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FDA Warns Amazon, Other Vendors About Sale of Skin Tag Removal Products

No over-the-counter medications have FDA approval for the removal of moles and skin tags

By Physician’s Briefing Staff | August 10, 2022

The U.S. Food and Drug Administration on Tuesday issued warning letters to three companies, including Amazon, for selling unapproved products for removing moles and skin tags.

No over-the-counter medications have FDA approval for that purpose, and the Food, Drug, and Cosmetic Act prohibits interstate sale of unapproved drugs and cosmetics.

"It is the FDA's duty to protect public health from harmful products not approved for the U.S. marketplace," Donald Ashley, director of the compliance office in the FDA Center for Drug Evaluation and Research, said in a statement. "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."

Besides Amazon, the FDA issued warning letters to Ariella Naturals and Justified Laboratories. The agency emphasized that it has not examined the mole and skin tag removal products sold by these companies for safety, effectiveness, or quality.

The warning letters put the companies on notice that failure to address the violations cited by the FDA may result in legal action, including seizure. Once they receive the warning letter, the companies have 15 days to inform the agency of any corrective measures they have taken.

The FDA said Tuesday that it will continue to use all the tools available to protect public health and remove fraudulent or unproven drug products from the American market. The warning letters were just the first step.

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