WASHINGTON ― President Joe Biden on Thursday announced several actions his administration is taking to help alleviate an alarming shortage of infant formula that has left desperate parents searching for food across the country.
The shortage has been building for months, first from the supply chain headaches that have wreaked havoc with the broader economy, but it grew after a February recall of formula by Abbott, the nation’s largest manufacturer of formula. The recall, which came after two infants died after eating tainted formula, also shut down a key factory in Sturgis, Michigan.
Senior administration officials told reporters on Thursday that more formula had been produced in the United States over the past month than in the month preceding the recall, but they also declined to predict when shelves would be fully stocked again. Retailers across the country have limited sales of formula to prevent hoarding.
“This administration is working around the clock to do everything we can to bring as much production to market while protecting the safety and well-being of families,” an administration official said, emphasizing the White House had been quietly working on this issue since the recall in February.
“We have had ongoing work with all manufacturers of infant formula to bring products to market, and we have really seen that pay off, and it’s helping to mitigate some of the challenges that we might otherwise be facing,” the official said. “At the same time, we absolutely recognize the frustration that American families are feeling right now.”
On Thursday, Biden spoke with retailers and manufacturers, including Walmart, Target, Reckitt and Gerber. Afterward, the White House announced it would ask state governments to provide more flexibility to the WIC program, which provides formula for poor families; would move to import more baby formula; and would ask the Federal Trade Commission and state attorneys general to crack down on any price gouging on formula.
All three steps will take some time to implement. Right now, the WIC program often limits what formula products families can buy, so loosening those regulations should make manufacturing easier. Some stores are also required to keep a certain amount of formula in stock, and lifting those restrictions should bring more formula to store shelves.
Right now, the United States manufactures about 98% of its formula domestically. The White House said the Food and Drug Administration would soon announce steps to increase imports.
Members of Congress in both parties, including House Appropriations chair Rosa DeLauro (D-Conn.) and Sen. Marco Rubio (R-Fla.), have suggested Biden invoke the Defense Production Act to increase formula supply. The White House said that option is under consideration.
“We’ll continue to explore every option on the table and look at any lever we can pull to address the situation,” the official said.
Republicans have complained that the FDA shuttered the Michigan facility without evaluating how a shutdown would affect the formula supply, and they have called the Biden administration too slow in responding to the formula crisis. And some Republicans have begun to question why the plant remains closed.
The Abbott shutdown occurred in response to a potentially serious health threat: Four babies got sick from Cronobacter sakazakii bacteria infections last fall after drinking formula from the plant, and two of them died. The FDA warned parents not to use certain formulas in February and Abbott recalled the affected products.
According to the Centers for Diseases Control and Prevention, “Cronobacter illnesses are rare, but they are frequently lethal for infants.”
During a series of inspections starting in January and continuing through March, FDA inspectors found Cronobacter sakazakii germs on surfaces at the Abbott plant on 20 occasions, according to the FDA’s Form 483 report, including on a “scoop hopper,” a piece of a equipment feeding scoops that “are placed directly inside infant formula containers and contact product.” The company also found Cronobacter in two finished products.
The FDA observed Abbott employees not following company protocols, such as by failing to sanitize their shoes when entering sensitive areas. Inspectors also saw water leaks, puddles, and debris-covered duct tape on the floor of a production room.
Abbott has said there is “no evidence” linking its formula to the four Cronobacter illnesses, since genetic sequencing of the Cronobacter that sickened two of the infants found different strains of the bacteria from the kind in the plant.
“Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative,” Abbott said in a statement. “The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.”
There shouldn’t be any Cronobacter in a baby formula factory, said Peter Pitts, a former FDA associate commissioner. It doesn’t really matter that infants had been sickened by different strains of the germ.
“It forced the FDA to go look at this plant, which was in horrible compliance condition. They stumbled onto the problem,” Pitts said. “The only thing worse than a shortage of baby formula is low quality formula. People keep asking who’s to blame here and the answer is Abbott.”
Abbott has said it could restart the plant within two weeks with the FDA’s approval; Pitts said inspectors are likely still vetting the facility’s sanitation.
Sen. Bob Casey (D-Pa.), one of the first lawmakers to inquire about the plant closure, welcomed efforts by the White House to alleviate supply, but he said that both Abbott and the FDA had yet to sufficiently explain their actions that led to the crisis.
“There’s real questions about when the world was notified, when folks were aware of the problem. … [There’s] a lot of failures here but in the short term you’ve gotta figure out a way to get people the formula you need,” Casey said.
Political concerns about the shortage are clearly growing. Rep. Abigail Spanberger (D-Va.), who represents a swing district, wrote on Twitter she discussed the shortage with White House chief of staff Ron Klain on Thursday and said they discussed using the Defense Production Act and lifting tariffs on imported formula.
“Quick action is needed, and the White House must take decisive action. In the longer term, I am pursuing legislation to ensure we do not ever face this challenge again,” Spanberger said.
After she returned to work from maternity leave in March, one day Maria Cintron sent her husband to the store to pick up some formula. She had been breastfeeding her 6-month-old but needed to supplement now that she’d returned to work.
Cintron said her husband came back with the wrong kind ― but it wasn’t because he’d made a mistake. It was because there was nothing else available at the store. She later went back to the store and saw the barren shelves for herself.
“It’s pretty ridiculous,” she said.
Just this week, Cintron said, they wound up buying liquid formula instead of the usual powdered kind, which is less expensive.
For Cintron, the shortage brought home the struggles facing the parents she serves as director of the HopeLine, a community resource center that helps low-income families in New York City. Cintron said her organization typically gives families a single can of baby formula powder when they pick up a box of food or diapers, but lately families have been asking for more while HopeLine has had less to give.
“A lot of our parents are coming back and asking us to make exceptions because they’re struggling to get formula themselves,” Cintron said. “It should be a given that we have this additional asset for them and we’re struggling to have it.”