DOJ drops criminal baby-formula probe; Abbott avoids charges

In a story that landed late Sunday, The Wall Street Journal reported that the Justice Department had dropped its criminal investigation into Abbott Laboratories over the contaminated Sturgis, Mich., baby-formula plant whose 2022 shutdown helped trigger a nationwide shortage.

Some prosecutors believed they had enough to charge Abbott under "a law previously applied to target other firms for allegedly distributing contaminated food products," and "some supervising officials viewed the case favorably," the Journal reported.

Senior officials nevertheless "chose to terminate the investigation" and pursued instead "a less severe approach: recovering funds that the company generated from selling formula through government-funded nutritional assistance programs."

For concerned consumers, two things stand out.

First, the Journal reports the plant was "suspected of contributing to infant fatalities" and "exacerbating a nationwide shortage" — exactly the facts that consumer advocates argued at the time required criminal accountability, not just a civil clawback.

Second, the decision lands at the same moment Congress and the Food and Drug Administration are still debating tighter formula-plant inspection rules; an absence of criminal charges removes one of the strongest deterrents on the books. WIC families, who depend on government-purchased formula, are precisely the consumers the civil-recovery settlement is calculated against.

Deadly bacteria behind the shutdown

The plant shutdown came after federal inspectors found traces of Cronobacter sakazakii, a potentially deadly bacteria that can cause serious illness in infants. Abbott recalled formula and shut down the plant in early 2022 after reports of infant illnesses among babies who had consumed formula made there.

The plant closure came at the worst possible time for families. Pandemic supply-chain problems had already strained supplies, and Abbott was one of the dominant producers in a highly concentrated infant-formula market. As shelves emptied, parents searched store to store, switched brands, paid inflated prices online, or sought emergency help from doctors and government agencies.

Now, after a years-long investigation, DOJ officials have reportedly decided not to bring criminal charges. Prosecutors had examined possible violations of the federal Food, Drug and Cosmetic Act and whether Abbott misled the government. At least one individual was reportedly under consideration for possible charges. But senior officials opted for a civil approach, including efforts to claw back profits Abbott earned from formula sold through federally funded nutrition programs such as the USDA's WIC (Women, Infants and Children) program.

A Justice Department spokeswoman told The Wall Street Journal that food safety remains a priority, but that the department does not believe in “regulation by prosecution.”

Abbott denies responsibility

Abbott has long denied that its formula caused the infant illnesses. The company has said no unopened, distributed Abbott formula tested positive for the bacteria that sickened babies, and that genetic testing did not link available patient samples to strains found in the plant. CDC testing later found that the available patient samples were not closely genetically related to Cronobacter strains found in environmental samples from the Sturgis facility.

That does not mean the plant was given a clean bill of health. In May 2022, Abbott entered into a federal consent decree with the FDA and DOJ that required corrective actions at Sturgis before production could fully resume. The decree called for outside expert oversight, plans to reduce and control bacterial-contamination risks, and ongoing FDA supervision of the plant’s food-safety practices.

The Sturgis episode exposed deep weaknesses in the U.S. infant-formula system. A single plant shutdown helped create a national emergency because the market was highly concentrated, import barriers limited alternatives, and many low-income families relied on WIC contracts that narrowed their formula options. The crisis forced the federal government to airlift formula from overseas and loosen import restrictions to bring more supply into the country.

For consumers, the DOJ decision means the Abbott case may end not with a criminal courtroom reckoning but with a financial settlement. That outcome is likely to satisfy neither side completely. Abbott maintains that its products were not linked to the illnesses. Food-safety advocates and some families are likely to argue that civil penalties do not provide enough accountability for a crisis that left infants at risk and parents desperate.

The larger question is whether the government has done enough to prevent a repeat. The FDA has since reorganized parts of its food-safety program and continued oversight of Abbott under the consent decree. But the formula market remains vulnerable to disruption, and parents still have limited visibility into how manufacturers, regulators and prosecutors handle safety warnings before they become national emergencies.

For families, the lesson is unsettling: even when infant food safety problems lead to recalls, shortages and federal investigations, criminal charges are far from certain. The Abbott probe may be over, but the debate over accountability in the baby-formula crisis is not.