Baby formula manufacturer Abbott Nutrition on Monday said it has reached an agreement with the Food and Drug Administration (FDA) on a path to restart operations at its Sturgis, Mich., plant.
The facility has been shuttered for more than three months while the FDA investigated whether powdered formula from the plant caused four babies to contract a rare bacterial illness. Two of them died, and a subsequent FDA inspection found unsanitary conditions at the plant.
Abbott said the FDA has not been able to definitively link its formula to the illnesses. The company said it has been making corrective improvements to address the FDA’s concerns.
Once the FDA confirms the initial requirements for startup have been met, Abbott said it could restart the site within two weeks.
The company did not immediately disclose what the requirements were, but added that the consent agreement needs to be cleared by a judge.
The Sturgis facility produces Similac, EleCare, Alimentum and several other of the top powdered formulas.
The shutdown has significantly worsened an already strained supply chain of infant formula and left parents scrambling, with many being forced to ration food or travel for hours to obtain formula. Retailers are also instituting purchasing limits to manage inventory.
It has hit the parents who rely on specialty formulas the hardest and Abbott said it would begin production of its specialty formulas first. However, formula from the shuttered plant won’t be on shelves until six to eight weeks after the plant restarts operations.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” Robert B. Ford, chairman and chief executive officer of Abbott said in a statement.
“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage.”
The Sturgis facility was shuttered after FDA inspectors said they observed significant food safety issues that risked contamination of formula, including five different strains of Cronobacter on the floor and on the wall.
Abbott says that while Cronobacter was found in the plant, genetic sequencing on the two available samples from ill infants did not match the strains found in the plant.
Four companies — Abbott, Reckitt Benckiser, Nestlé and Perrigo — control nearly 90 percent of the U.S. market for baby formula.
The White House has come under pressure in recent days from parents and lawmakers who are demanding action.
Republicans are largely centering their political attacks on the Biden administration. But both Democrats and Republicans are asking tough questions of the Food and Drug Administration (FDA) and raising concerns about the thoroughness of the agency’s food safety inspections.
At least two House committees are now investigating the shortages. Retail supply of formula has been spotty for months because of supply chain pressures and labor shortages, but many lawmakers have only recently begun to press FDA and the companies for answers.
Also Monday, the FDA issued guidance aimed at boosting imports of baby formula from abroad to stem the shortage. Companies need to apply with the FDA in order to be approved.
“The steps we are announcing today should continue to make a difference for families and we’ll be working overtime to get more formula on shelves,” a senior administration official said on a call with reporters Monday evening.
Updated at 8:25 p.m.