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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)

Guidance for advertisers

13 November 2019

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Advertising interface products

This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015 but incorporates amendments to the Therapeutic Goods Act 1989 (the Act) that came into effect on 6 March 2018, and has been further updated to provide specific information on advertising biologicals and to also include more background information on advertising requirements.

The Therapeutic Goods Advertising Code (No.2) 2018 was made on 31 October 2018 to replace the 2018 Code which will come into effect on 1 January 2019. A summary of the changes is available. To assist advertisers with implementation, we have also published guidance material; Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.

We recognise that there can be a regulatory 'interface', or potential overlap, between certain foods, medicines, devices, cosmetics and consumer goods. Products at this interface may seem very similar, but can be regulated differently.

We describe examples of three such interfaces below:

  1. Food medicine interface
  2. Cosmetic medicine interface
  3. Consumer goods medicine interface

Food medicine interface

Sometimes it isn't clear whether a product for oral consumption is a therapeutic good or a food. The potential overlap between certain foods and medicines is referred to as the food-medicine interface.

Generally, if your product is covered by a food standard, or is traditionally used as a food in the form that it is presented, it is regulated as a food. If your product is not a food, it is likely to be considered a therapeutic good.

TGA has developed a Food-Medicine Interface Guidance Tool (FMIGT) in consultation with Food Standards Australia and New Zealand (FSANZ) and Australian state and territory agencies. This tool helps you determine how your product is regulated. Use this guidance and the FMIGT to determine whether your product is a food or a therapeutic good.

Making therapeutic claims, statements or indications for a product that you intend to market as a food, might lead a consumer to think the product is for therapeutic use. This could result in your product being regulated as a therapeutic good.

Probiotics and advertising

A probiotic is a product containing live bacteria that is taken orally to restore the body's beneficial bacteria. Probiotics are presented as ready-to-eat yoghurt or milk products, in powders for mixing in food and drink, or in gelatine capsules. Probiotics are often positioned at the food-medicine interface.

Probiotics that are regulated as foods

Probiotic products that are clearly covered by a food standard, or that are traditionally used as foods in Australia or New Zealand in the form they are presented in, are regulated as foods.

For example, yoghurt and yoghurt drinks are covered by Food Standard 2.5.3 for fermented milk products. Accompanying general level health claims for such products would be limited to lactose digestion covered by the nutrition, health and related claims set out in Food Standard 1.2.7. High level health claims need to be separately approved by FSANZ.

A probiotic that is not covered by a food standard or that is not traditionally used as a food in Australia or New Zealand, however, is not automatically considered a therapeutic good.

Probiotics that are regulated as therapeutic goods

If the product is accompanied by a therapeutic claim, statement or instructions for use, it may meet the definition of a therapeutic good because:

  • by making such claims, you are representing it as a therapeutic good
  • it is perceived by a consumer to be for therapeutic use, even if you intend to market the product as food.

For example, a sachet of probiotic powder might be marketed as a food but other factors such as claims about its health benefits, warning statements or a dosage regime may lead consumers to believe it is a therapeutic good.

If you decide to market your product as a therapeutic good, it will be regulated as one. If the product is manufactured overseas, we must approve your products manufacturing before it can be imported and released for supply in Australia.

These kinds of products are often regulated as complementary medicines and listed on the ARTG. If you have suitable supporting evidence, listed therapeutic goods can make low-level therapeutic claims on the product label and in your advertising, in line with the Code.

If you would like your probiotic product to be regulated as a food rather than a therapeutic good, consider how you market and present it to consumers.

Further information

Contact a regulatory affairs consultant or your state or territory food authority for further information, or see the following useful links:

Cosmetic medicine interface

Most cosmetic products are generally not considered therapeutic goods, as they tend not to be for a therapeutic use and we do not regulate them. However, a cosmetic may be a therapeutic good, depending on its ingredients, route of administration and if therapeutic claims are made on the product label or in advertising. Products for topical use (including for use on teeth or the oral mucosa) may be regulated as a cosmetic or a therapeutic good depending on the type of product and the claims made. Generally, a product for topical use that is covered by the Excluded Goods Order will be regulated as a cosmetic. Products not covered by the order may still be regulated as cosmetics, provided that you do not make therapeutic claims.

  • 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 that are covered by the Cosmetics Standard 2007 made under the Industrial Chemicals (Notification and Assessment) Act 1989 not to be therapeutic goods.

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates cosmetic products under the Industrial Chemicals (Notification and Assessment) Act. That Act underpins the Cosmetics Standard 2007 and this Standard is supported by the NICNAS Cosmetic Guidelines 2007. Further information on the regulation of cosmetics is available from NICNAS.

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

Consumer goods medicine interface

We are currently developing this guidance.

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