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.

Did FDA just reveal manufacturer of contaminated Kellogg’s Honey Smacks cereal?

When CDC alerted the public on June 14th to an outbreak of Salmonella illnesses linked to Kellogg’s Honey Smacks breakfast cereal, the agency was coy as to who was the actual manufacturer of the contaminated product.

Today, with its weekly release of Warning Letters, FDA may have answered the question.

On July 26, 2018, FDA issued a formal Warning Letter to Kerry Inc., headquartered in Beloit, Wisconsin after an inspection of the company’s cereal-production facility in Gridley, IL revealed a manufacturing environment in which Salmonella had made itself at home.

The Warning Letter listed several serious violations of the Federal Food, Drug and Cosmetics Act, including:

  1. The Gridley facility’s hazard analysis did not include contamination of ready-to-eat cereal with environmental pathogens such as Salmonella, even though this type of contamination has occurred in the past
  2. Gridley repeated found Salmonella in its production environment, but took no corrective action
  3. Gridley recorded 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples between September 29, 2016 and May 16, 2018
  4. Gridley did not implement sanitation or preventive control procedures upon finding Salmonella in its manufacturing environment
  5. Gridley did not implement the company’s own written environmental monitoring program procedures.

The Warning Letter does not refer to Kellogg’s Honey Smacks, or to any other brand or variety of ready-to-eat breakfast cereal by name, nor does it make reference to the Salmonella outbreak linked to Honey Smacks.

This Salmonella-laced production plant manufactures ready-to-eat cereals and “rice crisps intended for pet food“, according to the Warning Letter. One of the Salmonella-positive environmental samples found as a result of the FDA inspection was from the “…bottom of the roll-up door between [the] cereal coating room and [the] processing room for rice crisps intended for pet food.”

In its initial Outbreak Investigation release, CDC said, “Thirty (77%) of 39 people interviewed reported eating cold cereal. In interviews, 14 people specifically reported eating Kellogg’s Honey Smacks cereal.” 

The Salmonella problem at Gridley dates back almost two full years, to September 2016. It is very likely that other brands of ready-to-eat breakfast cereal manufactured in this facility during the last two years also harbor Salmonella. Some pet foods may be at risk as well.

Where are the other recalls?