Washington (U.S.)- President Joe Biden’s administration, under fire from parents and politicians, announced steps Monday to alleviate a nationwide shortage of baby formula, including reopening the largest domestic manufacturing plant and increasing imports from overseas.
The FDA announced that it was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formulas into the United States.
“The FDA anticipates that the measures and steps it is taking with infant formula manufacturers and others will result in more and more supply being on the way or store shelves moving forward,” FDA Commissioner Robert Califf told reporters.
According to Califf, the United States will prioritize companies that can provide the largest shipments and quickly demonstrate that their formulas are safe and compatible with U.S. nutrition standards. The policy is designed to be a six-month temporary measure.
The imports announcement came shortly after regulators said they’d reached a deal to allow Abbott Nutrition to restart its Sturgis, Michigan-based plant, closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production.
Neither step will immediately impact the scarcity of formula, which has forced many parents to look for it online or at food banks.
After receiving FDA approval, Abbott estimates that new products will be available in stores in eight to ten weeks. The company has not specified a timetable for restarting manufacturing.
According to administration officials, getting imports into the U.S. supply chain will take several weeks. Products from Australia, New Zealand, and the United Kingdom are expected to meet importation standards.
But regulators said national industry data shows most U.S. stores, on average, still have 80% of their formula inventory in stock. They suggested some of the empty shelves seen in recent days may be due to panic buying by parents.
Monday’s announcement was previewed last week by the White House, leaning on the FDA and formula makers to find ways to alleviate the shortage quickly. Outrage over the issue has snowballed soon and handed Republicans a new talking point against President Biden ahead of the November elections.
The shortage stems from a February recall by Abbott that exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store 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 by four illnesses reported in babies who had consumed powdered formula from its plant. All four infants were hospitalized with a rare bacterial infection, and two died.
After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant. Under Monday’s agreement, Abbott must regularly consult with an outside safety expert to restart and maintain production.
Chicago-based Abbott has emphasized that its products have not been directly linked to bacterial infections in children. Samples of the bacteria found at its plant did not match federal investigators’ strains collected from two babies.
But FDA officials pushed back on that reasoning Monday on a call with reporters— their first time publicly addressing the company’s argument. FDA staffers noted they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match
“Right from the get-go, we were limited in our ability to determine with a causal link whether the product was linked to these four cases because we only had sequences on two,” FDA’s food director Susan Mayne said.
According to former FDA officials, fixing the violations uncovered at Abbott’s plant takes time. Companies need to exhaustively clean the facility and equipment, retrain staff, and repeatedly test and document that 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.
Paediatricians say baby formulas produced in Canada and Europe are roughly equivalent to those in the U.S. But traditionally, 98% of the infant formula supply in the U.S. is made domestically. Companies seeking to enter the U.S. face several significant hurdles, including rigorous research and manufacturing standards imposed by the FDA.
San Diego father Steven Hyde has faced heart-wrenching challenges finding a formula for his fragile medical daughter. She was on an Abbott formula but switched 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 overseas until costs and customs hurdles made that too difficult. Friends and strangers from out of state have sent him other brands, but Davis said each time she switches requires more blood tests and monitoring.
Davis said that despite her challenges, Zoie is walking, talking, and “doing pretty good” on other developmental milestones.
“She’s a shining light in my life,” he said.
