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The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $26,640 to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device marketed for the prevention of "SARS-CoV-2 Human Coronavirus".
V P & Associates allegedly advertised, on the company's website, a plant-based nasal and oral solution called Liquim that claimed it has 99.9% effectiveness against SARS-CoV-2 Human Coronavirus. The product had not been approved for inclusion in the Australian Register of Therapeutic Goods (ARTG) as a preventative for SARS-CoV-2 Human Coronavirus.
The Therapeutic Goods Act 1989 (the Act), prohibits advertising to the public for therapeutic goods that are not entered in the ARTG (unless a specific exemption, approval or authority applies). The inclusion of products in the ARTG through the regulatory approval process is an important safeguard to ensure the safety and satisfactory performance of medical devices supplied in Australia.
The TGA alleges that the advertising, on the company’s website, included a restricted representation that claimed Liquim is effective against SARS-CoV-2 Human Coronavirus. Any claims or references to preventing or treating a serious form of a disease, condition, ailment or defect are restricted representations.
Under the Act, the use of restricted representations in advertisements for therapeutic goods is unlawful without the prior authorisation of the TGA. No relevant authorisation has been granted for the advertised claims.
The TGA's highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods.
Important information for companies that advertise therapeutic goods
Advertisers are responsible for ensuring their therapeutic goods advertising is compliant with the Act. Educational information and resources about Australia's advertising rules for therapeutic goods can be found on the TGA website.
If you need regulatory assistance regarding your specific circumstances we encourage you to seek independent legal advice or the assistance of a regulatory affairs consultant. The TGA does not endorse consultants, however we maintain a list of industry organisations that may be able to help you find one.
The TGA takes action against illegal activity
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods.
The TGA reminds online advertisers that sanctions and penalties can apply if they advertise therapeutic goods in a way that does not comply with Australia’s advertising laws. The range of compliance and enforcement tools available include substantial fines and criminal or civil court action.
The TGA encourages the reporting of suspected non-compliant advertising.
The TGA website includes tips for consumers about how to spot a dodgy health product ad.