Clarifying the regulation of dietary supplements in Australia

Overview

Clarifying the regulation of dietary supplements in Australia

Medicines that are considered lower risk (due to containing low risk ingredients and making low level health claims) can be entered as ‘listed’ medicines on the Australian Register of Therapeutic Goods (ARTG) and are suitable for self-selection by consumers without a prescription or a pharmacist’s advice e.g. most vitamin and mineral supplements. 

Under the Therapeutic Goods Act 1989 (the Act), Sponsors are required to ensure that all therapeutic goods intended for inclusion in the ARTG comply with applicable standards. Ensuring product quality and labelling meet established standards supports the safety and efficacy of medicines supplied to the Australian public.

This consultation seeks feedback on issues relating to the application of certain United States Pharmacopeia-National Formulary (USP-NF) requirements for listed medicines and on options to provide greater regulatory clarity.

The issues under consideration and the proposed options are detailed in the Consultation document.

To respond to this consultation please click the 'Online survey' link below.

Responses can be entered directly into the text boxes provided, or submitted as a single PDF or Word document upload. 

Privacy and your personal information

The TGA collects your personal information in this submission in order to:

1. Clarify any issues raised in your submission or to confirm whether you consent to certain information being made publicly available.
2. Help provide context about your submission. For example, whether you are responding as an individual, a director of a company or representing an interest group.

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 identified individual, or an individual who is reasonably identifiable, from the information or opinion. The TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

Online publication of submissions

The TGA may disclose your full name, work title, company/organisation and submission on the Internet (i.e. make this information publicly available) with your consent.

You may specify whether there is anything in your submission which you would prefer to not be published online (e.g. names, email addresses, proprietary information) by:

1. Providing an additional, redacted copy of your submission; or
2. Providing details of content not to be published e.g. “Do not publish pages 3-5”, “Please redact contact details”; or
3. Identifying any text within your submission to remain confidential by having it clearly marked 'IN CONFIDENCE' and highlighted in grey.

Why your views matter

The TGA is requesting feedback to help ensure that the proposed changes are appropriate and support the safety and quality of listed medicines.