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.
Eric Gay/AP
Olivia Godden prepares a bottle of baby formula for her infant son at her home in San Antonio, Texas, May 13, 2022.
"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.
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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.
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FDA Commission 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.