FDA Issues Warning Letter for Injectable Tan Product

The US Food and Drug Administration (FDA) has issued a warning letter to Melanocorp Inc. concerning the sale and marketing of the product Melanotan II, which according to the agency, is both illegal and not FDA-approved.

The FDA recommends that consumers who are currently using Melanotan II stop using this product and consult their health care provider if they have experienced any adverse events that they suspect are related to its use. Melanotan II is an injectable tanning product that claims to be effective in protecting against skin cancer and rosacea.

According to the company's Web site, "Melanotan II is an analog of the peptide hormone alpha-melanocyte stimulating hormone that induces skin tanning. The drug was developed at the University of Arizona. Researchers there knew that one of the best defenses against skin cancer was a natural tan which has been slowly developed over weeks. They hypothesized that an effective way to reduce skin cancer rates in people would be to induce the body's natural tanning system to produce a protective tan prior to UV exposure."

According to the FDA, the company's claims are unsubstantiated and the product may pose a health risk. The agency also says the product should be regulated as a drug and not as a cosmetic, because of its claims. The product does not have an approved new drug application and because of this and the claims being made, the FDA believes the company is violating federal law.

Finally, the FDA cautions consumers about injecting any substance, particularly products that are not FDA-approved, into their bodies without the oversight of a licensed health care provider. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions. For more information, visit www.fda.gov/foi/warning_letters/s6491c.htm.