Federal health officials are taking too long to enforce recalls of potentially harmful or adulterated products—leaving consumers at risk for illness or death—because FDA does not have adequate policies or procedures to ensure companies take swift action. In a recent nut butter recall linked to a Salmonella outbreak and a cheese recall linked to Listeria monocytogene contamination, 165 days and 81 days passed, respectively, from the date FDA identified the adulterated product to the time the manufacturer issued a recall, government officials report.
According to the preliminary findings revealed in an ongoing audit conducted by the US Department of Health and Human Services’ Office of Inspector General (OIG), FDA is allowing some food safety investigations to stretch out for weeks without a recall, despite new legal authority granted to the agency under FSMA that can compel companies to initiate a recall.
For the investigation, OIG selected a sample of 30 imported and domestic voluntary food recalls that occurred during the past three years. OIG performed site visits at FDA district offices, conducted interviews and reviewed files related to the recalls. The officials found “FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the nation’s food supply. Specifically, we found that FDA’s policies and procedures did not instruct its recall staff to prescribe to the firms a time and a manner in which to initiate the voluntary recall. We also found that FDA did not have policies and procedures in place to ensure that firms initiated voluntary recalls promptly.”
FDA calls these delays “unacceptable,” but points out during the nearly three-year period reviewed by HHS, it oversaw thousands of recalls with an average recall initiation of less than a week. “While some food recalls are more complicated than others due to the nature of the product(s), contamination and investigation, the recall process should be as swift as possible, and the FDA is already taking concrete steps to address OIG’s concerns,” FDA says. “These steps include the establishment of a rapid-response team made up of agency leaders and the introduction of new technologies to make the process even swifter.”