Understanding complementary medicine interface issues

The 'Australian medical devices guidelines: 35. Device-medicine boundary products' assists sponsors in determining the status of therapeutic goods that are not readily identified as medicines or devices, for example: a medicine impregnated dressing or barrier protectants.

Most cosmetic products are generally not considered therapeutic goods, as they tend not to be for a therapeutic use. Such goods are not regulated by the TGA. However, a cosmetic may be a therapeutic good (medicine), depending on its ingredients, route of administration and if therapeutic claims are made on the product label or in advertising. In addition:

• Order that Goods are Therapeutic Goods No 2 of 1999 made under section 7 of the Act (see below) declares that products labelled or promoted for cosmetic purposes when promoted for oral consumption are, for the purposes of the Act, therapeutic goods
• Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 made under section 7 of the Act (see below) declares a number of products at the cosmetic/medicine interface not to be therapeutic goods.

The Australian Industrial Chemicals Introduction Scheme (AICIS) regulates cosmetic products under the Industrial Chemicals (Notification and Assessment) Act. Further information on the regulation of cosmetics is available from NICNAS.

Claims on cosmetic labels are regulated by the Australian Competition and Consumer Commission.

While products that are classed as therapeutic goods (including medicines) are regulated by the TGA at the federal level, foods (including many that make health claims) are predominantly regulated by state and territory food regulatory bodies. Food Standards Australia New Zealand (FSANZ) is the Commonwealth statutory authority responsible for developing food standards which make up the Australia New Zealand Food Standards Code (the Food Standards Code).

The Food Standards Code is enforced by the states and territories which regulate the sale and supply of food within their respective jurisdictions. The importation of food is regulated by the Commonwealth Department of Agriculture under the Imported Food Control Act 1992.

Our food-medicine interface guidance tool can be used to work out whether particular products are likely to be therapeutic goods or not. It is designed to take the user though the relevant definitions in the Act.

Further information can be found on the TGA website at Food and medicine regulation.

Section 7 of the Act enables the Secretary of the Department of Health (through the TGA) to declare that particular goods or classes of goods are therapeutic goods where satisfied they are therapeutic goods. The Secretary can also declare that particular goods or classes of goods are not therapeutic goods where satisfied they are not therapeutic goods.

When making a declaration that particular goods or classes of goods are therapeutic goods, the Secretary can disregard the fact that the goods are:

• goods for which there is a standard under the Food Standards Australia New Zealand Act 1991; or
• goods which, in Australia or New Zealand have a tradition of use as foods for humans in the form in which they are presented.

The following orders have been made under section 7 of the Act:

• Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 declares certain goods not to be therapeutic goods.
• Orders that Goods are Therapeutic Goods, including Order that Goods are Therapeutic Goods No. 1 of 2009 and Order that Goods are Therapeutic Goods Nos. 1, 2, 3 and 4 of 1999 and Order that Goods are Therapeutic Goods No. 1 of 1998, which declare that particular goods are therapeutic goods.

The Minister for Health is able, by making a determination under section 7AA of the Act, to exclude goods from regulation under the Act. The Minister, before making a determination will consider the following matters:

• whether it is likely that the goods might harm the health of members of the public if they were not regulated under the Act 
• whether it is appropriate in all circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by the Act to regulate the goods
• whether any risks to which the public might be exposed from the goods could be more appropriately managed under another regulatory scheme.

Any determination by the Minister excluding goods will be preceded by consultation with affected industry and other stakeholders and will be disallowable by the Parliament.

The Secretary of the Australian Government Department of Health (through the TGA) can, under section 9F of the Act, remove a product from the ARTG if satisfied that the goods are not 'therapeutic goods' as defined in the Act. 

The sponsor of the product will be notified of the proposed action and any submissions made by the sponsor will be considered before the product is removed from the ARTG. Particulars of a decision to remove a product from the ARTG will be published on our website. Refer to Food and Medicine Regulation on our website for more information.

A decision to remove the goods from the ARTG is an initial decision within the meaning of section 60 of the Act and sponsors may seek reconsideration by the Minister.