Friday, June 09, 2023

Biden FDA Knew of Tainted Baby Formula Months Before Recall Ordered

In another chapter in the ongoing saga of the Biden administration’s baby formula supply woes, the Food and Drug administration (FDA) is admitting it had knowledge of a deadly bacteria detected in a type of baby formula months before the brand was recalled.

Last November, the FDA inspected the Mead Johnson plant in Zeeland, Michigan — where Enfamil ProSobee Simply Plant-Based Infant Formula is made — and was informed Cronobacter bacteria had been detected in September.

Even after the initial contaminated batch was destroyed, another 145,000 cans for the formula were recalled in February in response to the discovery of the bacteria in the formula, although no additional instances of bacteria were found in the recalled cans of formula, the FDA indicated.

So, if you’re following the timeline, the February recall was issued five months after the discovery of Cronobacter, which the Center for Disease Control and Prevention (CDC) warns “can be deadly for young infants.” Symptoms in babies include fever, poor feeding, excessive crying, low energy, 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 explained to POLITICO about the recall rollout.

Compared to the Abbott recall two years ago, the FDA continued in a statement, the recent recalls are much narrower in scope, only impacting a few weeks of product with no additional facility closures.

In 2021, the United States experienced a shortage of baby formula after the detection of Cronobacter caused the shutdown of an Abbott Nutrition production plant in Michigan. The bacteria-tainted formula reportedly led to at least four infant illnesses, including two deaths.

“It’s stunning that it’s almost identical to what happened in 2021,” Mitzi Baum, CEO of STOP Foodborne Illness, a group that advocates on behalf of victims of outbreaks, told POLITICO in reference to the time it took the from the positive test to recall. “Lessons have not been learned.”

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

A House oversight subcommittee has launched an investigation into the latest formula crisis.

Food safety advocates say they are looking forward to greater scrutiny of the formula safety issues by Congress, though there is significant concern the issue could be lost within partisan debate.

the FDA told Fox Digital that “Under current law, Mead Johnson was not required to alert the FDA of the positive test and choose to not alert the FDA to the positive test.” The agency added that it is requesting further authority from Congress to require companies report things that may have prevented the Enfamil recall.

“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. 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,” an FDA spokesperson told Fox Digital.

In a 10-page report following the shortage, the FDA blamed outdated systems for failing to address a whistleblower complaint about problems at the facility.

House Republicans recently opened an investigation into the agency’s handling of the 2021 baby formula shortage, calling on FDA Commissioner Robert Califf to provide further information regarding their “poor response” to the situation.