FDA WARNING_LETTER - Amazon.com, Inc. - August 09, 2022

The FDA issued a Warning Letter to Amazon on August 4, 2022, regarding the distribution of unapproved new drugs on www.amazon.com. The FDA purchased "Deisana Skin Tag Remover, Mole Remover and Repair Gel Set" and "Skincell Mole Skin Tag Corrector Serum" through Amazon's website, which were then distributed via Amazon's Fulfillment by Amazon service.

These products are classified as "drugs" under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to their intended use for mole and skin tag removal, which affects the body's structure or function. The FDA states there are no legally sold over-the-counter (OTC) drugs for mole or skin tag removal, and has safety concerns, including potential delayed cancer diagnosis and scarring.

The products are considered "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), as they are not generally recognized as safe and effective for their intended uses. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(