Mich. baby formula plant at the heart of shortage reopens
Abbott Nutrition resumed production at its shuttered Sturgis, Mich., baby formula factory on Saturday, offering hope that a nationwide shortage that had left parents scrambling to find sustenance for their children could ease in thecoming weeks.
The company said it was resuming production “after meeting initial requirements” that were specified by a May consent decree with the Food and Drug Administration. The company was required to obtain an independent expert to review operations and compliance with the law, among other things.
“We understand the urgent need for formula, and our top priority is getting high-quality, safe formula into the hands of families across America,” Abbott said in a statement. “We will ramp production as quickly as we can while meeting all requirements.”
The factory was closed earlier this year after an FDA inspection turned up allegedly unsanitary conditions. The factory produced most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so its closure severely curtailed supplies.
The company has said previously that it will take two weeks for production to fully resume and another six to eight weeks to get the product on store shelves. The plant will prioritize the production of EleCare, a specialty amino acid-based formula for children with multiple allergies, before it ramps up production of its mainstream products. On Saturday, Abbott said it expected to release EleCare “to consumers beginning on or about June 20.”
The FDA on Saturday said that it “is continuing to work diligently to ensure the safe resumption of production of infant formula” at Abbott Nutrition’s Sturgis facility.
The temporary closure of the facility led to a dramatic disappearance of specialty formula, sparking panic among many parents who rely on the products to feed their children. The crisis raised questions about the fragility of the supply chain for a critical food source. Four major companies control 90% of the infant formula supply in the United States: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. Congress and others have heavily criticized FDA leadership, Abbott executives and even the White House for failing to head off the crisis.
FDA Commissioner Dr. Robert Califf has waffled about when the Sturgis facility would probably be up and running, telling lawmakers on May 19 that it might happen as soon as that following week. In a hearing last week, however, he said problems his agency found there were “beyond the pale” and might require more significant remediation.
The inspection in February took place after two infants were sickened and two others died after consuming contaminated formula, but the source of the contamination is unclear.