In recent years, both domestic and imported produce have been linked to reported outbreaks of food-borne illness. Contamination in produce is of particular concern because produce is often consumed raw. The Food and Drug Administration (FDA) has primary responsibility for ensuring the safety of both domestic and imported fresh produce. The authors were asked to examine (1) the resources FDA has spent on fresh produce safety and how it has allocated those resources, (2) the effectiveness of FDA's actions to oversee fresh produce safety, and (3) the extent to which FDA's planned actions to enhance fresh produce oversight address identified challenges. For this review, the authors analysed FDA spending data and estimates and FDA activities data, reviewed FDA plans, and interviewed FDA officials and others.