Consumer gains – The regulation of sports supplement pills

Consumers of sports supplements stand to gain from increased oversight of sports supplements in medicinal dosage form through regulation of such supplements as therapeutic goods (ie medicines).

The sports supplement industry has been regulated for some time now. For instance, oral sports supplements that contain certain high-risk substances, and claim to improve or maintain performance in sport or exercise, have been regulated under the Therapeutic Goods Act 1989 (Cth) (the Act) as therapeutic goods since 23 September 2020.[1]

Sports supplements in tablet, capsule or pill form will be subject to regulation by the Therapeutic Goods Administration (TGA) from 30 November this year.[2] Any supplement in medicinal dosage form that makes claims relating to performance in sport or exercise will be regulated as a therapeutic good from that date. The sports supplement industry has been aware of this upcoming change since 2020.

If the sports supplement is to be maintained on the market as medicine, manufacturers must ensure the sports supplement:

• is included on the Australian Register of Therapeutic Goods (ARTG); and
• meets the manufacturing, formulation, labelling and evidence requirements under the Act.[3]

If manufacturers do not want the sports supplement to be classified as a therapeutic good, the claims, ingredients and/or dosage of the sports supplement must be changed in a way that allows it to remain on the market as a food.

We wish to highlight that only a subset of sports supplements will be regulated by the TGA from 30 November 2023. Protein powders, nutrition bars and sports drinks will not be affected, so long as they do not contain any high-risk substances.

For advice on whether your sports supplement will be regulated and, if so, how to register it on the ARTG, please contact our team.

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Authored by: 

Kelly Griffiths, Partner
Clare Smith, Associate

[1] Therapeutic Goods Act 1989 (Cth) s 7(1); Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020.

[2] Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020.

[3] Ibid.