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Update on proposed clarification that certain sports supplements are therapeutic goods
A public consultation was held in late 2019 on a proposal to clarify that certain sports supplements are therapeutic goods. After consideration of stakeholder submissions and feedback from two stakeholder workshops in February 2020 (presentations from the workshops can be found at TGA presentations: Sports Supplements Consultation Stakeholder Workshops Sydney and Melbourne, 14 and 21 February 2020), the proposal has been refined to clarify the intent of the reform and avoid unintentionally capturing food products (such as whey protein, sugar substitutes and meal replacement shakes). It is proposed that the draft declaration would be amended to:
- remove the following criteria for products to be in scope of the declaration:
- containing substances in excess of the limits provided in Schedule 2918 and 29-19 of the Food Standards Code.
- containing ingredients exceeding the limits specified in the Permissible Ingredients Determination
- capture products that contain substances included in the World Anti-Doping Code Prohibited List (which lists the substances and classes of substances prohibited in sport, also referred to as the 'WADA Prohibited List'), the Poisons Standard, or the relevant substances list, only if the substances are added as ingredients to the formulation of the products (to avoid capturing products which contain these substances only because they are naturally present in other ingredients in the product).
What products would be captured by the refined proposal?
Therefore the refined proposal will capture products that are:
Products for oral administration that claim to improve or maintain physical or mental performance in sport, exercise or other recreational activity (e.g. gaming)
- contain ingredients that are not appropriate for food:
- a substance included in a schedule to the Poisons Standard
- a substance that is prohibited from sport under the World Anti-Doping Code
- a substance that the Secretary or their delegate includes in the list of relevant substances#
- are presented in a form associated with medicines rather than foods (i.e. a tablet, capsule or pill)
Please note that a decision has not yet been made on the proposal.
About the WADA Prohibited and relevant substances lists
The Australian Government is a State Party to the United Nations Educational, Scientific and Cultural Organization International Convention against Doping in Sport, which requires States Parties to adopt appropriate measures at the national and international levels that are consistent with the principles of the World Anti-Doping Code-this includes the Prohibited List. The proposed Declaration would adopt the Prohibited List at a point in time-any changes made by WADA to the Prohibited List after that point in time would require an update to be made to the Declaration in order to incorporate the revised list.
The relevant substance lists contains substances that the delegate of the Secretary of the Department of Health considers would, when added to sports supplements as an ingredient, mean they are taken for therapeutic use. For example, methyl liberine.
- A Regulatory Impact Statement, including a regulatory costing analysis is currently being prepared that will assist the government with its decision.
- Submissions to the public consultation, the RIS and the government's decision when it is made, including transition arrangements, will be published on the TGA website.
- It is anticipated that a decision will be made by government in April-May 2020.
For more information please contact Complementary Medicines via phone on 1800 020 653 or via email at TGA.firstname.lastname@example.org.