Business Talk

In Warning Letter to Amazon, FDA makes a case for closer oversight of third-party sellers

A new Warning Letter issued August 10 to Amazon CEO Andy Jassy makes the case that it’s the company’s problem – and not just its third-party sellers – that regulators are able to find unapproved drugs for sale on the company’s website, even though the company itself isn’t making the products. It’s not the first time Amazon has attracted the FDA’s scrutiny, although it could be a harbinger of additional regulatory actions to come.

On August 4, 2022 the FDA sent a Warning Letter to Amazon, referencing certain drug products sold on its website.

  • In the letter, FDA notes that “products intended for mole and skin tag removal” are available on the company’s website. As the agency explains, these products are not FDA approved for use without a prescription and pose dangers to patients (who may mistake a cancerous lesion for a mole and delay needed care). As of the time of this article’s publication, many such products are still available for sale, including some that have paid for a “sponsored” placement in Amazon’s search results.

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