T he U.S. Food and Drug Administration (FDA) has a statutory mission to ensure the safety of all food except for meat, poultry, and certain egg products over which the U.S. Department of Agriculture (USDA) has regulatory oversight. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the FDA has the authority to regulate the manufacturing, processing, and labeling of food, with the primary goal of promoting food safety. Congress has vested the FDA with the authority to take both administrative and judicial enforcement actions. The agency initiates and carries out administrative enforcement actions while judicial enforcement actions, including seizures and injunctions, require some type of involvement by the federal courts. While the FDA gathers information to recommend a judicial enforcement action, the Department of Justice represents the FDA before a federal court. This report focuses on the statutory authority for both the FDA and federal courts to initiate the following judicial enforcement actions: injunctions, seizures, and criminal prosecution. For more information about FDA administrative enforcement actions, see CRS Report R43794, Food Recalls and Other FDA Administrative Enforcement Actions , by [author name scrubbed]. Section 301 of the FFDCA prohibits the violation of any of the substantive provisions of the act and serves as the basis for the FDA's enforcement actions. Under Section 301, "causing" any of the prohibited acts as well as the act itself is prohibited. The specific enforcement mechanisms available to the agency to enforce the FFDCA are found throughout the act. Section 310(a) states that "all proceedings for the enforcement, or to restrain violations, of this [act] shall be by and in the name of the United States." Thus, private citizens do not have the right to sue to enforce the FFDCA. While the FDA may initiate these enforcement actions, the Department of Justice represents the FDA and the federal government in judicial enforcement proceedings. An injunction is a civil judicial order initiated against an industry participant to stop or prevent a violation of the FFDCA and to halt the flow of violative products in interstate commerce. An injunction also provides an opportunity for the involved parties to correct the conditions that triggered the violation before the FDA takes additional enforcement action. The FFDCA grants federal district courts with the jurisdiction to issue such an order. This section of the report first discusses types of injunctions available to the FDA and then describes the process for filing an injunction by the FDA. The section concludes by examining the legal standard considered by courts for initiating an injunction. The FDA can initiate three types of injunctions: a temporary restraining order, a preliminary injunction, and a permanent injunction. The FDA uses a temporary restraining order (TRO) to respond to an emergency situation where immediate, temporary relief is needed, such as responding to the presence of a public health threat, which the FDA must immediately control. A TRO generally lasts for 10 days, with a possible additional 10-day extension before the FDA must seek additional enforcement action if necessary. A request for a TRO filed in court by the FDA may be subject to an ex parte hearing (where the defendant is not present). Upon gathering evidence in support of a TRO, the FDA should file the request for a TRO within 60 days. As a general rule of practice, a court considers evidence older than 60 days to be "untimely" and insufficient to support a TRO request. A preliminary injunction is a court order that temporarily requires the industry participant to stop the allegedly violative behavior prior to the final determination of the merits of a legal claim. A preliminary injunction filed by the FDA may be subject to a full hearing where the parties present evidence by affidavit or by the testimony of witnesses. A permanent injunction is a final order of the court requiring the industry participant to stop the violative behavior. A federal district court generally issues a permanent injunction following a hearing where the court found that the industry participant violated provisions of the FFDCA and there is a likelihood that the violations would continue without judicial intervention. Defendants in an injunction proceeding and the government may also agree to a "Consent Decree of Permanent Injunction" as the result of a negotiated settlement. Under the consent decree, the industry participant and the government agree to terms relating to the resolution of the past violative conduct by the industry participant. The FDA, in partnership with the Department of Justice, first files a complaint for an injunction after the FDA has presented "timely evidence" of an FFDCA violation. Timely evidence includes the agency's identification of a health hazard or a gross consumer deception that requires immediate action to stop the violative practice. The agency may also seek an injunction if significant amounts of violative products owned by the same industry participant have entered interstate commerce or if an industry participant has refused a voluntary recall or has issued an inadequate recall. The agency may also choose to file for an injunction if a seizure is impractical or uneconomical. However, filing for an injunction does not preclude