GAO Report: FDA’s Food Recall Process Needs Strengthening

By Riëtte van Laack

The U.S. Government Accountability Office ("GAO") released a report on FDA’s food recall process prepared in response to a congressional directive in the Food Safety Modernization Act ("FSMA"), which provided FDA with mandatory recall authority for foods. In evaluating FDA’s implementation, the GAO considered how other government entities with recall authority, such as the Consumer Product Safety Commission, handle recalls and advise the public.

Since FSMA was enacted in 2011 and therefore FDA’s mandatory recall authority is relatively new, there is no information about an actual mandatory recall of food. Moreover, although FDA has had mandatory recall authority for other product categories such as medical devices, the Agency has rarely used that authority. Nevertheless, GAO developed some recommendations for FDA to more effectively implement and strengthen its new mandatory recall authority. Specifically, GAO recommends that FDA:

  • publish its currently internal document describing the steps it takes to order a food recall;
  • document its process for ordering food recalls in regulations or guidance, including the process of weighing whether a recall is warranted and whether the standard of proof for a mandatory recall is met;
  • define categories of ordered recalls in FDA’s central recall database;
  • determine and implement ways to improve the sharing of information among databases that contain recall information.

GAO also examined the challenges FDA faces in advising the public about food recalls or outbreaks of foodborne illness. GAO acknowledged that FDA faces a number of communication challenges when advising the public about food recalls or outbreaks of foodborne illness, ranging from balancing technical accuracy with timeliness of communications, to coordinating messages with other agencies and meeting the needs of diverse public audiences. For example, a delay in communication can result in more illnesses and deaths, but a premature communication can trigger major financial losses for the food industry and deter the consumption of certain healthful foods. GAO further recognized that FDA has taken steps to begin meeting these challenges, but concluded that FDA has yet to fully address recommendations from the GAO and others to fashion a comprehensive food recall communication policy and related implementation plans.

GAO recommends that FDA implement recommendations from others to address FDA communication challenges when advising the public about food recalls and outbreaks. Specifically, GAO recommends that FDA:

  • develop a policy for communications during emerging events;
  • implement a coordinated plan for crisis communication; and
  • consult with USDA on USDA’s experiences in advising consumers about recalls and determine whether those experiences may be helpful for FDA.

Although a significant part of the report is devoted to a discussion of possible options to compensate the food industry for erroneously ordered recalls, the report does not include a specific recommendation for a mechanism.