Amazon sold unauthorized mole removers, and the FDA isn’t happy about it

Amazon sold unauthorized mole removers, and the FDA isn’t happy about it

Unauthorized mole and skin tag removers sold on Amazon put the company in the crosshairs of the Food and Drug Administration, which sent a warning letter to the retail giant this month asking that it remove the products from its website.

The FDA warned Andy Jassy, Amazon’s CEO, that there aren’t any over-the-counter medications to remove skin tags or moles. As part of its research, the agency says it bought two of the offending products on Amazon: the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and the “Skincell Mole Skin Tag Corrector Serum.”

The “FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its letter. Moles should be examined by healthcare providers, the FDA says, and if people try to deal with them at home, there could be delays in cancer diagnoses.

A warning letter was also sent to two other companies that sell products to remove moles or skin tags from their websites. These were Ariella Naturals, Justified Laboratories and Justified Laboratories.

Warning letters are the FDA’s initial move against companies that violate US rules around the marketing and selling of unauthorized and unapproved drugs. The companies have 15 days to respond to the letters, which were all dated August 4th, explaining how they plan to address the issue and make sure the products are no longer sold. The agency can take more aggressive actions — like legal injunctions blocking the sale of the products — if the companies don’t comply with the law.

The two skin and mole removal products are no longer available for purchase on Amazon. But there are still multiple other mole and skin tag removal serums and creams for sale on Amazon, according to a search for “mole remover.”

Amazon has received warnings from the FDA before. In 2021, the FDA sent the company an untitled letter (a step below a warning letter), saying that the sale of sexual enhancement and weight loss products violated the law.

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