A fistful of infringements


Capsule with dollar signs spilling out

The TGA issues infringement notices to several individuals and entities over alleged unlawful advertising and importation of goods

ANPROS Pty Ltd – The TGA has issued three infringement notices totalling $39,960 to Melbourne-based company Analytical Products & Services Pty Ltd (ANPROS), for alleged unlawful advertising of hydrogen peroxide.

ANPROS allegedly advertised, on the company’s website, a medicine containing hydrogen peroxide for internal therapeutic use that at the time of advertising was not included in the Australian Register of Therapeutic Goods.

“Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully advertised to the general public in Australia,” the TGA noted in a statement.

“The TGA also alleges that ANPROS referred to a prohibited representation that suggested hydrogen peroxide could be administered by mouth or injected as a treatment for cancer.

“The Therapeutic Goods Advertising Code specifies that representations relating to the treatment, cure, prevention or diagnosis (including screening) of neoplastic diseases, including all types of cancer, are prohibited representations.

“ANPROS allegedly also implied, on the company’s website, that hydrogen peroxide is a treatment for emphysema. Any claims or references to treating a serious form of a disease, condition, ailment or defect are restricted representations.

“Under the Therapeutic Goods Act 1989, the use of prohibited or restricted representations in advertisements for therapeutic goods is unlawful without prior authorisation from the TGA.”

 

A Sydney man – The TGA has issued four infringement notices totalling $10,656 to a man from Sydney for the alleged unlawful advertising of hydrogen peroxide and Condy’s crystals (potassium permanganate).

The man allegedly advertised, on his eBay store, medicines containing hydrogen peroxide for internal therapeutic use and Condy’s crystals.

Neither medicine, at the time of advertising, were included in the Australian Register of Therapeutic Goods.

“It is alleged that the man also referred to a prohibited representation, on his eBay store, in relation to hydrogen peroxide as a treatment for cancer,” said the TGA.

“The Therapeutic Goods Advertising Code specifies that representations relating to the treatment, cure, prevention or diagnosis (including screening) of neoplastic diseases, including all types of cancer, are prohibited representations.

“The man also allegedly promoted hydrogen peroxide as a treatment for coronavirus.

“Under the Act, any claims or references to treating COVID-19 (and related terms) are restricted representations. The use of prohibited or restricted representations in advertisements for therapeutic goods is unlawful without the prior authorisation of the TGA.

“The TGA has informed the man that the alleged advertising, on his eBay store, must be immediately removed.”

 

Nafara Australia – The TGA has issued an infringement notice for $13,320 to the Sydney-based company Nafara Australia Pty Ltd for the alleged unlawful importation of face masks in relation to COVID-19.

Nafara Australia allegedly breached a condition of the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 importing medical face masks that were not, at the time of the importation, included in the Australian Register of Therapeutic Goods and were not being imported for supply to the National Medical Stockpile.

 

A Sydney man – The TGA has issued an infringement notice for $2,664 to a man from Sydney for the alleged unlawful importation of medical face masks in relation to COVID-19.

These masks were also not, at the time of importation, including in the ARTG or being imported for the National Medical Stockpile.

“Under the Therapeutic Goods Act 1989, therapeutic goods must be entered in the ARTG before they can be lawfully imported in Australia, unless a specific exemption, approval or authority applies,” the TGA noted.

“Where therapeutic goods are covered by an exemption, the conditions of the exemption must be complied with. Failure to do so exposes a company or any relevant individual to criminal prosecution or civil penalty proceedings.

“When manufacturers provide information to the TGA that the intended purpose of a mask is to prevent transmission of disease between people, this information confirms the mask is a medical device, regardless of whether other information, such as a customs slip, is subsequently added to the box stating the masks are ‘not for medical use’.

“The TGA is supporting suppliers of products that are not covered by the exemption to include them on the ARTG as a priority.

“The TGA has published guidance on face masks and respirators that are regulated by the TGA. This guidance helps consumers, health professionals, and government officials to determine when a face mask is a medical device and therefore must be included in the ARTG.”

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