Why the FDA Needs to Change Its Food Recall Policies

Add this to FDA’s growing list of things to do: improve the food recall initiation process.

According to a memorandum published on June 8, 2016, the Office of Inspector General (OIG) of the Department of Health and Human Services (which houses FDA) has preliminarily concluded that FDA does not have proper policies and procedures in place to effectively and efficiently initiate food recalls. Prior to the passage of the Food Safety Modernization Act (FSMA) in 2011, FDA could only request that companies voluntarily recall food products. FSMA gave FDA authority to require companies to recall food products, after first giving companies the chance to act voluntarily.

The problem, according to OIG, is that FDA has not established timeframes within which a firm should initiate a voluntary recall, either on its own or after an FDA request. The OIG “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” and the consequence is that the food products in question remain on market- and consumer- shelves, thereby putting consumers “at risk of illness or death for several weeks after FDA knew of potentially hazardous food.”

Although the OIG report focuses on the consumer impact on, the lack of policies and procedures to initiate a food recall also affects food companies when it comes to food safety and potential recalls. Without policies and procedures in place to require FDA to establish timeframes for moving a potential food recall forward, food companies are left with little guidance from FDA as to what is required of them. We’ve experienced and heard stories of FDA showing up at food facilities to taking potentially problematic samples as part of a routine audit or for an investigation, and then basically disappearing for weeks or even months, leaving food companies in the dark about what to do.

FDA needs to reexamine its internal policies and procedures for initiating food recalls and establish new ones that not only address the public health concerns but will also keep FDA from “ghosting” food companies in the midst of a potential recall. This issue is illustrative of a larger problem FDA has: lack of resources. Congress, through its passage of FSMA, imposed on FDA an enormous task but seemingly did not provide FDA with adequate funding to achieve all that FSMA requires. To be an effective partner with industry, FDA needs more funds devoted to improving the nation’s food safety system. Otherwise, FDA will likely be on the receiving end of more OIG reports identifying its inadequacies without the full capacity to address them.