Chairman Krishnamoorthi Launches Inquiry into FDA Response to Contaminated Baby Formula After Two Infant Deaths
Washington, D.C. (March 24, 2022)—Today, Rep. Raja Krishnamoorthi, Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf requesting information about FDA’s delayed response in addressing contaminated infant formula now linked to five hospitalizations and two deaths.
“FDA is tasked with protecting all Americans from life-threatening foodborne illness outbreaks, but fell short in protecting vulnerable infants from contaminated formula,” Chairman Krishnamoorthi wrote. “FDA must do more to ensure no lives are lost, or babies sickened, due to delayed inspections and late consumer warnings.”
According to reports, Minnesota health authorities alerted FDA in September 2021 that an infant’s Cronobacter sakazakii infection had been traced back to formula produced at an Abbott Nutrition Facility in Sturgis, Michigan. Between September and December, FDA received two more reports of Cronobacter sakazakii infections, as well as a complaint about a Salmonella Newport illness, linked to the facility. In September 2021, the agency inspected the facility and noted unsanitary conditions, but failed to issue a public warning about the contaminated products until February 17, 2022, when Abbott voluntarily recalled the formula. Subsequent inspections by FDA found that Abbott failed to maintain clean surfaces for handling formula and identified a history of Cronobacter sakazakii at the plant.
While Cronobacter sakazakii infections are rare, they can lead to severe and life-threatening illnesses, including sepsis and meningitis. When Cronobacter sakazakii causes meningitis, the mortality rate can be as high as 44%. As of February 17, 2022, FDA knew the Cronobacter sakazakii and Salmonella Newport infections had led to four hospitalizations and may have contributed to one death. On February 28, 2022, the Centers for Disease Control and Prevention announced a fourth Cronobacter sakazakii infection linked to the facility, which may have contributed to a second death.
In today’s letter, the Chairman requested that FDA provide information and documents explaining its delay in issuing a warning to consumers, as well as the reports FDA received from Minnesota health authorities regarding the infections, and the steps the agency plans to take to ensure it more quickly responds to reports of foodborne illnesses.
Click here to read the letter to FDA.