Justice Department drops Abbott criminal probe, seeks civil penalties instead

The Justice Department has closed its criminal probe into Abbott Laboratories over the infant formula crisis and is instead pursuing civil penalties. Abbott Nutrition’s plant in Sturgis, Michigan, was at the center of the investigation, with federal inspectors and investigators tying consumer complaints and infant illnesses to powdered formula produced there from September 20, 2021, through February 24, 2022. The Food and Drug Administration said the Centers for Disease Control and Prevention was notified on February 10, 2022. Abbott expanded a voluntary recall on February 17, 2022, covering Similac, Alimentum and EleCare powder formulas made at the facility, and later recalled one lot of Similac PM 60/40 on February 28. The CDC’s final outbreak summary listed four confirmed Cronobacter cases and two deaths, with cases in Minnesota, Ohio and Texas.

Prosecutors had considered a misdemeanor charge under the Federal Food, Drug, and Cosmetic Act and a separate count for misleading the government before dropping the criminal case, and they were also weighing charges against at least one individual. Instead, the government is now looking at clawing back money Abbott earned through federally funded nutrition programs. A Justice Department spokeswoman said the administration does not believe in regulation by prosecution.

Abbott has long denied wrongdoing. At the time of the recalls, it said there was no evidence linking its formulas to the illnesses and that no unopened distributed products tested positive for the bacteria. In an October 2022 earnings release, Abbott said the stoppage at Sturgis hurt sales, but that production of Similac, EleCare and metabolic infant formulas had restarted at the plant during the third quarter of 2022.

Congressional Research Service material put infant formula out of stock nationwide at 43% for the week ending May 8, 2022, as supply-chain strains collided with the recall.