FDA, Abbott Agree on Plan to Re-Open Shuttered Baby Formula Plant

Top baby formula manufacturer Abbott has reached an agreement with federal regulators on a plan to restart production at its shuttered Michigan plant. The Sturgis Abbott plant, which is the nation’s largest baby formula manufacturing hub, has been closed since February over a contamination issue. According to an Abbott spokesman, the plant will need six-eight weeks in order to resume production.

Abbott did not immediately detail the terms of the agreement with the Food and Drug Administration.

In February, the FDA launched an investigation of Abbott’s Sturgis, Michigan plant after receiving reports of Cronobacter sakazakii and Salmonella Newport infections among infants. In total, four infant illnesses were reported and later linked back to consumption of formula from the plant. Two of the affected infants later died.

A subsequent recall included products from three different brands – Similac, Alimentum, and EleCare – and has contributed to an accelerating nationwide shortage, according to NBC 4 New York.

The FDA had already signed off on the release specialty formulas for infants with food allergies, digestive problems and other conditions on a “case-by-case” basis. Many specialty formulas are produced exclusively at Abott’s Sturgis plant, which has accelerated concern over the facility’s closure.

After production resumes, Abbott said it will take between six-to-eight weeks before newly produced formulas begin to arrive on store shelves.

The company did not provide a timeline for when production can resume. FDA officials have also yet to disclose details of the plan, though both sides have stated that a verbal agreement is in place.

The FDA is expected to announce additional steps Monday to allow more foreign imports into the U.S. to address the supply problems. In addition, a number of bipartisan lawmakers have called on the Biden Administration to do more in order to combat the shortage.

Senator Marco Rubio (R-FL) called on the president to invoke the Defense Production Act in response to the crisis. “Invoke the Defense Production Act (DPA) to increase the domestic production of baby formula in the U.S.; Direct the FDA to expeditiously approve European Union-approved infant formula products for commercial sale in the United States; and Direct the FDA to expeditiously allow the re-opening of the Abbott formula plant in Michigan,” Rubio urged last week.

Biden has previously authorized the Defense Production Act in order to increase production of electric vehicle batteries.

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