Senior Democrats suggested Tuesday that a baby formula manufacturer could be criminally liable for unsanitary conditions that led to one of its factories being shut down earlier this year.
“I think there might be a need for indictment,” House Speaker Nancy Pelosi (D-Calif.) told reporters at a news conference.
Abbott Nutrition paused production at its formula factory in Sturgis, Michigan, in February after an inspection by the Food and Drug Administration found dangerous bacteria and shabby conditions in production areas.
The shutdown greatly exacerbated a formula shortage that has become a major political issue and a crisis for some families. Out-of-stock rates for formula products rose to 43% in early May, according to Datasembly, a retail data firm.
Democrats are speeding two bills to the House floor this week in response to the shortage. But the bills wouldn’t have an immediate impact on store shelves, even if the legislation quickly became law. Democrats also announced they would bring formula maker executives to Capitol Hill for hearings this month.
Four infants fell ill, and two died, from Cronobacter sakazakii infections last fall after consuming formula made at Abbott’s Michigan plant. The company stressed this week that there was “no conclusive evidence” its formula sickened the babies, since genetic sequencing revealed the children had been struck by a different Cronobacter strain than the one found in the company’s factory.
Companies and individuals can be held criminally accountable, with fines and jail time, for violations of the federal Food, Drug, and Cosmetic Act, which the FDA enforces.
Members of Congress have also questioned the FDA’s slow response to the Cronobacter infections. The agency knew of a possible foodborne illness connected to Abbott’s formula in September, but it didn’t start followup inspections until January and didn’t warn consumers until February.
“We are going to investigate Abbott and the chips should fall where they may,” Rep. Rosa DeLauro (D-Conn.) said Tuesday. “People have to be accountable, whether it is an FDA or whether it is at Abbott.”
In a letter to FDA Commissioner Robert Califf, Sen. Joe Manchin (D-W.Va.) said the agency had been “caught flat-footed” at every step of the crisis.
As for Democrats’ legislation, one measure would boost funding for the FDA by $28 billion. DeLauro said the agency could use the money to hire more inspection staff, which would bring more firms into the heavily regulated baby formula market.
“FDA does not have the adequate inspection force to be able to do that and to do it in a timely way,” DeLauro said. “I was told that they have only nine people to do this.”
The other piece of legislation would essentially codify steps that the U.S. Department of Agriculture has already taken to make sure that people enrolled in the Special Supplemental Nutrition Program for Woman, Infants and Children can use their benefits to buy more than one brand of formula. The benefits work like regular nutrition assistance, but with strict limitations on what foods are eligible for purchase.
Formula makers bid for state contracts that allow them to be the sole provider of formula to WIC recipients in a given state in exchange for a discount. Using pandemic waiver authority, the USDA has already given states leeway to let WIC recipients use their benefits for noncontract formulas. Abbott, the sole formula provider for WIC recipients in 23 states, has also said it would pay rebates for purchases of other formula brands through August.
The WIC flexibility doesn’t increase the supply of formula, but it makes life easier for low-income households. As many as 45% of all newborns in the U.S. benefit from WIC.
“To the extent that there is formula available, USDA’s waivers allow states to let WIC participants obtain whatever brand or type of formula is on store shelves, without the usual medical documentation,” Zoë Neuberger, a senior policy analyst with the Center on Budget and Policy Priorities, told HuffPost. “This puts WIC participants on more equal footing with other families. But it doesn’t address getting more formula on the shelves.”