Amazon Receives FDA Warning Letter For OTC Mole Removal Products

Amazon Receives FDA Warning Letter For OTC Mole Removal Products
  • The FDA's Center for Drug Evaluation and Research released a warning letter sent to Amazon Inc's AMZN CEO Andy Jassy for selling mole removal products over-the-counter.
  • The letter explains that the company is responsible for "introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs."
  • "There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses," the agency said.
  • The FDA noted that its concerns are reflected in the OTC final monograph for wart remover drug products (now a final administrative order under section 505G of the FD&C Act), "which specifically warns against the use of OTC topical wart remover products on moles and birthmarks."
  • FDA said it specifically purchased two mole and skin tag remover products via Amazon, "Deisana Skin Tag Remover, Mole Remover, and Repair Gel Set" and "Skincell Mole Skin Tag Corrector Serum," which were delivered by Amazon.
  • Amazon has 15 days to respond, with the FDA adding, "If you believe that the products you distribute are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration."
  • In an emailed statement to Benzinga, Amazon's Spokesperson said “Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and removed.”
    Price Action: AMZN shares are down 1.31% at $137.59 during the market session on the last check Tuesday.
  • Editor's note: The post has been updated to include Amazon’s statement.

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