The way in which sports supplements are regulated in Australia is being reviewed, which could lead to significant changes to the way these products are formulated, positioned and marketed.
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on a proposal to declare that certain sports supplements, when used, advertised or presented for supply in a particular way, are therapeutic goods (medicines), by way of an order made under sub-section 7(1) of the Therapeutic Goods Act 1989. The declaration would be known as Therapeutic Goods (Declared Goods) Order 2020 (Order).
The consultation closes on 3 December 2019. The Consultation Paper is available here.
In summary, the proposed declaration will result in a sports supplement being treated as a therapeutic good if the sports supplement:
1. is represented (expressly or by implication) as being for the improvement or maintenance of physical or mental performance in sport, exercise or any other recreational activity; and
2. is either:
a) represented to contain one or more of the following:
- a substance which appears in a schedule to the current Poisons Standard;
- a substance expressly identified in the WADA prohibited list;
- a “relevant substance” (which is any substance not included in a schedule to the Poisons Standard or expressly identified in the WADA prohibited list and which is listed in the Order – none are currently listed in the draft Order);
- a substance with equivalent pharmacological action to a substance mentioned in any of the three dot points above (including those which may be characterised as an active principle, precursor, derivative, salt, ester or stereoisomer);
- an ingredient in an amount which exceeds the maximum permitted amount in the Permissible Ingredients Determination when used in accordance with the directions for use in relation to the product;
- an amino acid which exceeds any limit for the amino acid in Schedule 29-18 of the Food Standards Code when used in accordance with the directions for use in relation to the product;
- a substance which exceeds any limit for the substance specified in Schedule 29-19 of the Foods Standards Code when used in accordance with the directions for use in relation to the product; or
b) manufactured in the dosage form of a tablet, capsule or pill; and
3. is used, advertised or presented for therapeutic use (or in a way that is likely to be taken for therapeutic use) including, for example, for increasing mental focus, increasing metabolism, losing weight and preparing for or recovering from workouts.
By being treated as a therapeutic good, significant additional compliance requirements would need to be met. This would also affect the ability of companies importing sports supplements into Australia via New Zealand to continue to rely on the Trans-Tasman Mutual Recognition Act (TTMRA).
As stated above, the consultation closes on 3 December 2019.
We note that a review of Food Standard 2.9.4 – Formulated Supplementary Sports Foods is currently being conducted by Food Standards Australia New Zealand on the basis that it considers the Standard is old and out-of-date in the manner in which sports supplements are regulated. Stage 1 of this review will examine the Australia New Zealand regulatory regime for sports products, including the food medicine interface, which is also addressed by the TGA’s consultation.
We will be monitoring closely the progress of the consultation as will industry groups, such as Complementary Medicines Australia and Direct Selling Australia.
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