The Therapeutic Goods Administration (TGA) has issued 27 infringement notices, totalling $101,412, to a NSW-based individual for the alleged unlawful supply of Melanotan II to Australian consumers in contravention of the Therapeutic Goods Act 1989 (the Act).
The infringement notices were paid in May 2026.
In Australia, Melanotan II is classified as a prescription-only medicine but is not approved for sale or use as a tanning agent. There are currently no products containing Melanotan II on the Australian Register of Therapeutic Goods (ARTG) or approved for supply in Australia.
The Act prohibits the supply and advertising of unapproved therapeutic goods in Australia and also bans the advertising of prescription-only medicines to the public, unless a relevant exemption applies. It is illegal to supply tanning products containing melanotan without a doctor's prescription, regardless of whether the product is a spray, tablet, injection, cream or any other form.
Consumers should be aware that unapproved therapeutic goods may pose significant health risks. Melanotan can cause serious side effects and should only be used under medical supervision. In 2025, the TGA issued a public warning outlining the dangers of tanning products containing melanotan and advised consumers to avoid their use.
The TGA's response reflects its ongoing enforcement approach to therapeutic goods used in cosmetic procedures, as outlined in TGA's Compliance Principles 2026 and 2027.
Individuals, health practitioners and businesses must understand their legal obligations under the Act before supplying, advertising or importing therapeutic goods. Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal penalties.
If you suspect non-compliance in relation to therapeutic goods or their advertising, you can report it to the TGA at any time.
