Consultation Hub

We asked for feedback on proposals for improving the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The proposals included changes to provisions of the Code that had been identified as being unclear, inconsistent, or otherwise difficult to work with. The proposals were designed to improve advertising compliance, minimise advertising compliance costs, and ensure Code provisions work as intended.

We canvassed stakeholder preferences for different options for some provisions. We also invited stakeholders to identify other areas where the Code could be improved.

We received 67 submissions in response to the consultation, including from sponsors, manufacturers, advertisers, marketers and sellers of therapeutic goods, peak industry bodies and associations, regulatory affairs firms, policy advocates, and health professional and consumer organisations. There was broad support for amending the Code to reduce complexity and increase clarity for users. Stakeholders also advocated for a review of current guidance on the Code to ensure it remains contemporary and easily accessible.

On some proposals, there were widely divergent views:

• There was broad support for clarifying the requirements around claims in advertising, including ‘therapeutic’ and ‘non-therapeutic’ claims, and the evidence requirements for each. But there was a divergence of views as to whether this should be done in the Code, or in guidance.
• The proposal to strengthen the rules around the use of language and images in advertising that may invoke a sense of fear or distress in consumers also produced a range of views.
• Stakeholder views about who should and who should not be allowed to make product endorsements and testimonials for use in advertising were widely divergent.
• There was also a range of views around the rules relating to advertising involving the offer or provision of free samples of goods, and the criteria that should apply when determining what types of goods should be exempted from any general restrictions on this practice.

However, stakeholders broadly supported the introduction of alternative mandatory statements in advertisements for typically ‘non-consumer’ therapeutic goods. Many stakeholders also indicated they wanted simpler rules around the use of existing mandatory statements and health warnings in advertisements.

Thank you to everyone who provided feedback.

In response to this feedback, we have decided to re-write the Code using a simplified structure and plainer language. We will also ensure the guidance on the Code is more accessible and user-friendly.

On specific Code issues, we are reflecting on feedback and undertaking further targeted consultations with members of the Therapeutic Goods Advertising Consultative Committee.

We aim to prepare and publish the new Code by the end of 2021. Please subscribe to the TGA Advertising email list to be notified of progress.

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, TGA has published final guidance on the requirements of TGO 110 and other matters related to nicotine vaping products and vaping devices. The final guidance incorporates stakeholder feedback on the draft guidance published in May 2021.

Public consultation on the Delegate’s interim decision, in relation to scheduling proposals referred to the November 2020 meetings of the Advisory Committee on Medicines and Chemicals Scheduling, was held between 3 February 2021 and 4 March 2021.

We received 807 submissions in response to the public consultation, including one submission that was received offline. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback that we received.

The Delegate’s final decisions on psilocybin and MDMA were deferred on 7 April 2021, pending an independent expert review and additional committee advice. The Delegate will consider all evidence provided, including the public submissions received, ahead of making the final decisions on these substances.

The final decisions for all other substances considered at the November 2020 meetings were published on 22 April 2021 on the TGA website.