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Wise Women's Choice was cited for marketing an unapproved new drug—a natural birth control cream claimed to immobilize sperm and prevent pregnancy—without FDA approval, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made drug claims on its product labeling, website (wisebirthcontrol.com), and Facebook group indicating the product was intended to affect human body function as a contraceptive, establishing it as a drug requiring premarket approval. The FDA identified that the company was actively offering and selling the unapproved product to U.S. consumers through its website and social media channels as of May 2023.