Response From TAG

This is the response I received by our Australian Government, read between the lines please, they say they monitor all Therapeutic Goods for the safety of the populace. Yeah right!!!!!!!

The Australian Government acknowledges the right of consumers to be able to make informed choices on matters of health care. Consumers also have a right to expect that medicines available in the marketplace are safe and of high quality.

The Therapeutic Goods Administration (TGA) is Australia’s national regulator for therapeutic goods, including medicines and medical devices. The TGA is responsible for administering the provisions of the Therapeutic Goods Act 1989 (the Act) and other related legislation. The regulatory framework for medicines outlined in the Act is designed to ensure that consumers have timely access to medicines that are of acceptable quality, safety and, where appropriate, efficacy.

In Australia, products such as vitamin, mineral and nutritional supplements and herbal, homoeopathic and aromatherapy products that make therapeutic claims are regulated as ‘complementary’ medicines.

Australia has a risk-based system where the level of evaluation and regulatory control of a therapeutic good is based on the relative safety of the product and the seriousness of the condition for which it is intended to be used.

Unless specifically exempt under therapeutic goods legislation, therapeutic goods must be ‘Listed’ (low risk) or ‘Registered’ (high risk) in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in, or exported from, Australia. Therapeutic goods must be manufactured by TGA-licensed manufacturers in accordance with the principles of Good Manufacturing Practice.

Most, but not all, complementary medicines are considered to be low risk medicines and are Listed in the ARTG. Listed medicines may only contain ingredients that have been approved by the TGA as being of low risk and may only make certain therapeutic claims. They are generally purchased from pharmacies, supermarkets and other retail outlets such as health food stores.

The Codex Alimentarius Commission (the Codex) was established in 1963 by two United Nations organisations – the Food and Agriculture Organization and the World Health Organization. Its main purpose is to protect consumer health and to ensure fair practices in international food trade, through the development of food standards and guidelines.

Codex standards and guidelines, such as the Guidelines for Vitamin and Mineral Food Supplements, specifically state that they only apply in countries where vitamin and mineral supplements are regulated as foods. As these types of products are regulated as medicines in Australia, they are not within the remit of the Codex Guidelines. Rather, they are regulated by the Therapeutic Goods Administration (TGA) in accordance with the Therapeutic Goods Act 1989.

The Codex Guidelines for Vitamin and Mineral Food Supplements specifically state that they only apply in countries where vitamin and mineral supplements are regulated as foods. As these types of products are regulated as medicines in Australia, they will not be affected by the Codex Guidelines.

The objectives of the regulatory scheme for therapeutic products in Australia are to protect public health and safety by ensuring that consumers have access to safe, high quality products.

I trust that this information is of assistance.