FDA warns Amazon, two other companies to cease unlawful sale of mole, skin tag removers
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The FDA has issued warnings to three companies for selling unapproved products to remove moles or skin tags, according to a press release.
Warning letters were sent to Amazon, Ariella Naturals and Justified Laboratories, which are all said to be in violation of the Federal Food, Drug and Cosmetic Act by selling products that claim to remove moles or skin tags.
There are no over-the-counter products approved for this indication and moles should be evaluated by a health care professional, the letters said.
"It is the FDA's duty to protect public health from harmful products not approved for the U.S. marketplace," Donald D. Ashley, JD, director of the FDA's Center for Drug Evaluation and Research Office of Compliance, said in the release. "The agency's rigorous surveillance works to identify threats to public health and stop these products from reaching our communities. This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law."
The warning letters informed the three companies they had 15 days to respond with actions they will take to address the violations.
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