Loading…
Amazon.com, Inc. was found to be distributing unapproved new drug products—specifically "Deisana Skin Tag Remover, Mole Remover and Repair Gel Set" and "Skincell Mole Skin Tag Corrector Serum"—through its website and Fulfillment by Amazon service in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The FDA identified that no over-the-counter drugs are legally permitted for mole or skin tag removal, and the agency had safety concerns about these products because self-diagnosis and treatment of moles could delay cancer diagnosis or lead to cancer progression. Amazon was responsible for introducing these unapproved drugs into interstate commerce and failed to ensure products sold through its platform complied with drug approval requirements.