TGA Issues Fines Over Alleged Illegal Supply of Melanotan II

TGA Issues Fines Over Alleged Illegal Supply of Melanotan II

21 May 2026

 

The penalties were paid in May 2026 following an investigation into the unlawful supply of the substance.

Melanotan II is classified as a prescription-only medicine in Australia but is not approved for use or sale as a tanning product. No Melanotan II products are currently listed on the Australian Register of Therapeutic Goods (ARTG) or approved for supply in Australia.

Australian law prohibits the supply and promotion of unapproved therapeutic goods, as well as the advertising of prescription-only medicines to the public unless an exemption applies. Tanning products containing Melanotan cannot legally be sold without a valid prescription, regardless of whether they are marketed as injections, tablets, sprays, creams or in any other form.

The TGA has warned that unapproved products can pose serious health risks. Melanotan has been linked to significant side effects and should only be used under appropriate medical supervision.

In 2025, the regulator issued a public warning advising Australians to avoid tanning products containing Melanotan due to safety concerns.

The enforcement action forms part of the TGA’s ongoing compliance efforts targeting therapeutic goods used for cosmetic purposes, in line with its Compliance Principles 2026–27.

The TGA reminds individuals, health practitioners and businesses to understand their legal responsibilities before supplying, importing or advertising therapeutic goods. Failure to comply with the law can result in infringement notices, regulatory action, or civil and criminal penalties.

Anyone who suspects unlawful activity involving therapeutic goods or their advertising can report it directly to the TGA.

 
Source: Therapeutic Goods Administration (TGA)