ABSTRACT
Civil actions are legal actions that the Food and Drug Administration (FDA) takes against a firm. The civil actions discussed in this chapter are seizure and injunction. A specialized form of injunction, the consent decree, is also discussed. When the FDA initiates civil actions it is represented in court by the U.S. Department of Justice, and the federal district court system has jurisdiction over any and all FDA-initiated actions. These actions initially are heard at the federal district court level and can potentially reach the U.S. Supreme Court. Actions initiated by the FDA through its administrative authority are referred to as Administrative Enforcement, and the FDA also has the authority to seek both civil and criminal actions against an industry participant. The type of action that the FDA takes against an industry participant will depend on the degree of the conduct it seeks to stop: The more willful the conduct, the more likely either civil or criminal actions will be sought rather than administrative.
