Vitamins and Dietary Supplements: Government Auditor reports serious enforcement failures by Therapeutics regulator

Posted by AFN Staff Writers on 1st September 2011

The Australian National Audit Office (ANAO) has found that the regulation of alternative medicines in Australia is being administered badly. An audit undertaken by the ANAO revealed that false safety and efficacy claims on alternative medicine products are being overlooked by the Therapeutic Goods Administration (TGA), which is the federal regulator for such products.

In a shock to consumers of vitamins, supplements and other complementary healthcare products, the ANAO has confirmed that almost 90% of alternative medicines in Australia do not meet the terms of Australian regulations when it comes to quality issues or side-effects.

The audit report, published yesterday, found that therapeutic goods companies flouting advertising rules are not being prosecuted by the TGA. According to the audit report, prosecution fines are too small for the TGA to justify the expense of investigating cases in which companies breach terms of regulation.

The ANAO’s audit report, titled Therapeutic Goods Regulation: Complementary Medicines, states that TGA’s regulation of alternative medicines in Australia is “limited in its effectiveness”.

Some two‐thirds of all Australians use alternative medicines, including vitamins, minerals, herbal, aromatherapy and homoeopathic products. Popular examples of complementary medicines in Australia include fish oil, St John’s Wort and glucosamine.

There are about 10,000 such medicines available on the Australian market. Consumption has continued to rise in recent years and, together with increasing exports of Australian‐manufactured complementary medicines, market growth has been estimated at between three and twelve per cent a year.

The regulation of complementary medicines came to public attention in Australia when the Department of Health and Ageing reported in late 2010 that, based on 2009–10 data, as many as 90 per cent of products reviewed were found to be non‐compliant with regulatory requirements.

Upcoming Symposium on marketing regulatory issues

The above news coincides with the recent announcement by Australian specialist compliance law firm FoodLegal that, in conjunction with the SAI Global group, it is to conduct a Symposium that focuses on the regulation of dietary supplements and health-related functional foods.

Expert speakers will be addressing the interface of separate regulatory regimes for foods and complementary health products. The health-orientated marketing laws for such products and dietary programs will be discussed by speakers including leading regulators from government food agency FSANZ and the Australian Competition and Consumer Commission (ACCC). The Symposium will also consider recent enforcement issues dealt with by the ACCC and the NSWFA concerning marketing and compositional requirements for health-oriented products.

The Symposium is opportune given the state of non-compliance identified by the audit report, and will provide the opportunity to hear several of Australia’s leading compliance experts and government regulators in these fields, especially in relation to the marketing of products with health functional claims or therapeutic properties.

The speakers have foreshadowed to Australian Food News that they will be highlighting the different regulatory criteria that apply from the perspective of different government agencies.

The FoodLegal Symposium is called ‘Healthy Bodies of Law: Food or Therapeutic? Finding Advantages In The Regulatory Differences’ and will be held at The Menzies Hotel in Sydney on Monday 10 October 2011. Pre-booking is required by prospective attendees in the next few weeks to secure a place. To obtain more information, click here.