FDA, Abbott agree on plan to resume production of infant formula at Michigan plant
The three-month closure has contributed to a nationwide shortage.
In a move to ease a nationwide shortage of infant formula, the Food and Drug Administration on Monday said it has agreed with Abbott Nutrition on a plan to reopen the company’s manufacturing plant in Sturgis, Michigan, after it was shut down following the discovery of a deadly bacteria inside.
The FDA also announced Monday it would make it easier for global manufacturers to sell their product inside the U.S. so long as they meet certain criteria.
Officials cautioned it might still take weeks before many parents see more infant formula on shelves, either from the Sturgis facility or from foreign suppliers. But the two developments were hopeful signs the crisis would resolve.
"With these additional flexibilities in place, we anticipate that additional products can quickly hit U.S. stores," FDA Commissioner Bob Califf told reporters in a press call, adding that he expects supply will "continue to improve over the next couple of months."
Companies that manufacture infant formula were already dealing with supply chain issues last fall when the FDA began investigating reports that four infants in three states fell ill with bacterial infections. After inspectors found a bacteria called Cronobacter sakazakii inside Abbott's Sturgis factory last February, Abbott closed its plant and agreed to a voluntary recall.
Abbott maintains that there is still no conclusive evidence linking its formula to four infant illnesses, which included two deaths.
"The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states," Abbott tweeted last week. "The formula from this plant did not cause these infant illnesses."
FDA officials on Monday, however, cautioned against any conclusions in the cases and said the investigation remains ongoing. They noted in particular that genetic sequencing of bacteria was only provided in two of the four cases and that more work needs to be done to rule out the causes.
The Sturgis facility closure seemed to be the tipping point for the supply crunch because of Abbott’s heavy influence in the U.S. market, where 90% of the nation’s supply comes from just four companies.
Also problematic was that the Sturgis facility was a top producer of specialty formula required by infants with specific medical needs.
According to Abbott, the latest agreement with the FDA lays out "the steps necessary to resume production and maintain the facility" but remains subject to court approval.
Abbott said it could restart operations at the site within two weeks pending an official green light from the FDA and that it would take six to eight weeks after that before the product is back on shelves.
"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage," said Robert B. Ford, chairman and chief executive officer of Abbott.
The FDA on Monday also announced it is easing import restrictions on foreign-made infant formula. The FDA said it is already in discussions with "some manufacturers and suppliers" regarding additional supply. It does not say which manufacturers, but said it's casting a broad net.
The United Kingdom, Australia and New Zealand have health and safety inspections similar to the United States, and new imports could potentially come from those places, according to one senior Biden administration official.
The FDA said global manufacturers interested in selling formula inside the U.S. must submit information about their products to regulators.
The FDA will, in turn, "quickly evaluate whether the product can be used safely and whether it provides adequate nutrition,” the agency said in a statement.
The U.S. normally produces 98% of the infant formula it consumes, according to the FDA.
Officials couldn't predict exactly how soon parents might see imported product on shelves other than to say supply would gradually improve over the next two months.
"I think we're looking at weeks in terms of getting the imported product into the market," said Susan Mayne, director of FDA's Center for Food Safety and Applied Nutrition.
ABC News' Ben Gittleson contributed to this report.
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