Individuals who were sentenced to death by lethal injection of drugs in Oklahoma and Texas (plaintiffs) filed a petition with the Food and Drug Administration (FDA). In their petition, the plaintiffs argued that the FDA had not approved the use of such drugs for human executions. For this reason, the plaintiffs contended that the states’ use of the drugs for human execution violated various provisions of the Federal Food, Drug, and Cosmetics Act (FDCA). In their petition, the plaintiffs requested that the FDA take certain investigatory and enforcement actions to prevent such violations. The FDA refused the plaintiffs’ request. The plaintiffs then made a similar request in federal court in a suit against the Secretary of Health and Human Services (Secretary) (defendant). The United States Supreme Court granted certiorari.