FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

FDA issues warning to companies selling unapproved new drugs for mole and skin tag removal

The FDA recently issued three warning letters to companies (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. Introducing these products into interstate commerce is in violation of the Federal Food, Drug, and Cosmetic Act. There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags. The mole and skin tag removal products sold by these firms have not been evaluated by the FDA for safety, effectiveness or quality and require FDA approval.

The warning letters alerted the companies that failure to adequately address the violations may result in legal action. The companies have 15 days from receipt of the letter to respond to the agency with actions they have taken to address any violations.

  1. Patients should not be using unapproved online products for mole and tag removals- we have seen serious issues with these products including infections and scarring.
  2. Please see us immediately if you use these unapproved products, and have an issue. Also report your adverse event to the FDA- https://www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda