FDA announces plans to ease the shortage of baby formula
Parents struggling to find baby formula could soon find some relief.
Abbott Nutrition, one of the largest formula manufacturers in the U.S., has reached an agreement with the government to reopen one of its closed factories and increase production.
Abbott shut down its facility in Sturgis, Mich., in February after several babies became ill after drinking formula. Two of them died of bacterial infections.
The Justice Department filed a complaint against Abbott, alleging the factory failed to comply with quality and safety regulations. Now Abbott and the government have agreed to a proposed settlement to resolve the complaint. It requires a third-party expert at the Michigan facility to help restart production and increase the formula supply safely.
In a written statement, Abbott said production at the facility could restart within two weeks, following FDA approval. It would take another six to eight weeks before formula from the plant would be available on grocery shelves.
In the meantime, the FDA is announcing other plans to ease the nationwide formula shortage. FDA Commissioner Robert Califf acknowledged the struggles many parents are facing.
“We know many parents and caregivers are feeling frustrated by their inability to access needed or desired infant formula and critical medical foods,” Califf said at an FDA briefing.
And he announced that the FDA is easing some restrictions on which manufacturers can sell infant formula in the U.S.: “Our new guidance streamlines the ability for companies, including those that do not normally sell infant formula in this country, to make products available to the U.S. market.”
Califf said these flexibilities will mean “additional products can quickly hit U.S. stores.”
“We are casting a broad net,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition. “We are seeking manufacturers around the globe who may have available product that could meet our standards for both nutrition and food safety.”
She said the FDA will help get that product into the United States.
The FDA is also allowing more flexibility for infant formula produced in the United States. Priority will be given to manufacturers that can demonstrate safety and nutritional adequacy and that can get product onto U.S. shelves the quickest.
“We are focused on getting as much product as possible on store shelves,” said Frank Yiannas, the FDA’s deputy commissioner for food policy and response.
“And we won’t rest until the infant formula market gets back to normal.”