The Food and Drug Administration (FDA) investigated nine infant deaths after consuming baby formula made by Abbott Nutrition at its Michigan factory. The agency reported two infant deaths earlier but did not publicly disclose the other seven death cases.
The nine deaths were among the 128 complaints made to the FDA between December 1, 2021 to March 3, 2022. According to ABC News, they only reported the two deaths because they could not find scientific evidence directly linking the other cases to the Abbott Plant.
Seven more deaths and other Cronobacter sakazakii cases
The two infant deaths were among the four confirmed outbreaks by the U.S. Centers for Disease Control and Prevention (CDC). The other seven deaths were reported to the FDA via its consumer complaint system.
The FDA received 128 consumer complaints linked to drinking Abbott Milk products. The symptoms of these complaints were primarily consistent with those found in gastrointestinal infections. Thirty-one (31) babies complained of fever, 42 reported vomitings, 47 had diarrhea, and six said they had blood in their stool. Most of the babies had a combination of the mentioned symptoms.
According to Fox Business, there were 25 incidents categorized as "Life-Threatening Illness/Injury" and 80 instances of "Non-Life Threatening Illness/Injury" reported to the agency. The children's identities were kept private and only identified by reference numbers.
In a statement to Business Insider, the FDA said that based on their thorough review and investigation of the 128 complaints, they could include only four complaints in the case series associated with the Abbott Nutrition investigation.
Abbott said their company identified no causal relationship between its baby formula and the deaths. The company explained that it conducted microbiological testing on products before distribution, and the test revealed that no formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. The company added that all products tested by Abbott and the FDA during the facility inspection returned negative for Cronobacter sakazakii and Salmonella.
Abbott Michigan Plant investigation
The report of two infant deaths and the sick babies linked to the milk formula consumption prompted an investigation into the baby food plant. During the investigation, the agency said they found leaky roofs, broken equipment, condensation, and unsanitary surfaces in the plant. As per FDA commissioner Robert Califf, they found the conditions at Abbott Nutrition's plant in Sturgis, Michigan, "egregiously unsanitary," which allowed bacteria to spread. He also cited insufficient hand-washing by staff and water pooling at the plant. They also found several instances of Cronobacter sakazakii in the environment of Abbott's Sturgis factory.
The Abbott Nutrition plant was shut down in February, leading to a nationwide shortage. The formula shortage prompted the FDA and The White House to take unprecedented measures to import formula from Europe and Australia.
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