The Justice Department is investigating behavior at Abbott Laboratories’ infant formula plant in Sturgis, Michigan, which led to its closure last year and exacerbated a nationwide infant formula shortage, people familiar with the matter said.
Lawyers with the Consumer Protection Division of the Justice Department are conducting the criminal investigation, the people said.
The branch, which has both criminal and civil powers, was involved in a settlement with Abbott last year that allowed its Sturgis plant to resume operations after Food and Drug Administration inspectors found a potentially deadly bacteria there.
“The DOJ has informed us of its investigation, and we are fully cooperating,” said an Abbott spokesman.
The investigation signals another review of Abbott’s operations at the facility, a major source of baby formula in the US, and potentially the more than $4 billion infant formula industry.
The Justice Department has investigated numerous food companies over the past decade that have shipped contaminated product that has resulted in illness or death.
Several have resulted in criminal prosecutions under the Federal Food, Drug and Cosmetic Act of 1938 against companies or executives involved in the manufacture of goods from ice cream to peanut butter. The law allows government officials to prosecute entities or individuals that introduce adulterated foods into interstate commerce.
In many recent cases, the DOJ has been successful in prosecuting defendants charged with misdemeanor placing contaminated food on the market, even without evidence that officers acted with criminal intent, according to Bill Marler, a Seattle attorney who represents victims of food-borne illnesses.
Abbott, based outside of Chicago, is one of the largest baby food manufacturers. The company sells, among other things, Similac.
Last January, FDA inspectors found bacteria at the factory after receiving reports of babies drinking the company’s formula and getting sick. At the Sturgis plant, inspectors found standing water, damage to drying equipment and defects in the seams of formula cans, among other things.
However, federal officials have not been able to conclusively link the bacteria at the facility to the infants’ illnesses. Abbott said the genetic sequencing of the bacteria in the sick babies did not match the strains found at the facility.
Abbott temporarily halted production at the Sturgis factory in February and recalled baby formula made at the plant. The moves contributed to an infant formula shortage that distressed parents and federal officials for months.
A nationwide shortage of baby food is leaving some desperate parents driving for hours in search of supplies. dr Steven Abrams, a pediatrician at the University of Texas at Austin, explains what parents do and don’t do during a crisis. Photo illustration: Laura Kammermann
To bolster supplies, the federal government waived regulatory requirements and tariffs to allow more foreign baby formula into the country, and the White House organized planes to fly baby formula to the United States
Abbott signed a legal agreement, called a consent decree, last May, detailing the steps needed to reopen the facility.
In the complaint accompanying that civil agreement, the Justice Department said that Abbott and several of his associates arranged for “adulterated food” to enter interstate commerce.
“Persistent deficiencies in manufacturing conditions and practices at defendants’ facilities indicate that defendants have been unwilling or unable to implement sustained corrective actions to ensure the safety and quality of foods manufactured for infants, a consumer group , which is particularly susceptible to foodborne pathogens,” the department said in the complaint.
Also in May, Abbott chief executive Robert Ford apologized for the company’s role in the formula shortage and said it was making investments to avoid a repeat. The company reopened the plant in June.
However, the limited supply of infant formula continued into September, when adults in about a third of households with infants who received infant formula struggled to get hold of it, according to data from the US Census Bureau. By October, federal officials said inventory levels had stabilized almost at the level they were before the Sturgis plant closed.
In 2020, the Justice Department filed criminal charges against Texas ice cream company Blue Bell Creameries LP and its former CEO after an investigation into a Listeria outbreak linked to three deaths and other illnesses.
Blue Bell agreed to pay $19 million and plead guilty to two misdemeanor charges related to shipments of contaminated ice. The former CEO has pleaded not guilty to the charges.
That same year, Chipotle Mexican Grill Inc. announced that it would pay a record $25 million to clear criminal charges arising from a series of foodborne illness outbreaks involving its restaurants and more than 1,000 people fell ill.
In 2015, Stewart Parnell, the former owner of Peanut Corp. of America, sentenced to 28 years in prison a year after he was convicted of presiding over a cover-up that led to a deadly salmonella outbreak.
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