Respondents (R) were sentenced to death by lethal injection of drugs. Rs petitioned the FDA and argued that the drugs that were going to be used were not by their labels approved for use in human executions. Rs argued that such unapproved usage violated the Act's provisions against misbranding. Rs claimed that the FDA was required to approve the drugs as safe and effective for human execution before they could be distributed in interstate commerce. Rs requested that the FDA take various investigatory and enforcement actions to prevent these violations. The FDA commissioner refused to take the requested action; only when serious danger to public health or a blatant scheme to defraud would require the FDA to take action and since lethal injection was a duly authorized governmental act, the FDA could not interfere. Rs sought judicial review of that action.