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On 23 September 2020 a declaration under subsection 7(1) of the Therapeutic Goods Act 1989 (the Act) was published clarifying that, from 30 November 2020, certain sports supplements are regulated as therapeutic goods (medicines).
Under the declaration, the following goods are therapeutic goods:
Goods for oral administration that are represented (expressly or by implication) as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity, and that:
- contain, or are represented (expressly or by implication) to contain, one or more of the following substances (however described or named):
- a substance included in a schedule to the current Poisons Standard; or
- a substance expressly identified on the Prohibited List that is added as an ingredient to the goods; or
- a relevant substance that is added as an ingredient to the goods; or
- a substance with equivalent pharmacological action to a substance mentioned in subparagraph (i), (ii) or (iii), including those that may be characterised as an active principle, precursor, derivative, salt, ester, ether or stereoisomer; or
- on or after 30 November 2023, are supplied in the dosage form of a tablet, capsule or pill other than those goods containing glucose only
when the goods are used, advertised, or presented for supply:
- for therapeutic use; or
- in a way that is likely to be taken to be for therapeutic use;
including, but not limited to, one or more of the following therapeutic uses:
- gaining muscle;
- increasing mental focus;
- increasing metabolism;
- increasing stamina;
- increasing testosterone levels, reducing oestrogen levels or otherwise modifying hormone levels;
- losing weight or fat;
- preparing for workout;
- recovering from workout
What happens to affected sports supplements?
When the declaration comes into effect (see When will the changes come into effect?), sports supplement products in scope of the declaration will not be able to be released for further supply by the person (a manufacturer, owner or supplier of the product) who is considered to be the sponsor of the product under the Act (see Role of the sponsor) until the product is compliant with the relevant legislative requirements. From the date of effect, anyone advertising the product must also comply with relevant legislative requirements relating to advertising (see Advertising hub).
After the date the declaration comes into effect, sports supplements in scope of the declaration intended to be marketed as foods will need to be changed to different product claims, ingredients, and/or dosage forms, as appropriate.
Alternatively, if the sports supplements are to be maintained on the market as medicines, the products will need to be entered in the Australian Register of Therapeutic Goods (ARTG) as a listed or registered medicine and the sponsor (the person who is legally responsible under the Act for the medicine in Australia) will need to ensure that their product meets the applicable legislative requirements for manufacturing, formulation, labelling, evidence and advertising.
Some manufacturers may make a business decision to withdraw their sports supplements from the market, rather than be regulated as therapeutic goods or reformulating to be regulated as a food.
What sports supplements are affected?
To be affected by the declaration, the sports supplements must first be making a claim related to maintaining or improving performance in sports, exercise or recreational activity. If a product is making the kinds of claims described in the declaration, it will only be declared to be a therapeutic good if it:
- Contains the following substances/ingredients:
- substances that are in a Schedule to the Poisons Standard, or
- substances that are prohibited from use in sports by the World Anti-Doping Authority ('the Prohibited List') and added to the product as an ingredient, or
- relevant substances that have been specified in the declaration as being inappropriate for inclusion in sport supplement foods because of the risk they pose to consumers, that are added to the product as an ingredient:
- dendrobium (Dendrobium nobile);
- methylliberine
- Is in the form of a tablet, capsule or pill
What sports supplements are not affected?
Only some sports supplements are affected by the declaration.
If a product does not make a therapeutic use claim (including sports-related claims), it will not be affected by the declaration e.g. artificial sweeteners, meal replacement shakes.
Sports supplements that only contain ingredients appropriate for food and are presented in a traditional food form will not be affected by the declaration, e.g. protein powders, nutrition bars and energy drinks. Note that sports supplements that do not fall within the declaration and that are marketed as foods and compliant with the relevant food standard(s) can still make sports related health claims as permitted by the standard(s) – see the FSANZ website for further information.
There are also many sports supplements that are currently listed or registered medicines on the Australian Register of Therapeutic Goods and for these products there will be no change as a result of the declaration.
Where can sports supplements that are medicines be purchased
The Poison Standard provides the rules that determine how different substances can be accessed or sold within Australia.
Medicines with lower risk ingredients (e.g. many vitamins, minerals, herbal preparations, probiotics) can be sold by general retail stores, health food shops, supplement stores, supermarkets or pharmacies.
If sports supplements contain ingredients 'scheduled' in the Poisons Standard (such as pharmacy- or prescription-only substances) they will, just like any other product that contains these substances, have restrictions on where they can be sold and be subject to the level of regulation applied to such medicines.
Why are the changes happening?
The changes have been implemented to address the safety risks of certain sports supplements that have been readily available for sale as foods in Australia. The declaration makes it clear in law which sports supplements are considered therapeutic goods in order to ensure that these sports supplements are being regulated according to the level of safety or risk they pose to consumers.
What consultation has occurred leading to the declaration?
Over 18 months a range of stakeholders were consulted in relation to the regulation of sports supplements. For more information refer to:
- Consultation: Proposed clarification that certain sports supplements are therapeutic goods
- Sports supplement consultation outcomes and government decision
- Regulation Impact Statement (RIS)
When will the changes take effect?
| Characteristic | Transition | Date of effect |
|---|---|---|
| Sports supplements that contain the substances/ingredients identified in the declaration | 10 weeks from making the declaration | 30 November 2020 |
| Sports supplements in the form of tablets, capsules or pills | Three-years | 30 November 2023 |