The Food and Drug Administration (FDA) has issued warning letters to 3 companies selling unapproved mole and skin tag removal products.

According to the FDA, the warning letters were issued to Amazon.com, Ariella Naturals, and Justified Laboratories. The Companies are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as these products, which claim to remove lesions, including moles and skin tags, have not been evaluated by the FDA for safety, effectiveness, or quality. 

The products are being sold as ointments, gels, sticks, and liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. There are currently no FDA-approved over-the-counter medications for removing moles and other skin lesions.

The agency also issued a consumer warning stating that the removal of these lesions is not a “do-it-yourself project”, and can be dangerous, leading to injuries and scarring. It may also result in a delayed skin cancer diagnosis if not properly evaluated.

“It is the FDA’s duty to protect public health from harmful products not approved for the US marketplace” said Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities. This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law.”

Health care professionals and consumers are urged to report any adverse events related to these unapproved products to the FDA’s MedWatch Adverse Event Reporting program.

References

  1. US Food and Drug Administration. FDA issues warning letters to three companies for selling unapproved new drugs for mole and skin tag removal. News release. Accessed August 10, 2022. https://www.prnewswire.com/news-releases/fda-issues-warning-letters-to-three-companies-for-selling-unapproved-new-drugs-for-mole-and-skin-tag-removal-301602622.html
  2. US Food and Drug Administration. Products marketed for removing moles and other skin lesions can cause injuries, scarring. Accessed August 10, 2022. https://www.fda.gov/consumers/consumer-updates/products-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring