The TGA has issued its preferred options for the reform of controls on nicotine vaping products (NVP)
The preferred options are included in the summary of feedback it received on a recently released consultation paper.
Currently, NVPs can only be lawfully distributed by a community pharmacy to consumers with a prescription.
However, reports suggest they are readily available through other channels, including illegally through retail outlets.
The regulator said it received over 4,000 responses to its consultation paper on potential reforms.
"A large number of the submissions from the general public appeared to be campaign responses that advocated changing the current regulatory framework in which NVPs are regulated as prescription medicines (which was outside the scope of the consultation)," it said.
According to the TGA, there was significant stakeholder support for its preferred option to strengthen border controls by requiring importers to obtain an import permit and by closing off the personal importation scheme.
However, individual vapers, vaping retailers, manufacturers and retailers, as well as pro-vaping associations, did not generally support any import controls.
The TGA said its preferred option is to require a pre-market assessment of NVPs against a product standard specifying certain quality and safety requirements.
Companies supplying NVPs to the prescription pharmacy market supported this approach, it said, "as did about half of State and Territory governments, half of health professional bodies and nearly half of individual health professionals."
Yet nearly half of the public health associations and health professional bodies argued that the regulator should go further by requiring that all NVPs be registered in the Australian Register of Therapeutic Goods. The TGA said they opposed its preferred pre-market assessment out of concern that it could be misinterpreted as TGA approval.
"A large number of individual vapers, vaping retailers, vaping manufacturers/importers and pro-vaping associations supported at least some regulation to ensure NVP quality and safety (but with NVPs regulated as consumer goods, instead of as prescription medicines)," said the TGA.
There was significant support for the TGA's preferred option to introduce warning statements, require pharmaceutical-like packaging, lower the maximum allowable nicotine concentrations, prohibit or restrict flavours and certain other ingredients, and limit NVP volume and overall nicotine content.
According to the regulator, many individual vapers, vaping retailers, manufacturers and pro-vaping associations, proposed scrapping the current prescription model but also that "many in this category supported some regulation to ensure NVP quality and safety."
"There was general support for the proposal to clarify that all vaping products containing nicotine are therapeutic goods from all categories of submitters except individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations," it said.