Three and a half months after the U.S. Food and Drug Administration began an inspection and shutdown of the Sturgis, Mich., facility of Abbott Nutrition, machinery is still silent, with no infant formula rolling off the production line.
“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.
On Monday, Abbott announced that it had come to an agreement with the FDA to fix safety problems identified by the agency, a first step to reopening the factory and easing the shortage. But even after FDA gives the all-clear for the factory to begin operating again, it will take two weeks to restart production and another six to eight weeks to get the product back on the shelves.
Experts say the formula crisis points to problems beyond conditions at the facility run by Abbott, the maker of Similac and the largest producer of milk formula in the country. For years, experts 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 percent of the infant formula supply in the United States: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. Perrigo produces store-brand infant formulas for major stores including Walmart, Target, Kroger, CVS, Walgreens and Sam’s Club. Only Abbott, Gerber and Mead Johnson 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 allowed 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 letter detailing needed fixes on March 18. They have installed nonporous, easily cleanable and sanitary floors, and increased finished product sampling and testing.
The FDA said Friday it was 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.
“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 inspection carry a risk of contamination,” an FDA spokeswoman said last week.
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 for survival are panicked. Grocery store shelves recently dipped more than 40 percent below full stock, and 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, as well as some additional flexibilities for domestic manufacturers and suppliers. The strict FDA labeling guidelines previously made it hard for such companies to get their baby formula into the country. Speaker Nancy Pelosi (D-Calif.) announced that the House would 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 in a statement last Wednesday.
Experts say it would not 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.”
Most formulas are made from a mix of protein concentrate from cow’s milk, rice starch, corn syrup and oils. They are sold ready to drink and in powdered forms that must be reconstituted with water. Because the minimum amounts of fat, protein, calcium and a number of vitamins is so stringently regulated, as many babies get 100 percent of their nutrition from formula for the first six months of life, a limited number of manufacturers have the ability to produce it effectively.
There are contamination risks, however, associated with powdered formula. Parents could introduce contaminants via a dirty spoon, an improperly cleaned bottle or even from a water source. In testing of the sick infants’ homes, the Centers for Disease Control and Prevention found cronobacter bacteria on a bottle of distilled water used to mix the formula.
FDA is working closely w/ our federal government partners to safely bring as much infant formula to US shelves as quickly as possible. This is a top priority for FDA. Our team will continue working around the clock to resolve the current supply challenges as quickly as possible.— Dr. Robert M. Califf (@DrCaliff_FDA) May 13, 2022
Some members of Congress have been frustrated by problems they see with both Abbott and the FDA. House Appropriations Committee Chair Rosa L. DeLauro (D-Conn.) has said she received a lengthy report from a former Abbott employee who registered a litany of complaints about conditions at the Sturgis plant with the FDA last October.
But the agency did not interview the whistleblower until late December, DeLauro said at a hearing in April. The FDA began its inspection at the plant on Jan. 31, and the recall was issued on Feb. 17, according to FDA documents.
“Why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves,” DeLauro said at the hearing in April.
Peter Pitts, former FDA associate commissioner, said the situation illustrates “a serious problem across the FDA portfolio, where there are a limited number of manufacturers. Making baby formula is a sophisticated, expensive proposition, so consolidation is going to happen. The downside is when one of those facilities goes offline.”
Pitts pointed to other consolidated industries, such as the production of insulin for diabetes, where there are only three main producers. More competition, he said, would create greater resilience in the system. Still, he said, “the FDA did the exact right thing. The FDA did not find any of the bacteria that sickened the children in Abbott’s product line, but Abbott admitted to lax safety protocols. The blame ultimately lies with Abbott to allow lax safety protocols.”
Dittmeier, with the National WIC Association, said that the shortfall of Abbott products has not been made up for by other manufacturers.
“They’ve promised ramped-up production for a number of weeks, yet it hasn’t translated to increased stock on the shelf,” he said, adding that formula is not evenly distributed across the country and that, anecdotally, rural grocery stores across the country have seen more empty baby formula shelves than urban ones.
Perrigo has run its formula facility at full capacity, 24 hours a day and seven days a week, said Bradley Joseph, vice president of corporate communications. He said that during the three months ending March 31, Perrigo shipped 37 percent more formula than the same period last year.
Gerber is running formula factories at capacity to accelerate product availability to retailers and online, as well as to hospitals for those most vulnerable, said Gerber spokeswoman Dana Stambaugh. Mead Johnson did not respond to requests for comment Friday.
Abbott said it has prioritized infant formula production at its other plant in Columbus, Ohio, converting other liquid manufacturing lines into making liquid Similac.
For the millions of American families scrambling to find food for their babies, another 10 weeks is untenable, assuming the FDA grants swift approval for the facility to resume manufacturing. The situation is particularly dire for the 1.2 million infants who receive formula benefits from WIC. In many parts of the country, shelves are bare of the products they are allowed to buy, and there are scant alternatives.
When Abbott issued a nationwide baby formula recall and shut down operations at its Sturgis plant in February, it disproportionately affected the neediest American families. For the states in which Abbott held major WIC contracts, the company agreed to honor the rebate for competitor products, meaning that families could substitute other items on store shelves for their approved WIC benefits and that Abbott would reimburse the state as if it were their own product.
They initially extended this agreement to the end of June, but if Abbott products were not on the shelves by then, Dittmeier said, it was unclear what it would mean for WIC recipients. “WIC will be limited in what they can cover,” he said.
On Friday, in the wake of consumer and policymaker concerns, and without a clear date by which the FDA would reopen the Sturgis facility, Abbott announced it would extend that reimbursement date to August 31.
Graphics by Hannah Dormido. Easter reported from Sturgis, Mich.