News Brief: FDA Warns Consumers Not To Use Products Marketed for Removing Moles and Other Common Skin Lesions

On June 9, 2022, the Food and Drug Administration (FDA) issued a consumer advisory urging people not to use products that are marketed for the removal of moles and other skin lesions — such as seborrheic keratoses and skin tags — because of the risk of potentially dangerous adverse effects.[1] These risks include skin injuries, infections requiring antibiotics, permanent scarring or discoloration, and delayed skin cancer diagnosis and treatment.

The agency emphasized that there are currently no FDA-approved medications for treating moles, seborrheic keratoses or skin tags. Moles can occur anywhere on the skin and come in a variety of shapes, sizes and colors (frequently brown, black or tan). Most moles are benign, but a minority may develop into melanoma, a type of skin cancer. Seborrheic keratoses are benign, warty growths that are often brown, whereas skin tags are small pieces of soft, fleshy, skin-colored tissue that sticks out from your skin, typically where the skin rubs together, such as the neck or armpits. The FDA warned that products marketed for cosmetic removal of moles, skin tags or other skin lesions usually contain high concentrations of salicylic acid or other potentially dangerous chemicals. In many cases, use of these products will not remove all or even part of the lesion. And even if the lesion is removed, it may cause permanent damage to the surrounding skin.

The FDA advised that patients seek medical attention if a mole or other skin lesion is growing, changing, bleeding or painful. People should not attempt to treat skin lesions themselves. Importantly, the FDA noted that attempted self-removal of a skin lesion may make it harder for a doctor to determine whether the lesion is skin cancer and to come up with an effective treatment plan. Moreover, if a skin cancer is not fully removed, it may grow and possibly spread to other parts of the body.
 

References

[1] Food and Drug Administration. Products marketed for removing moles and other skin lesions can cause injuries, scarring. June 9, 2022. https://www.fda.gov/consumers/consumer-updates/products-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring. Accessed July 25, 2022.