Is there such a thing as a “dietary supplement” in Australia?

In Australia there is no ‘Dietary Supplements’ category. Products marketed in other regions as ‘Dietary Supplements’ are regulated in Australia either as Foods (under Food Standards Australia New Zealand/ FSANZ) or Medicines (regulated by the Therapeutic Goods Administration/ TGA). Foods are further broken down into subcategories (i.e. Formulated Sports Foods, Meal Replacements etc) and similarly Medicines are broken down into subcategories (Listed, Listed Assessed or Registered Medicines). Most products that are classified as ‘Dietary Supplements’ internationally either sit in the Food category or Listed Medicine category in Australia. In our experience, the move from regions like the US to Australia isn’t always straightforward – the Australian regulatory environment is far stricter with many more nuances, so you may need to prepare yourself for changes such as label claims, ingredients and/or manufacturing site, and choose the right partner to support you through this process.

So, how will you know which category is right for your dietary supplement?

The first step we recommended before launching products into the Australian market from overseas is to determine the most appropriate regulatory classification for the product. This saves time and heartache in the long term, because you know before getting started which category is most suited to launch your products under, with the least amount of work, whilst protecting your existing product proposition and commercial attributes.

We’ve seen brands enter the Australian market to test the waters and find the product takes off (hooray!), however unfortunately quickly realise that their regulatory risk is untenable, so rather than being able to focus on growth, they are distracted by fixes to reduce their regulatory risk.

The regulatory category you choose for your product can depend on a number of factors, including:

• Where the product is made and what licensing the manufacturer holds
• Product claims and claim substantiation
• Ingredients and ingredient amounts
• Target audience for the product
• Product format (e.g. liquid, tablet, capsule etc)
• Product testing

In Australia, like other regions in the world, there is a grey area between Foods and Medicines, which means that sometimes it’s hard for you know exactly which category is right for your product. In our experience, it is important to choose the regulatory category which is going to work for you long-term, which is not always the same thing as the quickest path to launch.

We are happy to be able to offer a number of solutions to help take the complexity out of your Australian launch.