Navigating the fine line between foods and medicines

The concept of food as medicine is deeply rooted in historical and cultural practices. Food and medicine have long been interwoven, but in a world of legal, commercial and social responsibility, it is crucial to delineate the two. [1]

The food-medicine interface is the boundary at which foods and medicines (therapeutic goods) meet, and potentially overlap. [2] In some cases, a product could sit in either regulatory category, so it’s essential that you know the implications (and opportunities) of choosing one category over the other for marketing success, and to avoid the wrath of regulators.

At face value, the differences may be difficult to identify. Both are consumed orally and may contain similar types of ingredients, which may ultimately be recommended for a health benefit. [2] Products are often packaged in a similar way and may even be purchased through the same outlets, or recommended by a health practitioner.

However, foods and medicines, fall into two very distinct categories and are regulated by different authorities, thus compliance requirements differ.  Food Standards Australia New Zealand (FSANZ) is a statutory authority in the Australian Government Health portfolio and as the name suggests, this group develops food standards for both Australia and New Zealand. These standards combined together make up the Food Standards Code (Code) and defines the use of ingredients, processing aids, colourings, additives, vitamins and minerals [3]. Compliance with the Code is monitored by the states and territories in Australia and the Ministry for Primary Industries and public health units in New Zealand. [4] In 2015, Standard 1.2.7 (Nutrition, health and related claims) was published by FSANZ and facilitates the use of specific (pre-determined) health claims as well as self-notified and substantiated health claims. Prior to this, the use of health claims for foods was not permitted under the Code.

The Therapeutic Goods Association (TGA) is also a part of the Australian Government Department of Health, who have a broad portfolio which encompasses complementary / listed medicines. These medicines can contain low risk ingredients including vitamins, minerals and plant materials and can make low level indications (health claims). A sponsor can list a product on the Australian Register Therapeutic Goods (ARTG) providing that the medicine meets all legislative requirements surrounding safety, quality and efficacy. Once in market, the TGA can perform a compliance review on any medicine (or product that looks like a medicine) being sold in Australia. [5]

In recognition of this overlap, the TGA has developed a tool which can assist in determining if your product is a therapeutic good. [6] The TGA explain that to use this tool you first must be familiar with the basics of food and medicine regulation. [6]

So, if you require assistance in navigating this landscape and determining if your product is a food or medicine, and to discuss the opportunities of one regulatory category over the other for your product, please get in touch.

[1] Hettiarachchi CA, Wijesinghe SS (2021). Food-Medicine Interface and its Application in International Level, Comparative Jurisdictions and Sri Lankan Legal Context. World Nutrition;12(1):103-111

[2] Australian Government Department of Health and Aged Care: Therapeutic Goods Administration (2020). Let medicine by thy medicine, and food thy food. Accessed 25/10/22 https://www.tga.gov.au/news/blog/let-medicine-be-thy-medicine-and-food-thy-food

[3] FSANZ (2020) About FSANZ. Accessed 06/09/22 https://www.foodstandards.gov.au/about/Pages/default.aspx

[4] FSANZ (2021) Food enforcement contact. Accessed 06/09/22 https://www.foodstandards.gov.au/about/foodenforcementcontacts/Pages/default.aspx

[5] Australian Government Department of Health and Aged Care: Therapeutic Goods Administration. Listed Medicines. Accessed 06/09/22 https://www.tga.gov.au/products/medicines/non-prescription-medicines/listed-medicines

[6] Australian Government Department of Health and Aged Care: Therapeutic Goods Administration. Food-Medicine Interface Guidance Tool (FMIGT). Accessed 06/09/22 https://www.tga.gov.au/food-medicine-interface-guidance-tool-fmigt-0