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FDA evaluation of infant formula shows lack of urgency, mishandling of situation


— OPINION —

Last week, the U.S. Food and Drug Administration published the results of its internal review of the agency’s actions — and inaction — in connection with the February 2022 recall of powdered infant formula manufactured by Abbott Nutrition’s plant in Sturgis, MI. The FDA’s self-evaluation paints a grim picture. The report documents the ways the FDA mishandled the incident through a lack of urgency and many missed signals, resulting in a frightening nationwide shortage of infant formula – the sole source of nutrition for many infants and other people with certain metabolic conditions.

The agency’s evaluation evidences the often antiquated, dysfunctional and inadequate processes and structures the FDA relies upon to protect our food supply. For example, the report identifies critical areas for improvement including developing a specialized training program for investigators charged with inspection and oversight of infant formula and an inadequate process for whistle blower complaints that may have delayed its response.

While the FDA’s candor in acknowledging these deficiencies is somewhat refreshing, the fact that they even exist in 2022 demonstrates the FDA’s past inability or unwillingness to take decisive and necessary action to prevent this type of food safety disaster from reoccurring. The Food Safety Modernization Act, signed into law in 2011, was transformational because it focused on prevention and created a path for more effective and efficient food safety regulation. Yet, eleven years later, the Act’s full potential remains unrealized as the FDA continues to resist needed culture change and remains stuck operating in a reactionary mode without clear leadership on vital food safety issues.  

While the FDA evaluation neatly shares a collection of missteps involving Abbott Nutrition in a single document, it is devoid of much meaningful substance. The report presents the details of an investigation into the incident at the Sturgis plant that lacks depth, and the report makes no substantive calls for impactful agency change, leaving stakeholders disappointed once again. Most disheartening, the evaluation fails to address FDA’s fragmented food safety leadership. This deficiency should have been cited and explored under Finding 4, which instead simply acknowledges “a lack of clarity of roles,” without addressing the full scope of the problem or urging any solutions. Perhaps this lack of clarity would not have been an impediment to swift agency action at the Sturgis Plant had the FDA empowered a singular food safety expert with authority and oversight of the food program to manage and lead through this type of a crisis.

Similarly troubling are Findings 13 and 14 of the report, which identify gaps in understanding Cronobacter as impediments to the FDA’s response to the incident at the Sturgis plant and the effectiveness of the agency’s infant formula compliance program. Yes, Cronobacter is not a nationally reportable disease, but it is far from a new contaminant to powdered infant formula. Nonetheless, the report recommendation that follows Finding 14 suggests that updating a policy guide and resuming unannounced surveillance inspections will solve the problem. This proposal begs the question: how will these recommendations substantially reduce the possibility of contaminated powdered infant formula once again entering commerce and making people sick?  Moreover, why doesn’t the evaluation make a strong call to action to have Cronobacter added to the mandatory reportable list?  In the spring, Commissioner Califf testified that it is time and necessary for Cronobacter to be reportable to identify outbreaks. Indeed, reportable diseases are those considered to be of great public health importance.1 Since Cronobacter has a mortality rate of up to 80 percent in infants2, is there any legitimate disagreement that Cronobacter is a disease of great public health importance? The relative rarity of Cronobacter does not diminish its importance. Botulism is rare, yet it is on the reportable list.   

Stop Foodborne Illness is the “Voice for Safe Food.” We represent all consumers with a focus on those who have been affected by foods causing severe illness and, in many cases, death. We are raising our voice in response to the FDA’s evaluation because we know that consumers are the ones who incur the cost of deficient food safety systems and processes.

It is time for the FDA to engage in a transparent process that provides a clear roadmap to overcome the shortcomings its own report identified, including leadership accountability and culture change. The FDA’s mission is to ensure public health and safety, but the current fragmented leadership structure and lack of action will continue to fail to protect American consumers. Decisive, expert leadership must be empowered to correct the agency’s current trajectory and guide it toward a new and improved food safety culture.

1 https://medlineplus.gov/ency/article/001929.htm

2 https://jamanetwork.com/journals/jama/article-abstract/1911338

Sign our petition to get Cronobacter sakazakii on the mandatory reportable list.  Sign here: https://www.change.org/p/infants-are-dying-get-cronobacter-sakazakii-on-the-nationally-reportable-disease-list

Mitzi Baum

About the author: With more than two decades of experience at Feeding America, including time as the non-profit’s director of food safety, Mitzi Baum is the chief executive officer at the Chicago-based organization Stop Foodborne Illness. Baum worked at Feeding America for 23 years, helping guide the growth of what is now the largest hunger relief organization. It now includes more than 200 food banks and provides essential foods to 46 million people annually. Baum’s experience in the food sector began before her time with Feeding America. She had a 10-year restaurant management career, working in Atlanta, Cincinnati and Chicago, which included Chicago’s Lettuce Entertain You Enterprises. She is an adjunct instructor for Michigan State University’s Online Master of Food Safety program. She earned her Bachelor’s of Science in restaurant/hospitality management from Bowling Green State University and her Master’s of Science in Food Safety from Michigan State University.

 

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