Warning about products claiming to treat or prevent the novel coronavirus

The TGA has identified certain therapeutic goods such as complementary medicines or disinfectants being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia.

The advertising of therapeutic goods to consumers in Australia is subject to legislative requirements administered by the TGA. The promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation.

We remind advertisers to be very careful when considering making therapeutic claims related to novel coronavirus.

Consumers are advised to exercise caution when considering advertising claims related to novel coronavirus, and should immediately consult a health professional if they have health concerns.

Information for advertisers

There is a wide range of products being advertised in connection with novel coronavirus. Claims such as preventing the spread of coronavirus (for example, through the use of face masks or disinfectants), or increasing immunity to coronavirus (for example, by taking supplements), are considered to be therapeutic use claims.

Any product represented to be for therapeutic use is a therapeutic good (with a few limited exceptions). In almost all cases, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia.

All advertising for therapeutic goods (including exempt goods) to consumers must comply with all applicable requirements in the Therapeutic Goods Act 1989. This includes the requirement to comply with the Therapeutic Goods Advertising Code.

In particular, advertisers should be aware of the following requirements:

• Any representation made in the advertising of therapeutic goods which refers to novel coronavirus (explicitly or by implication) is a 'restricted representation' and cannot be used without prior approval from the TGA.
• Any therapeutic claim made in relation to novel coronavirus must be supported by appropriate evidence and must not mislead. For claims that imply clinical benefit in humans, this requires evidence from clinical studies. For disinfectants, these claims are likely to require evidence specific to novel coronavirus (see Disinfectants).
• Advertising must not be inconsistent with any current public health campaigns. Current information on the novel coronavirus is available on the Department of Health's novel coronavirus page, as well as state and territory health department websites. For example, promoting a mask as a 'must have' to protect yourself and your family from coronavirus would conflict with the Department of Health's advice that masks are not necessary for everyone.

If you are advertising therapeutic goods in relation to the novel coronavirus, you should be aware there are sanctions and penalties for advertising that does not comply with the Act and the Code. General information on advertising requirements can be found on the TGA Advertising hub.

Disinfectants

Advertisements for disinfectants (including those that are exempt from inclusion in the ARTG), are required to comply with the Act and the Code.

Products that make virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity (“specific claims”) are required to be included in the Australian Register of Therapeutic Goods prior to their supply. Further information can be found in the disinfectant table.

If you are intending to promote a disinfectant with explicit claims about killing novel coronavirus, to satisfy the Code requirements, you must have studies conducted with novel coronavirus to demonstrate this (compliance with the Therapeutic Goods Orders relating to disinfectants is not sufficient). In addition, prior restricted representation approval by TGA is needed.

Information for consumers

Using hand rubs, wipes and disinfectants, in accordance with the directions on the label, can be part of good hygiene practice. Good hygiene is the primary defence against the spread of infections, including novel coronavirus.

Medicines and supplements promoted as protecting against novel coronavirus are unlikely to be effective in preventing an infection. The TGA is also not aware of any medicines or supplements available without prescription that will prevent or assist with recovery from a novel coronavirus infection. If you become unwell and suspect you may have symptoms of novel coronavirus, you must seek medical attention.

We have received reports of topical antiseptics and other products being promoted for inappropriate uses (such as inhalation) in order to prevent novel coronavirus infections. Using products in a way that differs from the directions or instructions on the label can be dangerous.

If you are suspicious of claims made about a product, including those advertised as preventing or treating novel coronavirus, you can lodge a complaint via the online advertising complaint form.

For further information on novel coronavirus, including appropriate measures for preventing the spread of the virus, please visit the Department of Health's novel coronavirus web page.