The Therapeutic Goods Administration (TGA) urges consumers to steer clear of products containing 'melanotan'.
These products are usually marketed as injectable tanning products.
They are not included on the Australian Register of Therapeutic Goods (ARTG) and have not been assessed for quality, safety or efficacy by the TGA.
It is illegal to advertise and supply these products, and their use has proven serious side effects that can be very damaging to one's health.
A Current Affair recently featured a report on this issue, which also highlighted the dangers.
Risks to consumers
The TGA has previously warned consumers not to use Melanotan-I, Melanotan-II or any other related injectable tanning products.
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.
Melanotan-I (Afamelanotide) and Melanotan II are listed in Schedule 4 (prescription-only medicines) of the Poisons Standard. This means they require close regulation and monitoring by the TGA and medical authorities, and have the potential to cause harm if not used under the supervision and instruction of a health professional.
Melanotan and melatonin (use as a sleep aid) are different substances, and the above warnings do not apply to melatonin.
Advice to businesses supplying melanotan
These products are not approved for marketing or sale in Australia.
There are legal implications for advertising and supplying these products. Importing, exporting, manufacturing or supplying these products is illegal and can lead to prosecution.
The TGA is conducting a number of investigations into alleged illegal trade in performance and image enhancing medicines in the Australian market, which includes melanotan.
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.
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 impounded 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 advertising they see relating to melanotan and other unapproved products.
This can be done by submitting an advertising complaint to TGA.
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.
Strict penalties including heavy fines and criminal prosecution can result from contravening the Therapeutic Goods Act and Advertising Code.
