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Standard for unregistered nicotine vaping products
The Therapeutic Goods Administration (TGA) has introduced a new standard for prescription nicotine vaping products that have not been assessed by the TGA (unregistered nicotine vaping products). This standard, known as Therapeutic Goods (Standard for Nicotine Vaping Products (TGO 110) Order 2021 sets out the safety and quality requirements for unregistered nicotine vaping products.
Nicotine vaping products are products that contain nicotine in solution - whether in base or salt form - that are intended to be inhaled using a vaping device, such as an e-cigarette or other electronic nicotine delivery system. These products include nicotine-containing vape liquids, e-liquids and e-juices.
There are currently no nicotine vaping products that have been assessed by the TGA and registered in the ARTG. However, 'unapproved' goods that have not been assessed by the TGA can still be accessed by consumers on prescription via established access pathways.
In the absence of an approved nicotine vaping product, the TGA has developed this standard to help health practitioners and consumers understand what is in these products, to avoid products that contain ingredients with known inhalation risks and to minimise the risks of accidental exposure or ingestion of these products, particularly by children.
The new standard will come into effect on 1 October 2021 and includes rules about:
- what information is needed on the product's label (including an oversticker or in an information sheet provided with the product)
- what child-resistant packaging is needed
- limits on the concentration of nicotine in the product and for actual nicotine concentration/content to reflect what the product's label says
- ingredients that are prohibited in these products
- records that need to be kept by the Australian sponsor for the product.
Although the standard does not restrict the flavours of nicotine vaping products or container sizes, it is important to remember that these factors, and others, are restricted by the person's prescription. This then 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.
We have also published guidance to help explain the requirements in new standard as well as other matters related to nicotine vaping products and vaping devices.
This new standard incorporates feedback received during consultation. Thank you to everyone who provided feedback.