T he U.S. Food and Drug Administration (FDA) ensures 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 granted 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 courts. Additionally, administrative enforcement actions, such as inspections and warning letters, tend to precede any judicial enforcement action. The Food Safety Modernization Act (FSMA) expanded the FDA's enforcement authority with new and broader measures. This report focuses on the FDA's statutory authority to initiate the following administrative enforcement actions: inspections, warning letters, recalls, suspension of registration, administrative detention, and related legal issues. Inspections

The FDA conducts inspections of regulated facilities in order to oversee a firm's compliance with the FFDCA and corresponding regulations. The FFDCA grants the agency with the enforcement authority to inspect both facilities and records. Warning Letters

Section 309 of the FFDCA permits the FDA to decline to institute formal enforcement proceedings for "minor violations of this [act] whenever [the agency] believes that the public interest [would] be adequately served by a suitable written notice or warning." These warning letters give recipient firms an opportunity to take voluntary corrective actions before the FDA initiates more formal enforcement action. Recalls

The recall process permits the FDA to enforce the adulteration and misbranding provisions of the FFDCA by encouraging industry participants to remove the product and correct the violation. This section concludes with an analysis of the due process concerns related to the mandatory recall enforcement authority. If the FDA has issued a mandatory recall, the FDA then issues a written order to the firm to recall the product. Suspension of Registration

The FFDCA requires all food facilities to register with the FDA and to renew such registration biennially so that the agency may effectively oversee all areas of food production. If the FDA determines that a food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the agency may suspend the registration of a facility that created, caused, or was otherwise responsible. Food facility registration and the suspension of such registration enable the agency to determine the location and source of an outbreak of food-borne illnesses and thus notify facilities that may be affected quickly and efficiently. Administrative Detention

Under Section 304 of the FFDCA, a designated FDA employee may order the detention of any article of food that is found during an FDA inspection if the employee has reason to believe that such article is adulterated or misbranded. Under this administrative detention authority, FDA may prevent holders of illegal articles from moving the food before a federal district court issues a warrant permitting the agency to seize the food. Upon such appeal, the FDA must then grant the claimant the opportunity for an informal hearing.
The U.S. Food and Drug Administration (FDA) ensures 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 granted the FDA 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 courts. Additionally, administrative enforcement actions, such as inspections and warning letters, tend to precede any judicial enforcement action. The Food Safety Modernization Act (FSMA) expanded the FDA's enforcement authority with new and broader measures. This report focuses on the statutory authority and legal issues relating to the following administrative enforcement actions: inspections, warning letters, recalls, suspension of registration, and administrative detention.
Inspections: The FDA conducts inspections of regulated facilities in order to oversee a firm's compliance with the FFDCA and corresponding regulations. The FFDCA grants the agency with the enforcement authority to inspect both facilities and records. However, the act narrowly tailors this authority in order to balance the protection of the facility owners' Fourth Amendment rights and the promotion of public health.
Warning Letters: Under the FFDCA, the FDA also has the ability to decline to institute formal enforcement proceedings for minor violations of the act if the agency believes that it could adequately serve public interest through written correspondence to violators. These warning letters give recipient firms an opportunity to take voluntary corrective actions before the FDA initiates a more formal enforcement action.
Recalls: The recall process permits the FDA to enforce the adulteration and misbranding provisions of the FFDCA by encouraging industry participants to remove the product and correct the violation. FDA regulations outline several steps that both the firm and agency must take when issuing either a voluntary or mandatory recall. FSMA granted the FDA the authority to issue a mandatory recall. FSMA also established the opportunity for an informal hearing, at which a firm may dispute these types of recalls, in order to protect the due process rights of the recalling firms.
Suspension of Registration: The FFDCA requires all food facilities to register with the FDA so that the agency may effectively oversee all areas of food production. If the FDA determines that a food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the agency may suspend the registration of a facility that created, caused, or was otherwise responsible. This enforcement authority is intended to permit the agency to determine the location and source of an outbreak of food-borne illness and thus notify facilities that may be affected quickly and efficiently.
Administrative Detention: Under the FFDCA, an FDA employee may order the detention of any article of food that is found during an FDA inspection if the employee has reason to believe that such article is adulterated or misbranded. Under this administrative detention authority, the FDA may prevent illegal articles from being moved or consumed until the court grants a seizure order.