Unauthorized mole and skin tag removers sold on Amazon put the company in the crosshairs of the Food and Drug Administration, which this month sent a warning letter to the retail giant asking it to remove the products from its website.
There are no authorized over-the-counter drugs that remove moles or skin tags, the FDA said in its warning letter, which was addressed to Amazon CEO Andy Jesse. As part of its research, the agency says it has purchased two objectionable products on Amazon: “Desana Skin Tag Remover, Mole Remover and Repair Gel Set” and “SkinCell Mole Skin Tag Corrector Serum.”
“The FDA has safety concerns regarding drugs marketed OTC directly to consumers for these uses,” the agency said in its letter. Moles should be screened by healthcare providers, FDA says And if people try to deal with them at home, cancer diagnosis can be delayed.
The FDA also issued warning letters to two other companies selling mole and skin tag removal products on their websites: Ariella Naturals and Justified Laboratories.
The warning letter is the FDA’s initial move against companies that violate the US Rules surrounding the marketing and sale of unauthorized and unapproved drugs. The companies have 15 days to respond to the letters, which were all dated August 4, explaining how they plan to address the issue and making sure the products are no longer sold. If companies do not comply with the law, the agency can take more aggressive action – such as a legal injunction stopping the sale of products.
The two mole and skin tag removal products are no longer available on Amazon’s website. But according to a search for “mole remover,” there are still many other mole and skin tag removal serums and creams for sale on Amazon.
Amazon has already received warnings from the FDA. In 2021, the FDA sent the company an untitled letter (one step below a warning letter) stating that the sale of sexual enhancement and weight loss products violated the law.