FDA Acts on Unapproved Mole and Skin Tag Products Sold Online

Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

Two products sold on Amazon are the"Deisana Skin Tag Remover, Mole Remover and Repair Gel Set" and"Skincell Mole Skin Tag Corrector Serum," according to theThe warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.

"The agency's rigorous surveillance works to identify threats to public health and stop these products from reaching our communities," Donald D. Ashley, JD, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in the press release."This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products.

The statement emphasized that moles should be evaluated by a healthcare professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression. Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related

Source: News Formal (newsformal.com)

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