In February of this year, the FDA began investigating consumer reports of contaminated powdered baby formula manufactured at Abbott Nutrition’s Facility in Sturgis, Michigan. The FDA shut down the facility due to bacterial contamination after reports of four babies who fell ill with cronobacter bacteria, and two died. The brands impacted included Similac, Alimentum, and EleCare, and the halting of production exacerbated an already iffy supply of baby formula.
The baby formula shortage since has gotten dramatically worse as months passed, as specific formula brands that help babies with nutritional needs have become incredibly hard to find. Parents report having to drive to many different stores to find the formula they need and have been left with little recourse as watering down the formula, for example, is not a solution and could harm babies. But months after an Abbott manufacturing plant in Michigan halted production on its baby formula brands, the company reached an agreement with the Food and Drug Administration (FDA) to reopen the plant, which could help deal with the formula shortage.
Even through the months-long shutdown, Abbott has stated that there’s no evidence that the factory is linked to the bacterial outbreak.
FDA Commissioner Robert Califf said the company will correct the conditions in the facility that led to the contamination which resulted in the plant closure.
“The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards,” Califf said in a statement.
The agreement, called a consent decree, was approved by the U.S. District Court for the Western District of Michigan on May 16, 2022. Under the agreement, the Abbott factory in Sturgis can reopen and resume production within two weeks with the FDA go-ahead.
To receive that FDA go-ahead to resume production, Abbott must meet the agency’s food standards, in addition to other measures when the plant feels ready to resume production. Top FDA officials said to make a call that there is a direct relation was too early to make.
As pressure has been building for officials to do something about the dangerous baby formula shortage, the reopening of the Abbott facility is likely to help alleviate some of that supply issue. But it’s still going to take a while for us to see the shelves full again. The company notes that while production can start in as little as two weeks, it will still take approximately six to eight weeks for the formula to arrive on the store shelves.