The Food and Drug Administration admitted knowing about a deadly bacteria found in infant formula months before the product was recalled from store shelves, an FDA spokesperson confirmed to Politico.
On February 20, the FDA issued a press release from Reckitt announcing that two batches of the company’s Enfamil Prosobee Simply Plant-Based Infant Formula manufactured between August and September 2022 had been possibly contaminated with a deadly pathogen, Cronobacter sakazakii.
The Centers for Disease Control and Prevention reports that Cronobacter “infections in infants can be deadly.”
According to an FDA spokesperson, the administration became aware that the formula had tested positive for contamination during a November inspection – months before the recall announcement.
The FDA claimed that it did not follow up more thoroughly because it was a “limited inspection” and Reckett was still investigating the cause of the contamination.
During a February inspection, the FDA found that the company had failed to complete a proper “sanitation break,” or proper cleaning, following the contamination.
Inspectors “obtained additional information which, when combined with the positive sample, led to the agency’s concerns about the adequacy of cleaning in relation to the production of these two product lots that are the subject of the recall,” the FDA spokesperson stated.
The FDA and Reckitt noted that no reports of illness related to the contamination had been reported.
Cronobacter contaminations have caused four formula recalls in the past year, more recalls than in the last ten years combined. In 2021, Abbott Nutrition recalled large quantities of its baby 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 contaminations.
“It’s stunning that it’s almost identical to what happened in 2021,” Baum said. “Lessons have not been learned.”
“FDA continues to be reactive,” Baum continued. “It’s the internal processes that have not been fixed, if this is happening again.”
An FDA spokesperson explained that the recent increase in recalls indicates an improved system since the recalled batches have gotten smaller.
“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,” a spokesperson stated. “Compared to the Abbott recall and the temporary closure of the Sturgis facility, the recent recalls are much narrower in scope, only impacting a few weeks of product with no additional facility closures.”
Reckett did not respond to a request for comment, Politico reported.
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