In the face of fire from parents and politicians, President Joe Biden’s administration announced Monday measures to reduce the nationwide shortage of child resources, including reopening the largest domestic manufacturing plant and increasing imports from abroad.
The Food and Drug Administration says it is simplifying the review process for foreign manufacturers to introduce shipping formulas in the United States.
“We are hopeful that the global market will respond to this call and that international businesses will take the opportunity to help increase the supply of goods,” FDA Commissioner Robert Calif said in a statement.
Calliffe said he would prioritize U.S. companies that could deliver the largest shipments and would quickly document the fact that their formulas are safe and meet U.S. nutritional standards.
The import announcement regulators said they had reached an agreement to allow Abbott Nutrition to reopen its Stargis, Michigan-based plant, which had been shut down since February due to pollution issues. The company must revise its security protocols and procedures before resuming production.
None of the measures will have an immediate effect on the tight supply that many parents have searched for formulas online or at food banks. After receiving the FDA’s approval, Abbott said it would take eight to ten weeks before new products begin to arrive in stores. The company has not set a timeline for the resumption of production.
According to administration officials, it could take months for imports to enter the US supply chain. Even before the latest change, FDA officials said that imports of baby formulas have already increased by more than 300 percent compared to last year.
Monday’s announcement was previewed by the White House last week, which turned to the FDA and formula makers to find ways to quickly address the deficit. Anger over the issue quickly froze and gave Republicans a fresh word to use against President Biden ahead of the November election.
The deficit stems from Abbott’s February withdrawal that disrupted ongoing supply chains among formula makers, leaving fewer options on store shelves across much of the country. Deficits have managed to limit the number of containers customers can purchase per visit to retailers such as CVS and Walgreens.
Abbott’s voluntary withdrawal began with four illnesses reported among children who ate powdered formula from the Michigan plant. Four children were hospitalized for a rare bacterial infection and two died. After a six-week inspection, FDA investigators released a list of problems in March, including loose safety and sanitary standards and a history of bacterial contamination in various parts of the plant.
Chicago-based Abbott insists its products are not directly linked to bacterial infections in children. Samples of bacteria found in its plants do not match the strains collected from children by federal investigators. The company has repeatedly said it is ready to resume production, pending an FDA decision.
Former FDA officials say it takes time to fix the kind of problems that have been uncovered at Abbott’s plant, and the baby’s formula benefits more than other food benefits. Companies need to thoroughly clean facilities and equipment, retrain staff, conduct frequent inspections, and document no contamination.
As part of the FDA’s new import policy, regulators say companies must provide documentation of their factory inspections.
Pediatricians say infant formulas produced in Canada and Europe are roughly equivalent to those in the United States. But traditionally, 98 percent of infant formula supplies in the United States are made locally. Companies seeking to enter the United States face several major hurdles, including rigorous research and production standards imposed by the FDA.
San Diego father Steven Hyde faces a heart-wrenching challenge to find clues for his medically fragile daughter, who was at the Abbott formula but had to withdraw to other brands and switch with subsequent deficits.
Zoie Hyde was born 19 months ago without a kidney, a rare life-threatening condition that requires dialysis and a feeding tube until she weighs enough to have a kidney transplant. Hyde said he used an organic brand from abroad until costs and customs constraints made it too difficult. Friends and strangers from outside the state have sent him other brands, but each time he needs more blood tests and monitoring to switch, Davis said.
Despite her challenges, Joey is “doing pretty well” in walking, talking and other developmental milestones, Davis said.
“He’s a shining light in my life,” he said.