Beware the Barbie drug: the dangers of using Melanotan

The Therapeutic Goods Administration (TGA) urges consumers to steer clear of using products containing 'Melanotan' without advice from a medical professional. Melanotan is a prescription only medicine and regulated as a therapeutic product. Misuse has proven, serious side effects that can be very damaging to your health. If you have recently used unapproved Melanotan you should stop until you have consulted a medical professional.

Melanotan-I and (especially) Melanotan-II are typically promoted as tanning products and may be in the form of pills, creams, injectable and nasal or misting sprays. Regardless of the how the product enters the body, the associated risks remain, and are not new. In 2019 A Current Affair featured a report on this issue, which also highlighted the dangers.

Melanotan-II is not included on the Australian Register of Therapeutic Goods (ARTG) and it has not been assessed for quality, safety or efficacy by the TGA. Its development as a potential medicine was halted some years ago due to safety reasons.

Melanotan-I (afamelanotide) is approved as a prescription medicine to support the management of a rare incurable genetic disease, erythropoietic protoporphyria, but because of its side effects and highly specialised use, it should only prescribed and used under close medical supervision.

This makes it illegal to advertise either Melanotan I or II to the general public, and illegal to supply them without a doctors’ prescription. If advertising is found to contravene the Act, penalties including criminal and civil sanctions may apply irrespective of disclaimers.

Risks to consumers

The TGA has previously warned consumers against the use of Melanotan-I and Melanotan-II for tanning and weight loss.

Side-effects include darkened skin, increased moles and freckles, nausea, vomiting, loss of appetite, flushing of the face, involuntary stretching and yawning, and spontaneous erections.

The TGA counterpart in the United Kingdom also listed acne, kidney, brain and heart problems as reported side-effects.

No tan, fake or real, will protect skin against damage from sun exposure. Use of Melanotan to increase skin pigmentation artificially, will not protect against UV exposure the way a suitable sunscreen will.

Melanotan and melatonin (use as a sleep aid) are different substances, and the above warnings in relation to risks and side effects do not apply to melatonin products.

Warning to businesses supplying Melanotan

There are legal implications for advertising and supplying these products. Importing, exporting, manufacturing or supplying these products without a prescription is illegal and can lead to prosecution.

Melanotan, along with a range of other products that are marketed as image-enhancing, like peptides and synthetic human growth hormones, are increasing in popularity. Young people are particularly vulnerable to the marketing of these products as they seek 'miracle' solutions to body and performance pressures.

For clinics who may be using Melanotan products or advertising them to their clients, the TGA encourages them to familiarise themselves with the legal requirements of the advertising code and also the legal requirements around supply of prescription medicines.

Warning to advertisers, including social media influencers

Strict penalties including heavy fines and criminal prosecution can result from contravening the Therapeutic Goods Act and Advertising Code, such as advertising prescription substances directly to the public. The TGA has published guidance on advertising therapeutic goods on social media.

The TGA will take action in relation to illegal advertising of these products, including online advertising on social media platforms.

Contraventions of the advertising requirements under the Act can result in fines of up to $888,000 for individuals or $4.44 million for corporations, or civil penalties of up to $1.11 million for individuals or $11.1 million for corporations.

The TGA is working with social media and digital platforms to address allegedly unlawful advertising by users in relation to various therapeutic goods including Melanotan nasal sprays.

Purchasing medicines online

Australian consumers should exercise extreme caution when purchasing any medicines online.

Buying unapproved products online is extremely dangerous, because quality and safety simply cannot be guaranteed.

There is no knowing what ingredients are present in these products, and they could include substances that are harmful to your health.

Products purchased over the internet may be counterfeit, they may contain undisclosed ingredients, potentially harmful ingredients or contaminants, and may not meet the same standards of quality, safety and efficacy as those approved by the TGA. Using an unregulated product could be extremely detrimental to your health.

Despite some websites appearing to be Australian, these products are quite often coming from an overseas source. If they are detained at the border, you will not receive your goods, you will lose your money and there may be penalties if you are involved in promotion or sale of these products.

If a medicine needs a prescription in Australia, and you are told you can get it online without one – that should ring alarm bells.

Help the TGA to do its job: report illegal advertising

The TGA oversees the rules that govern the advertising of medicines and medical devices in Australia.

We have a system that relies, in part, on members of the public reporting misleading and illegal advertising to us so we can investigate. We encourage people to report suspected non-compliant advertising they see relating to Melanotan and other unapproved products.

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