Abbott Nutrition, the company that fueled a nationwide baby formula shortage when it shut down a top manufacturing facility in February over contamination concerns, said Saturday the site has resumed production of EleCare and other formulas.
The reopening of the Sturgis, Michigan facility, which was the result of an agreement with the federal Food and Drug Administration (FDA), raised hopes that the food shortages that have distressed stressed parents would ease.
Out-of-stock rates at stores across the country were up about 74 percent in the week ended May 28, according to Datasembly, which tracks retail sales data. The crisis that has been going on for months, which is due to supply problems caused by the pandemic, was exacerbated by the closure of the plant.
In a statement, Abbott said EleCare would be released to consumers around June 20 and that it was “working hard” to resume production of Similac and other formulas.
“We understand the urgent need for infant nutrition, and our top priority is putting high-quality, safe infant nutrition into the hands of families across America,” the company said. “We will ramp up production as quickly as possible while meeting all requirements.”
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In February, Abbott announced it would voluntarily recall three types of infant formula after four babies fed the formula made at the Sturgis plant contracted bacterial infections.
The FDA had received three consumer complaints about Cronobacter sakazakii, a bacterium that can cause serious, life-threatening infections or inflammation of the membranes that protect the brain and spine. Abbott said there was no “conclusive evidence” to link the company’s formulas to the diseases.
dr Food and Drug Administration commissioner Robert M. Califf told a House panel last month that the Sturgis plant had a leaky roof, water pooling on the floor and cracks in production equipment that allowed bacteria to enter and survive .
He described the “extremely unsanitary” conditions, but acknowledged that his agency was slow to address problems at the plant.
In a statement Saturday, the FDA said it had stationed investigators at the Sturgis facility for several days to observe improvements being made to flooring, roofing and equipment at the facility. Abbott reported that the facility tested negative for Cronobacter, the agency said.
A consent decree the company signed with the government provides for a number of new safeguards, including hiring a qualified expert to oversee improvements at the facility and notifying the FDA if contamination is found.
The agency said on Saturday the steps it has taken, and the restart of the Sturgis plant, “mean that more and more infant formula is either on the way to or already on store shelves.
The plant closure exacerbated an existing supply crisis as parents rushed to stock up on baby formula, sometimes driving for hours while networking on social media to help them get in touch with dwindling supplies.
Navigating the US Baby Food Shortage
A growing problem. A nationwide baby formula shortage — sparked in part by supply chain problems and exacerbated by a recall from baby formula maker Abbott Nutrition — has left parents confused and worried. Here are some ways to manage that uncertainty:
With shelves empty in some communities, some parents are so desperate that they feed their infants oatmeal and powdered fruit juice, despite pediatricians recommending infant formula or breast milk as important nutritional sources from birth through a baby’s first birthday.
In the near term, imports from Europe and other countries announced by the White House are likely to play a bigger role in alleviating the shortage than restarting the Sturgis plant, said Steven A. Abrams, a professor of pediatrics at the University of Texas Dell Medical School at Austin , said on Saturday.
The reopening of the Abbott facility will come as a relief to parents of severely allergic babies because EleCare caters to them, said Dr. abrams
“What’s in store for most families in the grocery store, importing the formulas from British, Australian and Mexican sources, will have a much bigger impact,” he said.