The Therapeutic Goods Administration (TGA) has issued two infringement notices totalling $25,200 to Sydney-based company Australian Chemical Research Pty Ltd for alleged breaches of the Therapeutic Goods Act 1989 (the Act).
Australian Chemical Research allegedly manufactured and supplied antibacterial/anti-viral hand sanitiser not included in the Australian Register of Therapeutic Goods (ARTG), and which was neither an exempt good nor a good that is excluded from the operation of the Act. Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully manufactured or supplied in Australia.
The company allegedly claimed the hand sanitiser kills 99.99% of germs, viruses and bacteria on hands, including the flu virus, the common cold virus and HIV. The label also stated that the active ingredients of the hand sanitiser included 80% iso-propanol. However, the product contained a large percentage of n-propanol, which is a less effective and potentially hazardous alcohol. Australian Chemical Research was not licenced to manufacture therapeutic goods, and did not have approval to do so.
The TGA reminds hand sanitiser manufacturers that these products are, in most cases, therapeutic goods, unless they have been excluded from the operation of the Act. Sanitisers excluded under the Therapeutic Goods (Excluded Goods – Hand Sanitisers) Determination 2020 must meet specific formulation, labelling and advertising requirements and cannot be promoted with claims about anti-viral action. Under the Therapeutic Goods (Excluded Goods) Determination 2018, antibacterial skincare products are also specifically prohibited from being presented as having anti-viral action.
The TGA has published Hand sanitisers: Information for manufacturers, suppliers and advertisers.
The TGA takes action against unlawful activity
The regulatory scheme is important to the safety of Australian consumers, and the TGA investigates suspected unlawful activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and where necessary, this may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.
Hand sanitisers: Information for consumers will help you understand more about buying and using hand sanitisers amid the coronavirus (COVID-19) pandemic.
TGA, 29 June 2020