The Therapeutic Goods Administration (TGA) has issued two infringement notices, totalling $26,640, to Melbourne-based company Ezy Company Pty Ltd (trading as Ezy Vapes) for alleged importation breaches relating to COVID-19 rapid antigen tests and nicotine vaping products.
It is alleged that Ezy Company Pty Ltd imported COVID-19 rapid antigen tests and nicotine vaping products that were not included in the Australian Register of Therapeutic Goods (ARTG) at the time of importation.
Under the Therapeutic Goods Act 1989 (the Act), therapeutic goods such as nicotine vaping products and COVID-19 rapid antigen tests must be included in the ARTG before they can be lawfully imported into Australia, unless a specific exemption or approval applies.
COVID-19 rapid antigen tests and nicotine vaping products also have additional requirements to be appropriately and lawfully accessed.
COVID-19 rapid antigen tests
In addition to being included in the ARTG (unless an exemption, approval or authority applies), all importers of COVID-19 test kits must apply for, and be granted, a biosecurity import permit unless they can demonstrate that the goods are for personal use only or, for lateral flow test kits, meet the import conditions published on the Australian Biosecurity Import Conditions (BICON).
A list of tests included in the ARTG is available on the COVID-19 test kit page.
Nicotine vaping products
Since 1 October 2021, consumers require a valid prescription from a doctor in Australia to legally import nicotine vaping products.
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 vigilant, especially when the seller does not ask for a valid prescription. Products sold online that are not entered in 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.
The TGA will continue to take a strong enforcement approach consistent with the nicotine vaping products compliance and enforcement plan.
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.