The Therapeutic Goods Administration (TGA) has been monitoring and taking action against individuals and companies capitalising on the current pandemic to market and sell products that claim to prevent or cure COVID-19.
Under the Therapeutic Goods Act 1989 (Act), with limited exceptions, any product represented to be for therapeutic use is a therapeutic good. The TGA regulates all therapeutic goods and requires that they must be registered on the Australian Register of Therapeutic Goods (ARTG) before they can lawfully be supplied or advertised in Australia.
The TGA also has strict requirements for the advertising of therapeutic goods. Advertisers of therapeutic goods should be aware that any references, either explicitly or implicitly, to a serious form of a disease, condition, ailment or defect is a restricted representation (as prescribed by the Therapeutic Goods Advertising Code (Code)). It is unlawful to make a restricted representation in advertisements for therapeutic goods without prior approval from the TGA. COVID-19 is a restricted representation.
Any therapeutic claim made in relation to COVID-19 must be supported by appropriate evidence and must not mislead consumers. Additionally, advertisements must not contradict any current public health campaigns. For example, the promotion of face masks as a necessity to protect individuals from COVID-19 contradicts the Commonwealth of Australia's Department of Health advice that masks are not necessary for everyone.
The TGA has published a warning to advertisers and consumers about illegal advertising relating to COVID-19 and has so far issued three fines.
The TGA has also reinforced that advertisements for disinfectants (including disinfectants that are exempt from registering on the ARTG) are required to comply with the Act and the Code. Advertisers of disinfectants who wish to make a claim about their product's ability to kill COVID-19 must be able to verify such claims with studies conducted in respect of novel coronavirus.
Similarly, although the passing of the Therapeutic Goods (Excluded Goods – Hand Sanitisers) Determination 2020 precludes specified hand sanitisers from the operation of the Act and the Code, enabling manufacturing of sanitiser to be carried out by new manufacturers quickly to meet demand, when advertised in a specified way, advertisers of these products are still prohibited from making a therapeutic use claim that directly or indirectly refers to COVID-19.
The TGA is encouraging the public to report any suspicious claims being made about products, especially those that reference COVID-19, and have swiftly taken action to fine companies that breach the advertising requirements in relation to therapeutic goods. As such, advertisers must take care to ensure that they:
Last reviewed: 11 May 2020