Health warnings on "melanotan" products sold for human use
Clinuvel has warned consumers against the use of what it terms are "counterfeit", "illegal" drugs sold as "melanotan I and II" that are promoted by citing research on afamelanotide. [4]
On August 8, 2008 the Danish Medicines Agency (DMA) issued a warning[48] against the usage of any product called "Melanotan" purchased on the internet, noting that claims that imply that it has an, "effect" for protection against skin cancer, "has not been documented". The DMA further warned that Melanotan has not undergone tests for its effect and possible side effects, and is an "illegal medicinal product" that it is not licensed for usage in the EU or the USA.
The UK Medicines and Healthcare products Regulatory Agency issued a similar warning on November 17, 2008[49] stating that "We are warning people not to use this product. Don’t be fooled into thinking that Melanotan offers a shortcut to a safer and more even tan. The safety of these products is unknown and they are unlicensed in the UK. The side effects could be extremely serious. If you have used either of these products do not use them again and if you have any concerns you should seek advice from your doctor.”
The FDA issued a warning letter to an online vendor in January 2009 selling "Melanotan ONE" as advertisements of the products on their website were in breach of the Federal Food, Drug, and Cosmetic Act as the site was selling "new drug" products "intended for human use".[50]
The Irish Medicines Board (IMB) issued a precautionary safety alert on February 27, 2009 regarding the use of "the unauthorised medicine Melanotan (I and II)", sold as a powder for injection, stating that "Melanotan is not authorised in Ireland and therefore the IMB cannot guarantee the efficacy, safety or quality of this product."[2] In its release, the IMB announced that its tests had found the presence of microbial contamination in a vial of water sold together with melanotan powder which "would expose recipients to a risk of serious infection".
The Norwegian Medicines Agency has issued warnings in 2007[51] and 2009[3] about the use of "Melanotan" sold online.