A Whistleblower employed at the Abbott Nutrition plant in Sturgis, MI., addressed a 34-page expose of inappropriate practices to the FDA on October 19th 2021. Copies of the statement were sent by FedEx to top officials in the agency including the Commissioner, Dr. Janet Wodcock, the Director of the Center for Food Safety and Applied Nutrition, Dr. Susan Mayne and to Katherine Hermsen, Assistant Commissioner of the Agency Office of Criminal Investigation.
According to Politico, the Whistleblower was not interviewed by the FDA until late December 2021. The plant was subsequently inspected on January 31st 2022, disclosing deficiencies and confirming the substance of the allegations. These included improper cleaning practices, falsified records and deviations from standard operating procedures all of which may be regarded as contributing to potential contamination of infant formula with Cronobacter sakazakii and Salmonella Newport . This pathogen was responsible for illness, hospitalization and fatalities in infants consuming Similac™, Alimentum™ and EleCare™ products. Despite the findings on January 31st, batches of formula were only recalled more than two weeks later on February 17th.
The sequence of events and the obvious failure of FDA at a number of levels to respond was the subject of question in the House Appropriations Committee chaired by Rep. Rosa DeLauro who is concerned over food safety and related issues, based on her professional training. She stated, "I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls". She added, "I am equally concerned that the FDA reacted far too slowly to the report". This is based on the four-month period between the receipt of the report and the recall, during which infants may have been exposed to infection.
The structural and cultural problems at the FDA revealed in the Politico article reinforce the need for a dedicated Food Safety Agency that would incorporate the jurisdictions of both the Food Safety And Inspection Service of the USDA and the food-related remit of the FDA. Establishing a dedicated agency as in the E.U. would create a center for scientists, regulators and inspectors experienced in aspects of food safety including imported and domestically produced items. A new agency would be free of the restraints and culture of the FDA
The question remains whether a band-aid will be simply applied to the FDA in place of the required radical surgery involving transplantation.