The J.M. Smucker company has five working days left to respond to an FDA warning letter about conditions in its Jif peanut butter plant that was the source of a Salmonella outbreak in 2022.

If the Valentine’s Day deadline is not met, the iconic company will be in the crosshairs of the Food and Drug Administration, but the agency wouldn’t tell Food Safety News what actions it may take or wher it is in the investigation process. The boilerplate language in the Jan. 24 warning letter states:

“Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.”

The letter is part of an ongoing investigation into the cause of the Salmonella outbreak that sickened at least 21 people in 17 states in 2022, according to the Centers for Disease Control and Prevention. The outbreak strain of Salmonella Senftenberg matched Salmonella found in the production plant.

The FDA said the company did not use effective means of removing contaminated peanut butter from equipment lines after detecting Salmonella on Feb. 4, 9, and 10, 2022.

According to the CDC, illnesses started on dates ranging from February 20, 2022, through May 24, 2022. 

The Food and Drug Administration sent its warning letter eight months after inspecting the Jif peanut butter plant in Lexington, KY. That inspection, which ran from May 19 through June 9, 2022, resulted in a recall on May 20, 2022, of all peanut butter manufactured at the facility from Oct. 1, 2021, to May 20, 2022.  

The warning letter details many infractions at the production plant, but the FDA has not yet released the Form 483 report that was generated following the inspection. Form 483 reports are only issued when severe infractions are discovered.

An FDA spokesperson told Food Safety News “the agency is unable to comment on enforcement actions while they are pending. As a result of this multi-state outbreak, the FDA began an investigation in April 2022 and found that peanut butter manufactured at Smucker’s facility was the source of the outbreak.”  

The spokesperson did confirm for Food Safety News that Smuckers had repeatedly discovered Salmonella in the production plant and in its finished product.

“During an inspection, the FDA collected evidence that on numerous occasions, Smucker’s internal testing found Salmonella in both the environment and in the finished product,” the spokesperson said. “Although Smucker’s attempted to address some potential sources of Salmonella and tested the peanut butter for Salmonella before distributing it, the firm’s actions were not sufficient to prevent contaminated product from reaching consumers and causing illnesses. The FDA has asked the firm to respond within 15 working days stating how they will address these issues.”

The warning letter has harsh words for the Smucker company’s operation of its Jif peanut butter plant, saying that the product made there was adulterated because it was “prepared, packed or held under insanitary conditions wherby it may have been contaminated with filth or rendered injurious to health.” Such infractions are illegal under the federal Food, Drug, and Cosmetic Act and can result in fines, plant closures, and jail time for owners, operators, and other employees.

The FDA inspectors found records showing that the presence of the same Salmonella Senftenberg strain was found in the Lexington, KY, facility since 2010, which matched the clinical cluster. That match is indicative of a resident strain, according to the FDA.

The FDA nailed down further contamination during its inspection in 2022.

“Your finished product testing records from January 1, 2021, to February 23, 2022, indicate that you detected Salmonella in your RTE 9ready-to-eat) peanut butter on numerous occasions, i.e., October 22 and December 15, 2021; and February 4, 9, 10, 20, and 21, 2022, and that your corrective actions were not sufficient to address the root cause of the contamination,” according to the FDA warning letter.

The following excerpt from the warning letter outlines some of the problems. The notation of (b)(4) indicates information that the FDA has redacted from the publicly released version of the warning letter.

“For example, on February 17-18, 2022, you identified a leak in the air intake vent of the cooling chamber of Roaster (b)(4), as a source of water entering your equipment, and stated you immediately repaired the vent. However, on February 20, 2022, after the repair was completed, you detected Salmonella in (b)(4) of the (b)(4) lots on Lines (b)(4) ((b)(4), and (b)(4)) using your standard (b)(4) samples per lot sampling program. Subsequently, per your practice, you “collect[ed] [and tested] (b)(4) samples ((b)(4) sample composites) from the lot[s] produced immediately prior to and after the product that tested positive.” After testing (b)(4) lots that initially tested negative for Salmonella, you identified two additional positive lots:

