $1.5 billion annually. ASMI's mission is to advance consumer health through responsible self-care. This means driving a viable and responsible industry and empowering the consumer with evidence-based products and information with the aim of improving health and wellbeing. To find out more about ASMI, please visit (www.asmi.com.au).