Democrats, battered with low approval ratings from voters over high inflation and soaring gasoline prices, are deflecting blame for the latest crisis: a massive baby formula shortage.
Party leaders are blaming Abbott Nutrition for scarce baby formula after the Food and Drug Administration shuttered its Sturgis, Michigan, plant citing safety and quality issues.
Abbott officials deny their formula is responsible for four infant illnesses that caused two deaths and said they are ready to reopen the plant.
The FDA shuttered the plant in February after four infants became sick and Abbott issued a formula recall.
On Monday, the Justice Department got involved.
The feds filed a complaint and a proposed consent decree that would allow the plant to reopen but would require Abbott to take specific actions to ensure safety and compliance with FDA regulations.
“The actions we are announcing today will help to safely increase the supply of baby formula for families,” Attorney General Merrick Garland said while announcing a complaint filed in federal court in Michigan. “The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”
The closure has led to a widespread shortage of some of the most popular and most specialized brands of infant formula.
“There were babies who died from taking this formula, so they were doing their jobs,” White House press secretary Jen Psaki said last week in a final appearance at the podium before leaving the Biden administration.
Her replacement, Karine Jean-Pierre, kept the focus on Abbott. “We cannot forget how we got here,” she said. “Abbott closed the facility because of safety concerns from the FDA.”
Transportation Secretary Pete Buttigieg also blamed the company, not the supply chain slowdowns. He told CBS News, “Fundamentally, we are here because a company was not able to guarantee that its plant was safe.”
Abbott, however, said it found no evidence linking the Sturgis plant to the formula consumed by the sickened infants, and the company said it implemented all the corrective measures sought by the FDA weeks ago after a lengthy inspection.
The Centers for Disease Control and Prevention this month closed its investigation into the infant illnesses linked to the powdered formula, but the FDA is keeping the facility closed. Production was halted on all but a limited number of formula cans for babies with emergency needs. The agency said it is requiring Abbott to expand testing protocols to ensure no contaminated baby formula leaves the plant.
Democrats have been under tremendous pressure to alleviate the shortage. Republicans have been hammering the party over empty store shelves and for neglecting panicked parents while allowing pallets of formula bought by the federal government to be shipped to the southern border to feed the children of illegal immigrants.
As pressure has mounted on the Biden administration, FDA Commissioner Robert Califf told NBC News that it was “entirely within the realm of possibility” that Abbott would be able to fully reopen the Sturgis plant under a two-week plan submitted to the FDA by company officials.
Abbott officials said it would take an additional six to eight weeks to get the formula back on store shelves after the FDA clears the company to open.
Abbott denies responsibility for infant illnesses and deaths.
Company officials said the particular strain of Cronobacter sakazakii bacteria that made the infants ill was not found in their plant after an FDA and company investigation.
“The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness,” Abbott officials said in a statement. “Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.”
Abbott officials said an open container of formula in one of the infant’s homes tested positive for Cronobacter but did not match strains detected in the Abbott plant.
Among the four infants who became ill, two died, but the FDA did not directly blame the bacteria. Cronobacter, an FDA statement said, “may have contributed to the cause of death for both patients.”
The FDA is also under the scrutiny of House lawmakers, who say the agency moved too slowly to crack down on Abbott even after they were made aware of “a potential link” between an infant sickened with Cronobacter sakazakii and formula produced in the Abbott plant in September, four months before Abbott voluntarily recalled the implicated formula.
House Appropriations Committee Chair Rosa L. DeLauro, Connecticut Democrat, has called on the Health and Human Services Department inspector general to investigate the FDA’s response and whether it is capable of monitoring baby formula safety.
“The delay between the September inspection and the recall raises serious questions about the FDA’s ability to adequately regulate the infant formula industry,” Mrs. DeLauro wrote in March. “It seems evident that the FDA could have acted sooner to prevent additional illnesses and deaths after the initial inspection.”
Two weeks ago, Ms. DeLauro said she received a 34-page report from a former Abbott employee who accused the company of covering up quality and safety issues in the plant. The letter said Abbott failed to adequately test formula for contamination before putting it on store shelves.
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility,” Ms. DeLauro said at an oversight hearing on April 28. “We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA.”
Abbott has denied the accusations.
“This former employee was dismissed due to serious violations of Abbott’s food safety policies,” Abbott officials said in a statement. “After dismissal, the former employee, through their attorney, has made evolving, new and escalating allegations to multiple authorities.
“Abbott is reviewing this new document and will thoroughly investigate any new allegations.”
The company continues to deny it is the cause of the four infant illnesses.
“A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility,” company officials said.
Ms. DeLauro rejected Abbott’s conclusion that the infants were not sickened from formula from the Sturgis plant, and she said Democrats should make clear to parents why there are shortages.
“We want to make sure they understand we want to protect them from the contaminated product that was on the market from Abbott nutrition,” she told MSNBC on Sunday.