No DIY mole removal. FDA cracks down on Amazon, other companies for selling unapproved products

Even behemoths like Amazon aren’t immune to FDA warning letters. After the regulatory agency caught wind of the sale of unapproved mole and skin tag removal agents, it slapped the sellers with warning letters. 

The agency issued three warning letters to Amazon, Ariella Naturals and Justified Laboratories for selling unapproved mole and skin tag removal products via interstate commerce, an act in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). There are no over-the-counter, FDA-approved drug products for mole and skin-tag removal.

The FDA also doled out a consumer warning on the products, advising consumers to avoid the unapproved drugs due to potentially harmful side effects and risks, such as scarring, infection requiring antibiotics, and skin injuries. The agency has already received reports of people who developed permanent skin injuries and infections after using products labeled as mole or skin tag removals, according to the warning.

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations," an Amazon spokesperson said. "The products in question have been investigated and removed.”

The products are sold as ointments, gels, sticks and liquid that often contain high concentrations of salicylic acid and other harmful ingredients. People who buy these products for cosmetic usage should note that the product might cause scarring and discoloration to the surrounding skin, and the result “may be more distressing and noticeable than the original lesion,” the FDA warned.

The agency went on to list the dangers of treating moles and skin tags yourself, reminding consumers that sometimes what looks like a mole could be skin cancer, and seeking medical attention is always the best route.

“A product claiming to be “natural” or “organic” does not mean it is harmless,” the FDA noted. “Even products that claim to be “all-natural," herbal or homeopathic may contain high concentrations of salicylic acid or other ingredients that can cause injury or infection. So even if salicylic acid isn’t listed as an ingredient, that doesn’t mean the product is safe to use.”

The FDA urged the companies to address the matter outlined in the warning letters. Failure to respond with a written response within fifteen working days explaining the steps taken to address violations could result in “legal action including, without limitation, seizure and/or injunction.”