Abbott said it would take several weeks for the new product to resume in-store.
WASHINGTON – Baby formula maker Abbott said Monday it has reached an agreement with U.S. health regulators to resume production at its largest domestic factory, though it will be much more than a month before any new products are shipped from the site to help alleviate shortages. the country the parents face. .
Abbott did not immediately disclose the terms of an agreement with the Food and Drug Administration, which has been investigating safety issues at its plant in Sturgis, Michigan since earlier this year. The consent decree constitutes a legally binding agreement between the FDA and the company on the steps required to rebuild the factory.
An FDA spokeswoman did not immediately respond to a request for comment on Monday night’s announcement.
After the resumption of production, according to Abbott, it will take six to eight weeks before new products begin to arrive in stores. The company has not set a deadline for the resumption of production.
The FDA is expected to announce additional steps Monday to allow more foreign imports to the U.S. to address supply problems. This comes at a time when President Joe Biden’s administration is facing strong pressure to do more to alleviate the shortage that has forced many parents to look for mixes online or in food banks.
The Abbott plant came under close scrutiny earlier this year after the FDA began investigating four bacterial infections among infants who used the powder mixture from the plant. Two of the babies died.
In February, the company halted production and recalled several brands of powdered formula, squeezing supplies that were already tight due to supply chain disruptions and stockpiling during COVID-19. The shortage has forced retailers, such as CVS and Target, to limit the number of containers that customers can purchase per visit.
Outrage over the issue quickly grew and gave Republicans a new point to talk against Biden ahead of the November by-elections.
Abbott is one of four companies that produce about 90% of American formula, and its brands occupy nearly half of that market.
After a six-week inspection, FDA investigators released a list of problems in March, including volatile safety and sanitation standards, as well as a history of bacterial contamination in several parts of the plant.
The company Abbott from Chicago stressed that its products were not directly related to bacterial infections in children. Bacterial samples found at his plant did not match strains collected from children by federal investigators. The company has repeatedly stated that it is ready to resume production pending an FDA decision.
Former FDA officials say fixing the problems identified at Abbott’s plant takes time, and baby formulas are receiving more attention than other food businesses. Companies need to thoroughly clean facilities and equipment, retrain staff, repeatedly inspect and document the absence of pollution.
On Monday, FDA Commissioner Robert Calif told ABC News that there would be an announcement to import baby formula from abroad. The key issue is that the instructions for the formula be in languages that are understandable to mothers and caregivers, he noted.
Pediatricians say that infant formulas manufactured in Canada and Europe are roughly equivalent to those in the United States. But traditionally 98% of baby formulas in the US are made domestically. Companies seeking to enter the U.S. face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.
San Diego’s father Stephen Davis faced difficult problems finding a formula for his medically fragile daughter who used the Abbott formula, but was forced to switch due to the recall and subsequent shortage of other brands.
Zoe Davis was born 19 months ago without a kidney, a rare life-threatening condition that requires dialysis and tube feeding until she weighs enough for a kidney transplant. She is four pounds ashamed of this stage, said Davis, his mortgage lender and caretaker.
“Her life depends on her weight gain,” he said.
Davis said he used the organic brand from abroad until costs and customs hurdles made it too difficult. Davis said friends and strangers from abroad sent him other stamps, but every time she switches, more blood tests and monitoring are required.
Despite the problems, Zoe walks, talks and is “pretty good” at other stages of development, Davis said.
“She shines a light in my life,” he said.