• (b)(4), Salmonella detected in 2 of (b)(4)-sample composites
• (b)(4), Salmonella detected in 2 of (b)(4) sample composites

“The next day, on February 21, 2022, you detected Salmonella in a (b)(4) lot on Line (b)(4) using your standard (b)(4) samples per lot sampling program. Similar to February 20, after testing (b)(4) lots that initially tested negative for Salmonella you identified additional positive lots:

• (b)(4), Salmonella detected in 5 of (b)(4)-sample composites
• (b)(4), Salmonella detected in 4 of (b)(4)-sample composites
• (b)(4), Salmonella detected in 5 of (b)(4)-sample composites
• (b)(4), Salmonella detected in 4 of (b)(4)-sample composites

“You indicated that ‘[e]ven when the additional samples test negative, we destroy all (b)(4) production lots to provide the further assurance we have bracketed and eliminated any potential contamination.’ However, your positive test results for lots for which Salmonella was previously not detected show the limitations of reliance on your testing program to identify contamination as a way to prevent contaminated products from reaching consumers. Further, the S. Senftenberg outbreak shows that neither your corrective actions nor your finished product testing were adequate to prevent contaminated product from reaching consumers and causing illnesses.”

In addition, the FDA’s warning letter outlines many other problems within the plant and in procedures used in the production and testing of peanut butter made at the facility.

There were problems with Hazard Analysis and Risk-based Preventive Controls including but not limited to:

• You did not identify and evaluate the hazard of contamination with environmental pathogens, such as Salmonella spp. at certain post-roasting processing steps, as a known or reasonably foreseeable hazard to determine whether it requires preventive control;

• Your corrective action procedures did not ensure appropriate action was taken, when necessary, to reduce the likelihood that environmental contamination will recur;

• Your environmental monitoring records from July 24, 2018, November 26, 2018, October 9, 2019, and November 4, 2019, revealed four Salmonella-positive environmental swabs located at roaster (b)(4), stairs leading to a platform “(b)(4)”, the floor of the entrance to the blanch nut tank rooms (b)(4) and (b)(4), and the floor broom in the roaster (b)(4). You determined that the root causes for each Salmonella-positive environmental swab were roof leaks or increased foot traffic during repairs in response to roof leaks; and

• Your environmental monitoring records from 2021 revealed five Salmonella-positive environmental swabs in your facility on July 6, July 8, July 12, September 3, and November 16, 2021. These Salmonella-positive swabs were found on the floors near your blanch nut tank rooms, roaster booth (b)(4), the stairs at the top level of the nut house (b)(4), and the stairs leading to a platform “(b)(4)”. The detection of Salmonella in your facility in 5 locations in 2021, many of which were similar to locations wher you detected Salmonella in 2018 and 2019, show that your corrective action procedures in response to environmental contamination in 2018 and 2019 were not sufficient.

The FDA stated that precautions taken at the production plant were not enough to ensure clean products and specifically cited water leaks as an ongoing problem.

“We are concerned that the history of contamination events associated with water in your facility and results from the WGS database suggest that Salmonella may be resident within your production facility,” according to the FDA.

Puddles of standing water ranging in size from 4 feet wide to 8 feet wide were found in the production plant. Plus, a Smucker’s internal investigation found a defective flange on a cooler inlet of a peanut roaster that allowed rainwater and unfiltered air to enter the roaster’s cooling zones.

The FDA inspectors noted that while some corrective actions may help some problems, “constant vigilance is needed to ensure water does not become a source or route of cross-contamination in your dry processing environment.

In a response to comments on the inspectors’ concerns, the company stated that it had found Salmonella in the finished product on Oct. 22 and Dec. 15, 2021. It told the FDA that it has “a robust finished product testing program specifically because of this possibility, as even a validated kill step, such as the roasters that are validated to deliver over a (b)(4) kill, does not eliminate the potential that Salmonella could survive the roasting process on rare occasion.”

The FDA disagrees with that assessment. Inspectors evaluated the roasting process and disagreed with the company’s point about a “properly validated and implemented process control at your peanut roasting step would allow for the survival of Salmonella such that the pathogen would be detected in your finished product because it survived the roasting step.”

The full warning letter can be read by clicking here.