Willie R. Tubbs, FISM News
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The news website Politico reported Monday that the Biden Food and Drug Administration (FDA) knew a factory had produced bacteria-tainted baby formula three months before the parent company issued a voluntary recall.
According to an article by Helena Bottemiller Evich, the FDA learned in November that Cronobacter sakazakii had been found in a batch of formula at a Michigan plant belonging to Reckitt, producer of the well-known formula brand Enfamil. However, it was not until February that 145,000 cans of Enfamil ProSobee Simply Plant-Based Infant Formula were officially recalled voluntarily by Reckitt.
“The batches in question tested negative for Cronobacter and other bacteria and this is an isolated situation,” a Reckitt press release shared through the FDA’s website reads. “After a thorough investigation, we have identified the root cause, which was linked to material from a third party. We have taken all appropriate corrective actions, including no longer sourcing this material from the supplier.”
Reckitt, which cited “an abundance of caution” as its rationale for the voluntary recall, said it had received no reports of any babies experiencing any health issues and that no other Enfamil products were affected.
“The health and safety of infants is our highest priority,” the release reads.
All of our products undergo rigorous and industry-leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration. It is for this reason that we have the highest level of confidence in the safety and quality of every infant formula we make.”
‘LESSONS HAVE NOT BEEN LEARNED’
While the Reckitt recall was comparatively smaller than the much more publicized U.S. recalls of a year ago and appears thus far to have not resulted in harm, some child advocates are puzzled as to why the FDA responded to the Reckitt issue in principally the same way as it did the larger recall.
“It’s stunning that it’s almost identical to what happened in 2021,” Politico quoted Mitzi Baum, CEO of STOP Foodborne Illness, as saying. “Lessons have not been learned.” She added, “FDA continues to be reactive. It’s the internal processes that have not been fixed, if this is happening again.”
Whatever one’s political leanings, it is inarguable that the risk of babies ingesting Cronobacter sakazakii requires urgency.
The CDC indicates that this type of bacteria, one that lives on dry food like powdered formula and herbal teas, can lead to infections that “are often very serious for babies who are younger than 2 months or were born prematurely; they can die. Infections can also be very serious for older people and people whose bodies have trouble fighting germs, like people with HIV, organ transplants, or cancer.”
REPUBLICANS HOLD HEARING TO ADDRESS FORMULA CRISIS
With the nation’s formula supplies still not fully recovered from last year’s shortage, the FDA has drawn immense criticism, particularly from Republicans, for being ineffective in its inspection processes.
Tuesday, the Republican-led House Oversight Subcommittee on Health Care and Financial Services grilled FDA representatives on a host of issues during a hearing.
The Abbott Nutrition infant formula plant in Sturgis, Michigan, produces 20% of the nation’s supply of baby formula.
Despite this data being readily available, @US_FDA did not prioritize the facility's inspection.
@RepLisaMcClain wants to know why. pic.twitter.com/JCWXd6UlnL— Oversight Committee (@GOPoversight) March 28, 2023
“The FDA is responsible for the safety of 78% of the U.S. food supply. But Biden’s FDA is not prioritizing food safety,” Rep. Lisa McClain (R-Mich.), the subcommittee chairwoman, tweeted.
In a different tweet, McClain blamed an FDA work-from-home policy for contributing to a lack of oversight.
“We know that the @US_FDA’s telework policies and lax approach to oversight left it unprepared to address infant formula shortages after the Sturgis facility was shut down,” McClain wrote.
Frank Yiannas, former FDA deputy commissioner for food policy & response, who testified before the subcommittee, did not dispute claims that formula supply issues had gone unaddressed.
“The nation remains one outbreak, one tornado, flood or cyberattack away from finding itself in a similar place to that of February 17, 2022,” Yiannas said.