A member of Congress and consumer groups are expressing shock and asking hard questions about reports of additional infant deaths attributed to baby formula from Abbott Nutrition.
Following a report on Wednesday citing a Food and Drug Administration document showing the additional deaths, bringing the total to 9, U.S. Rep. Rosa DeLauro, D-CT, slammed the Food and Drug Administration. The report only came to light because of an FOIA request filed by eFoodAlert.
“We now know that contrary to initial reports, 9 babies who were fed Abbott powdered infant formula manufactured in their Sturgis, Michigan facility have died,” said Congresswoman DeLauro who chairs the House Appropriations Committee. “This is heartbreaking and shameful. Many of these deaths could have likely been prevented if Abbott Nutrition and the FDA did not drag their feet to investigate credible allegations of substandard food safety practices at the plant. And what is deeply disturbing is the timeline in which these events unfolded.
“In February 2021, an entire year before the voluntary recall, Abbott and the FDA were alerted to allegations concerning problems at the Sturgis, Michigan manufacturing facility through a complaint filed by an employee. The problems included failing equipment in need of repair and formula released without adequate evidence that it was safe for consumption. Abbott confirmed receipt and submitted a formal response to the complaint two months later.
“Despite knowing this information, it was not until September 2021 that the FDA conducted a routine inspection of the facility and learned of the potential link between a specific rare and deadly foodborne pathogen and powdered infant formula manufactured by Abbott. At the same time, an infant in Minnesota given formula manufactured in Abbott’s Sturgis, Michigan facility was diagnosed with Cronobacter sakazakii. This was the first case reported.”
Consumers also filed more than 100 reports of life-threatening and non-life-threatening illnesses with the FDA in relation to formula produced by Abbott Nutrition. Abbott has a 48 percent market share of the infant formula market in the United States and produces the popular Similac and Elecare brands.
The complaints included documented symptoms of fever in 31 babies, vomiting in 42 babies, diarrhea in 47 babies, and blood in stool in 6 babies. Most parents reported that their babies suffered from multiple symptoms. Other symptoms included loss of appetite, rash, lethargy, dehydration, irritability, weight loss, and difficulty breathing. Most of which are associated with cronobacter infection.
“While these infants suffered from different symptoms, there remains one constant: The sick babies were fed an Abbott powdered formula,” DeLauro says. “Each new revelation begs more questions.
“Why did FDA not immediately investigate the causes of these deaths linked to powdered infant formula? Why was a whistleblower’s report outlining credible allegations of wrongdoing not immediately escalated both times the FDA received it? And why did Abbott wait months after reports of infant deaths and hospitalizations to finally recall their contaminated product? I expect Abbott and the FDA to answer to these questions.
“I extend my condolences to the families and parents who lost their babies, and I vow I will not stop fighting to uncover what went wrong. Once we get to the bottom of what went wrong, I expect the individuals responsible for this crisis to be held accountable.”
Consumer groups speak out
Similar to the outrage expressed by Rep. DeLauro, representatives from Consumer Reports and the Environmental Working Group spoke out about the infant formula situation.
Brian Ronholm, Director of Food policy for Consumer Reports, who recently served a witness in the House Committee on Appropriations hearing on the infant formula crisis, including the shortage caused by the shut down of the Abbott production plant, said parents should never have to scramble to find food for their babies.
“Consumer Reports strongly supports the Keep Infant Formula Safe and on the Shelves Act because it would strengthen FDA’s oversight of infant formula manufacturers and prevent another crisis from happening again. The bill would ensure the plentiful supply of safe infant formula and hold manufacturers accountable by increasing the frequency of inspections of these plants, requiring these plants to share test results with the FDA, and requiring manufacturers to notify the FDA when they become aware of circumstances that could lead to a shortage.”
Scott Faber, Senior Vice President of Government Affairs for the Environmental Working Group said Rep. DeLauro is right on target with her assessment of the situation.
“EWG applauds Rep. DeLauro for increasing scrutiny of the country’s infant formula facilities,” said Faber. “The crisis that has crippled the ability of parents across the country to find the formula they need to feed their babies could have been avoided if the FDA had the necessary resources and leadership structure to make food safety a priority.”
(To sign up for a free subscription to Food Safety News,click here)
