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Codex

10 May 2005

Proposed Codex guidelines will not impact on the way vitamin and mineral supplements are regulated in Australia

The Therapeutic Goods Administration (TGA) is aware that many consumers have expressed concerns that the draft Guidelines for Vitamin and Mineral Food Supplements, as developed by the Codex Alimentarius Commission (Codex), will have an effect on the regulation of vitamin and mineral supplements in Australia. These concerns appear to originate from information posted on several Internet sites.

The proposed Codex Guidelines for Vitamin and Mineral Food Supplements will NOT apply in Australia and will have NO IMPACT on the way these types of products are regulated in Australia.

In Australia, vitamin and mineral supplements are regulated as complementary medicines. As such, they are required to meet the same standards of quality and safety as other types of complementary medicines under Therapeutic Goods Act 1989. The TGA is responsible for the regulation of these medicines in Australia. In some other countries, these products are regulated as foods and are subject to the standards and guidelines that apply to food.

What is the Codex Alimentarius Commission?

The Codex Alimentarius Commission 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 are developed by committees of the Commission, which are open to all member countries, including Australia. The Codex Committee on Nutrition and Foods for Special Dietary Uses has developed draft Guidelines for Vitamin and Mineral Food Supplements.

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

The regulation of vitamin and mineral supplements in Australia

The Australian Government acknowledges and supports the right of consumers to be able to make informed choices on matters related to health, and to expect that medicines available in Australia, including vitamin and mineral supplements, will be safe and of high quality.

Australia has a risk-based system where the level of evaluation and regulatory control of a medicine is based on the relative risk of the product and the seriousness of the condition for which it is intended to be used. All therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in, or exported from, Australia, and must be manufactured in accordance with the principles of Good Manufacturing Practice, which ensures they are of acceptable quality.

Most complementary medicines, including most vitamin and mineral supplements are considered to be low risk medicines, as they may only contain substances that have been approved by the TGA as being of low risk. While low risk medicines must meet certain requirements related to quality and safety, they are not individually evaluated by the TGA for effectiveness. Low risk complementary medicines are generally restricted from making claims referring to serious diseases or conditions, or claims relating to the treatment, management, cure or prevention of any condition or disease. However, sponsors of such medicines are required to hold evidence to support claims made for their products and to make such evidence available to the TGA upon request.

The current Australian regulatory framework for complementary medicines under Therapeutic Goods Act 1989 is not subject to the standards and guidelines of the Codex Alimentarius Commission. It is administered by the TGA and provides Australians with timely access to complementary medicines that are safe and of high quality.

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