The U.S. Food and Drug Administration (FDA) has issued a warning to three companies selling unapproved skin tag and mole removal products. Amazon, Ariella Naturals and Justified Laboratories violated the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to a statement that “there are no FDA-approved over-the-counter products for mole removal and skin tag removal.” Warning letter warns These companies, failing to address violations could lead to legal action.
“FDA has a responsibility to protect public health from harmful products that enter the U.S. market without approval,” FDA attorneys said in the statement. “The agency’s rigorous oversight is designed to identify threats to public health and prevent these products from entering our communities. This includes the involvement of online retailers like Amazon in the interstate sale of unapproved pharmaceuticals.” The product in question has not been reviewed FDA safety or efficacy evaluation.
In a consumer warning, the FDA said these products may cause a variety of health problems, including infections that require antibiotics, skin damage and scarring. “In fact, the FDA has received reports of people developing permanent skin damage and infections after using products marketed as moles or skin tag removers,” according to the warning.
The sale of such products may also result in delayed treatment of serious health conditions. “Self-diagnosis and treatment of moles can lead to delays in [skin] cancer diagnosis and treatment, and even cancer progression,” the statement said. “Moles should be evaluated by a healthcare practitioner.”
Also, in addition to identifying any cancerous or precancerous sites, a board-certified dermatologist can minimize scarring , control any blood loss, and according to the American Academy of Dermatology (AAD), when they remove spots from the skin, help reduce the risk of infection.
Bottom line is that removing a skin tag or mole is not a DIY project, and treating it this way can cause minor problems at best and harmful health complications at worst. When you notice a new spot on your skin, your best bet is to make an appointment with a healthcare provider as soon as possible to find out the best course of action.
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