The Therapeutic Goods Administration (TGA) has issued three infringement notices totalling $39,960 to Melbourne-based company, Italian Princess Coffee Brands Pty Ltd (trading as Zafe Zone), for alleged unlawful advertising in relation to COVID-19.

According to the TGA, Zafe Zone allegedly promoted its disinfectant as effective against coronavirus, without having the necessary authorisation from the TGA.

“Promoting disinfectants that have not been subjected to the TGA’s regulatory framework has the potential to put the public at risk,” Adj. Professor John Skerritt, deputy secretary of the Department of Health said.

“If businesses are thinking about diversifying to include disinfectants, hand sanitisers or other therapeutic goods, we encourage them to look at the legal requirements for advertising on our website, seek assistance from a legal or regulatory adviser, or contact us if they’re uncertain.”

Under the Therapeutic Goods Act 1989, claims or references that a disinfectant has an effect against viruses, including coronavirus, are prohibited representations. The use of prohibited representations in advertisements for therapeutic goods is unlawful without permission from the TGA.

According to the TGA, the advertising allegedly breached the Therapeutic Goods Advertising Code (No.2) 2018 by promoting a therapeutic good as being safe, harmless or without side-effects. Advertisements for therapeutic goods must not state or imply that the goods are safe. The TGA also alleges Zafe Zone falsely advertised the product had been approved by the TGA.

Zafe Zone responds to alleged advertising infringements

In a statement published on its website, Zafe Zone said it is considering its legal options in relation to the TGA’s infringement notices.

“To clarify, the alleged infringements relate to advertising; there are no issues with Zafe Zone products themselves,” the company stated.

“Zafe Zone is disappointed that the TGA did not first contact Zafe Zone to warn of any advertising concerns before issuing the infringement notices.

“As soon as Zafe Zone was made aware of advertising material that needed to be adjusted or clarified to avoid confusion, it sought to make those changes and notify each of its distributors to do the same.

“Zafe Zone is proudly an Australian business that is helping meet the growing needs of local commercial businesses during the coronavirus pandemic.

“We are not a manufacturer or producer of disinfectant products; we are a distributor of products. We are committed to ethical business practices and are working hard to ensure our advertising is clear and abides by relevant legislation.

“We look forward to continuing to work with our partners and Australia’s essential businesses in the fight against this deadly disease by improving the standards of disinfection and protection in our community.”

Another Melbourne-based company also received $37,800 in fines for its advertising of Zafe Zone products.

Any person, including businesses, advertising therapeutic goods to consumers must comply with the requirements for advertising. The TGA encourages people to report suspected non-compliant advertising via its advertising complaints form.

The TGA has published a list of disinfectant products that have been included in the Australian Register of Therapeutic Goods (ARTG) with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label.

The TGA recently fast tracked changes to its guidelines under Therapeutic Goods Order 104, 2019 to allow listed disinfectants to make validated claims to kill the COVID-19 virus on surfaces. The new arrangements were uploaded to the TGA website on 23 March 2020.

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