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FDA Center for Food Safety and Applied Nutrition Acknowledges Delays Over Infant Formula Complaint

05/13/2023

Dr. Susan Mayne, currently Director of the FDA Center for Food Safety and Applied Nutrition, admitted that her Agency was tardy and unresponsive to epidemiologic evidence of outbreaks of Cronobacter infection in children attributed to contaminated infant formula in September 2021.  In addition, the Agency failed to take action following a detailed report from a credible whistleblower in October 2021.  The implicated plant operated by Abbott Nutrition in Sturgis, MI. was inspected on January 31st and was closed on February 17th concurrent with an extensive recall.

 

In a classic Washington understatement, Dr. Mayne averred, “These timelines are less than ideal” but again, in bureaucratic standard operating procedure, denied responsibility.

 

It is possible that the members of the House Oversight Subcommittee were engaged in gathering additional information, having previously heard from Frank Yiannas who criticized the structure of the FDA in response to food safety. He emphasized the ongoing vulnerability of the U.S. to future disruption associated with climatic events, a culture favoring inaction, mismanagement and the persistence of pathogens in the large plants responsible for the bulk of U.S. production.

 

Dr. Mayne, was criticized in a wide-ranging 2022 article on the FDA by investigative journalist Helena Bottemiller Evich in ProPublica. The review of the infant formula debacle commented adversely on her management style, inability to make decisions or to implement action.  Dr. Mayne previously announced that she will leave the FDA at the end of the present month.