Roughly five months before an official recall was issued, the U.S. Food and Drug Administration (FDA) was already well aware of an alleged bacterial contamination issue at Mead Johnson’s infant formula production plant in Zeeland, Mich.
The agency recently admitted to such, revealing that the facility, which manufactures Enfamil ProSobee Simply Plant-Based Infant Formula, had been identified as containing Cronobacter bacteria.
An initial batch of formula was destroyed at that time, but another 145,000 cans of the stuff were released into the market with the FDA’s knowledge. A formal recall was issued five months later, and none of the recalled cans were found to contain Cronobacter, according to the FDA.
The U.S. Centers for Disease Control and Prevention (CDC) says that Cronobacter “can be deadly for young infants.” Symptoms in babies include poor feeding, fever, low energy, excessive crying, seizures, spine swelling, and bloodstream infections.
“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 said about the recall.
How come Cronobacter became such a problem during the coronavirus “pandemic?”
In a later statement, the FDA made a comparison to the more well-known Abbott recall, suggesting that the Johnson Mead one and others “are much narrower in scope, only impacting a few weeks of product with no additional facility closures.”
“Under current law, Mead Johnson was not required to alert the FDA of the positive test and choose [sic] to not alert the FDA to the positive test,” the agency also told Fox News.
The FDA also indicated that it is petitioning Congress for greater authority to require that companies report these kinds of things in the future so as to prevent recalls like this from having to occur.
“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,” an FDA spokesperson added in a statement to Fox Digital.
“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.”
As you may recall, 2021 was a really bad year for infant formula availability due to several recalls, including another involving Cronobacter at an Abbott Nutrition plant in Michigan. In that instance, at least four infants got sick from the product and two allegedly died.
The FDA compiled and released a 10-page report following the infant formula shortage that ensued, explaining that a whistleblower had complained about problems at the facility.
That same year, House Republicans launched an investigation into the FDA’s handling of the shortage, calling on FDA Commissioner Robert Califf to provide further details as to the agency’s “poor response” to the situation.
The FDA has since announced that it will not be firing any of its employees over the mishandling of the baby formula fiasco. Instead, the agency will “undergo an overhaul,” according to Fox News, which will include a “new, transformative vision,” Califf added.
The FDA’s regulatory authority will be consolidated under a new food safety plan called the “Human Foods Program.” How this new program will prevent situations like the baby formula recall from ever happening again remains unknown as the FDA has yet to produce any specific details about the plan.
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