Unauthorized mole and skin tag removers sold on Amazon put the company in the crosshairs of the Food and Drug Administration, which warning letter to the retail giant this month with a request 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 Jassy. As part of its investigation, the agency says it purchased 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 is concerned about the safety of drugs sold OTC directly to consumers for these uses,” the agency said in its letter. Moles should be examined by health care providers, FDA says and if people try to treat them at home, there can be delays in cancer diagnosis.
The FDA has also sent warning letters to: two other companies sell products for removing moles and skin tags on their websites: Ariella Naturals and Justified Laboratories.
Warning letters are FDA’s first step against companies violating the US rules on the marketing and sale of unauthorized and unauthorized drugs. The companies have 15 days to respond to the letters, all dated Aug. 4, explaining how they plan to address the issue and ensure the products are no longer sold. The agency can take more aggressive actions — such as legal orders blocking sales of the products — if the companies don’t comply with the law.
The two mole and skin tag removal products no longer appear to be available on Amazon’s website. But there are still several other mole removal serums and creams and skin tags for sale on Amazon, according to a search for “mole remover.”
Amazon has previously received warnings from the FDA. In 2021, the FDA sent the company a nameless letter (one step below a warning letter), stating that the sale of sexual enhancement and weight loss products has broken the law.