Australia: Full Enforcement of the Medicinal Dosage Form for Sports Supplements

As regulated in Subsection 7 (1) of the Therapeutic Goods Act 1989 (the Act) released on 23 September 2020, all sports supplements that are supplied in the dosage form of tablet, capsule, or pill other than goods containing glucose only, that are used, advertised, or presented for therapeutic use with claims relating to performance in sport, exercise, or recreational activity, will be fully regulated as therapeutic goods starting from 30 November 2023.

The therapeutic use or likely to be taken for therapeutic use also includes:

• Gaining muscle

• Increasing metabolism

• Losing weight/fat

• Modifying hormone level

• Preparing for /recovering from the workout

The 3 years transition period ending intends that the sports supplements are required to be included in the Australian Register of Therapeutic Goods (ARTG), while if the goods maintained labelled as medicines, instead of foods, the goods must be included in the ARTG either as listed medicines or registered medicines.

The regulation also enforced the sports supplements that contain, or are represented to contain either of the following substances effectively from 30 November 2020:

• Substance included under the schedule to the current Poisons Standard

• Substance identified on the Prohibited List that is added as an ingredient to the supplements

• Relevant substance added as an ingredient

• Substance with equivalent pharmacological action to the substance mentioned above, including those characterized as an active principle, precursor, derivative, salt, ester, ether, or stereoisomer

Sports supplements with no therapeutic use claims, contain appropriate food ingredients, and are packed in the traditional food form are excluded from the regulation, for instance, protein powders, nutrition bars, and energy drinks.

Source: Therapeutic Goods Administration (TGA)

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