Abbott Reaches FDA Deal to Reopen Infant Formula Plant to Reduce National Shortage

A woman buys baby food at a Target store in Annapolis, Maryland, May 16, 2022, as nationwide baby food shortages continue due to supply chain disruptions related to the coronavirus pandemic that have already depleted baby food stocks in the country. further exacerbated by a major product recall in February.

Jim Watson | AFP | Getty Images

Abbott has reached an agreement with the Food and Drug Administration (FDA) to reopen its Michigan plant to ease a nationwide shortage of infant formula, the company said on Monday.

Abbott said it could restart the Michigan plant within two weeks, subject to FDA approval. However, from the start of production, the mixture will hit store shelves in six to eight weeks, according to the company. An agreement between Abbott and the FDA, called a consent decree, is subject to court approval.

“This is an important step towards reopening our Sturgis facility so we can address the shortage of infant formula across the country,” said Abbott CEO Robert Ford. “We look forward to working with the FDA to reopen the facility quickly and safely.”

Mothers struggle to find formula for their babies, with shelves empty in many stores across the US. More than 40% of infant formula was out of stock in the US during the week ending May 8, according to Datasembly, a company that tracks retail data.

The Biden administration is also taking steps to import baby food from other countries, White House press secretary Karine Jean-Pierre told reporters on Monday. The US produces 98% of the infant formula consumed. The Food and Drug Administration (FDA) will allow foreign companies to apply to supply infant formula to the US market with approval while meeting drug regulator safety standards.

“We have alerted embassies, retailers and manufacturers to identify potential companies that will use the FDA’s new import process,” said Jean-Pierre.

The shortage was partly caused by the closure of Abbott Nutrition’s Michigan plant after four formula-fed infants contracted bacterial infections, two of whom subsequently died. Abbott is the largest manufacturer of infant formula in the United States.

FDA checks have found the presence of Cronobacter sakazakii, a bacteria that can cause blood poisoning, at a plant in Sturgis, Michigan. According to the FDA, Abbott’s internal records also showed that the company destroyed some of its products due to the presence of bacteria in the plant.

In February, Abbott announced a voluntary recall of its Similac PM 60/40, Similac, Alimentum and EleCare products manufactured at its Michigan plant. Abbott said last week that none of the formula distributed to consumers from the Sturgis plant tested positive for the bacteria, and genetic sequencing of two samples from sick infants did not match the Cronobacter strains found at the plant.

The FDA completed its review in March. The Centers for Disease Control and Prevention has found no additional cases of Cronobacter infection in infants after consuming products from a facility in Michigan.

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