In January 2011, the FSMA amended the Federal Food, Drug, and Cosmetic Act to give the Food & Drug Administration (FDA) authority to order the recall of all food products when a company fails to voluntarily recall the products. Until passage of this act, FDA could ask companies to voluntarily recall adulterated or misbranded food products, but could not order them to do so unless the product was infant formula. FSMA directed the Government Accountability Office (GAO) to report on issues associated with FDA’s new authority to order food recalls. Last week, the GAO published its report, entitled “Food Safety: FDA’s Food Advisory and Recall Process Needs Strengthening”.

According to the GAO, the report “examines key government entities having the authority to order product recalls and how FDA implements its authority; (2) examines the challenges FDA faces, if any, in advising the public about food recalls or outbreaks of foodborne illnesses and examines how FDA has addressed these challenges; and (3) identifies mechanisms that may compensate the food industry for erroneously ordered food recalls or erroneous food-related advisories.” The report notes far-reaching implications of FDA’s expanded food recall authority, including the substantial risk to the public and industry if advisories are issued erroneously. Specifically, the report notes that unwarranted food safety advisories and recalls “can trigger serious economic losses for the food industry and discourage the consumption of healthful food, such as fresh produce.”

To strengthen FDA’s process for ordering recalls, the report recommends that the Secretary of Health and Human Services direct the Commissioner of FDA to take the following actions:

  • document FDA’s process for ordering food recalls in publicly available procedures;
  • document FDA’s process for ordering food recalls in regulations or industry guidance to include information on how the agency will weigh evidence on whether a recall is necessary;
  • document definitions for categories of ordered recalls in the agency’s central recall database; and
  • identify and implement ways to improve information sharing among its databases that contain recall data.

In addition, to address FDA “communication challenges in advising the public about food recalls and outbreaks,” the GAO recommends that FDA implement recommendations previously provided to FDA by others, including past recommendations from the GAO, Institute of Medicine, National Research Council and FDA’s own Advisory Committee on Risk Communication. These past recommendations encouraged FDA to implement a policy for communications during emerging events, develop a “coordinated plan” for crisis communications, and to consult with the U.S. Department of Agriculture (USDA) on “lessons learned in advising consumers to determine if any of USDA’s practices may be feasible at FDA.” While the report does not provide recommendations regarding whether to compensate the food industry for erroneously ordered food recalls, it does evaluate various mechanisms that might be available to compensate producers in the case of an erroneously ordered food recall or food-related advisory. Examples include a dedicated federal government program or federal government-subsidized insurance.

A copy of the report is available here.