NSW individual fined for alleged offences relating to unapproved erectile dysfunction medicines

The TGA has issued 13 infringement notices totalling $42,900 to a New South Wales-based individual for the alleged unlawful advertisement and supply of erectile dysfunction medicines. 

In February 2023 the TGA, with the assistance of New South Wales Police, executed 3 search warrants connected to an individual operating in the Newcastle area. More than 55,000 potentially dangerous products were seized.

Laboratory testing of products seized during the search identified medicines that can only be supplied to Australians with a prescription including:

• Tadalafil
• Sildenafil
• Dapoxetine

 The individual did not have approval or authority to import these prescription-only medicines, and the products seized are not listed in the Australian Register of Therapeutic Goods (ARTG). This means that they are not approved for supply in Australia, have not been reviewed for safety or quality, and pose an unacceptable risk to consumer health. 

 Any unapproved erectile dysfunction product comes with an increased risk of side effects. 

 Advertising prescription-only medicines directly to consumers is prohibited under the Therapeutic Goods Act 1989. Any references to prescription-only medicines, overtly or by implication, through abbreviations or the use of colloquialisms, are unlawful.

 Businesses must understand their legal obligations prior to importing, advertising, or supplying therapeutic goods. Consequences for non-compliance with relevant laws may include not only financial penalties, but also civil or criminal proceedings.

 If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

 Contact for members of the media:

• Email: news@health.gov.au 
• Phone: 02 6289 7400