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Ariella Naturals was cited for marketing unapproved new drugs—specifically "Ariella Skin Tag Remover & Mole Corrector and Repair Lotion Set" and "Ariella Skin Tag Remover and Mole Remover"—in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made drug claims on its website (tryariella.com) establishing intended use for mole and skin tag removal without FDA approval. The FDA emphasized particular safety concerns, noting that no OTC drugs are legally permitted for mole or skin tag removal, and that such products could lead consumers to delay cancer diagnosis or forgo proven medical treatments.