FDA announces plans to ease the shortage of baby formula
Abbott, one of the largest formula-makers in the U.S., has reached an agreement with the government to bring a closed factory back on line. And the FDA is easing some restrictions on imported 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 federal government to reopen one of its closed factories and increase production.
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 store shelves.
Meantime, the FDA announced it is temporarily streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the U.S.
Neither step will have an immediate effect on tight supplies.
Abbott shut down its facility in Sturgis, Mich., in February over contamination concerns that led to it being the target of a Justice Department complaint. The complaint alleged the Abbott factory failed to comply with quality and safety regulations.
A proposed settlement between the agency and Abbott requires a third-party expert at the Michigan facility to help restart production and increase the formula supply safely.
We’ve agreed to enter into a consent decree – a legal agreement – with the FDA for our Sturgis, Mich., plant, a major step toward reopening our facility and helping to ease the infant formula shortage.— Abbott (@AbbottNews) May 16, 2022
Read more here: https://t.co/NiUfVJEKWy pic.twitter.com/jr2DXwOUk7
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 foreign 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.
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."
Information from the Associated Press was used in this report.
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