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Consultation: Proposed clarification that certain sports supplements are therapeutic goods
This consultation closed on 3 December 2019.
Invitation to comment
The TGA sought 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.
For more detail, please refer to the consultation paper and item 1 of Schedule 2 of the proposed order at Attachment A.
- Consultation: Proposed clarification that certain sports supplements are therapeutic goods (pdf,547kb)
- Consultation: Proposed clarification that certain sports supplements are therapeutic goods (docx,450kb)
- Consultation: Attachment A: DRAFT Therapeutic Goods (Declared Goods) Order 2020 (pdf,106kb)
- Consultation: Attachment A: DRAFT Therapeutic Goods (Declared Goods) Order 2020 (docx,92kb)
Document released for consultation on Tuesday, 22 October 2019.
Interested parties to respond by close of business Tuesday, 3 December 2019.
Feedback will be released following consideration of submissions. (See 'What will happen').
About the consultation
The TGA sought comments from interested parties on a proposed approach to resolve some of the uncertainty around the regulatory status of sports supplements, to ensure they are regulated appropriately to safeguard public health and safety.
Submissions received in response to this consultation will inform the delegate's considerations as to whether or not the proposed order should be made.
Any decision as to the making of the proposed declaration remains under consideration pending this consultation process and associated deliberations.
In Australia, food and medicines are regulated under separate legislated frameworks commensurate with their intended use and the potential risks they pose to public health and safety. Whether a product for oral consumption is a food or a medicine in law can depend on its specific combination of ingredients, claims and overall presentation.
Sports supplements often carry explicit or implied claims relating to sport, fitness or recreational performance that mean they are likely to be consumed for therapeutic use, yet some of them may be considered to be food under law. Yet it is appropriate that those sports supplements that are taken to be for therapeutic use are subject to the same national system of controls that are established for other therapeutic goods.
Content of submissions
The TGA invited comments from interested parties. Comments could address any or all of the issues discussed in the consultation paper.
In addition, submissions can:
- include relevant evidence, and/or examples, to support the views expressed
- include any other relevant information, e.g. scientific and technical, economic, international obligations, business and consumer information
- identify and discuss any perceived omissions or alternative approaches, in addition to those included in the consultation paper
- identify what you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.
Any questions relating to submissions should be directed to the Complementary and OTC Medicines Branch, by email to TGA.firstname.lastname@example.org or by telephone to 02 6289 4627.
What will happen
All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and a summary of the submissions will be posted on this website.
A decision about making the order will be taken after submissions have been considered.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.