Updated: FDA slaps Amazon with a warning letter for selling OTC mole removal products
The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “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 in its Aug. 4 warning.
Citing a Federal Register notice from 1990, the agency 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.
The Seattle-based online shopping market 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.”
An Amazon spokesperson told Endpoints, “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.”
The agency also sought to make clear that Amazon was the one that “introduced or delivered for introduction into interstate commerce” the products via its Fulfillment by Amazon service.
“Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was ‘fulfilled’ by Amazon; your website states, ‘With Fulfillment by Amazon (FBA), [sellers] store [their] products in Amazon’s fulfillment centers, and [Amazon] pick[s], pack[s], ship[s], and provide[s] customer service for these products,'” the FDA writes.
The agency previously warned Amazon last July for distributing dozens of products intended for sexual enhancement and weight loss.
Editor’s note: Article updated with Amazon comment.