The Food and Drug Administration has admitted it knew about the deadly bacteria found in infant formula months before the product was withdrawn from stores, an FDA spokesperson confirmed. Politico.
On February 20, the FDA issued a press release from Reckitt, confirming that two batches of Enfamil Prosobee’s purely plant-based infant formula manufactured between August and September 2022 are deadly pathogens. announced that it may have been contaminated with Cronobacter sakazakii.
of Centers for Disease Control and Prevention reported that Cronobacter “can be fatal in infant infections.”
According to an FDA spokesperson, the agency learned that tests in November, months before the recall announcement, tested positive for contamination in the formula.
The FDA claimed it was a “limited examination” and did not follow up more thoroughly because Reckett was investigating the source of the contamination.
During an inspection in February, the FDA found that the company had failed to complete proper “sanitary breaks” or proper cleaning following contamination.
Inspectors “received additional information that, when combined with the positive samples, led to agency concerns about the adequacy of the cleaning associated with the production of these two product lots subject to the recall,” an FDA spokesperson said. .
The FDA and Reckitt noted that there have been no reported cases of contamination-related illness.
Cronobacter contamination has resulted in four formula recalls in the past year. That’s more than the number of recalls in the last decade combined. In 2021, Abbott Nutrition recalled a large quantity of infant formula under similar circumstances.
Mitzi Baum, CEO of STOP Foodborne Illness, a nonprofit dedicated to preventing foodborne pathogens, told Politico that the FDA has not learned from previous contamination.
“It’s amazing that it’s almost identical to what happened in 2021,” said Baum. “No lessons learned.”
“The FDA remains reactive,” Baum continued. “If this happens again, it’s an internal process that hasn’t been fixed.”
An FDA spokesperson explained that the recent increase in recalls indicates that the system has improved as smaller batches are being recalled.
“As part of FDA’s oversight to ensure safe and nutritious infant formulas, the FDA recently worked with manufacturers through inspections and ongoing meetings to limit the scope of these recalls and reduce market exposure. We have minimized disruption to the public,” a spokesperson said. “Compared to the Abbott recall and the temporary closure of the Sturgis facility, the recent recall is much narrower in scope, affecting only weeks of product without additional facility closures.”
Reckett did not respond to a request for comment, Politico reported.
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