Our expert says:
Hi Kim 8, thank you for the question.
In 2007, the FDA issued a Warning Letter to an American online vendor illegally marketing melanotan II on the internet as a drug that prevents skin cancer and assists tanning. The FDA has not licensed melanotan II, and explained: "There is no evidence that the product is generally recognized as safe and effective [GRAS/E] for its labeled uses." The FDA concurrently gave a blanket warning advising consumers to, "Stop using Melanotan II, an unapproved product".
On August 8, 2008 the Danish Medicines Agency (DMA) issued a warning 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 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 another online vendor in January 2009 selling "10 MG MT 2 [Melanotan II] -American Lab" 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".
The Irish Medicines Board (IMB) issued a precautionary safety alert on February 27, 2009 regarding the use of "the unauthorized medicine Melanotan (I and II)", sold as a powder for injection, stating that "Melanotan is not authorized in Ireland and therefore the IMB cannot guarantee the efficacy, safety or quality of this product." 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 and 2009 about the use of "Melanotan" sold online, while a spokesman for the Australian Therapeutic Goods Administration warned consumers to be "very wary" of using it.
In late July 2010 the Swedish Medical Products Agency issued a warning against the usage of melanotan II.
The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal
advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.