further enforcement action by the FDA such as a recall or criminal prosecution. The FDA can strengthen its request for an injunction action in the complaint by demonstrating that the agency provided the defendants with adequate notice of the alleged violation(s) and an opportunity to correct the alleged violation(s). While prior notice is not legally required, such information can demonstrate the defendant's resistance to FFDCA compliance to a court, and thus support the agency's request for judicial involvement with an injunction. Types of notice may include letters, meetings, and telephone calls. Notice is adequate if it is given to individuals with authority to prevent or correct violations and includes sufficient information to show that the proper action to correct these violations has not yet been taken. Courts have found that corporate officers as well as the corporate entity itself may be subject to FDA enforcement actions, including an injunction. The Supreme Court has stated that "the public interest in the purity of its food is so great as to warrant the imposition of the highest standard of care on distributors." Because corporate agents and corporate entities both have the ability to inform themselves of the conditions of their facilities, the FDA has the authority to seek relief against executives as well as legal corporate entities. Thus, in order to successfully state a claim against individual defendants for the purposes of an injunction, the government must allege that the individuals had responsible relationships related to the furtherance of the transactions that ultimately violated the FFDCA. Pursuing enforcement action against an agent or corporation does not preclude additional enforcement action against the other. The court in U.S. v. Blue Ribbon Smoked Fish, Inc. found that the injunction against the corporate entity did not preclude an injunction against the agents of that entity due to the agents' supervisory and managerial roles over the food processing and the corresponding responsibility for the sanitation of the plant. The FFDCA expressly authorizes federal district courts to grant injunctive relief to enforce its provisions. After the FDA and the DOJ have filed a complaint requesting an injunction, the court will determine whether the government's complaint meets the legal standard for an injunction. The standard for a statutory injunction initiated by the government, however, differs from the injunction standard for private litigants. A private litigant must establish that he or she is likely to succeed on the merits; that he or she is likely to suffer irreparable harm in the absence of preliminary relief; that the balance of equities weighs in favor of the party seeking the injunction; and that the injunction is in the public interest. The government, however, does not need to prove irreparable harm, as courts presume harm is present when a statutory violation has occurred. In order for the court to make such a presumption, the purpose of the statute at issue must focus on protecting public interest, such as food safety. The elevated standard of care that food processors must meet that is inherent in the FFDCA justifies this difference in legal standards. In order for the court to issue an injunction, the government must show that the defendant has violated the FFDCA and "some cognizable danger of recurrent violation" of the statute is present. When evaluating the risk of recurrent violations, courts may infer a likelihood of future violations from past unlawful conduct. More specifically, courts may consider "the bona fides of the expressed intent to comply, the effectiveness of the discontinuance and, in some cases, the character of past violations" to determine whether the defendant would continue to violate the FFDCA. For example, the court in U.S. v. Chung's Products found a danger of recurrent violations when the defendant refused to provide information about the conditions and records of a facility, impeded entry of FDA investigators, and repeatedly failed to put in place the FFDCA required controls for C. botulinum. This record of noncompliance, according to the court, showed a "cognizable danger of future violations necessitating a permanent injunction." The scope of the injunction depends on the specific legal violations. A court may adjust the scope of the injunction depending on the likelihood that future violations may occur and whether the injunction can prevent these recurring violations. The court in U.S. v. N.Y. Fish, Inc. found multiple FFDCA violations by the defendants and the absence of any credible actions by the defendants to remedy even the most serious of the violations. While the court acknowledged that an injunction where the defendant has already taken remedial measures is overbroad and unnecessary, the court found that a broad injunction was appropriate in this case because of the inaction by the defendants and the likelihood that alleged violations would continue. Courts generally find the possibility that an injunction may put a party out of business as irrelevant with regards to determining the necessity and scope of an injunction. In U.S. v. Blue Ribbon Smoked Fish, the defendant-corporate agents opposed the substance of the government's proposed permanent injunction, arguing that the injunction would force the company out of business.