Honey Smacks manufacturer pleads guilty to food safety violations

Kerry, Inc., manufacturer of the breakfast cereal that was responsible for a 2018 Salmonella outbreak that sent thirty-four victims to hospital, has pled guilty in federal court to a charge that it manufactured the cereal under insanitary conditions.

The contaminated Kellogg’s Honey Smacks breakfast cereal caused 135 confirmed illnesses in 36 states.

According to a news release from the US Department of Justice (DOJ), the company has agreed to pay a criminal fine and forfeiture amount totaling $19,228,000.

The plea agreement has not yet been accepted by the court.

According to the DOJ’s news release, if the agreement is accepted, “…the $19.228 million fine and forfeiture will constitute the largest-ever criminal penalty following a criminal conviction in a food safety case.”

The company shut down operations at its Gridley, Illinois, facility in December 2018 due to a drop in demand for the products manufactured at that location.

In October 2022, Ravi Kumar Chermala, Kerry’s former Quality Assurance Director, pled guilty to three misdemeanor counts of introducing adulterated food into Interstate Commerce.

Kerry Inc. released a statement on February 3, 2023, in which the company regretted “…the unacceptable practices and failures that occurred at Gridley.”

On the Q-T

The FDA’s investigation into this Salmonella outbreak–and the subsequent actions taken against the manufacturer–have been surrounded by a veil of silence from the beginning.

Honey Smacks cereal was manufactured by Kerry Inc. under a third-party contract with the Kellogg Company. At the time of the initial investigation, the FDA declined to reveal the name of the manufacturer it believed to be responsible for the Salmonella outbreak.

It was only after the CDC had declared the outbreak to be over that the FDA revealed the name of the manufacturer.

The FDA also declined to identify the Salmonella serotype it had discovered during the inspection of Kerry’s manufacturing facility and declined to reveal whether the strain it found was a genetic match to the strain recovered from outbreak victims.

In July 2018, Kerry initiated a recall of 82 tons of Soy Honey Cluster. Two days later, General Mills recalled six production batches of Cheerios Protein Oats and Honey cereal. In both cases, the potential for Salmonella contamination was given as the reason for the recall. Yet, no public notice was posted on the FDA website in either case.

What next?

The next step in this process will be for the Court to decide whether or not to accept the plea agreement.

The case has been assigned to U.S. District Court Judge James E. Shadid and Magistrate Judge Jonathan E. Hawley in Peoria, Illinois, and a sentencing date of March 14, 2023, has been set.

Information regarding upcoming court hearings or other significant developments in the case will be posted on the DOJ’s Information for Victims in Large Cases website.

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Kerry’s former quality assurance director pleads guilty to Honey Smack outbreak

This story by Dan Flynn first appeared in Food Safety News on October 24, 2022, and is reposted here with permission.

A fast-moving, but somewhat secretive federal prosecution has extracted guilty pleas for three misdemeanors from the quality assurance director for a food manufacturer working for the Kellogg Company.

Ravi Kumar Chermala, 47, pleaded guilty on Oct. 21 to three misdemeanor counts of Introducing adulterated food into Interstate Commerce. It was part of a plea deal that is among a half dozen documents in the case that are sealed, and therefore not available for public viewing. The federal Magistrate for the Central District of Illinois, Jonathan P. Hawley, has scheduled sentencing for Jan. 30. 2023.

The charges stem from the multistate outbreak of Salmonella Mbandaka infections from Kellogg’s Honey Smacks cereal, which sickened 135 people in 35 states in 2018. The infections required hospitalizations for 34 patients. The Kellogg Company recalled Honey Smacks cereal on June 14, 2018.

According to federal prosecutors, Chermala was quality assurance director for various Kerry manufacturing plants, including a facility in Gridley, IL, that manufactured Kellogg’s Honey Smacks breakfast cereal for Kerry’s customer, the Kellogg Company.

At the time of the recall, the Kellogg Company said it “had launched an investigation with the third-party manufacturer who produces Honey Smacks,” naming Kerry’s possible role.

In pleading guilty to the three misdemeanors, Chermala admitted that between June 2016 and June 2018, he directed subordinates to not 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 the presence of pathogens in the plant, limiting the facility’s ability to accurately detect unsanitary conditions.

“Food safety professionals cannot conceal potentially dangerous problems from customers or government regulators,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work with its law enforcement partners to hold accountable those who engage in such conduct.”

