The product was packed by a co-manufacturing facility owned by Kerry Inc. The Kerry facility was issued a Warning Letter in July. This facility was found to have a Salmonella issue.
From that warning letter, "Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room (Line (b)(4)) and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan".
So in this case, why was Kellogg still packing RTE cereal in that plant if these issues were identified in the co-manufacturer's own records? Did their audit analysis find these issues?
(Reading the Warning Letter at the time it was issued, it was easy to assume it was an ingredient rather than a finished RTE product because of the prevalence of Salmonella found by FDA as well as the company's own internal testing. Seeing that the company was packing RTE cereal is concerning, based on what is in the FDA Warning Letter).
From that warning letter, "Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room (Line (b)(4)) and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan".
So in this case, why was Kellogg still packing RTE cereal in that plant if these issues were identified in the co-manufacturer's own records? Did their audit analysis find these issues?
(Reading the Warning Letter at the time it was issued, it was easy to assume it was an ingredient rather than a finished RTE product because of the prevalence of Salmonella found by FDA as well as the company's own internal testing. Seeing that the company was packing RTE cereal is concerning, based on what is in the FDA Warning Letter).
https://www.fda.gov/food/recallsoutbreaksemergencies/outbreaks/ucm610827.htm
FDA Investigated Multistate Outbreak of Salmonella Mbandaka Infections Linked to Kellogg’s Honey Smacks Cereal
Update - September 28, 2018
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.
FDA Investigated Multistate Outbreak of Salmonella Mbandaka Infections Linked to Kellogg’s Honey Smacks Cereal
Update - September 28, 2018
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.
Case Counts
Total Illnesses: 135
Hospitalizations: 34
Deaths: 0
Last illness onset: 8/29/2018
States with Cases: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MS, MT, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV
Total Illnesses: 135
Hospitalizations: 34
Deaths: 0
Last illness onset: 8/29/2018
States with Cases: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MS, MT, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV
What was the Problem and What was Done?
What Products were Recalled?
- On May 17, 2018 the FDA learned about a cluster of Salmonella Mbandaka illnesses in multiple states.
- In the following weeks, the FDA, CDC, and state partners worked together to collect additional information to identify a food item of interest. Interviews with ill people allowed health partners to identify Kellogg's Honey Smacks cereal as a possible source of the illnesses.
- •As a result of discussions with the Kellogg company and the contract manufacturer, Kerry Inc. on June 14, 2018, The Kellogg Company voluntarily recall Honey Smacks cereal.
- On June 14, 2018 the FDA began collecting environmental and product samples from the contract manufacturer's facility.
- On June 15, 2018 the FDA updated our web posting to include a list of known countries where the recalled product was distributed and to advise that consumers not eat and discard recalled Kellogg's Honey Smacks cereal.
- On September 26, 2018 the FDA and CDC updated their web postings to include additional cases linked to this outbreak. The CDC also reports that this outbreak investigation is over. Consumers should still check their homes and throw away any recalled cereal.
What Products were Recalled?
Description (Retail) Size BEST if Used By Date
Honey Smacks (with limited distribution outside the U.S.) 15.3 oz. JUN 14, 2018 through JUN 14, 2019
Honey Smacks 23 oz. JUN 14, 2018 through JUN 14, 2019
What are the Symptoms of Salmonella Infections?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Children are the most likely to get salmonellosis. The rate of diagnosed infections in children less than five years old is higher than the rate in all other people. Children younger than five, the elderly, and those people with weakened immune systems are more likely to have severe infections. It is estimated that approximately 400 persons in the United States die each year with acute salmonellosis.
What Do Restaurants and Retailers Need To Do?
Retailers should not sell and should discard all recalled products. The recalled products were distributed across the United States including Guam and Saipan, and internationally in:
Honey Smacks (with limited distribution outside the U.S.) 15.3 oz. JUN 14, 2018 through JUN 14, 2019
Honey Smacks 23 oz. JUN 14, 2018 through JUN 14, 2019
What are the Symptoms of Salmonella Infections?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment. Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Children are the most likely to get salmonellosis. The rate of diagnosed infections in children less than five years old is higher than the rate in all other people. Children younger than five, the elderly, and those people with weakened immune systems are more likely to have severe infections. It is estimated that approximately 400 persons in the United States die each year with acute salmonellosis.
What Do Restaurants and Retailers Need To Do?
Retailers should not sell and should discard all recalled products. The recalled products were distributed across the United States including Guam and Saipan, and internationally in:
Aruba/Curaçao/Saint Maarten (Netherlands Antilles), the Bahamas, Barbados, Tortola (British Virgin Islands), Costa Rica, Guatemala, Haiti, Mexico, Panama, and Tahiti (French Polynesia).
Retailers, restaurants, and other food service operators should always practice safe food handling and preparation measures. It is recommended that they wash hands, utensils, and surfaces with hot, soapy water before and after handling food.
•Wash and sanitize display cases and refrigerators regularly.
•Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store food.
•Wash hands with hot water and soap following the cleaning and sanitation process.
•Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination.
What Do Consumers Need To Do?
The FDA is advising consumers to not eat and discard recalled Kellogg's Honey Smacks cereal. If already purchased, consumers should throw it away or return to the place of purchase for a refund.
Consumers should always practice safe food handling and preparation measures. It is recommended that they wash hands, utensils, and surfaces with hot, soapy water before and after handling food.
Additional Information
•Multistate Outbreak of Salmonella Mbandaka Infections
•FoodSafety.gov on Salmonella
•CDC Salmonella
•Wash and sanitize display cases and refrigerators regularly.
•Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store food.
•Wash hands with hot water and soap following the cleaning and sanitation process.
•Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination.
What Do Consumers Need To Do?
The FDA is advising consumers to not eat and discard recalled Kellogg's Honey Smacks cereal. If already purchased, consumers should throw it away or return to the place of purchase for a refund.
Consumers should always practice safe food handling and preparation measures. It is recommended that they wash hands, utensils, and surfaces with hot, soapy water before and after handling food.
Additional Information
•Multistate Outbreak of Salmonella Mbandaka Infections
•FoodSafety.gov on Salmonella
•CDC Salmonella
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