Regulation of sport supplements in Australia: information for importers and sellers

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 WADA’s 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. 

The information below describes:

• which sport supplements are therapeutic goods
• how and why sport supplements are regulated in Australia
• what you need to know to comply with therapeutic goods laws.

Sport supplements that are foods

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), 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:

• contain ingredients appropriate for foods
• are presented in traditional food forms
  • powders
    • branch chain amino acids
    • whey protein powders (as a single ingredient or with other food ingredients)
    • meal replacement shakes
    • artificial sweeteners.
  • beverages
    • energy drinks.
  • bars
    • nutrition bars
    • functional foods such as apple cider vinegar or chia seeds.

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.

Sport supplements that are therapeutic goods

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:

1. It contains (or is represented to contain) a restricted ingredient, see Sport supplement products containing restricted ingredients below.

Or

2. It is in the dosage form of a tablet, capsule, or pill (other than those containing glucose only) (from 30 November 2023).

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 if until it is entered in the ARTG.

Sport supplement products containing restricted ingredients

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):

• included in a Schedule in the Poisons Standard such as:
  • caffeine at a dosage of 600 mg or greater daily
  • any prescription-only ingredient such as Deanol (DMAE), Levodopa, Rauwolfia Serpentina, Rauwolfia Vomitoria, Tryptophan (100mg or greater daily), 5-HTP (5-hydroxy-tryptophan) (100mg or greater daily), Vincamine, Yohimbine, Noopept (Omberacetam), oxedrine (greater than 30mg daily)
• a ‘relevant substance’ as defined in the Declared Goods Order
  • dendrobium (Dendrobium nobile) and methylliberine (Dynamine), at the time of publication
• included on The WADA Prohibited List by the World Anti-Doping Agency.
  • substances on this list are prohibited because they have the potential to enhance performance, mask detection of prohibited substances, pose actual or potential risk to athletes, or are not approved for use in humans.

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: Using derivative or synonyms in ingredient lists.

Therapeutic claims made about sport supplement products

Therapeutic goods make claims for, or are likely to be taken for, therapeutic use, which can include:

• influencing, inhibiting or modifying a physiological process in the human body, or
• preventing, diagnosing, curing or alleviating a disease, ailment or defect.

Therapeutic claims (i.e., the therapeutic use) for sport supplement products may include a description such as, how it will help, support or improve:

• gaining muscle
• increasing mental focus
• increasing metabolism
• increasing stamina
• modifying hormone levels
  • increasing testosterone levels
  • reducing oestrogen levels
• injury repair
• losing weight or fat
• preparing for a workout
• recovering from a workout.

Using derivative or synonyms in ingredient lists

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:

• Levodopa: Mucuna Pruriens, Velvet bean, Cowhage
• Yohimbine: Yohimbine bark (extract), African Bark, Asipdosperma quebracho, Corynanthe johimbe, Pausinystalia johimbe, quebracho-blanco
• Rauwolfia Serpentiana: Rauwolscine, Indian snakeroot
• Oxedrine: synephrine
• Rauwolfia Vomitoria: Rauvolfia, Rauvolfia Senegambiae, Senegambiae DC extract.

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 Sport Supplements that are therapeutic goods.

How do I become compliant?

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:

1. If you are the sponsor, you must enter the product in the ARTG as a listed or registered medicine. For more information visit TGA Business services: getting started with the TGA, on our website
2. Stop your supply and advertising of unapproved therapeutic goods until such time as they are included in the ARTG
3. Remove therapeutic claims in advertising, until such time as they are included in the ARTG, and are permitted to be advertised under the advertising rules
4. Change the product formulation to remove Scheduled or Prohibited substances.

See our webpage Overview of the regulation of listed medicines and registered complementary medicines for information on listed and registered medicines.

Sport supplement decision tree

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.

What are the benefits of entering products in the ARTG?

If you are the sponsor of a sport supplement product, there are many benefits of entering your therapeutic sport supplement product in the ARTG:

• you will meet your obligations to comply with legislation
• you can avoid compliance or enforcement action being taken against you by the TGA
• you will build consumer confidence as your medicine will include an ARTG listing or registration number on the label and can be viewed on the publicly available 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.

What are the labelling requirements for therapeutic goods?

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.

Consequences of non-compliance

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.  

Further information

• Is my sport supplement a therapeutic good?
• Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023
• Therapeutic Goods (Declared Goods) Order 2019
• TGA Business services: getting started with the TGA
• The Prohibited List | World Anti-Doping Agency (wada-ama.org)
• Food Standard 2.9.4 (foodstandards.gov.au)
• Frequently asked questions: Sport supplements section 7 declaration
• Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines