10/22/2019 | News release | Distributed by Public on 10/21/2019 20:07
This consultation closes on 3 December 2019
Invitation to comment
The 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.
For more detail, please refer to the consultation paper and item 1 of Schedule 2 of the proposed order at Attachment A.
Document released for consultation on Tuesday 22 October 2019.
Interested parties should 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 is seeking 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 invites comments from interested parties. Comments can address any or all of the issues discussed in the consultation paper.
In addition, submissions can:
How to submit
It is preferred for submissions to be lodged using the online questionnaire form .
Alternatively, complete the Consultation submission form to upload your submission in either pdf or word format.
Hardcopy submissions with a printed cover sheet may be mailed to:
Sports Supplements Consultation
Complementary and OTC Medicines Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be directed to the Complementary and OTC Medicines Branch, by email to [email protected] 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.