Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring

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As we get older, we can develop new growths on our skin that we may consider unattractive. These lesions are parts of the skin that look abnormal and include moles, seborrheic keratoses (wart-like growths), and skin tags. Removing them isn't a do-it-yourself project, and it can be dangerous to try. Please see a health care provider to have them evaluated and removed, if necessary.

Currently, there are no U.S. Food and Drug Administration approved prescription or over-the-counter (OTC) drugs for treating moles, seborrheic keratoses, or skin tags. But there are potentially dangerous products being sold that claim to help remove these lesions. The products are sold as ointments, gels, sticks, and liquids and may contain high concentrations of salicylic acid (a chemical) or other harmful ingredients.

On Aug. 4, 2022, the FDA issued warning letters to Amazon.com, Ariella Naturals and Justified Laboratories for introducing mole and skin tag removal products not evaluated by the FDA for safety, effectiveness or quality, and require FDA approval. Introduction or delivery for introduction of these products into interstate commerce without an approved application is an additional violation of the Federal Food, Drug, and Cosmetic Act.

The FDA is advising consumers to avoid these products because of their potentially harmful side effects and serious risks. These risks include skin injuries, infection requiring antibiotics, scarring, and delayed skin cancer diagnosis and treatment. In fact, the FDA has received reports about people who developed permanent skin injuries and infections after using products marketed as mole or skin tag removers.

Moles are clusters of skin cells that can appear anywhere on your body. They come in different shapes, sizes, and colors – often brown, black, or the color of your skin tone. A seborrheic keratosis is a warty, often brown, growth. A skin tag is a small piece of soft, fleshy, skin-colored tissue that sticks out from your skin, usually in areas where the skin rubs together, such as the neck or armpits. Skin tags and seborrheic keratoses appear as we get older.

Most moles, seborrheic keratoses, and skin tags are not cancerous. But sometimes skin cancer can look harmless. Melanoma is one type of skin cancer that is particularly dangerous and can spread if not caught early.

If a mole or skin tag is growing, changing, bleeding, or is painful, you should seek medical attention. Do not treat the skin issue yourself. If you remove it or change how it looks, health care providers may have a harder time determining if it is skin cancer and coming up with an effective treatment plan. If a skin cancer is not fully removed, it may continue to grow and possibly spread to other parts of your body. Dermatologists and other skin specialists are trained to identify suspicious lesions, examine them, and help patients decide the best treatment.

Products marketed for the cosmetic removal of moles, skin tags, or other skin lesions usually contain high concentrations of salicylic acid or other potentially dangerous substances. These products often don't remove the lesion, or don't remove all of it. Worse, even if the lesion falls off, the product may cause permanent injury to the surrounding skin, such as scarring or discoloration. In some cases, the end result may be more distressing and noticeable than the original lesion, especially if you apply the product to your face. A product claiming to be "natural" or "organic" does not mean it is harmless. Even products that claim to be "all natural," herbal, or homeopathic may contain high concentrations of salicylic acid or other ingredients that can cause injury or infection. So even if salicylic acid isn't listed as an ingredient, that doesn't mean the product is safe to use.

You can report an adverse event involving any mole, seborrheic keratosis, or skin tag remover by using the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

If you have a question about a medication, call your health care professional or the FDA. The FDA's Division of Drug Information (DDI) will answer almost any drug question. DDI pharmacists are available by email, [email protected], and by phone, 1-855-543-DRUG (3784) and 301-796-3400.

08/10/2022