Restarting of Abbott Nutrition plant to help ease formula shortage
WASHINGTON — Under fire from parents and politicians, President Joe Biden’s administration announced steps Monday to ease a nationwide shortage of baby formula, including reopening the largest domestic manufacturing plant and increasing imports from overseas.
The Food and Drug Administration said it was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the U.S.
“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.
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, Chicago-based 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 U.S. supply chain will also take several weeks, according to administration officials. Products from Australia, New Zealand and the U.K. are expected to meet the standards needed for importation.
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.
The shortage stems from a February recall by 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 by four illnesses reported in babies who had consumed powdered formula from its plant. All four infants were hospitalized with a rare type of 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.
Abbott 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 two babies by federal investigators.
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.