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CooperSurgical distributed a direct-to-consumer video promoting Paragard (intrauterine copper contraceptive) that presented efficacy claims while failing to include any risk information, thereby misbranding the drug in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to submit the promotional video for FDA review at the time of initial dissemination as required by regulations. The FDA found these violations concerning from a public health perspective because the promotional communication created a misleading impression about Paragard's safety profile.