Regulator cracks down on COVID-19 breaches

business owners holding up red cards for reprimand

Pete Evans’ company fined $25k for alleged COVID-19 advertising breaches, plus two companies and one WA woman fined over COVID-19 test kits

The TGA has issued two infringement notices to the company Peter Evans Chef totalling $25,200 for alleged breaches of the Therapeutic Goods Act 1989. Mr Evans is the sole director/secretary of the company.

The first infringement notice was issued in relation to a number of complaints sent to the TGA about the promotion of a ‘BioCharger’ device that occurred during a Facebook live stream on 9 April 2020.

Mr Evans allegedly live streamed on his Facebook page, which has more than 1.4 million followers, claims that the device could be used in relation to “Wuhan Coronavirus”.

The TGA says this claim “has no apparent foundation … which the TGA takes extremely seriously”.

A second infringement notice was issued for alleged advertising breaches on the website, which is maintained by the company Peter Evans Chef.

According to the TGA, the page for the BioCharger included claims such as:

“proven to restore strength, stamina, co-ordination and mental clarity”

“sharpening your mental clarity”

“recovery….from an injury, stress”

“accelerating muscle recovery and reducing stiffness in joints”.

As the BioCharger device has been represented as being for therapeutic uses, it is a therapeutic good within the meaning of the Therapeutic Goods Act 1989, and is therefore subject to the regulatory framework administered by the TGA.

Unless a specific exemption applies, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied or advertised in Australia, explains the TGA.

Meanwhile the TGA has issued two infringement notices totalling $25,200 to Queensland company CK Surgitech Pty Ltd for alleged breaches the Act.

It is alleged the company made a false or misleading statement in an application to have their IVD Rapid Test kits for SARS-CoV2 (the COVID-19 virus) included in the ARTG.

The company also allegedly breached a condition of the Therapeutic Goods (Medical Devices – Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 by importing COVID-19 test kits that were not included in the ARTG and were not being imported in relation to an authorised pathology laboratory as required by the Exemption.

A further infringement notice for $12,600 has been issued to Melbourne based company Labtest Direct Pty Ltd for the alleged advertising of COVID-19 Rapid Test kits.

The Facebook advertisement posted in April 2020 included a reference to COVID-19, which is a restricted representation under legislation—a restricted representation refers to serious diseases, conditions or disorders.

The use of restricted representations in advertisements for therapeutic products is unlawful without the express permission of the TGA. These include representations in relation to COVID-19.

“Illegal advertising of therapeutic goods is of significant concern to the TGA given the current COVID-19 pandemic,” says the regulator.

A woman in Western Australia has additionally been issued an infringement notice for $2,520 by importing COVID-19 test kits that were not included in the ARTG, and were not being imported in relation to an authorised pathology laboratory as required by the Exemption.

The Australian Border Force detected the importation by the woman at the border.

COVID-19 test kits are classified as Class 4 in-vitro diagnostic (IVD) medical devices, and as such must not be imported into Australia unless they are included in the ARTG, or meet the conditions of the Exemption.

“These contraventions are a serious concern for the TGA due to the current COVID-19 pandemic. Any alleged breaches relating to products supplied as part of Australia’s response to the pandemic will be given the highest priority by the TGA,” said the regulator.

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