TGO 110 – Standard for Vaporiser Nicotine - Consultation

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.