The United Kingdom’s Medicines and Healthcare products Regulatory Agency has warned against using Melanotan purchased on the Internet. I’ve written about Melanotan before — it is a drug that tans the skin, increases the libido, and suppresses appetite. It has been in testing for the better part of a decade, but is still not approved for sale in the United States or Europe.
This hasn’t stopped US-based Melanocorp from selling the drug just the same. In 2007, the U.S. Food and Drug Administration issued a warning letter to Melanocorp to stop selling melanotan in the United States,
Melanocorp, Inc. advertises the product Melanotan II on its Web site as an injectable tanning product, with additional claims that it is effective in protecting against skin cancer and rosacea (a flushing and redness of the skin). These claims cause Melanotan II to be classified as a drug under the Federal Food, Drug and Cosmetic Act, as well as a new drug because there is no evidence that it is generally recognized as safe and effective for its labeled uses. This product does not have an approved new drug application. The product’s introduction and delivery into interstate commerce, therefore, violates federal law. 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from inappropriately prescribed medications, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs.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 the oversight of a licensed health care provider.
Issuance of this Warning Letter is consistent with FDA’s focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. 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.
Melanocorp stopped taking orders for Melanotan in the U.S. shortly afterward, but apparently still sells to consumers in other countries. According to The Guardian, there are at least 18 companies that sell Melanotan on the Internet.