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Tipsheet

FDA Explains Why Additional Reported Infant Deaths Weren't Made Public in Connection to Abbott Investigation

AP Photo/Eric Gay

The U.S. Food and Drug Administration investigated more infant deaths than initially reported among babies who consumed powdered formula from Abbott Nutrition's Sturgis, Michigan, plant. 

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According to a Freedom of Information Act request obtained by eFoodAlert, FDA received reports of nine infant deaths between December 1, 2021, and March 3, 2022. In addition to the deaths, there were 25 reported consumer complaints classified as a “Life Threatening Injury/Illness” and 80 identified as “Non-Life Threatening Injury/Illness.”

By Feb. 28, the U.S. Centers for Disease Control and Prevention had announced five illnesses resulted in hospitalization, four from Cronobacter sakazakii and one from Salmonella Newport, with the former infection possibly having contributed to death in two patients.

In addition to these bacteria, other infections that are listed in the consumer complaints include proteus mirabilis, E. coli, clostridioides difficile (C. diff), shigella, and astrovirus.

In many of the most serious cases, identifying information such as the date of the adverse event, infant’s age, and key details have been redacted, but the following is what's known about the reported deaths:

Complaint ID #171222, reported December 1, 2021. Infant arrived to the ER in cardiac arrest. Cronobacter sakazakii and Proteus mirabilis. Infant had consumed Similac Pro-Total Comfort (Powder) infant formula, Lot #23495K80.

Complaint ID #172435, reported February 22, 2022. Vomiting, swollen organs, trouble breathing. Infant had consumed Similac Advance, Lot #34875K80.

Complaint ID #172477, reported February 22, 2022. Screaming. Infant had consumed Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, et al, infant formula powder, Lot #34869K80.

Complaint ID #172479, reported February 23, 2022. Fever, diarrhea, loss of appetite, vomiting. Infant had consumed Similac Advanced infant formula. Lot number not available.

Complaint ID #172541, reported February 24, 2022. Tested positive for Cronobacter sakazakii. Infant had consumed Similac PM 60/40, Lot #27032K800.

Complaint ID #172585, reported February 24, 2022. No details available. Infant had consumed EleCare infant formula, Lot number not available.

Complaint ID #172607, reported February 28, 2022. Cause of death and opinion pending further studies (Congenital). Infant had consumed Similac Elecare powdered infant formula, Lot #34771Z21 1306305

Complaint ID #172632, reported March 2, 2022. Salmonella meningitis, ventriculitis, vomit, diarrhea, seizures, bradycardia. Infant had consumed Similac Pro Advance infant formula, Lot #25598SHO 0557 015 SIMESPWD.

Complaint ID #172636, reported March 2, 2022. Salmonella. Infant had consumed Similac Total Comfort, Lot #26834K80.

(eFoodAlert)

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There is no evidence definitively linking Abbott Nutrition’s products to the babies who became ill or died, but eFoodAlert notes the common denominator is that each one of them reportedly consumed the company’s powdered formulas.

An FDA spokesperson said it investigated all 128 consumer complaints but for "various reasons" only four were included in the case series associated with the Abbott Nutrition investigation. 

"While we do know that Abbott Nutrition products were reportedly consumed by the infants in the 128 consumer complaints, all except those we reported were excluded from the case definition for this investigation for various reasons," an FDA spokesperson told Townhall in an email. 

These reasons include no clinical diagnosis of Cronobacter, the presence of pathogens that were not identified in the FDA's investigation of the Sturgis plant, or indications the infection stemmed from a source other than the formula. 

"Of the nine deaths, two were previously reported as part of the investigation. Based on whole genome sequencing of Cronobacter, we were unable to definitively demonstrate that these two deaths were attributable to consumption of Abbott Nutrition product," the spokesperson added. "There is no scientific evidence linking the other seven deaths with the evidence from those case complaints and our investigation of the Abbott Nutrition Sturgis plant, including extensive product testing, which is why these additional complaints were not previously made public in connection with the Abbott investigation."

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Abbott said in March that it found evidence of Cronobacter in its Sturgis facility though not where product was present. It also denied finding the bacteria in its finished products. Furthermore, the cultures the CDC received from environmental samples were not a genetic match to the bacteria found in the babies the CDC received cultures for, reports eFoodAlert.

FDA stresses that Cronobacter contamination can happen "anywhere in the supply chain, even in the consumer's home."

The latest report comes as questions continue to mount over the timeline of events leading up to FDA's warning to consumers and the company's recall, which prompted the ongoing formula shortage. 

A whistleblower complaint was first issued to the U.S. Labor Department’s Occupational Safety and Health Administration about the Sturgis plant in February 2021, a full year before the recall, according to the Wall Street Journal. OSHA informed the FDA and Abbott three days later. 

Similar allegations were made by a former Abbott employee eight months later, in October 2021.

That whistleblower informed senior FDA officials about troubling food safety violations at the Michigan plant prior to the infant deaths, including “lax cleaning practices, purposely falsified records and efforts by plant officials to keep FDA from learning about serious issues related to the plant’s own system for checking for bacteria in formula,” Politico reported.

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Abbott pushed back on the February 2021 allegations in a statement to ABC News, however, saying an internal investigation has "not been able to confirm the allegations."

"We believe this to be a former employee who was dismissed due to serious violations of Abbott's food safety policies," the company spokesperson told ABC News, noting the employee never discussed concerns about product safety while employed but that it’s another example of "a pattern of ever-evolving, ever-escalating allegations."

The FDA is facing allegations that it dragged its feet on the warnings, however. The agency conducted a “routine surveillance inspection” of Abbott’s plant in September 2021, but waited until Jan. 31 to follow up with another investigation. Recalls weren’t issued until Feb. 17, 2022. 

Most of the complaints shown in the FOIA request came after the recall.

Responding to the latest report about the additional infant deaths, Congresswoman Elise Stefanik told Townhall there must be “accountability.” 

“The Biden FDA repeatedly failed to listen to any warnings to address the baby formula crisis before it happened,” the New York Republican said in an email. “For months, they ignored my February letter until the shortage had already reached a crisis, and now we know the warnings go back even farther. 

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“As the mother of a nine-month-old, I know firsthand there is nothing more harrowing than a parent unable to feed their baby,” she continued. “This baby formula crisis never should have happened, and there must be accountability for the FDA’s failure to address these warnings and the unnecessary panic the Biden administration caused for families across America."

The Department of Health and Human Services’ Office of Inspector General announced last week it is opening an investigation into the FDA's response leading up to the recall. 

By the end of May, the formula out-of-stock rate reached 73.58 percent, according to Datasembly.

The FDA spokesperson told Townhall the agency is working around the clock to bring more infant formula to market, "including ensuring Abbott takes the appropriate corrective action to address insanitary conditions and resumes safe production at its Sturgis facility."

Abbott reopened its Sturgis facility on Saturday with select products expected to reach consumers later this month. 

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