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.

 

FDA suppresses Salmonella details from Kerry cereal plant inspection

On May 17, 2018, the US Food and Drug Administration (FDA) learned about a multistate outbreak of Salmonella Mbandaka illnesses. FDA, the US Centers for Disease Control and Prevention (CDC), and agencies from the affected states joined together to investigate the source of the outbreak.

On June 14, 2018, CDC alerted the public to the multistate outbreak, which it had determined to be linked to Kellogg’s Honey Smacks cereal. The cereal was manufactured for The Kellogg Company by an unnamed third-party contract manufacturer.

On June 14, 2018, The Kellogg Company issued a voluntary recall of the implicated Honey Smacks cereal. That same day, according to FDA, the agency began to collect environmental and product samples from the unidentified contract manufacturer’s facility.

On June 14, 2018, according to information received by eFoodAlert in response to a Freedom of Information Act request, FDA initiated an inspection of a Kerry Inc. facility located in Gridley, IL. The inspection was completed on June 29, 2018.

According to the FDA Establishment Inspection Report, “Kerry Inc. is a large manufacturer of cereal based ingredients, and cereal products for food companies in the United States.”

On July 12, 2018, Kerry Inc. recalled more than 82 tons (165,600 lbs) of Soy Honey Cluster (30 lb. case, plastic bag in cardboard box; four different production lots). All of the recalled product was delivered to Minnesota. The reason given for the recall was, “[A]n ingredient in this product was manufactured during the time-frame and on the same piece of equipment that was associated with a salmonella outbreak.”

On July 16, 2018, General Mills, Inc. (Minneapolis, MN) recalled approximately 115 tons (16,308 cases) of Cheerios Protein Oats & Honey (Net Wt. 19 oz. (583g) UPC 16000-44473. 12 boxes/case, Net Wt. 14.1 oz. (399g) UPC 16000-45137. 16 boxes/case; Better if used by 05MAY2019, 06MAY2019, 07MAY2019, 08MAY2019, 09MAY2019, 10MAY2019). The recalled cereal was distributed nationwide. The reason given for the recall was, “Cheerios Protein Oats and Honey cereal may be contaminated with Salmonella.” 

One of the main ingredients in Cheerios Protein Oats & Honey is ‘Clusters’ and consists of: whole grain oats, soy protein, brown sugar, lentils, sugar, corn syrup, rice starch, honey, caramel (sugar, caramelized sugar syrup), salt, molasses, natural flavor, caramel color, baking soda. Vitamin E (mixed tocopherols) added to preserve freshness.

Neither Kerry nor General Mills issued a public recall notice.

As part of its June 14-29, 2018 “comprehensive … preventive controls inspection,” FDA used swabs to sample 200 separate locations in the process/manufacturing environment. Three samples categorized as ‘Normal Everyday Sample … Breakfast Foods Ready To Eat” were also collected for lab analysis.

Salmonella was found in all three of the product samples and in three (3) of the 200 environmental swab samples. The Salmonella-contaminated sites included:

  • Bottom of roll-up door between the cereal coating room and a processing room for rice crisps intended for pet food
  • Dryer let in a (redacted) Line 
  • Yellow plastic on roll-up door between one of the warehouse spaces and the northeast entry into a coating room.

Kerry’s own records documented a persistent and long-standing Salmonella contamination in the company’s production facility. 

According to FDA’s Inspectional Observations (Form 483), Kerry had documented 113 Salmonella-positive samples throughout the Gridley facility between September 29, 2016 and May 16, 2018.

Four of the Salmonella-positive samples were from the coating room and one from a cereal (production?) room.

Kerry did not take effective action to correct the Salmonella contamination or prevent its reoccurrence according to the Form 483 report.

Although the timeline strongly suggests that Kerry Inc. was the source of the Salmonella Mbandaka outbreak which, as of the last reported update on September 4th, had sickened 130 people in 36 states and sent 34 of them to hospital, FDA’s collective lips are sealed.

The specific type or strain of Salmonella found in the environmental and product samples was redacted from the lab reports supplied to eFoodAlert in response to the Freedom of Information request.

The agency has declined to reveal whether the Salmonella found during the Kerry inspection is the same strain responsible for the outbreak. 

When asked why this information was not forthcoming, a spokesperson for FDA responded that the information in the redacted reports was “all we can provide at this time.”

CDC continues to advise the public to avoid consuming Kellogg’s Honey Smacks cereal, regardless of production lot and expiry date. Although the number of new confirmed cases of illness appears to be on the decline, the agency has not yet declared the outbreak to be over.