FDA announces plans to help allow foreign baby formula manufacturers to stay on the U.S. market with long-term authorization.
Finally, there is some good news on the baby formula shortage crisis.
Abbott Laboratories’ Michigan plant has been shutdown by the Food and Drug Administration (FDA) over the past few months. Its closure led to the nationwide shortage of baby formula, as it was the nation’s leading maker of formula in a market that has been tightly controlled to prevent foreign supplies from entering.
The company on July 1 assumed operations at its Sturgis, Michigan baby formula plant, which was closed last month due to heavy rains, a company spokesperson told Reuters on Saturday.
The company saw its Sturgis facility shuttered by the Food and Drug Administration in February after two infants died from a rare bacteria which may have come from the plant.
At the time, it also recalled infant formula products, including Similac, in response to reports of bacterial infections in babies who consumed products made at the facility.
Before the recall, Abbott controlled 40% of the infant formula market.
The company indicates it will begin producing the specialty formulas that have been in short supply.
Abbott had said it would restart EleCare production, followed by specialty and metabolic formulas, after it reopened.
The plant had previously been shut down for months after an FDA inspection that found Cronobacter sakazakii bacteria, which can be deadly to infants, in several areas. Similac, Alimentum and EleCare powdered infant formulas made at the plant were recalled, and the closure exacerbated shortages caused by supply chain disruptions. Families across the United States have struggled for months to find formula for infants and for people with specific nutrition needs.
Production had been underway for less than two weeks before the closure from the storm.
More than 20% of formula products — powder, ready-to-drink and liquid — have been out of stock for the past month, according to data through July 3 from market research firm Information Resources Incorporated (IRI).
The FDA has also announced plans to help allow foreign baby formula manufacturers to stay on the U.S. market with long-term authorization, to broaden market options and prevent shortages from occurring again.
The FDA aims to provide a path for overseas producers that have already sent supplies to the U.S., under temporary emergency approval, to stay on the market by meeting existing requirements. The plans also will make it easier for new importers to navigate the FDA’s regulatory review process.
“The need to diversify and strengthen the U.S. infant formula supply is more important than ever,” FDA Commissioner Dr. Robert Califf and Susan Mayne, director of the agency’s Center for Food Safety and Applied Nutrition, said in a statement. “The recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become.”
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