Special Agent in Charge Lynda M. Burdelik of the FDA Office of Criminal Investigations in the Chicago field office said this prosecution “reinforces that if an individual violates food safety rules or conceals relevant information, we will seek to hold them accountable. 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.”

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.

Further information about the case will be posted to the department’s Information for Victims in Large Cases website at https://www.justice.gov/largecases.

Trial Attorney Cody Matthew Herche and Senior Trial Attorney James T. Nelson of the Department of Justice, Civil Division’s Consumer Protection Branch are prosecuting the case.

The misdemeanor counts in the case were filed with the court on Aug. 23, 2022. Defense attorneys Jesse Mentz and Michael Kim Krouse are both from the multinational law firm of Arnold & Porter Kaye Scholer.

At the time of the Honey Smack recall, Kerry was subject to an FDA inspection that went to upper management. The resulting warning letter said in part:

“The United States Food & Drug Administration (FDA) inspected your Kerry Inc. facility, located at 320 West Gridley Road, Gridley, IL 61744-8723, from June 14 to 29, 2018. The inspection was initiated as (redacted) in three environmental swabs taken from your (redacted) cereal (“cereal”) production rooms during FDA’s inspection. Further, the FDA’s Whole Genome Sequencing (WGS) analysis of the three isolates of (redacted).

“During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

“Based on FDA’s inspectional findings and the analytical results for the environmental samples collected during the inspection, we determined that the cereal manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4) in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)).”

FDA’s inspection resulted in the issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during the inspection. It went to Kerry’s CEO in Beloit, WI.

Court documents are silent as to whether or not others are responsible for the outbreak. With six of 11 items docketed in the case being sealed, it is difficult to reach a complete picture.

Op-Ed. FDA acknowledges Kellogg – Kerry tie in Honey Smacks cereal outbreak

Now that the outbreak is over and the question is purely academic, FDA has acknowledged Kerry Inc. to be the manufacturer behind the Salmonella Mbandaka outbreak linked to contaminated Kellogg’s Honey Smacks breakfast cereal.

Earlier today, FDA released an update to its outbreak investigation report, stating:

“The FDA, CDC, along with state and local officials investigated a multi-state outbreak of Salmonella Mbandaka infections linked to Kellogg’s Honey Smacks sweetened puffed wheat cereal. The FDA worked with Kellogg’s to voluntarily recall Honey Smacks from the market and conducted an inspection at the manufacturing facility owned by Kerry, Inc., resulting in a warning letter identifying specific problems at the facility.

The FDA is working with Kellogg’s to ensure Honey Smacks are safe when they are again available to consumers and is continuing to warn consumers against eating any Honey Smacks with a marked “best if used by” date before June 14, 2019.”

The acknowledgment came just two days after CDC declared the outbreak to be at an end, and just three days after a spokesperson for FDA declined eFoodAlert’s request to identify the strain of Salmonella found during the agency’s inspection of the Kerry Inc. manufacturing facility in Gridley, Illinois.

Why the secrecy? Why the delay?

News of the outbreak first broke on June 14, 2018, with a voluntary recall announced by The Kellogg Company, and an outbreak investigation notice from FDA and CDC.

On July 26th, FDA released the text of a Warning Letter issued to Kerry Inc. pursuant to an inspection of the company’s Gridley, Illinois facility.

On July 31st, I submitted a Freedom of Information Act request to FDA for the inspection and lab reports on which the warning letter was based.

On September 25th, almost two months after making the request, I received the redacted reports. I immediately inquired as to why the specific Salmonella strain found inside the Kerry cereal production plant was redacted from the report. I was told, “The information you have received via foia is all we can provide at this time.”

Why should this matter?

The Kellogg Company is not Kerry’s only customer.

As I reported three days ago, Kerry initiated its own voluntary recall on July 12th. The recall was not publicized. On July 16th, General Mills also issued an unpublicized recall for a Cheerios variety that contained an ingredient matching the description of the material recalled by Kerry.

According to a spokesperson for CDC, with whom I had an exchange of email messages in late August, no other cereals were linked to the outbreak. Nevertheless, many milder cases of salmonellosis always go unreported, especially by those who cannot afford a visit to the doctor or clinic.

There is no way of knowing whether anyone became infected as a result of eating the recalled General Mills cereal. And, in the absence of a public recall notice, US consumers were left ignorant of the risk.

Breakfast cereals, especially sweetened cereals, are consumed preferentially by children – one of the most vulnerable sectors of the population. In this instance, FDA put the ‘privacy’ concerns of Kellogg, Kerry, and other companies above its mandate to protect the public from contaminated food.