As of September 25, 2018, 135 people infected with the outbreak strain of Salmonella Mbandaka were reported from 36 states. Illnesses started on dates from March 3, 2018, to August 29, 2018. Ill people ranged in age from less than one year to 95, with a median age of 57. Sixty-nine percent of ill people were female. Out of 101 people with information available, 34 (34%) were hospitalized. No deaths were reported.
WGS analysis did not predict antibiotic resistance in bacteria isolated from 91 ill people and 8 food and environmental samples. Testing of five clinical isolates using standard antibiotic susceptibility testing methods by CDC’s National Antimicrobial Resistance Monitoring System (NARMS) laboratory also did not show antibiotic resistance.
Epidemiologic and laboratory evidence indicated that Kellogg’s Honey Smacks cereal was the likely source of this multistate outbreak. In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Sixty-three (75%) of 84 people interviewed reported eating Kellogg’s Honey Smacks cereal. Ill people in this outbreak reported this cereal more often than any other cereals or food items.
Health officials in several states collected Kellogg’s Honey Smacks cereal from retail locations and ill people’s homes for testing. Laboratory testing identified the outbreak strain of Salmonella Mbandaka in a sample of unopened Kellogg’s Honey Smacks cereal collected from a retail location in California.
Laboratory testing also identified the outbreak strain in samples of leftover Kellogg’s Honey Smacks cereal collected from the homes of ill people in Montana, New York, and Utah. WGS showed that Salmonella bacteria isolated from sick people and the cereal were closely related genetically. This result provides more evidence that people in this outbreak got sick from eating Kellogg’s Honey Smacks.
On June 14, 2018, the Kellogg Company recalled all Honey Smacks cereal that were on the market within the cereal’s one-year shelf-life. As of September 26, 2018, this outbreak investigation is over.
Food and ingredient manufacturing company Kerry Inc. pleaded guilty yesterday to a charge that it manufactured breakfast cereal under insanitary conditions at a facility in Gridley, Illinois, that was linked to a 2018 salmonellosis outbreak.
Pursuant to a plea agreement filed with a criminal information in federal court in Peoria, Illinois, Kerry pleaded guilty to a misdemeanor count of distributing adulterated cereal marketed as Kellogg’s Honey Smacks. The company also agreed to pay a criminal fine and forfeiture amount totaling $19.228 million. If the guilty plea is accepted by the court, the $19.228 million fine and forfeiture will constitute the largest-ever criminal penalty following a criminal conviction in a food safety case.
“Consumers depend on food manufacturers to take appropriate steps to ensure food safety,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The Department is committed to holding accountable those who fail to meet this obligation.”
“Today’s announcement should serve as a reminder that food manufacturers have a critical responsibility to produce and sell food that is safe for American consumers to eat,” said Assistant Commissioner Justin D. Green for the Food and Drug Administration’s (FDA) Office of Criminal Investigations. “We will continue to pursue and bring to justice those who put the public health at risk by allowing contaminated foods to enter the U.S. marketplace.”
The criminal information unsealed today alleges that Kerry manufactured Kellogg’s Honey Smacks cereal under insanitary conditions and distributed it in violation of the Food, Drug, and Cosmetic Act. According to the plea agreement, tests performed as part of Kerry’s environmental monitoring program found numerous instances of Salmonella in the environment at the Gridley facility. During the time period June 2016 to June 2018, routine environmental tests detected Salmonella in the plant approximately 81 times, including at least one positive Salmonella sample each month. According to the plea agreement, employees at the Gridley facility routinely failed to implement corrective and preventative actions (CAPAs) to address positive Salmonella tests.
In June 2018, the FDA and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States could be traced to Kellogg’s Honey Smacks cereal produced at Kerry’s Gridley facility. In response, Kellogg’s voluntarily recalled all Honey Smacks manufactured at the plant since June 2017. The CDC eventually identified more than 130 cases of salmonellosis linked to the outbreak, with illness onset dates beginning in March 2018. The CDC did not identify any deaths related to the outbreak.
Salmonellosis can cause symptoms such as diarrhea, fever, and abdominal cramps that last several days in healthy adults. Absent prompt treatment, salmonellosis can cause severe dehydration and even death in infants, young children, the elderly, transplant recipients, pregnant women, and individuals with weakened immune systems.
In a related case, Ravi K. Chermala, Kerry’s Director of Quality Assurance until September 2018, previously pleaded guilty to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce. Chermala oversaw the sanitation programs at various Kerry manufacturing plants, including the Gridley facility. In pleading guilty, Chermala admitted that between June 2016 and June 2018, he directed subordinates not to report certain information to Kellogg’s about conditions at the Gridley facility. In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions. Chermala is scheduled to be sentenced on Feb. 16.
The court set a March 14 sentencing date for Kerry. Further information about the Kerry and Chermala cases will be posted to the Department’s Information for Victims in Large Cases website at https://www.justice.gov/largecases.
FDA’s Office of Criminal Investigations is investigating the matter.
Senior Trial Attorney James T. Nelson of the Civil Division’s Consumer Protection Branch is prosecuting the case. Former Trial Attorney Cody Matthew Herche and Associate Chief Counsel Jason Hadges of FDA’s Office of Chief Counsel provided substantial assistance.
For more information about the enforcement efforts of the Consumer Protection Branch, visit the Branch’s website at http://www.justice.gov/civil/consumer-protection-branch