The Defense Manufacturing Act requires suppliers of baby formula manufacturers to fulfill these orders earlier than other customers.
WASHINGTON – President Joe Biden on Wednesday used the Defense Manufacturing Act to speed up the production of infant formula and authorize flights to import supplies from abroad as he faces growing political pressure due to domestic deficits caused by the closure of the country’s largest production security-sensitive. plant.
Ordering the Defense Manufacturing Act requires formula manufacturers to fulfill these orders earlier than other customers. Biden also allows the Department of Defense to use commercial aircraft to overseas formulas that meet federal standards in the U.S., in what the White House calls “Operation Fly Formula”.
Infant formula shipments across the country have been severely cut in recent weeks after Abbott Nutrition’s February recall exacerbated persistent supply chain disruptions among formula makers, leaving fewer options on store shelves and increasingly concerned parents struggling. trying to find food for their children.
The announcement came two days after the Office of Food and Drug Administration said it was streamlining the review process to make it easier for foreign manufacturers to supply more formulas to the United States.
In a letter Wednesday to the Department of Health and Human Services and the Department of Agriculture, Biden instructed agencies to work with the Pentagon to determine an overseas supply of US-compliant formulas next week so that Defense Department charter flights can fly quickly to the U.S.
“The import of infant formula will serve as a bridge to this increase in production,” Biden wrote.
Regulators said Monday they have reached a deal that allows Abbott Nutrition to restart its plant in Sturgis, Michigan, the nation’s largest formula plant, which has been closed since February due to pollution problems. The company should review its safety protocols and procedures before resuming production.
After receiving FDA approval, Abbott said it would take eight to ten weeks before new products begin to arrive in stores. The company has not set a deadline for the resumption of production.
Abbott’s voluntary recall was caused by four diseases of infants who consumed a powder mixture from his plant. All four infants were hospitalized with a rare type of bacterial infection, two died.
After a six-week inspection, FDA investigators released a list of problems in March, including unfulfilled safety and sanitation requirements, as well as a history of bacterial contamination in several parts of the plant. As of Monday, Abbott should regularly consult with an external safety expert to restart and maintain production.
The company Abbott from Chicago stressed that its products were not directly related to bacterial infections in children. Samples of bacteria found at his plant did not match strains collected from two babies by federal investigators.
But on Monday, FDA officials dismissed the argument during a conversation with reporters – for the first time publicly speaking with the company’s argument. FDA officials noted that they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.
“From the beginning, we were limited in our ability to determine through causation whether the product was related to these four cases because we had sequences in only two,” said FDA Food Director Susan Maine.
According to former FDA officials, correcting the violations found at the Abbott plant will take time. Companies need to thoroughly clean facilities and equipment, retrain staff, repeatedly inspect and document the absence of pollution.
As part of the FDA’s new import policy, regulators said companies would need to provide documentation of their factory inspections.
Swiss conglomerate Nestlé said on Tuesday it had already increased production and increased planned supplies to the U.S. to close the deficit. Nestlé also carries out air deliveries.
Nestlé has said it prioritizes shipping two products it has already imported – Gerber Good Start Extensive HA from the Netherlands and Alfamino from Switzerland – because they serve a critical need. The products are designed for children with allergies to cow’s milk.
Nestlé has said it is considering a new FDA guide that is temporarily lifting restrictions on imports of baby formula, and could start importing more varieties.
“We are reviewing the instructions and assessing where we can use Nestlé’s global power grid to help,” a company spokesman said in a statement.
