Shuttered formula plant to reopen
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 frantic parents.
Under the deal, Abbott must work with outside experts to upgrade its standards and reduce bacterial contamination at the Sturgis, Mich., facility, which the Food and Drug Administration has been investigating since early this year.
The arrangement, 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.
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 also expected to announce additional steps to allow more foreign imports into the U.S. to address the supply problems.
The moves come as the Biden administration faces intense pressure 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 become a new point of criticism 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.
Pediatricians say baby formulas produced in Canada and Europe are roughly equivalent to those in the U.S. But traditionally, 98% of the infant formula supply in the U.S. is made domestically.
Companies seeking to enter the U.S. face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.