(BUFFALO, N.Y.) — The Food and Drug Administration and Abbott Nutrition have agreed on a plan to resume operations at its infant formula facility in Sturgis, Michigan, the two announced on Monday.
While the news will be welcomed by frustrated parents who are struggling to find formula on shelves, it still could be several more weeks before they see relief.
According to Abbott, the agreement with the FDA lays out “the steps necessary to resume production and maintain the facility” but remains subject to court approval. Abbott said that once the FDA gives it the official green light, it could restart operations at the site within two weeks 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. We look forward to working with the FDA to quickly and safely re-open the facility,” said Robert B. Ford, chairman and chief executive officer of Abbott.
It’s estimated that Abbott Nutrition is one of only four companies that control 90% of the market. The industry was already dealing with supply chain issues when federal inspectors found evidence of a deadly bacteria at the Sturgis plant and shut it down.
Abbott maintains that there is still no conclusive evidence linking its formula to four infant illnesses, which included two deaths.
FDA Commissioner Bob Califf told ABC’s “Good Morning America” that the administration wants to take a deeper look behind what caused the nationwide shortage of formula beyond the Sturgis plant.
“There is formula out there. It’s just not in the right place at the right time,” he said.
Ahead of call with reporters Monday evening, the FDA also announced it is easing import restrictions on foreign-made infant formula.
The agency said global manufacturers interested in selling its 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 FDA said it is already in discussions with “some manufacturers and suppliers” regarding additional supply. It does not say which manufacturers.
The U.S. normally produces 98% of the infant formula it consumes, according to the FDA.
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