The Therapeutic Goods Administration (TGA) has issued three infringement notices, totalling $7,992, to a Melbourne-based individual for alleged importation breaches involving nicotine vaping products.
It is alleged that the individual imported liquid nicotine vaping products that were not entered, into the Australian Register of Therapeutic Goods (ARTG) at the time of importation.
Under the Therapeutic Goods Act 1989 (the Act), therapeutic goods must be entered into the ARTG, unless a specific exemption, approval or authority applies, before they can be lawfully imported into Australia.
Vaping products that contain nicotine are prescription only medicines included in the current Poisons Standard. Prescription only medicines pose a higher level of risk and are entered into the ARTG after evaluation for quality, safety and efficacy.
There are currently no TGA approved nicotine vaping products registered in the ARTG. Medicines that are not in the ARTG are known as ‘unapproved’ medicines.
If a doctor prescribes an unapproved nicotine vaping product for smoking cessation, the products can be accessed through an Australian pharmacy (via the Authorised Prescriber Scheme or Special Access Scheme), or from an overseas website (via the Personal Importation Scheme).
The TGA has published comprehensive information about nicotine vaping products.
Consumer information
From 1 October 2021, consumers require a valid prescription from a doctor in Australia to legally import nicotine vaping products purchased from overseas websites.
A valid prescription continues to be required to purchase nicotine vaping products from Australian pharmacies.
It remains illegal for other Australian retailers to sell nicotine vaping products to consumers.
The TGA has published information for consumers on how to legally access nicotine vaping products, following consultation and a prescription from their doctor, as a treatment to help stop smoking.
The TGA advises consumers that if they are considering buying nicotine vaping products online it is important to be careful, especially when the seller does not ask for a valid prescription. Products sold online that are not entered into the ARTG may be counterfeit (fake), containing undeclared (hidden) ingredients. Consumers are encouraged to ask the overseas supplier the following questions about the ingredients, packaging, labelling and manufacturing of the product.
Compliance and enforcement
The TGA is taking prompt and appropriate action to ensure compliance with the Act. Our nicotine vaping products compliance and enforcement plan sets out an intelligence-informed, risk-based approach.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
The TGA encourages the reporting of suspected non-compliant advertising.
