The owner of Melanocorp Inc., Brian Manookian, received a Warning Letter from the FDA about the illegal sale and marketing of Melanotan II. On the company’s web site, Melanotan II is marketed as a preventative against skin cancer and as a tanning agent. In addition to being advertised as an injectable tanning product, Melanocorp claims that Melanotan II protects against rosacea and skin cancer. However, according to the FDA, those claims are unsubstantiated and there is no evidence that the product is safe and effective for its labeled uses. Also, Melanotan II does not have an approved new drug application. Therefore, Melanocorp is violating federal law by introducing the product into interstate commerce. Consumers are urged not to inject products, particularly unapproved products, into their bodies without a doctor’s guidance. Use of unapproved products may lead to adverse side effects and bodily harm. Consumers who are using the Melanotan II tanning product should immediately stop, and if they suspect that they have experienced adverse effects from these products, they are urged to notify their doctor and the FDA.
For more information on this subject matter, please refer to the section on Defective and Dangerous Products.