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FDA Sends Amazon a Warning Letter

At issue is company's distribution of products illegally marketed as drugs.

Ad Alert

FDA Sends Amazon a Warning Letter

At the beginning of every year, TINA.org looks into its crystal ball to conjure up a list of deceptive ad trends consumers need to be wary of that year. At the top of this year’s list was “Amazon’s liability.” TINA.org wrote:

Amazon’s liability as a marketer and seller of third-party products has been a hot topic in the courts for a couple years now. But in 2022, we may expect to see more lawsuits seeking to hold Amazon accountable for the marketing and sale of third-party products on its site, given the large role Amazon plays in not only the marketing and sale but also the distribution of these products to consumers.

The FDA didn’t sue Amazon but it did send the company a warning letter earlier this month over its distribution of two mole and skin tag removers illegally marketed as drugs. The FDA wrote in its Aug. 4 letter, which it addressed to Amazon CEO Andy Jassy:

FDA purchased the mole and skin tag remover products, “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum” through your website, www.amazon.com. These products, which are defined as drugs by [the Federal Food, Drug, and Cosmetic Act, because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or intended to affect the structure or any function of the body] … were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.

Currently, there are no FDA-approved remedies for treating moles or skin tags.

While the products at issue in the FDA warning letter are no longer available for purchase on Amazon, searching for them on Amazon leads to other products intended for mole and skin tag removal. In search results for the since-removed Deisana product, there is even a video showing how another skin tag remover works. The purported remedy is a sponsored product, which means if a consumer clicks on it, Amazon makes money. Cha-ching.

TINA.org reached out to Amazon for comment. Check back for updates.

Find more of our coverage on Amazon (and its brands) here.


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