The chairman of a U.S. House subcommittee has demanded that the FDA provide Congress with an explanation of why it took so long to deal with an ongoing outbreak linked to infant formula.
Democratic Rep. Raja Krishnamoorthi, chairman of the House Subcommittee on Economic and Consumer Policy, sent a letter to FDA Commissioner Dr. Robert Califf seeking information about the outbreak of Cronobacter sakazakii infections.
The subcommittee Krishnamoorthi chairs is part of the House Committee on Oversight and Reform, which is the principal oversight committee for the House and has broad authority to investigate “any matter” at “any time” under House Rule X.
The outbreak Krishnamoorthi’s letter concerns have hospitalized at least four babies. Two have died and those deaths remain under investigation. The outbreak is linked to three brands of powdered infant formula produced by Abbott Nutrition at its Sturgis, MI, factory. The brands involved are Similac, Alimentum, and EleCare.
“Newly released FDA inspection reports show that Abbott Nutrition failed to maintain sanitary conditions and procedures at the plant for years. FDA must do more to protect vulnerable infants from foodborne illnesses and warn their caregivers of potential dangers,” Krishnamoorthi wrote to Califf.
“FDA was first on notice of the contaminated formula in September 2021, when Minnesota health authorities alerted FDA that they had traced one infant’s Cronobacter sakazakii infection back to a formula produced at the facility.”
The representative reminded the Food and Drug Administration commissioner that the FDA had inspected the Abbott facility in September 2021 and noted unsanitary conditions at the plant, but did not issue a warning. The FDA received two more reports of Cronobacter sakazakii infections tied to the facility between September and December.
The FDA issued a warning to consumers on Feb. 17 this year, and Abbott recalled the three implicated formulas. The company later recalled a lot of its Similac PM 60/40.
“Between January 31 and March 18, 2022, FDA again inspected the facility. Shockingly, FDA found that the Abbott facility failed to maintain clean surfaces for handling formula. FDA also found a history of Cronobacter sakazakii contamination at the plant, including eight such instances between 2019 and 2022,” Krishnamoorthi stated in his letter.
“FDA is tasked with protecting all Americans from life-threatening foodborne illness outbreaks but fell short in protecting vulnerable infants from a contaminated formula. FDA must do more to ensure no lives are lost, or babies sickened, due to delayed inspections and late consumer warnings.”
The U.S. representative specifically requested that the FDA provide the Subcommittee on Economic and Consumer Policy with answers to two key questions. He set a deadline of April 7, 2022, for the agency to answer:
1. Why did FDA wait until Feb. 17, 2022, to issue a warning to consumers not to use certain powdered infant formula produced at the Abbott Nutrition facility in Sturgis, Michigan?
2. What steps, if any, is the FDA taking to ensure that it more quickly inspects facilities, and issues consumer warnings, after reports of foodborne illnesses linked to particular facilities?
Krishnamoorthi also demanded that the FDA produce all documents and communications, from Sept. 1, 2021, to the present, by April 7, 2022, related to the following topics:
- Reports from Minnesota health authorities regarding Cronobacter sakazakii or Salmonella Newport infections traced back to the facility; and
- FDA’s steps to address the reported infections at the facility.
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