The Food and Drug Administration (FDA) released a report Tuesday blaming Abbott Nutrition for triggering the nationwide baby formula shortage, while admitting that the agency botched the handling of the ensuing crisis.
The report was commissioned in May by Commissioner Robert Califf and the investigation was led by Dr. Steven Solomon, the director of the agency’s Center for Veterinary Medicine. Solomon concluded that the FDA failed to deliver whistleblower complaints to the proper parties in time, investigators for the agency lacked formula-specific training and the agency had a lack of scientific understanding of the pathogen that infected formula, Cronobacter Sakazakii.
Today, we released a comprehensive evaluation of our response to multiple reports of Cronobacter illness in infants consuming Abbott infant formula products, the conditions at Abbott’s manufacturing plant in Michigan, and issues that led to a shortage of formula in the U.S. pic.twitter.com/bFSQkjpOFq
— U.S. FDA (@US_FDA) September 20, 2022
“Simply put, if the FDA is expected to do more, it needs more,” Solomon said in a statement. However, the report placed the ultimate blame for the crisis on Abbott, which shut down its Sturgis, Michigan, plant in February after the FDA connected it to several babies who became ill and died from Cronobacter infections believed to come from the company’s formula.
“Conditions observed at the Abbott Nutrition facility were not consistent with a strong food safety culture,” the report reads. “The FDA does not have the authority to require manufacturers of infant formulas or certain medical foods to notify it when they become aware of a circumstance that could lead to a shortage of these products for U.S. consumers, or to require manufacturers to put in place risk management plans.”
The shutdown of Abbott’s plant led to a nationwide shortage of formula, leaving millions of infants with insecure food supplies, particularly those who require specialized formula. The shortage quickly became a crisis, leading to widespread criticism of not only Abbott but the FDA and Biden administration.
Abbott maintains that there is no proven link between its product and the Cronobacter infections. In May, executive Christopher Calamari took some responsibility for the shortage but continued to stress that there was no conclusive link, in his eyes, between Abbott and the infant deaths.
The plant was shut down in February, months after a whistleblower report was sent to the FDA outlining safety concerns at the facility. One failure of the agency, alluded to by FDA officials, is that it took so long for the proper officials to see the whistleblower complaint, and the top food safety official at the agency didn’t see it at all until the crisis was underway. (RELATED: Baby Formula Shortage May Have Been Caused By Factory Employee Playing With Stun Gun: Report)
Abbott restarted production in June before pausing once again due to flooding. Much of the shortage has alleviated, potentially due to the restarting of production and some steps taken by the government, such as loosening import regulations for formula.