TGO 110 – Standard for Vaporiser Nicotine - Consultation

Closed 31 Mar 2021

Opened 17 Feb 2021

Feedback updated 20 May 2021

We asked

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. 

You said

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.

We did

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.

Published responses

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

Overview

The Therapeutic Goods Administration (TGA) is seeking comments on a proposed standard for vaporiser nicotine products.

Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs). This includes vape liquids, e-liquids and e-juices that contain nicotine and/or nicotine salts. This does not include other nicotine replacement therapies (NRTs) containing nicotine, such as patches, gum, lozenges, mouth spray and inhalators nor nicotine-containing products that are not intended for use in ENDs, such as chewing tobacco and snuff.

This standard relates only to unapproved goods – that is, medicines that have not been approved by the TGA and are not registered in the Australian Register of Therapeutic Goods (ARTG). While it is anticipated that a number of vaporiser nicotine products may seek approval by the TGA as medicines in the coming years, it is also anticipated that there will be a significant number of prescriptions written for unapproved goods for smoking cessation.

The proposed standard is in the form of a Therapeutic Goods Order (a TGO) and would be TGO 110. TGOs are legal standards made under section 10 of the Therapeutic Goods Act 1989 (Act) which specify safety and quality rules for medicines imported into, exported from or supplied in Australia. TGOs can apply to approved or unapproved products, or both, and may be limited to a certain type of medicine. TGOs cannot specify requirements for vaping devices. TGOs are made by the Minister or their delegate.

Feedback is sought on a range of potential requirements that could be included in TGO 110.

The TGA’s proposed options – which are subject to feedback in the current public consultation - are set out in the draft Therapeutic Goods (Standard for Vaporiser Nicotine) (TGO 110) Order 2021 (draft TGO 110). The draft TGO is provided to show you how potential requirements would be documented in a legal instrument (see Related documents below).

Scope

This consultation covers the following topics:

  • Part 1: Proposed scope of TGO 110.
  • Part 2: Potential requirements for unapproved vaporiser nicotine products. This covers labelling, ingredients, packaging, nicotine concentration and container volume.
  • Part 3: Related matters. This covers topics related to vaporiser nicotine products; specifically, default standards (pharmacopoeia) and nicotine purity, and compounding.

The following topics are not within the scope of this consultation:

  • Vaporiser products that do not contain nicotine, which will not be covered by TGO 110.
  • Clinical guidelines and recommended dosage regimes for nicotine-containing products for smoking cessation.
  • Laws about access to vaporiser nicotine products.

Please refer to Related section below for the printable Word version of this consultation.

What happens next

We will review all feedback received and, if appropriate, revise the requirements in draft TGO 110 before providing it to the Minister or his delegate for approval. We propose to finalise and publish TGO 110 in April or May 2021 to allow enough time for stakeholders to become familiar with the requirements, and to organise procurement of compliant products, before the requirements come into effect on 1 October 2021.

Audiences

  • Aboriginal and Torres Strait Islander People
  • Men
  • Women
  • Families
  • Parents
  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Local governments
  • Health professionals
  • Health workforce
  • General public
  • Community groups
  • Businesses
  • Health staff
  • HPRG (TGA) Staff
  • Prescription medicines
  • Medical Devices & IVDs
  • Other

Interests

  • Regulatory policy
  • Tobacco
  • Prescription drugs