Category: food safety

Jif Salmonella outbreak much larger than reported by CDC

In the weeks and months following the May 20, 2022, recall of Jif peanut butter products, the US Food and Drug Administration (FDA) received more than 200 reports from consumers complaining of illness after consuming the recalled products.

This information was supplied to eFoodAlert by the FDA in response to a Freedom of Information Act request.

In comparison, the US Centers for Disease Control and Prevention (CDC) reported just twenty-one confirmed cases of Salmonella Senftenberg linked to consumption of Jif peanut butter.

It is usual for an outbreak of foodborne illness to be significantly larger than indicated by CDC statistics. Indeed, the CDC reminded the public of this in its investigation report, saying, “The true number of sick people in this outbreak was likely much higher than the number reported. This is because many people recover without medical care and are not tested for Salmonella.”

By the numbers

The CDC tally

The CDC received lab-confirmed reports of outbreak cases in 21 individuals from 17 different states. Four people were hospitalized.

  • The first victim (“Patient Zero”) became ill on February 19, 2022.
  • The 21st victim became ill on May 23, 2022.
  • The youngest victim was less than one year old.
  • The oldest victim was 85 years old.
  • The median age of the victims was 59 years.
  • 75% of the victims were female.
  • 100% of the victims interviewed reported having consumed Jif peanut butter in the days before becoming ill.

The FDA tally

From January 1, 2022, through October 11, 2022, the FDA fielded a total of 320 queries and complaints relating to Jif peanut butter. Of these, 319 were specifically related to products manufactured at the Lexington, Kentucky, manufacturing plant linked to the outbreak.

  • 235 of the complainants reported having suffered an illness after consuming Jif peanut butter
  • 204 of the complainants reported specific symptoms; the remaining 31 reports mentioned “illness” or “adverse events”
  • Most of the individuals who reported symptoms suffered from multiple ill effects, including:
    • diarrhea: 166
    • cramps or abdominal pain: 124
    • vomiting: 80
    • nausea: 67
    • fever or chills: 63
    • Weakness, lethargy or fatigue: 33
    • headache: 31
    • Fainting, disorientation, dizziness, brain fog: 10
  • 8 reported bloody diarrhea
  • 4 reported a confirmed Salmonella diagnosis
  • 2 suffered from colitis
  • 2 suffered sepsis (a potentially serious, more generalized infection)
  • 1 individual reported a perforated bowel and peritonitis
  • 1 reported kidney failure

The recall

On May 20, 2022, The J.M. Smucker Co. announced a voluntary recall of peanut butter manufactured at its Lexington, Kentucky, production facility during a period of several months, up to and including the recall date.

The recall notice listed a variety of products and packaging formats from individual serving size packets weighing less than one ounce to 96-ounce twin packs, including:

As of October 21, 2022, the recall has not been completed.

The takeaways

CDC versus FDA reporting

The differences between the data reported by the FDA and the CDC are a function of how the two agency systems operate.

The CDC relies on reports of lab-confirmed cases of foodborne illness, and reports only on those cases, whereas the FDA receives and tabulates complaints from consumers, regardless of whether or not there was lab confirmation of an infection.

Both systems provide useful and complementary information that enables epidemiologists to determine the scope of an outbreak and–with a bit of luck thrown in to season the pot–trace it to its source.

In fact, it is likely that the number of people affected by the contaminated peanut butter was far larger even than the 200+ individuals reported by the FDA. There is no way of knowing how many people suffered mild symptoms and either didn’t realize they were linked to a Jif product or didn’t bother making a report.

The consequences for the company

In 2006, Peter Pan peanut butter manufactured by ConAgra was responsible for an outbreak of 425 Salmonella infections. An FDA inspection revealed that the company had been aware of a Salmonella contamination problem in their production plant, but did not reveal this information to the FDA investigation team. The government laid charges against ConAgra and entered into a plea agreement with the company in 2015. ConAgra pled guilty to a criminal misdemeanor, was fined $8 million, and had to forfeit an additional $3.2 million in assets.

In 2009, Peanut Corporation of America was responsible for a deadly outbreak of Salmonella infections that sickened 714 people and killed nine of them. Company management had knowingly shipped contaminated peanut butter to its customers. Once again, the government brought criminal charges. This time, the owners received prison sentences.

In 2012, Sunland Inc., the largest producer of organic peanut butter in the USA, was the source of a Salmonella outbreak that sickened 42 people. Again, the coupany was found to have knowingly shipped contaminated product. The FDA suspended Sunland’s food facility registration, effectively shutting down the company’s operations, but no charges were laid.

Earlier today, the FDA declined eFoodAlert’s request for a copy of the Jif Establishment Inspection Report on the basis that, “…disclosure could reasonably be expected to interfere with enforcement proceedings.”

The FDA has a range of possible enforcement proceedings at its disposal, ranging from a simple Warning Letter all the way up to referring the case to the Department of Justice for the laying of criminal charges.

