Food Safety Issues: FDA Judicial Enforcement Actions (CRS Report for Congress)
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| Release Date |
March 3, 2015 |
| Report Number |
R43927 |
| Report Type |
Report |
| Authors |
Emily M. Lanza, Legislative Attorney |
| Source Agency |
Congressional Research Service |
Summary:
The 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's administrative enforcement actions, see CRS Report R43794, Food Recalls and Other FDA Administrative Enforcement Actions, by Emily M. Lanza.
Injunctions: 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 industry participant 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. Unlike the legal standard for injunctions for private litigants, the government does not need to prove irreparable harm for a court to grant an injunction.
Seizure: The government may seize an article of food that is adulterated or misbranded in interstate commerce. A seizure is a civil action used by the federal government when the removal of adulterated or misbranded goods from interstate commerce is necessary to reduce consumer accessibility to those goods. The government proceeds by filing a Complaint for Forfeiture and obtaining a warrant for the arrest directing the U.S. Marshal to seize the article of food.
Criminal Prosecution: The FDA's Office of Criminal Investigations conducts and coordinates criminal investigations and prosecutions for violations of the FFDCA. Potential defendants of a criminal prosecution are strictly liable for violations of the act. The government grants potential defendants notice and a hearing before proceeding with any criminal investigations. The government may prosecute both corporations and corporate officials for violations of the FFDCA under the Park doctrine, which grants the government the ability to prosecute both corporations and corporate officials. The FFDCA also outlines various penalties for persons and/or companies found guilty of violations of the act.
Food safety and oversight, including enforcement actions such as those described above, are of a continual interest to Congress. H.R. 609 and S. 287, introduced in the 114th Congress, propose restructuring federal oversight of food safety and would impact the federal government's enforcement of various food safety issues.
