FDA was aware of bacteria in baby formula months before issuing latest recall

AP Photo/Andrew Harnik

The latest recall of baby formula was reportedly announced three months after Food and Drug Administration officials had become aware that some products at a major plant tested positive for deadly Cronobacter bacteria, showcasing the administration's lack of preparation and slow response to ongoing food safety issues in the United States.

According to an FDA spokesperson who spoke to Politico, the agency acknowledged being aware of a harmful bacteria present in baby formula well in advance of its removal from retail outlets.

In a press release dated February 20th, the FDA declared that Reckitt had disclosed the potential contamination of two batches of their Enfamil Prosobee Simply Plant-Based Infant Formula produced from August to September 2022 with Cronobacter sakazakii, a dangerous pathogen.

The Centers for Disease Control and Prevention reports that Cronobacter “infections in infants can be deadly.”

Months before the recall was announced, the FDA became aware that the formula had tested positive for contamination during an inspection in November, as confirmed by a spokesperson from the administration.

The FDA justified their lack of a more comprehensive follow-up by stating that the inspection was only a "limited" one, and that Reckett was still conducting an investigation into the source of the contamination.

In February, the FDA discovered that the company had not carried out a thorough "sanitation break," or cleaning, after the contamination had occurred.

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.

According to Politico, Mitzi Baum, the CEO of STOP Foodborne Illness, a non-profit organization focused on preventing foodborne illnesses, stated that the FDA has failed to learn from past incidents of contamination.

“It’s stunning that it’s almost identical to what happened in 2021,” Baum stated. “Lessons have not been learned.”

“FDA continues to be reactive,” Baum added. “It’s the internal processes that have not been fixed, if this is happening again.”

According to the FDA spokesperson, the recent surge in recalls demonstrates an enhancement in the system, as the recalled batches have become 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,” the 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.”