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Parents struggling to find the baby’s source may soon find some relief.
Abbott Nutrition, one of the largest formula manufacturers in the United States, has reached an agreement with the government to reopen a closed factory and increase production.
Abbott closed his facility in Stargis, Mitch, in February after several children became ill after drinking the formula. Two of them died of bacterial infections.
The judiciary has filed a lawsuit against Abbott, alleging that the factory failed to comply with quality and safety regulations. Now Abbott and the government have agreed on a proposed settlement to resolve the complaint. The Michigan facility needs a third-party expert to help resume production and help securely increase supply.
In a written statement, Abbott said that after FDA approval, production at the facility could resume within two weeks. It will take another six to eight weeks to get the formula from the plant on the grocery shelves.
Meanwhile, the FDA is announcing other plans to reduce the nationwide shortage of resources. FDA Commissioner Robert Calif acknowledged the struggles many parents face.
“We know many parents and caregivers are frustrated by their inability to access the necessary or preferred baby formula and complex medical foods,” Calliffe said in an FDA briefing.
And he announced that the FDA was relaxing some restrictions on manufacturers that could sell baby formula in the United States: “Our new guidelines extend the power of companies that do not normally sell baby formula in this country to the US market to make their products available.”
Callie said the flexibility would mean “excess products could quickly hit U.S. stores.”
“We’re throwing a wide net,” said Susan Maine, director of the FDA’s Center for Food Safety and Applied Nutrition. “We are looking for manufacturers around the world who can have products that can meet our standards for both nutrition and food security.”
He said the FDA would help get the product to the United States.
The FDA is allowing more flexibility for baby formula produced in the United States. Preference will be given to manufacturers who can demonstrate safety and nutritional adequacy and they can get products on the fastest U.S. shelves.
“We’re focused on getting as many products as possible on store shelves,” said Frank Yanas, FDA’s deputy commissioner for food policy and response.
“And we’re not going to rest until the baby formula market is normal.”