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The Therapeutic Goods Administration (TGA) is warning consumers against using Melanotan II tanning products.
Melanotan II is a prescription-only medicine in Australia and is not approved for use as a tanning agent. There are currently no products containing Melanotan II included in the Australian Register of Therapeutic Goods (ARTG) or approved for supply in Australia.
As part of an investigation, the TGA seized products suspected to contain Melanotan II. TGA laboratory testing has confirmed the presence of Melanotan II in these products. Testing found the estimated amount across the 5 nasal spray bottles, labelled ‘Pure Tans Triple Strength 30 MG’, ranged between 22 mg and 54 mg of Melanotan II based on the labelled volume of 20 mL per bottle. The inconsistent dosage across the bottles further increases the chance of adverse events resulting from the use of these products.
The TGA issued 27 infringement notices, totalling $101,412, to the NSW-based individual for the alleged unlawful supply of the Melanotan II products to Australian consumers. The infringement notices were paid in May 2026.
Consumers are warned that products containing Melanotan II may pose serious health risks. We have previously issued a warning to advise consumers of these risks. These products have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation. Consumers cannot be certain of the ingredients, strength or quality of these products.
We advise consumers to exercise extreme caution when buying medicines and medical devices online.
Products purchased online:
- may be fake
- may contain undisclosed or harmful ingredients
- may not contain the ingredients stated on the label
- may not meet Australian standards for quality, safety and efficacy
- may be available for sale despite not being approved in Australia.
For your safety, always buy medicines and medical devices from reputable sources and consult your healthcare provider or local registered pharmacy if you have any concerns.
Information for consumers
- Stop using tanning products containing Melanotan II and take any remaining product to your local pharmacy for safe disposal.
- If you have any concerns arising from your use of this product, consult your health care practitioner.
- If you suspect you have had a side effect (also known as an adverse event) to this or a similar medicine, report it to the TGA.
- If you are considering purchasing medicines from overseas watch this short video on the risks associated with buying medicines and medical devices online.
Action we are taking
The supply and advertising of unapproved therapeutic goods in Australia is prohibited unless a relevant exemption applies. Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal penalties.
Our investigation and compliance activities identify unapproved therapeutic goods that compromise the health and safety of consumers. Our investigations attempt to locate the source of supply of therapeutic goods to remove the products from the market. Individuals, health practitioners and businesses must understand their legal obligations under the Therapeutic Goods Act 1989 (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. Penalties that can be imposed for breaches of the Act include civil penalties of up to $1.82 million per breach for individuals or $18.2 million per breach for corporations, and criminal penalties of up to 7 years imprisonment.
For more information on the types of actions we may take in instances of substantiated non-compliance, please see the Compliance and enforcement hub on the TGA website.
Report counterfeit medicines and medical devices
If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:
| Phone: | 1800 020 653 |
|---|---|
| Online: | Report a problem or side effect |
| Email: | info@tga.gov.au |
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