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Smart Women's Choice was cited for marketing an unapproved new drug—a vaginal contraceptive cream—without FDA approval 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 and social media platforms (Facebook and Instagram) stating the product was "hormone-free, completely safe, natural birth control that cannot fail when used as directed," establishing it as a drug intended to prevent disease and affect body function. The FDA determined these marketing claims for an unapproved product constituted illegal introduction into interstate commerce.