The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Hendersonville, Tenn.-based Melanocorp, Inc., for the illegal sale and marketing of the product Melanotan II on the company’s Web site.
Consumers who currently are using the product, which is not FDA-approved, are urged to stop using Melanotan II and consult their healthcare provider if they have experienced any adverse affects that they suspect are related to its use.
"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 the 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."
The Melanocorp Web site—which is currently disabled—advertises Melanotan II as an injectable tanning product and claims that it is effective in protecting against skin cancer and rosacea (a condition marked by redness and flushing of the skin). For such claims to be made, the product must be classified as a drug under the Federal Food, Drug and Cosmetic Act, and specifically as a new drug because there is no evidence that it is generally recognized as safe and effective for its labeled uses.
However, because Melanocorp, Inc. does not have an approved new drug application for Melanotan II, these claims are considered false and misleading—which means that the product’s introduction and delivery into interstate commerce violates federal law.
Melanotan II was developed at the University of Arizona in hopes of reducing skin cancer rates by inducing the body’s natural tanning system to produce a tan prior to UV exposure, because a tan is considered to be the body’s natural defense against UV rays. It was the second synthetic version of the peptide hormone alpha-melanocyte stimulating hormone (a-MSH) which tends to induce melanogenesis, a process by which the skin's tanning cells (melanocytes) produce the skin's tanning pigment (melanin). The first synthetic version, Melanotan, currently is being further developed by the Melbourne, Australia-based Clinuvel Pharmaceuticals Limited.
The risks run by patients who use unapproved new drugs could include adverse side effects from inappropriately prescribed medications, dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs. The FDA cautions consumers about injecting any substance, particularly products that are not FDA-approved, into their bodies without consulting a licensed healthcare provider.
Consumers and healthcare providers can notify the FDA of any complaints or problems associated with Melanotan II by filing a report with MedWatch, FDA's voluntary reporting program.
Sources: FDA, University of Arizona
