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FDA Issues Warning Letters to Three Companies Selling OTC Mole and Skin Tag Removal Products

Amazon among firms cited for unapproved new drugs.

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By: Christine Esposito

Editor-in-Chief

The US Food and Drug Administration (FDA) has issued three warning letters to companies for introducing mole and skin tag removal products into interstate commerce that are unapproved new drugs, 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, asserts the agency. “It is the FDA's duty to protect public health from harmful products not approved for the U.S. ma...

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