WASHINGTON — President Joe Biden on Wednesday invoked the Defense Production Act to speed production of infant formula and authorized flights to import supply from overseas, as he faces mounting political pressure over a domestic shortage caused by the safety-related closure of the country's largest formula manufacturing plant.
The Defense Production Act order requires suppliers of formula manufacturers to fulfill those orders before other customers. Biden is also authorizing the Defense Department to use commercial aircraft to fly overseas formula supplies that meet federal standards to the U.S., in what the White House is calling “Operation Fly Formula.”
Supplies of baby formula across the country have been severely curtailed in recent weeks after a February recall by Abbott Nutrition exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves and increasingly anxious parents struggling to find nutrition for their children.
The announcement comes two days after 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.
In a letter Wednesday to the Department of Health and Human Services and the Department of Agriculture, Biden directed the agencies to work with the Pentagon to identify overseas supply of formula that meets U.S. standards over the next week, so that chartered Defense Department flights can swiftly fly it to the U.S.
“Imports of baby formula will serve as a bridge to this ramped-up production,” Biden wrote.
Regulators said Monday that they’d reached a deal to allow Abbott Nutrition to restart its Sturgis, Michigan, plant, the nation's largest formula plant, which has been closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production.
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.
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.
Chicago-based 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.
Fixing the violations uncovered at Abbott’s plant will take time, according to former FDA officials. 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.
Swiss conglomerate Nestlé said Tuesday it had already increased production and moved up planned shipments to the U.S. to alleviate the shortages. Nestlé is also rushing the shipments via air.
Nestlé said it prioritized the shipment of two products that it was already importing — Gerber Good Start Extensive HA from the Netherlands and Alfamino from Switzerland — because they serve a critical need. The products are made for babies who are allergic to cow’s milk.
Nestlé said it is reviewing the new guidance from the FDA, which temporarily relaxes import restrictions on baby formula, and it might start importing more varieties.
“We are reviewing the guidance and assessing where we may be able to tap into the Nestlé global nutrition network to help,” a company spokesperson said in a statement.