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.