US allows more ba formula imports to fight shortage

Under fire from parents and politicians, President Joe Biden’s adminration announced steps Monday to ease a nationwide shortage of ba formula, including reopening the largest domestic manufacturing plant and increasing imports from overseas.
The Food and Drug Adminration said it was streamlining its review process to make it easier for foreign manufacturers to begin shipping formula to the US.
“We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to ass in bolstering the supply of products,” said FDA Commissioner Robert Califf, in a statement.

Califf said the US will prioritise companies that can provide the largest shipments and quickly show documentation that their formulas are safe and meet US nutrition standards.
The imports announcement came shortly after regulators said they’d reached a deal to allow Abbott Nutrition to restart its Sturgis, Michigan-based plant, which has been closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production.
Neither step will have an immediate effect on tight supplies that have left many parents searching for formula online or in food banks.
After getting the FDA’s OK, 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.
Getting imports into the US supply chain could take several months, according to adminration officials. Even before the latest change FDA officials said imports of ba formula are already up more than 300 per cent from last year.
Monday’s announcement was previewed last week the White House, which has been leaning on the FDA and formula makers to quickly find ways to alleviate the shortage. Outrage over the issue has quickly snowballed and handed Republicans a fresh talking point to use against President Biden ahead of November elections.
The shortage stems from a February recall Abbott that exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on stores shelves across much of the country. The shortage has led retailers like CVS and Walgreens to limit how many containers customers can purchase per visit.Abbott’s voluntary recall was triggered four illnesses reported in babies who had consumed powdered formula from the Michigan plant. All four infants were hospitalised with a rare type of bacterial infection and two died.

After a six-week inspection, FDA investigators published a l of problems in March, including lax safety and sanitary standards and a hory of bacterial contamination in several parts of the plant.
Chicago-based Abbott has emphasised 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 federal investigators. The company has repeatedly stated it is ready to resume manufacturing, pending an FDA decision.
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.
As part of the FDA’s new import policy, regulators said companies would need to provide documentation of their factory’s inspections.
Pediatricians say ba formulas produced in Canada and Europe are roughly equivalent to those in the US. But traditionally, 98 per cent of the infant formula supply in the US is made domestically. Companies seeking to enter the US face several major hurdles, including rigourous research and manufacturing standards imposed the FDA.
San Diego father Steven Hyde 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 Hyde 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.
Hyde 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 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.