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The information below describes:
In Australia, some sport supplements are declared by law to be therapeutic goods (medicines) to ensure they meet strict quality and safety standards. They are then regulated under the Therapeutic Goods Act 1989 (the Act) by us, at the Therapeutic Goods Administration (TGA).
In simple terms, a product is considered a therapeutic good under the Act if it is legally declared to be one or represented as being for therapeutic use. A product has a therapeutic use if (among other things) it influences, inhibits or modifies a physiological process in the body.
Although there are exemptions in the Act for goods with a tradition of use as foods or with applicable food standards, a declaration that a good is a therapeutic good overrules these exemptions.
The Australian sponsor is responsible for entering therapeutic goods in the Australian Register of Therapeutic Goods (ARTG) before they are imported, manufactured, supplied or advertised in Australia.
We routinely review sport supplement product advertising. We also undertake laboratory testing of products sampled from the Australian market. This helps to determine if they contain ingredients that they shouldn’t such as ingredients scheduled in the Poisons Standard or the World Anti-Doping Agency (WADA) list of prohibited ingredients.
When contraventions of the Act are identified, we will resolve non-compliance using regulatory tools and strategies commensurate to the level of offence.
Sport supplements may fit into one of two possible regulatory schemes: foods or therapeutic goods. Under the law, a product can either be a food or a therapeutic good, but not both.
If a product has an applicable food standard and is captured by the Therapeutic Goods (Declared Goods) Order 2019, the Declared Goods Order overrules the food standard exemption and the product is legally considered a therapeutic good.
Where a product does not meet the definition of being a therapeutic good but does meet the criteria to be a food then that sport supplement will be regulated under the relevant food standard.
Products that are generally considered foods:
A product that makes therapeutic claims is not automatically considered a therapeutic good without considering other factors.
It is important to note that a product for which there is an applicable food standard (unless captured by the Declared Goods Order) cannot be a therapeutic good under the Act and will therefore be regulated as a food, regardless of whether it is compliant with the food standard.
For example, a product that comes under a food standard (and is not captured by the Declared Goods Order) and makes therapeutic claims, may be considered a non-compliant food and subject to appropriate action by the relevant state or territory food regulator.
Sports supplements can be regulated as therapeutic goods for two general reasons, because they are declared to be a therapeutic good or because they are presented for therapeutic use and not excluded as a food.
To provide greater clarity on the regulatory status of particular sport supplement products, the Declared Goods Order was amended making sport supplements that fit certain criteria therapeutic goods and not foods.
Sport supplements for oral consumption are declared to be therapeutic goods if they make a therapeutic claim related to maintaining or improving performance in sports, exercise, or recreational activity and if it satisfies one of the following:
Therapeutic goods must be entered in the ARTG before they can be imported, advertised, or supplied in Australia.
Applying to enter your product in the ARTG does not mean it will be approved for distribution and sale in Australia. It may be subjected to an assessment by us before it can be entered in the ARTG, which can include the evidence that supports the claims you want to make.
You cannot advertise or supply the product in Australia until it is entered in the ARTG.
Your product is a therapeutic good if it contains ingredients that are (or a substance with an equivalent pharmacological action to the following substances/ingredients):
Substances included in the Poisons Standard and WADA Prohibited List may be known by other names. Substances assessed to be chemically equivalent to an ingredient included on one of these lists are also considered to fall within the definition of a therapeutic good. For more information see the: 'Using derivative or synonyms in ingredient lists' section of this guidance.
Therapeutic goods make claims for, or are likely to be taken for, therapeutic use, which can include:
Therapeutic claims (i.e., the therapeutic use) for sport supplement products may include a description such as, how it will help, support or improve:
Substances included in the Poisons Standard and WADA Prohibited List may be known by other names. Substances assessed to be chemically equivalent to an ingredient included on one of these lists are also considered to fall within the definition of a therapeutic good.
While some manufacturers use botanical names or synonyms on their labels, if an ingredient is listed in, or is chemically equivalent to or a derivative of, an item in a Schedule to the Poisons Standard then the product must be entered on the ARTG.
Examples of botanical names for prescription only ingredients include:
Disclaimers or statements such as ‘not a therapeutic good’
A disclaimer or caveat (e.g. on the product’s label), such as ‘not a therapeutic good’, does not change the nature of the product. Every sport supplement will need to be included in the ARTG when they meet the criteria in the Declared Goods Order, as outlined in the 'Sport Supplements that are therapeutic goods' section of this guidance.
If a sport supplement product you are importing, supplying or advertising is a therapeutic good you will need to do one or more of the following to ensure you comply with the Act:
We have developed the Is my product a therapeutic good? tool, which can be used to work out whether or not particular products are likely to be therapeutic goods or not.
If you are still unsure, you may wish to engage the services of a regulatory affairs consultant to assist you.
If you are the sponsor of a sport supplement product, there are many benefits of entering your therapeutic sport supplement product in the ARTG:
To begin the process of including your product on the ARTG visit TGA Business services: getting started with the TGA.
It is important to note that including your medicine in the ARTG, does mean that your product has been ‘TGA approved’ or ‘certified’ and the medicine cannot be advertised to say that. For more information see The claim 'TGA approved' must not be used in advertising.
It is common for sport supplements to be imported from international markets to the domestic Australian market.
Where you have a product that is a therapeutic good, it is important to know that it is the responsibility of the Australian sponsor to ensure that the label complies with the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).
The information that is generally included in a ‘nutritional panel’ is usually insufficient to comply with TGO 92.
The label must declare all active ingredients (and certain excipient ingredients) included in the product. If any ingredient is removed from the imported product, this change must be uniformly applied to the labelling. There should be no mention of the removed ingredient on any part of the label.
We undertake regular checks on sport supplements and their ingredients. If ingredients found differ to those mentioned on the label, you may be subjected to large fines and/or criminal prosecution.
For breaches of the TGA laws, the consequences include heavy fines, civil or criminal court action and jail time.
For more information see the Compliance and enforcement hub.
Title changed from 'Regulation of sport supplements in Australia: information for importers and sellers' to 'Importing or supplying sport supplements' as part of migration to new 'Guidance' content type:
Title changed from 'Regulation of sport supplements in Australia: information for importers and sellers' to 'Importing or supplying sport supplements' as part of migration to new 'Guidance' content type:
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