US reaches deal to reopen shuttered baby formula plant
At least two months required before new product ships
WASHINGTON — U.S. officials on Monday reached an agreement to allow baby formula maker Abbott to restart its largest domestic factory, though it will be two months or more before any new products ship from the site to help alleviate the national shortage facing parents.
Under the agreement, Abbott must work with outside experts to upgrade its standards and reduce bacterial contamination at the Sturgis, Michigan, facility, which the Food and Drug Administration has been investigating since early this year. The deal, which must be reviewed by a federal judge, amounts to a legally binding agreement between the FDA and the company on steps needed to reopen the factory.
The agreement was filed in court by the U.S. Department of Justice, on behalf of the FDA.
After production resumes, Abbott said it will take eight to ten weeks before new products begin arriving in stores. The company didn’t set a timeline to restart manufacturing, which must be cleared with the FDA.
The FDA is expected to announce additional steps Monday evening to allow more foreign imports into the U.S. to address the supply problems. It comes as the administration of President Joe Biden faces intense pressure to do more to ease the shortage that has left many parents hunting for formula online or at food banks.
Abbott’s plant came under scrutiny in January when the FDA began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died.
In February, the company halted production and recalled several brands of powdered formula, squeezing supplies that had already been tightened by supply chain disruptions and stockpiling during COVID-19. The shortage has led retailers like CVS and Walgreen’s to limit how many containers customers can purchase per visit.
Outrage over the issue has quickly snowballed and handed Republicans a fresh talking point to use against Biden ahead of November’s midterm elections.
Abbott is one of just four companies that produce roughly 90% of U.S. formula, and its brands account for nearly half that market.
After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.
Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from the babies by federal investigators. The company has repeatedly stated it is ready to resume manufacturing, pending an FDA decision.