Watch this space…

Read more about Salmonella in peanut butter in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

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“Reads like a true crime novel” – Food Safety News

Jif hid Salmonella problem from FDA and consumers

Management at the Jif peanut butter plant in Lexington, Kentucky, knew that some Jif peanut butter products manufactured between December 2021 and late February 2022 were contaminated with Salmonella, but did not report this to the FDA or initiate a product recall at the time.

This information is contained in documents supplied to eFoodAlert by the US Food and Drug Administration (FDA) in response to a Freedom of Information Act request.

The Lexington plant is owned and operated by The J.M. Smucker Co. (Smucker).

The backstory

In the first quarter of 2022, the CDC began to receive reports of individuals who had become infected with a single genetic strain of Salmonella Senftenberg.

Thirteen patients were interviewed, all of whom reported having consumed Jif peanut butter in the week before becoming ill.

Ultimately, the CDC would identify twenty-one outbreak victims, residing in 17 states. Four of the victims were hospitalized.

Upon learning of the link to Jif peanut butter, the FDA carried out genetic fingerprinting of a strain of Salmonella Senftenberg that had been found at the Jif manufacturing plant during a 2010 inspection. That strain was a genetic match for the strain recovered from the outbreak victims.

On May 19, 2022, a team of investigators from the FDA arrived at the Lexington facility to begin their inspection, which included the collection of environmental samples for lab analysis, review of documentation, and a visual inspection of the premises.

On May 20, 2022, The J. M. Smucker Co. recalled multiple production lots of various Jif Peanut Butter products, encompassing items produced between October 1, 2021 and May 20, 2022 (Lot codes with the first four digits of 1274 through 2140).

On May 21, 2022, the CDC released a Food Safety Alert, advising consumers of the outbreak and the product recall.

The FDA inspection results

According to the Inspectional Observations (FDA Form 483) issued on June 9, 2022, following completion of the inspection, the company had found sporadic Salmonella contamination in the production environment beginning in 2018 and continuing through 2021.

Some of the Salmonella-positive results were from samples taken on the floor near the peanut roasters.

In addition, the company’s finished product sampling program found Salmonella in finished, ready-to-eat peanut butter in 2017 (March 21), 2018 (February 18), 2020 (April 14 and November 17), 2021 (October 22 and December 15) and 2022 (February 4, 9, 10, 20 and 21).

The report does not indicate whether the contaminants found by the company were Salmonella Senftenberg.

The company did not recall any products when it first learned of the Salmonella-positive results. Nor did it report either the Salmonella findings or the equipment defect that was behind the contamination to the FDA’s Reportable Food Registry.

According to the FDA, “Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.” (emphasis added)

During the course of its inspection, the FDA collected 205 environmental swab samples from various parts of the production lines and plant environment.

None of the FDA’s swab samples yielded Salmonella.

The FDA also tested two jars of Jif Creamy Peanut Butter obtained in response to consumer complaints, without finding Salmonella in either jar.

What went wrong

The company installed two new roasters in the fall of 2021. The first of these went into full production on November 4, 2021, and the second on December 10, 2021.

Peanut butter produced from these roasters had been distributed since November 2021, even before the second roaster was in full production.

On February 17-18, 2022, after finding Salmonella in samples of ready-to-eat peanut butter produced on February 4, 9 and 10, 2022, management discovered a puddle of water in the bottom of both roasters.

The source of the puddles was traced to a defective flange on the roasters’ [redacted] inlets, which allowed rainwater and unfiltered air to enter the roasters and contact the roasted peanuts after the roasting step.

This defect had been in place since the installation of the roasters, and had gone unnoticed for several months.

The roasters were cleaned on February 17th and February 18th, respectively, and were returned to production.

On February 20th and again on February 21st, in-line samples consisting of jars of finished product were found to be Salmonella-positive.

The bottom line

A single paragraph on the third page of the list of Inspectional Observatioons (Form 483) sums up the situation (FDA’s redactions indicated as []).

“Furthermore, on 05/31/22, we observed you did not address contaminated, or potentially contaminated, finished peanut butter distributed to consumers. On 02/17-18/22, you identified a breach in the [] systems, which contaminated the [] of roasters [] and []. Based on your investigation, the breach was determined to be an approximate 1 inch opening in the [] gasket and had existed since the installation of roasters [] and []. Peanut butter produced using roasters [] and [] had been distributed since November 2021. You did not take any measures to alert consumers and/or recall the contaminated peanut butter distributed between December 2021 and February 2022. Additionally, you did not report this event in the FDA’s Reportable Food Registry (RFR).”

Inspectional Observation from FDA Form 483, supplied in response to Freedom of Information Act request

The FDA has not yet released the complete Establishment Inspection Report (EIR), which was also sought as part of eFoodAlert’s Freedom of Information Act request.

Read more about Salmonella in peanut butter in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

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.