20/10/21: Australian Government Federal Health TGA Media Release
The Therapeutic Goods Administration (TGA) has issued seven infringement notices totalling$18,648 to a Melbourne-based individual responsible for the Vapespot website, for alleged breaches of the Therapeutic Goods Act 1989 (the Act). The alleged breaches relate to the advertising of nicotine vaping products.(//www.tga.gov.au/legislation-legislative-instruments)
The Vapespot website allegedly advertised nicotine pods that contain a Schedule 4 prescription only medicine included in the current Poisons Standard . Under the Act, vaping products that contain nicotine are prescription only medicines and cannot be advertised to the Australian public.(//www.tga.gov.au/publication/poisons-standardsusmp)
The TGA gave the individual detailed guidance about the legal requirements for importers,suppliers and advertisers of nicotine vaping products. Although changes were made to the website, they failed to substantially address the TGA’s concerns and it appeared that attempt swere made to conceal ownership of the website.
The TGA takes non-compliance with the rules for advertising nicotine vaping products very seriously and will take escalated compliance action in cases where individuals and businesses have previously been provided with education materials or have been warned about the new requirements.
The rules around the import, manufacture, supply and advertising of nicotine vaping products balance the need to prevent adolescents and young adults from taking-up nicotine vaping (and potentially cigarette smoking), while enabling current smokers to access these products for smoking cessation with appropriate medical support.
The TGA has published comprehensive information about nicotine vaping products .(//www.tga.gov.au/nicotine-vaping-products)
Consumer information
From 1 October 2021, consumers require a valid prescription from an Australian doctor to legally import a nicotine vaping product from online suppliers.(//www.tga.gov.au/media-release/ prescriptions-now-required-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 consultationand a prescription from their doctor, as a treatment to help stop smoking.(//www.tga.gov.au/nicotine-vaping-products-informationconsumers)
Compliance and enforcement
The TGA is taking prompt and appropriate action to ensure compliance with the law. Our nicotine vaping products compliance and enforcement plan sets out an intelligence-informed, risk-based approach.(//www.tga.gov.au/nicotine-vaping-productscompliance-and-enforcement)
The TGA encourages the reporting of suspected non-compliant advertising .(//www.tga.gov.au/advertising-enforcement-and-outcomes)
If you suspect
non-compliance in relation to therapeutic goods more broadly, you can report illegal
or questionable practices online to the
TGA.(//www.tga.gov.au/report-perceived-breach-or-questionable-practices)
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