FDA Cracks Down on Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal
There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags.
The U.S. Food and Drug Administration issued three warning letters to three companies, including Amazon, for selling unapproved products for removing moles and skin tags, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags.
“It is the FDA’s duty to protect public health from harmful products not approved for the U.S. marketplace” says Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a news release. “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.”
The FDA has issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring. The sale of these products risks public health and may jeopardize consumers’ health when used without consulting a health care professional.
The FDA issued the warning letters to:
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 introduction or delivery for introduction of these products into interstate commerce without an approved application is an additional violation of the FD&C Act.
Today’s warning letters alert the companies that failure to adequately address the violations cited by the FDA may result in legal action including seizure and/or injunction. The companies have 15 days from receipt of the warning letter to respond to the agency with actions they have taken to address any violations. The FDA will continue to use all tools available to protect public health and remove fraudulent or unproven drug products from the U.S. marketplace. Warning letters are not meant to be final agency action.
The FDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. The FDA works to protect consumers by informing about the risks and how to buy online safely.