(qlmbusinessnews.com via theguardian.com – – Tue, 17th May 2022) London, Uk – –
Michigan plant had been under investigation for safety concerns and it will take over a month to begin shipping product
The baby formula maker Abbott has reached an agreement with US health regulators to restart production at its largest domestic factory amid a nationwide formula shortage that has left shelves bare and parents scrambling.
Monday’s agreement with the Food and Drug Administration (FDA) amounts to a legally binding agreement between regulators and the company on steps needed to reopen the plant in Sturgis, Michigan, which had been under investigation for safety concerns.
However, it will be well over a month before any new products ship from the site to help alleviate the situation. After production resumes, Abbott said it will take between six and eight weeks before the formula will begin arriving in stores.
Abbott is one of just four companies that produce roughly 90% of US formula, and its brands account for nearly half that market.
The company didn’t set a timeline to restart production or offer further details about the terms of the deal.
The FDA announced additional steps to ease the supply chain crunch, saying it was was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the US.
“The FDA expects that the measures and steps it’s taking with infant formula manufacturers and others will mean more and more supply is on the way or on store shelves moving forward,” FDA commissioner Robert Califf told reporters.
Califf said the US will prioritize companies that can provide the largest shipments and quickly show documentation that their formulas are safe and compatible with US nutrition standards. The policy is structured as a temporary measure lasting six months.
It comes as Joe Biden’s administration 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 early this year after the FDA began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died.
The crunch intensified when, 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 such as CVS and Walgreens to limit how many containers customers can buy in each 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.
After a six-week inspection, FDA investigators published a list of problems at the Abbott factory in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.
The Chicago-based company 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.
Former FDA officials say fixing the type of problems uncovered at Abbott’s plant takes time, and infant formula facilities receive more scrutiny than other food facilities. Companies need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.
Pediatricians say baby formulas produced in Canada and Europe are roughly equivalent to those in the US. But traditionally, 98% of the infant formula supply in the US is made domestically. Companies seeking to enter the US face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.
Steven Davis, a San Diego father, has faced heart-wrenching challenges finding formula for his medical fragile daughter, who was on an Abbott formula but has had to switch with the recall and subsequent shortages in other brands.
Zoie Davis was born 19 months ago with no kidneys, a rare life-threatening condition that requires dialysis and a feeding tube until she weighs enough for a kidney transplant. She’s 4lb shy of that milestone, said Davis, a mortgage lender.
“Her life is dependent on her weight gain,” he said.
Davis said he used an organic brand from overseas until costs and customs hurdles made that too difficult. Friends and strangers from out of state have sent him other brands, but each time she switches it requires more blood tests and monitoring, Davis said.
Despite her challenges, Zoie is walking, talking and “doing pretty good” on other developmental milestones, Davis said.
“She’s a shining light in my life,” he said.
The shortage is weighing particularly on lower-income parents such as Clara Hinton, 30, of Hartford, Connecticut, who has a 10-month-old daughter, Patience, who has an allergy that requires a special formula.
Hinton, who has no car, has been taking the bus to the suburbs, going from town to town, and finally found some of the proper formula at a box store in West Hartford. But she said the store refused to take her food stamps card, and she recently ran out of formula from an already opened can she got from a friend.
“She has no formula,” she said. “I just put her on regular milk. What do I do? Her pediatrician made it clear I’m not supposed to be doing that, but what do I do?”