• The FDA sent warning letters to the three companies
  • The products are considered "unapproved new drugs"
  • Using such products may lead to delayed cancer diagnosis and treatment

The U.S. Food and Drug Administration (FDA) has sent warning letters to three companies over "unapproved new drugs" to remove moles and skin tags. One of them is Amazon.

The products being offered or distributed by the three companies haven't been evaluated by the FDA, the agency noted in a news release Tuesday. Since they are considered unapproved new drugs, introducing them to "interstate commerce" violates the Federal Food, Drug and Cosmetic Act (FD&C Act).

In fact, there is so far "no FDA-approved over-the-counter drug product for the removal of moles and skin tags," according to the FDA. This means no such products can be "legally sold."

One of the three companies is Amazon, which was cited by the FDA over its distribution of products "Deisana Skin Tag Remover, Mole Remover and Repair Gel Set" and "Skincell Mole Skin Tag Corrector Serum" via The FDA also sent a warning letter to Ariella Naturals over its "Ariella Skin Tag Remover & Mole Corrector and Repair Lotion Set" and "Ariella Skin Tag Remover and Mole Remover 2 pcs" products.

JB Exchange Inc./Justified Laboratories also received a warning letter for taking orders of "Skincell Advanced Mole Skin Tag Corrector Serum" and "Skincell Mole Skin Tag Corrector Serum" on its website.

The companies have 15 days to respond to the FDA after receiving the letters.

"If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration," the FDA noted in its letters.

According to the agency, selling such products could put the health of people at risk. Apart from the risks of scarring or injuries that may result from using them, people may opt to self-diagnose and self-treat these skin issues using the products instead of seeing a health care professional. This may lead to "delayed cancer diagnosis and treatment, and even cancer progression."

As the agency explained, "most moles, seborrheic keratoses, and skin tags are not cancerous." However, there are times when skin cancer can look harmless, too. And it can be quite dangerous if the cancer is not caught early on.

"Removing them isn't a do-it-yourself project, and it can be dangerous to try," the FDA noted. "Please see a health care provider to have them evaluated and removed, if necessary."

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. Reuters / ANDREW KELLY