The FDA Has Cracked Down on Amazon for Selling Unapproved Skin Tag Removal Products

Health Information Relationships

The Food and Drug Administration (FDA) has issued a warning to three companies for selling unapproved skin tag and mole removal products. The companies—Amazon, Ariella Naturals, and Justified Laboratories—are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), per a statement, which says “there are no FDA-approved over-the-counter drug products for the removal of moles and skin tags.” The warning letters cautioned the companies that failure to address the violations could result in legal action.

“It is the FDA’s duty to protect public health from harmful products not approved for the U.S. marketplace,” an FDA attorney said in the statement. “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.” The products in question haven’t been evaluated by the FDA for safety or effectiveness.

In a consumer warning, the FDA said the products could potentially cause various health issues, including infection requiring antibiotics, skin injuries, and scarring. “In fact, the FDA has received reports about people who developed permanent skin injuries and infections after using products marketed as mole or skin tag removers,” per the warning.

The sale of such products could also lead to delayed treatment for serious health conditions. “Self-diagnosis and treatment of moles could lead to delayed [skin] cancer diagnosis and treatment, and even cancer progression,” the statement said. “Moles should be evaluated by a health care practitioner.”

Plus, in addition to identifying any cancerous or precancerous spots, a board-certified dermatologist can minimize scarring, control any blood loss, and help reduce infection risk when they remove a spot on your skin, per the American Academy of Dermatology Association (AAD).

The bottom line is that skin tag or mole removal isn’t a DIY project, and treating it as such can lead to minor issues at best, and harmful health complications at worst. When you notice a new spot on your skin, your best bet is to book an appointment with a health care provider ASAP to find out the best course of action.



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