WASHINGTON (AP) – Baby formula maker Abbott said Monday it has reached an agreement with U.S. health regulators to restart production at its largest domestic plant. , though it will be more than a month before any new products ship to help alleviate the deprivations parents face.
Abbott did not immediately detail the terms of its settlement with the Food and Drug Administration, which has been investigating safety concerns at the Sturgis, Michigan, plant since earlier this year. . The consent decree is the equivalent of a legally binding agreement between the FDA and the company regarding the steps needed to reopen the plant.
An FDA spokesman did not immediately respond to a request for comment on Monday night’s announcement.
Once production resumes, Abbott said it will take six to eight weeks before the new products start hitting stores. The company did not set a timeline for restarting production.
The FDA is expected to announce additional steps on Monday to allow more imports from abroad into the US to address supply issues. It comes as President Joe Biden’s administration faces massive pressure to do more to alleviate shortages that have left many parents hunting for formula online or at food banks.
Abbott’s factory came under close scrutiny earlier this year after the FDA began investigating four cases of bacterial infection in infants drinking formula from the factory. Two of the infants died.
In February, the company halted production and recalled several brands of powdered formula, squeezing supplies that have been tight due to supply chain and stockpiling disruptions during COVID-19. Shortages have led retailers like CVS and Target to limit the number of containers customers can buy per visit.
Outrage over the issue quickly surfaced and gave Republicans a new argument to use against Biden ahead of the November midterm elections.
Abbott is one of four companies that make about 90% of U.S. formula, and its brands make up nearly half of that market.
After a six-week inspection, FDA investigators released a list of issues in March, which included lax safety and hygiene standards as well as a history of bacterial contamination in certain areas. factory parts.
Chicago-based Abbott has stressed that its products are not directly linked to bacterial infections in children. Bacterial samples found at its factory did not match bacterial strains collected from infants by federal investigators. The company has repeatedly stated its willingness to resume production, pending an FDA decision.
Former FDA officials say fixing problems discovered at Abbott’s plant takes time and baby formula facilities receive more oversight than other food facilities . Companies need to clean entire facilities and equipment, retrain employees, test multiple times, and document that there is no contamination.
On Monday, FDA Commissioner Robert Califf told ABC News that an announcement is imminent about the import of infant formula from abroad. It is important to ensure formula instructions are in a language that mothers and caregivers can understand, he notes.
Pediatricians say baby formula produced in Canada and Europe is roughly equivalent to that in the US. But traditionally, 98% of the infant formula supply in the US is produced domestically. Companies seeking to enter the US face a number of major hurdles, including rigorous research and manufacturing standards imposed by the FDA.
San Diego dad Steven Davis has faced heartbreaking challenges finding formula for his medically fragile daughter, who is using Abbott formula but has had to switch to recalls and subsequent shortages in other brands.
Zoie Davis was born 19 months ago, without a kidney, a rare life-threatening condition that required dialysis and a feeding tube until she was healthy enough for a kidney transplant. Davis, a mortgage lender and caretaker for his daughter, says she doesn’t have 4 pounds left.
“Her life depends on her weight gain,” he said.
Davis said he used an organic brand from abroad until the cost and customs barriers made it too difficult. Friends and strangers from abroad sent him other brands, but each time she switched required more blood tests and monitoring, Davis said.
Despite her challenges, says Davis, Zoie is still walking, talking, and “doing pretty well” at other developmental milestones.
“She was a bright light in my life,” he said.
https://www.wfla.com/top-stories/baby-formula-maker-abbott-says-it-has-reached-deal-to-restart-production/ Baby formula maker Abbott says deal reached to restart production