THURSDAY, Sept. 6 (HealthDay News) -- The U.S. Food and Drug Administration has warned a Tennessee-based company, Melanocorp, Inc., to cease the sale and marketing of an injectable tanning product called Melanotan II on the basis that it is unapproved and mislabeled.
Melanotan II was marketed as a product that could protect against skin cancer and rosacea. Such claims can only be made by drugs, and Melanotan II does not have an FDA-approved new drug application.
"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, in a statement. "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."
Users of Melanotan II are recommended by the FDA to stop using the product and contact their physician if they experienced any adverse effects from the product. Health care providers and consumers can report any problems with Melanotan II by contacting MedWatch, the FDA's voluntary reporting program, by phone or online.
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