Understanding complementary medicine interface issues

Some products may have attributes of two or more therapeutic good categories (e.g. medicine, device, biological) with different intended actions or effects and the appropriate regulatory pathway is not immediately obvious. These are referred to as ‘boundary products'. 

Other products may contain more than one type of therapeutic good with more than one therapeutic action or effect and are referred to as ‘combination products’.

Understanding rules for boundary and combination products provides information to assist 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.

A product may be regulated as a cosmetic or a therapeutic good (medicine), depending on such things as the product’s ingredients, route of administration and the claims made on the product’s label or in advertising. 

In general, products that are for dermal application, make only cosmetic claims and do not contain an ingredient included in a schedule to the Australian Poisons Standard, are regulated as cosmetics:

• The Australian Industrial Chemicals Introduction Scheme (AICIS) regulates chemical ingredients used in cosmetic products under the Industrial Chemicals Act 2019. Further information on the regulation of cosmetics is available here.
• The Australian Competition and Consumer Commission regulates claims on cosmetic labels. 

A product for dermal application that makes therapeutic claims (such as preventing, diagnosing or treating a disease or symptoms, or influencing, inhibiting or modifying a physiological process in persons) would generally be regulated as a therapeutic good.

Where there is a lack of certainty if certain goods are therapeutic goods, there are provisions under the Therapeutic Goods Act 1989 (the Act) for the TGA to define legally that particular goods are/are not therapeutic goods. For example, under the Therapeutic Goods (Declared Goods) Order 2019, products labelled or promoted for cosmetic purposes when presented for oral consumption are, for the purposes of the Act, therapeutic goods.

For more information see: Legal clarifications of goods that are/are not therapeutic goods.

Further information can be found on our website at Determining if your product is a cosmetic or therapeutic good.

Products intended for oral consumption may be regulated as food or medicines under the law. This depends on factors such as their ingredients, how they are presented and the claims made about the product. In addition, there may be specific legislation declaring the goods to be or not to be therapeutic goods.

Products that are classed as therapeutic goods are regulated by the TGA at the federal level, while foods (including many that make health claims) are predominantly regulated by state and territory food regulatory bodies. Food Standards Australia New Zealand (FSANZ) 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 Department of Agriculture, Fisheries and Forestry (DAFF) under the Imported Food Control Act 1992.

Sometimes it can be hard to tell the difference between medicines and foods as health claims can be made for some foods. We use the definition of a therapeutic good in the Act to determine if a product is or is not a therapeutic good (medicine).

In general, a good is considered a therapeutic good if the good:  

• is represented to be for therapeutic use  
• does not have a food standard in the Australia New Zealand Food Standards Code  
• does not have a tradition of use as a food in Australia or New Zealand in the form it is presented  
• or has been determined or declared to be a therapeutic good under provisions in the Act

In general, a good is considered to not be a therapeutic good if: 

• there is a food standard in the Australia New Zealand Food Standards Code 
• it has a tradition of use as a food in Australia and New Zealand in the form it is presented
• or it has been determined or declared to not be a therapeutic good under provisions in the Act   

Further information can be found on our website at Know how food and medicine are regulated. Our Food-Medicine Interface Guidance Tool (FMIGT) can be used to work out the likely regulatory status of products on a case‑by‑case basis, taking into account factors such as presentation, claims, dosage form, composition and tradition of use as food in Australia or New Zealand.

Occasionally it is necessary for the TGA to define legally that particular goods are therapeutic goods and should therefore be regulated by the TGA under the Act.

Section 7 of the Act enables the TGA to declare that particular goods or classes of goods are, or are not, therapeutic goods . A determination can also be made under section 7AA of the Act to exclude goods from regulation under the Act. 

The following orders have been made under sections 7 and 7AA of the Act:

• Therapeutic Goods (Declared Goods) Order 2019 declares that particular goods are, or are not, therapeutic goods
• Therapeutic Goods (Excluded Goods) Determination 2018 excludes certain goods from being regulated as therapeutic goods.

Any determination or declaration by the TGA is preceded by consultation with affected industry and other stakeholders.

The TGA can 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 Know how food and medicine are regulated 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.