FDA admits to knowing about deadly bacteria found in baby formula factory months before product recall

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Republicans investigate Biden admin's response to baby formula shortage

Rep. Lisa McClain, R-Mich., and Louisiana mother Amber Bergeron discuss the formula shortage and Enfamil raising prices.

The Food and Drug administration (FDA) admitted to having knowledge of a deadly bacteria detected in a type of baby formula months before the brand was recalled.

In November, the FDA inspected the Mead Johnson plant, where Enfamil ProSobee Simply Plant-Based Infant Formula is made, and was informed that Cronobacter bacteria had been detected at the Zeeland, Michigan facility, in September.

Despite the initial contaminated batch being destroyed, another 145,000 cans were recalled after the bacteria was found in the formula. No bacteria was found in the recalled cans of formula, according to the FDA.

The February recall came around five months after the discovery of Cronobacter, which the Center for Disease Control and Prevention (CDC) says "can be deadly for young infants." Symptoms in babies include fever, poor feeding, excessive crying, low energy, seizures, spine swelling, and bloodstream infections.

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Baby formula was in short supply during 2021 (Paul Hennessy/SOPA Images/LightRocket via Getty Images)

"As part of the FDA’s oversight to ensure safe and nutritious infant formula, the agency’s more recent engagements with manufacturers through inspections and ongoing meetings has limited the scope of these recalls and minimized disruptions to the market," an FDA spokesperson told Politico regarding the recall. 

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"Compared to the Abbott recall… the recent recalls are much narrower in scope, only impacting a few weeks of product with no additional facility closures," the FDA said in a statement.

Reckitt, which owns Mead Johnson, did not respond to Fox News Digital's request for comment.

FDA told Fox Digital that "Under current law, Mead Johnson was not required to alert the FDA of the positive test and choose to not alert the FDA to the positive test." The agency added that it is requesting further authority from Congress to require companies report things that may have prevented the Enfamil recall.

Robert Califf testifies before a Senate Committee on Health, Education, Labor and Pension hearing on the nomination to be commissioner of Food and Drug Administration on Capitol Hill in Washington, Tuesday, Dec. 14, 2021. (Manuel Balce Ceneta)

"It was only during an unrelated inspection of the company that FDA discovered the positive test, and was told that analysis to the cause was ongoing. The FDA has reviewed conditions during recent inspections of powdered infant formula manufacturers, including routine surveillance inspections, for-cause inspections to follow up on consumer complaints, and other interactions with manufacturers," an FDA spokesperson told Fox Digital.

In 2021, the United States experienced a shortage of baby formula after the detection of Cronobacter caused the shutdown of an Abbott Nutrition Michigan production plant. The bacteria reportedly led to at least four infant illnesses, including two deaths.

In a 10-page report following the shortage, the FDA blamed outdated systems for failing to address a whistleblower complaint about problems at the facility.

Baby formula  (Scott Olson)

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House Republicans recently opened an investigation into the agency's handling of the 2021 baby formula shortage, calling on FDA Commissioner Robert Califf to provide further information regarding their "poor response" to the situation.

This story has been updated to reflect additional comment from the FDA. Fox News' Julia Musto and Anders Hagstrom contributed to this report.