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Submissions received and Government response: Proposed clarification that certain sports supplements are therapeutic goods

24 September 2020

A consultation paper on a proposed clarification that certain sports supplements are therapeutic goods was released on 22 October 2019 for public comment until 3 December 2019.

This consultation was initiated in response to concerns of the Australian Government relating to the safety risks of some sports supplements that are readily available for sale as foods in Australia. There have been serious adverse events reported both domestically and internationally associated with the use of certain sports supplements, including deaths and liver transplants. These events are tragic for the individuals and have a significant impact on society as a whole, affecting the individuals' families, friends and communities, as well as posing a significant cost to the Australian healthcare system. In addition, these events generally occur in otherwise healthy younger people for whom there is usually no medical reason to take the product that poses a risk of such harm.

The consultation paper outlined the regulatory complexities between foods and therapeutic goods and raised the growing concerns related to issues of consumer safety and jurisdictional responsibility associated with sports supplements. The consultation paper included a draft proposed declaration under the authority of subsection 7(1) of the Therapeutic Goods Act 1989 (TG Act) that certain sports supplements are therapeutic goods.

Submissions received

The TGA thanks stakeholders for their significant engagement and the valuable feedback provided to this consultation. We received approximately 19,500 responses, including:

Written submissions

Of the 44 written submissions, 31 respondents agreed to all or part of their submission being published, 5 requested that their name but not their submissions be published and 8 requested that no information relating to their submission be published. These are provided according to publication preference below.

A B C D E G H M N P R S V

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A

B

  • Bulk Nutrients - publish name only

C

D

E

G

H

M

N

  • Nutrition Warehouse - publish name only

P

R

S

V

Industry campaign

Online survey

  • 5,364 responses were received to an online survey on the proposal. Of those that provided a response to the demographics questions, 89.5% were from respondents who self-identified as consumers and the remaining were stated to be from health professionals (3.4%) and small business owners (2.4%). Of the responses received:
    • 1,608 gave permission to publish some or all of the respondent's details and responses.
    • 21 gave permission to publish the respondent's name and organisation only.

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Spreadsheet containing the responses to the online survey (xlsx,586kb)*

Overview of stakeholder submissions

Healthcare professionals, government bodies including regulators, athletes and sports associations strongly favoured the proposed clarification while many in the sports supplement industry and consumers opposed it.

Several submissions from consumers, industry, healthcare professionals and consumer representative groups called for a broader set of criteria for the proposal that would affect a greater number of products (such as extending the dosage form criteria to include gels and wafers) and stronger enforcement actions that would impose a greater regulatory burden than what was presented in the initial consultation proposal.

The 'Save Aussie Supplements' campaign claimed that the proposal would lead to the withdrawal from sale of a large number of products ("70 000") from the Australian market with the potential loss of tens of thousands of jobs across the country. However, these claims were based on stakeholder misunderstanding that the scope of affected products was broader than intended. Many believed that the proposal would affect all sports supplements (including protein powders and meal replacement shakes); that the proposal would not be subject to any further review or consultation; and that it would be implemented the day after the consultation closed (3 December 2019), resulting in stores being raided and products being physically removed from shelves. None of these scenarios were intended or envisaged by the proposed clarification.

Industry expressed alarm that sports supplements containing naturally-occurring food-appropriate substances could be declared to be therapeutic goods due to the following criteria included in the initial proposal:

  • amino acids and other nutritive substances in excess of the limits allowable for Formulated Supplementary Sports Foods according to Schedule 29-18 and 29-19 of the Food Standards Code.
  • ingredients exceeding the limits specified in the Permissible Ingredients Determination.
  • naturally occurring food substances banned by the World Anti-Doping Code.

Some consumers favoured stronger regulatory control for these products, however many consumers who regularly use sports supplements were opposed to the proposal. As explained above, much of this opposition stemmed from concerns that commonly used food products (such as protein powders and bars) would be affected by the proposal and that changes would be implemented immediately when the consultation closed. Other common concerns were the potential for increased cost of products, less product choice and economic impacts.

Almost no opposition was received to the aspects of the proposal relating to substances include in a schedule to the Poisons Standard, with many respondents believing products containing scheduled ingredients were already considered to be therapeutic goods.

TGA response to stakeholder submissions

To address the initial industry concerns in relation to the proposal, the TGA published Frequently asked questions: sports supplements proposal and consultation on 2 March 2020.

The insights gained from stakeholder consultation submissions led to a refinement of the initial proposal by the TGA to clarify the intended scope of the proposal in order to avoid unintentionally declaring legitimate food products to be therapeutic goods. Further targeted stakeholder consultation (in the form of two workshops) was then conducted on the refined proposal with retailers, manufacturers, consumer representative bodies, sporting associations, regulatory consultants and government bodies. The refined proposal was generally positively received by workshop participants and considered to have improved the clarity of the intent and scope of the initial proposal. The refined proposal was then published on the TGA website on 17 March 2020: Update on proposed clarification that certain sports supplements are therapeutic goods.

The TGA produced a Regulation Impact Statement (RIS) to assist the decision making on this matter. The options proposed in the RIS included taking no action (status quo) and three separate proposals to declare (under the authority of section 7 of the TG Act) that certain sports supplements are therapeutic goods, based on the ingredients they contain and/or their presentation in medicinal form.

Declaration

Following consideration by Government of the safety concerns relating to the use of sports supplements, consultation stakeholder submissions and the Regulation Impact Statement, a declaration has been made under section 7 of the Therapeutic Goods Act 1989 and will come into effect on 30 November 2020:

By way of a section 7 declaration under the Therapeutic Goods Act 1989, the following goods will be declared to be 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:

  1. contain, or are represented (expressly or by implication) to contain, one or more of the following substances (however described or named):
    1. a substance included in a schedule to the current Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard); or
    2. a substance expressly identified on the World Anti-doping Code Prohibited List that is added as an ingredient to the goods; or
    3. a relevant substance (that has been specified by the Secretary of the Department of Health) that is added as an ingredient to the goods; or
    4. 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
  2. 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:

  1. for therapeutic use; or
  2. 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:

  1. gaining muscle;
  2. increasing mental focus;
  3. increasing metabolism;
  4. increasing stamina;
  5. increasing testosterone levels, reducing oestrogen levels or otherwise modifying hormone levels;
  6. losing weight or fat;
  7. preparing for workout;
  8. recovering from workout

Further information on the regulatory decision, the timelines for implementation, fact sheets for consumers and industry are available at: Changes to the regulation of sports supplements in Australia.