FDA Warns of Injury, Scarring Risk from Mole Removal Products

OTC mole removal products may cause serious complications, including a failure to diagnose skin cancer, the FDA warns

Over-the-counter (OTC) products to self-remove moles and skin lesions, such as seborrheic keratosis, can lead to serious damage to the skin, infection and may delay skin cancer diagnosis and treatment, according to a warning issued by federal regulators.

The FDA issued a mole removal consumer warning on June 9, recommending consumers not use OTC products marketed for removing moles and other skin lesions.

Skin lesions like moles, seborrheic keratoses, or wart-like growths, and skin tags should only be removed by a trained medical professional in a doctor’s office, the agency warns. At-home products should not be used to remove these skin problems, and the agency reminds consumers that there are no FDA approved prescription or over-the-counter drugs for treating or removing moles, seborrheic keratoses, or skin tags.

OTC Mole Removal Risks

The FDA warns of potentially serious side effects from at-home mole removal products, which may be sold as ointments, gels, sticks, and liquids. These products may contain high concentrations of salicylic acid or other harmful ingredients. Even products claiming to be natural or organic are not harmless and can still cause serious side effects, according to the agency.

The agency indicates that, typically, the products don’t fully remove the lesion and the products can cause serious harmful side effects, including skin injuries, infection requiring antibiotic treatment, severe scarring and delayed skin cancer diagnosis and treatment.

The FDA says it has received reports of consumers who developed permanent skin injuries and infections after using products marketed as mole or skin tag removers. The end result is often worse than the original skin lesion. Typically, the products result in serious scarring and the end result is more noticeable than the original concern.

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Moles are clusters of skin cells that appear on the body. They come in different shapes and sizes and colors. Seborrheic keratosis is a warty growth, and a skin tag is a small piece of soft, fleshy skin-colored tissue that sticks out from the skin in ares where the skin rubs together like the neck or armpits.

These types of skin problems often worsen as we age, but  most are not cancerous, medical experts say. However, if the skin lesion is removed or the appearance is changed it may be more difficult for a doctor to determine if the lesion is cancerous or potentially harmful.

If consumers attempt to remove skin lesions at home and they are cancerous, but the skin cancer is not fully removed properly, it can continue to grow and can spread to other parts of the body.

Dermatologists are trained to identify suspicious lesions, examine them and help patients decide the best treatment, at times removing them. Removing skin lesions is not an at-home do-it-yourself project and can be dangerous.

If a skin lesion is changing or bleeding, you should seek medical attention, the agency advises. You should also see a healthcare provider to have the skin lesion evaluated for cancer.

Consumers who suffered side effects from OTC mole, seborrheic keratosis, or skin tag removal products should report the adverse event to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.


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