Texas-based Blue Bell Creameries has been ordered to pay $17.25 million in criminal penalties for shipments of contaminated products linked to a 2015 listeriosis outbreak. Blue Bell pleaded guilty in May 2020 to two misdemeanor counts of distributing adulterated ice cream products. The $17.25 million fine and forfeiture amount is the largest-ever criminal penalty following a conviction in a food safety case.
“The health of American consumers and the safety of our food are too important to be thwarted by the criminal acts of any individual or company, Americans expect and deserve the highest standards of food safety and integrity. We will continue to pursue and bring to justice those who put the public health at risk by distributing contaminated foods in the U.S. marketplace.”Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration
The plea agreement and criminal information filed against Blue Bell allege that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the Food, Drug and Cosmetic Act.
According to the plea agreement, Texas state officials notified Blue Bell in February 2015 that samples of two ice cream products from the company’s Brenham, Texas factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems. Blue Bell directed its delivery route drivers to remove remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform customers about the potential Listeria contamination.
“The results of this investigation reflect the determination of the Defense Criminal Investigative Service to hold companies that sell food products to the military accountable and ensure they comply with food safety laws.”Michael Mentavlos, Special Agent-in-Charge of the DCIS Southwest Field Office
In March 2015, tests conducted by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) linked the strain of Listeria in one of the Blue Bell ice cream products to a strain that sickened five patients at a Kansas hospital with listeriosis, the severe illness caused by ingestion of Listeria-contaminated food. The FDA, CDC, and Blue Bell all issued public recall notifications on March 13, 2015.
Subsequent tests confirmed Listeria contamination in a product made at another Blue Bell facility in Broken Arrow, Oklahoma, which led to a second recall announcement on March 23, 2015.