Injectable Tanning Serum Subject to Counterfeit

A research peptide developed to prevent skin cancer has become a popular alternative for tanning beds and spray tans among young people in Ireland. The drug, called Melanotan, is not approved by any federal health agency but is available for purchase online or through dealers.

When: Developed in the late 80s, The Irish Times recently reported on the trend in its March 4, 2009 edition.

Where: The UK and Australia

How: Melanotan was originally created by the University of Arizona and developed by Clinuvel Pharmaceuticals in Australia. Despite having never been approved for use, it gained a popular following online.

Additional details:

Melanotan, a research peptide, was originally developed by the University of Arizona in the 1980s to prevent skin cancer. The peptide is a synthetic version of melanin, a naturally-occurring hormone that gives the skin pigment. Despite its use in clinical trials Melanotan has not been approved for use by any regulating agency.

Melanotan I, also known as afamelanotide, is currently under development at Clinuvel Pharmaceuticals in Australia. The manufacturer has warned consumers against buying unlicensed, counterfeit drugs being sold under the same name as Melanotan.

Melanotan II, or M2, is similar to Melanotan I but has been subject to fewer clinical trials and has been linked to increased arousal in men.

On February 7, 2007, the U.S. Food and Drug Administration (FDA) issued a warning to the owner of Melanocorp Inc., a Melanotan distributor out of Hendersonville, TN for the illegal sale and marketing of Melanotan II, which has not been approved by the FDA or any other regulatory agency. As of March 19, 2009, Melanocorp was still advertising and selling Melanotan II on its web site, noting that the drug was U.S.-made and was available to ship worldwide, with the United States as its only exception.

In November 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning against Melanotan saying, “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.” At the time of the release, the MHRA said it had contacted 18 different companies explaining that advertising or supplying Melanotan is illegal.

Irish Medicines Board (IMB) Chief Executive Pat O’Mahony had a stark warning for those tempted to try Melanotan. “People are taking a serious risk to their health. You know the old adage – your health is your wealth. You’re really playing a dangerous game. With an unlicensed product, you don’t know what you’re getting. This is a very risky practice.”

Official statements:

On September 5, 2007, the U.S. FDA released a statement saying, “This product is being mislabeled, marketed and sold illegally as a preventative against skin cancer and as a tanning agent,” said Steven Galson, M.D., M.P.H. director of FDA’s Center for Drug Evaluation and Research. “Protecting the public from unapproved products such as this that make unsubstantiated claims and may pose a health risk is a top priority at the FDA.”

On November 17, 2008, the UK MHRA released a statement saying, “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.”

On August 8, 2008, the Danish Medicines Agency released a statement saying, “Melanotan is a medicinal product for injection, but its effect and side effects have not been investigated, and we therefore warn against using it.”

Multimedia:

“Melanotan I, NBC News Report.” November 1991. Retrieved March 20, 2009.

“Tan without the Sun,” Health Central News. November 3, 2006.

Related sources:

“Paying too high a price for a tan?” The Irish Times. March 4, 2009.

“Suntan Drug Greenlighted for Trials,” Wired Science Blog. January 29, 2009.

“FDA Halts Sale Of Libido-Increasing Injectable Tanning Drug,” Consumerist. September 6, 2007.

“FDA Warns About Unapproved Product, Melanotan II,” FDA. September 5, 2007.

“UA-developed synthetic hormones speed a tan,” Arizona Daily Star. March 21, 2006.

“Evaluation of Melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study,” Science Direct. April 12,1996.