Consultation Hub

We asked for feedback on a proposed standard for nicotine vaping products that have not been assessed by the TGA (unregistered nicotine vaping products). While it is possible that in the future there may be nicotine vaping products that have been assessed and approved by the TGA as medicines, we expect that in the meantime there will be a significant number of prescriptions written for unapproved goods for smoking cessation. We proposed a set of minimum safety and quality requirements for unregistered nicotine vaping products to support health professionals and consumers in knowing what is in the product being prescribed and used and to reduce the risks of accidental poisonings.

In this consultation we also asked for feedback on a proposal to exempt those unregistered nicotine vaping products that meet the requirements in the proposed standard from having to meet certain other default standards in the European Pharmacopoeia and the United States Pharmacopeia. 

We received 103 submissions in response to the consultation, including from research, government, health professional, consumer and industry organisations, as well as from individual consumers. There was broad support for the creation of a standard for unregistered nicotine vaping products. Respondents provided a range of views and suggestions to improve the standard, including:

• more strict labelling requirements, such as the need for a consistent measure of the concentration of nicotine in the product and clear rules about which label warning statements (e.g. ‘KEEP OUT OF REACH OF CHILDREN’, ‘Avoid contact with eyes’, ‘Avoid contact with skin’)
• the need for accurate labelling of nicotine concentration or content in the product
• information about additional ingredients associated with known inhalation harms
• diverse views on whether the standard should specify limits on nicotine concentration, container volume and flavours
• a preference that the standard also apply to products that may be listed on the Australian Register of Therapeutic Goods (ARTG) in the future as ‘Export Only’ medicines
• suggestions about different types of information manufacturers and others should be expected to hold about the products
• requests for the regulation of vaping devices.

Thank you to everyone who provided feedback and helped in the development of the standard.

In response to this feedback, the standard includes updated labelling requirements for nicotine concentration (including requiring nicotine concentration to be specified in mg/mL and warning statements to be provided), the prohibition of three additional ingredients with established inhalation risks, record keeping requirements for sponsors, a limit of nicotine concentration of 100 mg/mL in products and a requirement for actual nicotine concentration/content of a product to be within +/- 10% of what it says on the label. The standard has also been expanded to cover ARTG-listed ‘Export Only’ products.

Although the standard does not restrict the flavours of nicotine vaping products (other than those containing prohibited ingredients) or container sizes, it is important to remember that these factors, and others, are restricted by the person’s prescription. This allows the prescribing health professional and patient to work together to make sure that the right product is supplied to support nicotine and smoking cessation.

The new Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 was published in May 2021 and comes into effect on 1 October 2021. This standard will apply to all unregistered nicotine vaping products in Australia (including compounded and clinical trial products and ARTG-listed as ‘Export Only’ products).

The Therapeutic Goods (Exempt Monographs) Determination 2021 (“the Determination”) was made at the same time as the standard. The purpose of the Determination is to exempt unregistered nicotine vaping products from certain pharmacopoeial standards that automatically apply to therapeutic goods.

To help explain the new requirements we have published draft guidance to support this standard. We expect to finalise this guidance in June 2021.

Between September and December 2020, the TGA sought feedback to help inform the planning and design of the implementation of identifiers for Australian medical devices and the establishment of the Australian Unique Device Identification database. This is the second consultation and builds on the findings from the first. Specifically the TGA sought feedback on:

1. What are the benefits of an Australian UDI System across the broader health system?
2. Should the first phase of an Australian implementation be limited to a small number of high-risk devices?
3. If the Australian implementation fully aligns with the IMDRF guidance, what will the impact be?
4. What mechanisms should be considered for submitting the UDI data to the TGA?
5. What might the benefits be for implementing the EU Basic UDI-DI in Australia?
6. What are the benefits of the Global Medical Device Nomenclature (GMDN) and how is it being used?

Ninety responses were received with sixty percent of responses from medical device manufacturers and/or sponsors. The remaining respondents represent most other segments of Australia’s healthcare system, however it was noted that no submissions were received from Registries or General Practitioners.

Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses demonstrate continued strong support for the Australian implementation as well as many valuable comments and suggestions on the implementation approach and phasing.

The TGA appreciates all the feedback and thanks all respondents.

We have analysed all responses and the results will inform Australian Government policy decisions going forward. In line with your strong feedback on ongoing engagement, the TGA will continue to work closely with stakeholders as we progress the implementation.

Public consultation on the Delegate’s interim decision on nicotine scheduling was held between 23 September and 12 November. The interim decision and public consultation relate to a delegate-initiated proposal referred to the June 2020 meeting of the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25).

We received 2385 submissions in response to the public consultation, including seven submissions that were received offline. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback that we received.

The Delegate considered all submissions prior to making the final decision on nicotine scheduling. The final decision was published on 21 December 2020 on the TGA website.