The U.S. Food and Drug Administration (FDA) has concluded its internal review of the agency’s response to the U.S. infant formula supply crisis, precipitated by a food safety incident involving Abbott Nutrition, a major formula supplier that issued a significant recall of Cronobacter sakazakii-contaminated product and halted production at its Sturgis, Michigan facility for several months. The report details key findings and recommendations that will allow the agency to respond more quickly during a public health emergency, which FDA Commissioner of Food and Drugs, Robert M. Califf, M.D., M.A.C.C., states the agency has already begun implementing.

The report is the result of information collected from over 40 interviews with more than 60 FDA staff members and leaders who were directly involved with the events that transpired during the infant formula crisis. The report focuses on aspects of the response that are within the agency’s purview and does not consider external factors, such as the limited number of existing infant formula manufacturers, weak links in the ingredient supply chain, and inadequate control of product distribution.

The report highlights five major areas where improvements are most needed, for which specific recommendations are provided:

  1. Modern information technology that allows for the access and exchange of data in real time to all responsible stakeholders
  2. Sufficient staffing, training, equipment, and regulatory authorities to fulfill FDA’s duties
  3. Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously
  4. Increased scientific understanding about Cronobacter, its prevalence and natural habitat, and how new knowledge may translate into appropriate control measures and oversight
  5. Assessment of the infant formula industry, its preventive controls, food safety culture, and preparedness to respond to events.

Although the recall and halted production of formula produced by Abbott Nutrition’s Sturgis facility was a large contributor to the infant formula supply crisis, interviews conducted for the report have revealed that there is no single action that can explain the events that occurred; rather, the report identifies a confluence of systemic vulnerabilities that demonstrate the need for continued modernization and investment in the expertise and tools that are required to adequately anticipate and address public health challenges.

The infant formula supply crisis underlined the need for an integrated, multidisciplinary approach to food safety incidents that includes scientific, clinical, nutritional, analytical, and inspectional expertise; legal processes; supply chain and policy considerations; and resources to support such multidisciplinary work. The report also identifies several areas in which FDA lacks specific authorities and resources, which the agency must secure to support its workforce.

In addition to the present report, Dr. Califf has requested a broader and more comprehensive evaluation—which is being conducted by an external group supported by the Reagan-Udall Foundation—of the structure, function, funding, and leadership of FDA’s Foods Program. Although the Reagan-Udall evaluation is still in progress, Dr. Califf stated that the agency will make systemic changes based on the recently released report as soon as possible, and that FDA has already begun implementing improvements such as enhancing the agency’s emergency response structure; streamlining the ways in which the public can contact FDA to report concerns with food products; and developing a sophisticated data system to track production, distribution, and purchase of infant formula.

Dr. Califf also urges industry stakeholders to do their part in strengthening the U.S. food supply chain as FDA has little authority to “compel many companies to ‘do the right thing’ without intervention,” and because the resiliency of the infant formula supply chain will rely on greater diversification of manufacturers, investment in new manufacturing facilities, and a commitment by infant formula producers to consistently and continuously adhere to FDA’s quality and safety standards. He urges industry to read the full report to learn how to support FDA in bolstering food safety and security for vulnerable consumers.