Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2022-23

Closed 15 Sep 2022

Opened 4 Aug 2022

Contact

Complementary Medicines Evaluation Section

listed.medicines@health.gov.au

Feedback updated 1 Dec 2022

We asked

The TGA sought feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes were intended to address the following issues:

  1. Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus, and Larrea tridentata.
  2. Liver injury associated with Valeriana officinalis

You said

A total of 9 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.

The TGA received:

  • 3 responses to the proposed update to the warning statement for Chelidonium majus and Larrea tridentata.
  • 9 responses to the proposed liver injury warning statement for Valeriana officinalis.

The responses varied in stance and recommendations, however the majority of respondents from the complementary medicines industry did not support the proposals, with many suggesting rewording or clarification of the warning statement. Concerns were raised about the length and complexity of warning statements, the reference to general liver injury symptoms which can potentially cause confusion among consumers, the lack of clearly established causality between valerian use and liver injury, and lack of similar warning statements in international regulation.

We did

The feedback and recommendations provided by respondents were taken into consideration, and the proposed changes have been finalised. The final changes incorporate variation compared to the original proposals.

The final changes will commence on 1 March 2023. A 12 month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2024.

Results updated 1 Dec 2022

The TGA thanks all those who participated in this consultation.

Please see the Final Decisions Document for specific details of the finalised changes identified below, and the reasoning given for these final decisions which were made in consideration of the consultation responses received.

Overview of final decisions

The proposed warning statements for Chelidonium majus, Larrea tridentata, and Valeriana officinalis (valerian) have been altered following consultation feedback. The warning statements were revised to communicate the concern more concisely. The word ‘WARNING’ was also removed, and the word ‘rare’ added to communicate that the risk of liver injury is rare. The warning statements clarify the symptoms of liver injury so consumers can differentiate between general symptoms and ‘unusual’ symptoms which may be indicative of early liver injury and prompt the need to see a doctor.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes address the following issues:

  1. Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata
  2. Liver injury associated with Valeriana officinalis

To view the details of the proposed changes and respond to this consultation, please click the link under 'View Consultation and Submit Response' at the bottom of this page.

You can respond to any or all of the proposed changes. Responses may be typed into the provided text boxes, or you can upload your response as a single or multiple PDF or Word document/s. 

Privacy and your personal information

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

  1. 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.
  2. 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).

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. 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 and assessed listed medicines.

What happens next

All public submissions will be considered after the end of the consultation period.

Final decisions on the proposed changes will be published by Thursday 1 December 2022. Public submissions received as part of the consultation may be published if consent was given.

Finalised changes will be included in an update to the Permissible Ingredients Determination on Wednesday 1 March 2023. A transition period of 12 months from the commencement of the new Determination will be provided to allow sponsors of existing listed and assessed listed medicines to bring their products into compliance. The transition period will end on Friday 1 March 2024 unless otherwise specified.

Audiences

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