Baby Formula Production Ready To Resume At Michigan Plant, Abbott Says

NORTH CHICAGO, IL — Amid a nationwide baby formula shortage, Abbott Laboratories announced it was ready to reopen a manufacturing facility where production was halted three months ago to investigate possible bacterial contamination.

Representatives of the North Chicago-based company said in a statement Thursday that they could resume producing baby formula at their Sturgis, Michigan, plant within two weeks, subject to approval by the Food and Drug Administration.

"We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas," it said. "From the time we restart the site, it will take six to eight weeks before product is available on shelves."

Abbott voluntarily recalled powdered baby formula produced at the Sturgis facility following four reports of infections with the Cronobacter sakazakii bacteria among infants who consumed formula made there. Two of the four babies infected later died.

According to company officials, a "thorough review of all available data" revealed no evidence linking Abbott formulas to the illnesses.

All four infants had each consumed different types of formula produced over a nearly yearlong period, and their illnesses took place in three separate states over a period of several months, the company statement said.

In all four cases, state or federal food safety regulators tested samples of the formula used by the sick infant and, in each case, the unopened containers tested negative, according to the company. And genetic testing of samples from the two ill infants also showed that they were infected with different strains of Cronobacter than the type found in the Sturgis plant, the company said.

"We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we've been seeing and hearing the stress and despair of parents who are facing empty shelves," the company said.

"We deeply regret the situation and since the recall, we've been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum," company officials added. "We also began releasing metabolic formulas that were on hold earlier this month at FDA's request to those who need these unique formulas."

Several parents have filed class action lawsuits alleging that the company is responsible for illnesses in infants who consumed its powdered baby formula.

Meanwhile, out-of-stock rates rose from 28 percent last month to 34 percent in the first 10 days of May, and purchase limits have been put in place at some local retailers.

"We understand the situation is urgent," said Abbott company officials, "getting Sturgis up and running will help alleviate this shortage."

Biden administration officials said the FDA is working "around the clock" to increase supply.

FDA Commissioner Dr. Robert Califf said the agency would continue to do everything within its authority to ensure the production of safe baby formula products.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it,” Califf said in a statement. “Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. "

UPDATE: FDA Chief Testifies About Abbott Labs Recall, Unsanitary Conditions