The Food and Drug Administration (FDA) is cautioning consumers not to purchase skin tag and mole removal products online and sent warning letters to three companies for selling the unapproved items.
In the letter, the agency said the products were not evaluated for safety, effectiveness or quality and therefore violated the Federal Food, Drug and Cosmetic Act.
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The FDA has not approved any prescription or over-the-counter drugs for treating moles, seborrheic keratoses or skin tags. Using these products may cause injuries and scarring that may “jeopardize consumers’ health when used without consulting a health care professional,” the agency said in a statement.
The following companies were given 15 days to respond to the FDA’s Aug. 4 letter regarding the products cited below:
Amazon.com:
• Deisana Skin Tag Remover, Mole Remover and Repair Gel Set
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• Skincell Mole Skin Tag Corrector Serum
Ariella Naturals:
• Ariella Skin Tag Remover & Mole Corrector and Repair Lotion Set
• Ariella Skin Tag Remover and Mole Remover (two pieces)
Justified Laboratories:
• Skincell Advanced Mole Skin Tag Corrector Serum
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• Skincell Mole Skin Tag Corrector Serum
As of this article’s publication, Ariella Naturals continues to list the cited products on its website; Amazon and Justified Laboratories no longer have them listed.
Meanwhile, Amazon offers other mole and skin tag removal products that were not mentioned in the FDA’s warning letter.
Advice on removing skin lesions
The FDA recommends that moles be evaluated by a health care provider because self-diagnosis and treatment may lead to a delayed cancer diagnosis or even cancer progression.
Anyone with a mole or skin tag that is growing, changing, bleeding or painful should seek medical attention and not treat it themselves, the FDA said. Removing it on your own may change how it looks and make it difficult for a health professional to determine if the lesion is cancerous.
“If a skin cancer is not fully removed, it may continue to grow and possibly spread to other parts of your body,” the FDA said in a message to consumers. “Dermatologists and other skin specialists are trained to identify suspicious lesions, examine them and help patients decide the best treatment.”
Unapproved products may have high concentrations of potentially dangerous substances, even if they claim to be natural or organic. What’s more, they may not completely remove a skin lesion, and if they do, the result may be permanent damage to the surrounding skin, such as scarring or discoloration, that looks worse than the lesion did.
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