The Food and Drug Administration has said it has investigated nine babies’ deaths possibly linked to Abbott Nutrition formula
US authorities launched an investigation into the death of nine infants in the early 2021. They were all said to have consumed Abbott Nutrition baby food before they became ill and died, according to the Food and Drug Administration.
The FDA has only recently acknowledged the deaths of two infants and the two cases where babies became ill from ingesting formula made at the Abbott Nutrition Plant in Sturgis. According to the FDA, the formula could have been infected with the cronobacter Sakazakii bacteria.
The FDA could not determine the cause of any of these deaths beyond reasonable doubt. The Washington Post reported that in certain cases, there wasn’t enough formula to run a test. Other cases showed that infants with cronobacter infection were also infected using genomic sequencing. This was after an examination at Abbott Nutrition this spring.
Website eFoodAlert reported the first concern about the recipe. Phyllis Entis (food safety expert) obtained access to all complaints via a Freedom of Information Act request. The FDA received 128 consumer complaints between December 2021 to March 2022.
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Apart from the nine fatal cases, the complaints described 25 instances in which infants suffered “life-threatening illness/injury,” with 80 more babies sustaining “non-life-threatening illness/injury.” However, most of the complaints were not corroborated by medical professionals, as the Post reports.
With a lack of hard evidence pointing to a connection between consumption of the formula produced at the Sturgis plant and illness, the FDA said in a statement that based on its “thorough review and investigation of all 128 consumer complaints reported to the agency … only four complaints could be included in the case series associated with the Abbott Nutrition investigation.”
In its Friday own statement, the company maintained that no deaths related to products.
“Before distribution, Abbott performs microbiological tests on all products. No Abbott formula was distributed to customers that tested positive for Salmonella or Cronobacter Sakazakii. All the products retained by Abbott were tested and returned to the FDA for Salmonella and Cronobacter Sakazakii. Sturgis was clean of Salmonella.” the formula manufacturer said.
During testimony before Congress in late May, FDA Commissioner Robert Califf described the conditions at the company’s Sturgis plant as “Unsanitary and egregious” and “shocking.”
After the FDA reviewed the facility’s improvements, the Abbott Nutrition manufacturing plant reopened Saturday.
In February, the facility was closed by the government watchdog. Because Abbott Nutrition’s output accounted for about 40% of all baby formula sold in the US, the closure contributed to a shortage in the market, which has not yet been overcome.
