Abbott Nutrition has halted production at the Michigan plant that helped drive a nationwide baby formula shortage after storms pummeled the region and caused widespread flooding.
“As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant,” the company said in a statement.
Abbott said the delay should not worsen the formula shortage, however, because there was “ample existing supply,” noting that it had produced 8.7 million pounds of infant formula in June for the United States — the equivalent of 168.2 million 6-ounce feedings. A spokesperson said that represented 95 percent of Abbott’s output in the month before its February product recall and the Sturgis plant’s closure.
But the incident highlights the fragile nature of the supply chain when it comes to formula, many newborns’ only food source. Four companies have dominated the U.S. formula market in recent years. Abbott had produced 40 percent of the nation’s powdered formula, much of it at the Sturgis factory, before the February shutdown.
Abbott noted that it had informed the Food and Drug Administration of the closure — days after the agency signed off on the facility’s reopening — and that it would “conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production.”
“This will likely delay production and distribution of new product for a few weeks,” Abbott said.
Blame for the national shortage has fallen fairly equally on Abbott and the FDA, with the FDA’s commissioner, Robert M. Califf, getting raked over the coals by policymakers in several congressional hearings in recent weeks.
Abbott resumed production after meeting requirements specified by a May consent decree with the FDA, which included, among other things, obtaining an independent expert to review operations and compliance with the law.
“While this is an unfortunate setback and a reminder that natural weather events can also cause unforeseen supply chain disruptions, I want to reassure consumers the all-of-government work to increase supply means we’ll have more than enough product to meet current demand,” Califf tweeted Wednesday night. “We know Abbott is working quickly to assess the damage and will be reporting its progress to us in the days ahead. Once the company establishes a plan, FDA will be back in the facility working to ensure that they can restart producing safe and quality formula products quickly.”
The closure comes about a week after newly released documents showed the FDA had investigated reports that as many as nine children had died since early 2021 after consuming baby formula produced at the Sturgis plant — seven more than previously acknowledged by the FDA.
The agency was unable to definitively trace the problem back to the factory in any of the nine cases. In some cases, there was not enough leftover formula to test, or testing indicated a different strain of bacteria.
The factory was closed this year after an FDA inspection turned up allegedly unsanitary conditions. It made most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so its closure severely reduced supplies.
The company has said previously that it expected new production of EleCare, an amino acid-based formula for children with multiple allergies, to begin reaching consumers by next week.
The White House’s efforts to import formula to ease the domestic shortfall have stepped up, with nine flights scheduled this week. By Sunday, the Department of Health and Human Services said in a statement, Operation Fly Formula flights will have imported nearly 12 million 8-ounce-bottle equivalents of infant formula, much of it special metabolic products for babies and others with allergy issues.
Retail stores’ stocks of regular formula remain low, despite the federal government’s efforts. Store shelves were 76.5 percent stocked for the week ending June 12, according to data research firm IRI. The problem is particularly acute in the Upper Midwest. Low-income Americans have been hit especially hard, with food banks and other assistance programs reporting low supplies.
The FDA also announced steps Wednesday to bring 4.5 million pounds of formula base powder from Mead Johnson’s Singapore facility to a facility in Minnesota to step up production of Enfamil for newborns. The FDA estimates that this will produce about 5.7 million cans, the equivalent of about 66 million bottles, between July and November.
Abbott has not given a date for reopening the flood-affected plant.