Baby formula factory says it’s still months away from production
Three and a half months after the U.S. Food and Drug Administration began an inspection and shutdown of Abbott Nutrition’s Sturgis, Mich., facility, machinery is still silent, no infant formula rolling off the production line.
On the north side of the city of 10,000, nestled between the local airport and a neighborhood of onestory homes, Abbott is among the region’s biggest employers. Locals say they were shocked by allegations of unsanitary conditions that led to the shutdown, which has drastically reduced the availability of formula across the country and left parents scrambling to feed their newborns.
“In the past, the employees would even talk about how, like, they’d have to gear up. And boy, if you went and touched something, you’d have to gear up again. So it really threw me for a loop when I heard about it,” said Cindy Conrod, standing behind
the counter at her downtown Sturgis appliance shop.
Experts say the formula crisis points to problems beyond conditions at the facility operated by Abbott, maker of Similac and the largest producer of milk formula in the country. For years, they have been warning that industry consolidation has left the production of formula - a highly regulated product that is notoriously difficult to manufacture - in the hands of a small number of makers vulnerable to this sort of disruption.
Four major companies control 90% of the infant formula supply in the United States: Abbott, Mead Johnson, Gerber and Perrigo Nutritionals. Perrigo produces store-brand infant formulas for major stores including Walmart, Sam’s Club, Target, Kroger, CVS and Walgreens. Only three of these - Abbott, Mead Johnson and Gerber hold the contracts for a food assistance program for mothers and young children called the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Benefit recipients are permitted to use only products made by the company contracted with their state. About half the total infant formula purchased is by WIC recipients.
“How did these companies essentially build a monopoly? And each of these companies’ operations are also highly centralized so that when one facility goes offline for even a matter of weeks, you can have this ripple effect across the entire industry,” said Brian Dittmeier, senior director of public policy at the National WIC Association, a nonprofit advocacy group representing provider agencies and recipients.
This is precisely what happened.
In February, the FDA ordered Abbott to shut down its production facility in Sturgis, which produces Similac, Elecare and several other leading powdered formulas. Cronobacter bacteria had been found in infants who consumed formulas produced at the Sturgis plant. Two infants became sick, and two died. This prompted a voluntary recall by Abbott as well as an FDA inspection that found the plant did not maintain acceptable sanitary conditions.
Abbott says that after a painstaking investigation, the FDA still has not been able to produce clear evidence linking its formulas to the infants’ illnesses and deaths. Abbott officials said they began implementing improvements and taking corrective actions before receiving the FDA’S letter detailing needed fixes on April 8. They have installed nonporous, easily cleanable and sanitary floors, added a 3D-augmented reality system to provide clearer images of product as it moves through the facility, and increased finished product sampling and testing.
In a statement this week, the company said it can resume production within two weeks if the FDA signs off. Once the facility reopens, Abbott says it will take six to eight weeks before the product is available on shelves.
The FDA, however, says it is still investigating the facility. Among the deficiencies it found were water leaks and standing water on the floor, workers not wearing appropriate protective gear and a number of swabs in the facility that tested positive for cronobacter sakazakii bacteria, according to the FDA report. Abbott Nutrition did not respond to phone calls and an email asking for comment.
“The plant remains closed as the company works to correct findings related to the processes, procedures and conditions that the FDA observed during its inspection of the facility, which raised concerns that powdered infant formula produced at this facility prior to the FDA’S inspection carry a risk of contamination,” an FDA spokeswoman said.
Although the FDA has said it is working with Abbott and other manufacturers to bring safe products to the U.S. market, it is unclear when the facility will be allowed to reopen. In the meantime, parents of children who rely on formula. In April, grocery store shelves dipped 43% below full stock. Retailers are rationing popular brands.
On Friday, FDA Commissioner Robert M. Califf said the FDA intends to allow foreign manufacturers and suppliers to ship their formula into the United States - the FDA’S strict labeling guidelines previously made it hard for such companies to get their baby formula into the United States - as well as some additional flexibilities for domestic manufacturers and suppliers. House Speaker Nancy Pelosi, D-calif., announced that next week the House will take emergency action to allow WIC recipients to buy any available formula.
“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it,” Califf said Wednesday in a statement.
Experts say it wouldn’t be unusual for the FDA to take more than three months to close out such a significant investigation. Sarah Sorscher, deputy director of regulatory affairs at Center for Science in the Public Interest, said one challenge is that the FDA has yet to be able to identify the root cause of the contamination.
“They didn’t understand where or why the formula became contaminated, so they are grappling with corrective steps to take to prevent another outbreak,” she said. “There are a limited number of companies that can make these products and make them safely. So right now if you need a standard formula it’s a grim scavenger hunt and you may need to visit multiple stores, but the people in the toughest situation are those who require special formulas for rare metabolic problems. Parents are getting desperate.”