Melanotan-I and 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.
These products are not included on the Australian Register of Therapeutic Goods and have not been assessed for quality, safety or efficacy by the TGA. This makes it illegal to advertise or supply them. 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 using Melanotan-I, Melanotan-II or any other related injectable or ingestible 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.
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-I (Afamelanotide) and Melanotan II are listed in Schedule 4 (prescription-only medicines) of the Poisons Standard. This means they require regulation and monitoring by the TGA and medical authorities because they 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 in relation to risks and side effects do not apply to melatonin products.
Warning 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.
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.
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.
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 digital platforms to address allegedly unlawful advertising by users in relation to various therapeutic goods including Melanotan nasal sprays.