Food and medicine regulation

Manufacturers and importers of products need to know whether the products are regulated as therapeutic goods or as food because different regulatory requirements apply.

Consumers may also want to check if the products they are using are classified and regulated suitably.

Products that are classed as therapeutic goods (this includes medicines) are regulated by the TGA at a federal level while foods (including many that make health claims) are predominantly regulated by state and territory food regulatory bodies.

The issue of whether particular products are food or therapeutic goods has become more complex over recent years as health claims are made in relation to a wider range of products, including products that have traditionally been regarded as food. In 2013, a Food Standard (Standard 1.2.7) that sets out rules for the use of nutrition content and health claims on food labels and advertisements became law.

It's swallowed and makes health claims - so is it a medicine or food?

Generally a product that is swallowed will be either one form of therapeutic good (a medicine) or a food. Often, claims made about a product or the appearance of the product may suggest that it is a therapeutic good. However, the fact that health claims are made about a product does not automatically make it a therapeutic good. Nor does the fact that the product comes in capsules or powders, or is labelled as a 'dietary supplement'.

The potential regulatory overlap between certain foods and medicines is referred to as the 'food-medicine interface' and regulators, manufacturers and importers all need a way to work out whether theTherapeutic Goods Act 1989 or state or territory food legislation covers particular products.

How do I work out whether it is a medicine?

The 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 Therapeutic Goods Act.

When answered in the order in which they are posed, the series of questions reflects the process by which the TGA comes to a view about whether a product at the food-medicine interface is likely to be a therapeutic good and therefore regulated as a medicine by the TGA.

The Tool has been endorsed by the states and territories and is used when the TGA and state and territory food regulators need to work out whether or not the TGA is responsible for regulating a particular product, for instance a product that has been identified by Australian Customs and Border Protection Service (Customs) or is being advertised on the internet.

Similarly, manufacturers and importers would be able to use the Tool to assist in working out which regulatory regime would apply to their products.

The Guidance Tool is only for use in determining which regulatory regime applies to a product. It does not enable a determination to be made about whether the product would meet all the requirements of the relevant legislation. It is the responsibility of the manufacturer or importer to ensure that their products comply with all relevant requirements under the applicable regulatory scheme.

The Tool consists of seven questions based on the definitions of 'therapeutic goods' and 'therapeutic use' in the Therapeutic Goods Act. The purpose of the questions is to come to a view about whether the relevant product is a therapeutic good and therefore regulated under the Therapeutic Goods Act.

Every product has to be considered individually and on a case-by-case basis. Products that appear to be very similar may nevertheless have individual attributes which indicate one is a food and the other a therapeutic good.

What is the result of determining if it is a medicine or food?

If after applying the Tool a product is considered to be a therapeutic good, the TGA may take action against the importer, exporter, manufacturer or supplier if the product is not included in the Australian Register of Therapeutic Goods (ARTG) or is otherwise not exempt or approved under the Therapeutic Goods Act. If the product may be a health risk to the public (for example, it contains substances that are only available when prescribed by a health professional), the TGA can publish an alert to the public and if necessary, order a recall of the product.

If a product is not a therapeutic good and it is in the ARTG, the TGA can take action under section 9F of the Therapeutic Goods Act to remove the product.

If a product is considered by the TGA not to be a therapeutic good, it is likely to be the responsibility of state and territory food regulators. In such a case the TGA contacts relevant state or territory food regulators for appropriate action to be taken.

When does the TGA get involved?

The TGA will typically need to consider whether a product is a therapeutic good or a food when:

• a product is imported and Customs inquires whether it is a food or a therapeutic good
• the sponsor of a therapeutic good which is included on the ARTG complains to the TGA that a very similar product of a competitor is not in the ARTG
• the TGA undertakes a compliance review of a particular product that has been listed on the ARTG as a complementary medicine and finds that it is food, not a therapeutic good
• a product is supplied within Australia and a state or territory government agency asks for advice on whether it is a therapeutic good.

The TGA works with Food Standards Australia New Zealand (FSANZ), Customs , the Australian Government Department of Agriculture, the Australian Federal Police and relevant state and territory agencies as appropriate when it is necessary to decide whether products are regulated as food or as therapeutic goods.

Who regulates food?

Products for oral use that are not regulated under the Therapeutic Goods Act are likely to be regulated under food legislation. 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.

More information about the regulation of food can be found at the following locations:

• Food Standards Australia New Zealand (FSANZ)
• Department of Agriculture
• NSW Food Authority
• Victorian Department of Health
• Queensland Department of Health
• Western Australian Department of Health
• South Australian Department of Health
• Tasmanian Department of Health and Human Services
• Australian Capital Territory Health Directorate
• Northern Territory Department of Health

What happens when a product is removed from the Australian Register of Therapeutic Goods (ARTG)?

If the Secretary of the Australian Government Department of Health (through the TGA) comes to a view that a product that is on the ARTG is not in fact a therapeutic good the Secretary can remove the product from the ARTG under section 9F of the Therapeutic Goods Act. This could be for instance, because the product has a tradition of use as food for humans in Australia or New Zealand in the form in which it is presented. However, before that can be done, the sponsor must be notified and given the opportunity to make written submissions in response. The product cannot be removed without the Secretary taking into account any submissions made by the sponsor. The sponsor can then seek a review by the Minister for Health of the decision and then a review by the Administrative Appeals Tribunal.

In such a case, and wherever the TGA comes to the view that a product is food not a therapeutic good, relevant state and territory regulators are informed so appropriate action can be taken.

What happens to therapeutic goods that are not on the Australian Register of Therapeutic Goods (ARTG)?

If the TGA comes to a view that a product is a therapeutic good but is not on the ARTG, the TGA will normally first contact the supplier and provide information about relevant regulatory requirements. Listing on the ARTG may be required for a product to be lawfully imported or supplied. If it appears that the product represents a potential risk to public health, the TGA will normally publish an alert on the TGA website and consider other regulatory action.