Food or Medicine?
A guide to navigating the food-medicine interface in Australia.
The idea of "Food as Medicine" is gaining recognition in the Western world yet has been a cornerstone of health in many cultures worldwide for centuries. It is important to understand that while food and medicine are closely linked, they are two distinct entities. In Australia there is no separate regulatory category for a dietary supplement, it is either a food or a medicine. This distinction is critical for commercial and legal reasons. The point where food and medicine intersect is known as the food-medicine interface. Occasionally, a product may belong to either category, but it is crucial to choose the right classification to safeguard the interests of consumers, increase market success, and prevent ramifications with regulators. Although some foods have therapeutic properties, food and medicine are regulated by separate authorities.
Therapeutic Goods
The Therapeutic Goods Administration (TGA), which is Australia's national medicines regulator, regulates therapeutic goods at a federal level. According to the Therapeutic Goods Act of 1989 therapeutic goods are defined as products that are used for therapeutic purposes. Listed medicines, also known as complementary medicines, are non-prescription medicines that fall under this category. They may contain pre-approved low-risk ingredients such as minerals, vitamins, and botanicals, which have been pre-assessed by the TGA for safety and quality. Listed medicines may also carry pre-worded low-level health claims or indications. To sell or supply a medicine in Australia, it must be listed on the Australian Register of Therapeutic Goods (ARTG) and meet all safety, quality, and efficacy requirements. The TGA also conducts strict post-market surveillance of listed medicines or products advertised as medicines.
Foods
Food products are not required to be registered with Food Standards Australia New Zealand (FSANZ), which is an independent statutory agency established by the Food Standards Australia New Zealand Act 1991 (FSANZ Act). However, they must comply with regulatory requirements related to ingredients, labelling, and quality. Food standards are compiled in the Australia New Zealand Food Standards Code and enforced within Australia by the states and territories which regulate the sale and supply of food within their respective jurisdictions. In 2015, a Food Standard (Standard 1.2.7) was implemented to regulate the use of specific nutrition content and health claims on food labels and advertisements. This standard also allows self-notified and substantiated health claims. Consequently, the issue of whether a product is classified as a food or a therapeutic good has become more complex due to the allowance of health claims on a wider range of food products. Therefore, determining the appropriate regulatory pathway for a product may not always be straightforward.
How do I know where my product sits?
It is important to bear in mind that foods and medicines are fundamentally distinct from each other, and one should not be expected to do the job of the other. When trying to determine if a product is classified as food or medicine, there are various factors to take into account. While there are a few similarities between the two, such as both being consumed orally, there are also many differences. Generally, food is consumed for nutrition, while medicine is used to treat and prevent disease. Yet there can be ambiguity in determining whether a product is a food or a medicine. For example, blueberries are food, but a blueberry extract in a capsule may be classified as a medicine. However, the fact that the blueberry is in a capsule does not automatically make it a therapeutic good. To solve this issue, the TGA has developed a tool that can assist in determining if a product is a therapeutic good. However, before using this tool, it is important to have basic knowledge of food and medicine regulation.
Next Steps
If you're unsure whether your product falls under the food or medicine category, we can assist you with our expertise in both regulatory environments. Our team can help you navigate the food-medicine interface and guide you through the pros and cons of each regulatory category for your product. Feel free to contact us for further assistance.
References
1. Australian Government, Department of Health & Aged Care Therapeutic Goods Administration. [Internet]. ACT AU: TGA; 2014. Food and medicine regulation; [cited 2024 Mar 28]; Available from: https://www.tga.gov.au/news/news/food-and-medicine-regulation
2. Australian Government, Department of Health & Aged Care Therapeutic Goods Administration. [Internet]. ACT AU: TGA; 2020. Let medicine be thy medicine, and food thy food; [cited 2024 Mar 28]; Available from: https://www.tga.gov.au/news/blog/let-medicine-be-thy-medicine-and-food-thy-food
3. Australian Government, Department of Health & Aged Care Therapeutic Goods Administration. [Internet]. ACT AU: TGA; 2020. What are therapeutic goods?; [cited 2024 Mar 28]; Available from: https://www.tga.gov.au/about-tga/what-we-do/what-are-therapeutic-goods
4. Australian Government, Department of Health & Aged Care Therapeutic Goods Administration. [Internet]. ACT AU: TGA; 2024. Listed medicines; [cited 2024 Mar 28]; Available from: https://www.tga.gov.au/products/medicines/non-prescription-medicines/listed-medicines#:
5. Zealand, Food Standards Australia New. [Internet]. ACT AU: TGA; 2023. About us; 2023; [cited 2023 Mar 28]; Available from: https://www.foodstandards.gov.au/about-us