FDA Issues 3 Warning Letters to Companies Selling Unapproved Drugs for Mole and Skin Tag Removal

The US Food and Drug Administration (FDA) issued 3 warning letters to Amazon, Ariella Naturals, and Justified Laboratories for adding unapproved mole and skin tag removal products into interstate commerce.¹ The unapproved drugs violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Currently, the FDA has not approved any OTC drugs for the removal of moles and skin tags.

The FDA’s purpose is to protect consumers from harmful food or drug products that are not approved in the United States. In the instance of Amazon, online retailers must be more diligent about the products that are sold through their website, and that no products violate federal laws.

The warning letters informed the 3 companies that these products have not been evaluated by the FDA for safety, effectiveness, or quality. The companies have also been informed that failure to address the violations could result in legal actions, including seizure and/or injunction. Once the companies have received their warning letter, they each have 15 days to respond to the FDA with steps they have taken to address the violation of the FD&C Act.

Warning letters are only 1 of the many steps the FDA takes to ensure the public’s health and safety. The FDA will continue to prevent any fraudulent or unapproved drugs from entering the US marketplace.

The FDA encourages all consumers and health care providers to report any adverse events to the MedWatch Adverse Event Reporting Program via mail, fax, or online. This aids the FDA in its role of protecting consumers’ safety from unsafe food or drug products.

Reference:

1. FDA issues warning letters to three companies for selling unapproved new drugs for mole and skin tag removal. FDA. Published August 9, 2022. Accessed August 10, 2022. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-three-companies-selling-unapproved-new-drugs-mole-and-skin-tag-removal