The FDA is also allowing more flexibility for infant formula produced in the United States. “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.
Baby formula has been in short supply in many stores around the U.S. for several months. 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.
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.production at the facility could restart within two weeks, following FDA approval.
“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.
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