Tag: FDA

Jif’s Salmonella outbreak. What we know so far

The US Centers for Disease Control and Prevention (CDC) is investigating an outbreak of Salmonella Senftenberg infections believed to be linked to consumption of Jif peanut butter products.

Jif peanut butters are manufactured by The JM Smucker Co.

outbreak-salmonella-peanut-butter-cdc-case-count-mapThe fourteen confirmed cases are scattered across twelve US states, including Arkansas (1), Georgia (2), Illinois (1), Massachusetts (1), Missouri (1), New York (1), North Carolina (1), Ohio (1), South Carolina (1), Texas (2), Virginia (1), and Washington (1). Two of the victims have been hospitalized.

The first reported victim became ill on February 17, 2022.

Outbreak victims range in age from less than one year old to 85 years old. The median age is 56, and 71% of the victims are female.

Interviews conducted with five of the outbreak victims revealed that all five had consumed peanut butter prior to falling ill. Two of the five had eaten Jif Creamy Reduced Fat peanut butter, one person reported Jif Natural Creamy Low Sodium peanut butter, and one person reported Jif Natural Creamy peanut butter.

The CDC cautions that the true number of sick people in an outbreak such as this is likely much higher than the number reported, and the outbreak may not be limited to the states with known illnesses. 

According to the US Food and Drug Administration (FDA), the outbreak strain is closely related to a strain of Salmonella recovered in 2010 from an environmental sample in the Lexington, Kentucky, manufacturing plant where the implicated Jif peanut butter products are made.

A review of the FDA’s inspection database reveals that the Lexington facility was inspected on five separate occasions since 2009, including inspections in 2009, 2010, 2011, 2015, and 2018.

The 2010 and 2015 inspections were classified as Voluntary Action Indicated (VAI), meaning the inspector found deficiencies that needed to be corrected by the company. There is no list of the reported deficiencies in the database for either of the VAI inspections.

Recall status

jif-front-backThe JM Smucker Co. has recalled a long list of Jif products, covering all lot codes from 1274425 to 2140425, but only with the first seven digits ending in 425 (the identifier code for the Lexington production plant).

Recalled products were distributed across the United States and exported to Canada.

The company has issued a separate recall notice listing the products distributed in Canada.

In addition to being sold through retail stores and other outlets, peanut butter is often used as an ingredient in other products. Recalls of products containing Jif peanut butter have already begun.

For an up-to-date linked list of announced recall notices, please select the Jif/Smucker Recalls menu item at the top of the page.

CDC’s advice to consumers

  • Do not eat any recalled Jif brand peanut butter. Throw it away.
  • This product has a very long shelf life, so be sure to check any Jif peanut butter you have at home to make sure it has not been recalled.
  • Wash surfaces and containers that may have touched the recalled peanut butter using hot, soapy water.
  • Call your healthcare provider if you have one or more of these symptoms after eating recalled peanut butter:
    • Diarrhea and a fever higher than 102°F
    • Diarrhea for more than 3 days that is not improving
    • Bloody diarrhea
    • So much vomiting that you cannot keep liquids down
    • Signs of dehydration, such as:
      • Not peeing much
      • Dry mouth and throat
      • Feeling dizzy when standing up

CDC’s advice to businesses

  • Do not sell or serve recalled Jif brand peanut butter.
  • Wash and sanitize containers and surfaces that may have come in contact with recalled peanut butter.

Read more about previous outbreaks of Salmonella involving 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

Salmonella outbreak linked to Jif peanut butter products

The FDA, together with the CDC and state and local partners are investigating an outbreak of fourteen (14) Salmonella Senftenberg infections in twelve US states.

Two people have been hospitalized.

Cases have been reported in Arkansas (1), Georgia (2), Illinois (1), Massachusetts (1), Missouri (1), Ohio (1), North Carolina (1), New York (1), South Carolina (1), Texas (2), Virginia (1), and Washington (1).

Image supplied by CDC

According to the FDA, five out of five outbreak victims who were interviewed reported consuming peanut butter prior to becoming ill. Four of the five specifically mentioned Jif peanut butter.

Although the FDA has not yet found the outbreak strain in a finished product sample, the agency reports that a strain of Salmonella recovered from an environmental sample collected at the Jif Lexington, Kentucky, production plant twelve years ago (in 2010) is a genetic match for the Salmonella strain recovered from victims in this current outbreak.

This archival culture, combined with the information from outbreak victims who had consumed Jif peanut butter, catalyzed a voluntary recall on the part of The J.M. Smucker Co., the manufacturer of the Jif family of products.

The recall

The recall includes lot codes from 1274425 to 2140425, but only for lot codes that end in “425,” which is the identifier code for the Lexington, Kentucky production plant. Recalled products were distributed nationwide in the United States.

For a complete list of affected products, please refer to the J.M. Smucker recall notice.

As the recalled products have a two-year shelf life, the FDA urges consumers to check their pantries and discard or return any of the products included in the recall.

The lot code can be found near the bottom of the product label, directly below the BEST IF USED BY date, as illustrated here.

FDA recommends:

  • Consumers, restaurants, and retailers should not eat, sell, or serve any recalled Jif brand peanut butter that have lot code numbers 1274425 through 2140425. This product has a two-year shelf life so consumers should check any Jif peanut butter in their home.
  • If you have used the recalled Jif brand peanut butter that have lot code numbers 1274425 through 2140425, you should wash and sanitize surfaces and utensils that could have touched the peanut butter.
  • If you or someone in your household ate this peanut butter and have symptoms of salmonellosis, please contact your healthcare provider.

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

Abbott’s walk of shame

As reported yesterday, Abbott Nutrition has entered into a Consent Decree of Permanent Injunction that spells out the conditions under which the company will be permitted to recommence and continue powdered infant formula production at its Sturgis, Michigan, plant.

Despite the company’s protestations of innocence regarding the outbreak of four cases of Cronobacter sakazakii illnesses–including two deaths–in infants who consumed Abbott’s products, the formal Complaint filed by the US Justice Department sets out very clearly the extent of Abbott’s culpability.

The Complaint

After summarizing the relevant statutes, regulations and rules, the Complaint lists the following supporting evidence, found during the inspections carried out by US Food and Drug Administration (FDA) investigators in September 2021 and January-February 2022.

  • FDA lab analysis found C. sakazakii on several surfaces in the production area, including the cover of a hopper that feeds scoops directly into infant formula containers. The sample was collected at the time a batch of formula was being packaged, and the scoops come into direct contact with product.
  • Abbott’s own environmental samples confirmed the presence of Cronobacter spp. on surfaces in the powdered infant formula production area between September 25, 2019, and February 20, 2022. The company did not perform the necessary test to determine whether or not the bacteria were Cronobacter sakazakii.
  • On January 31, 2022, FDA investigators noted the presence of pooled water on several levels of a multi-story spray dryer tower while the spray dryer was being used to produce a batch of powdered infant formula.
  • Abbott’s own records documented a total of 310 “water events” (leaks and condensation) between January 1, 2020, and February 1, 2022, in dry-production areas for powdered infant formula (e.g. during spray-drying and/or container-filling operations). Several of those leaks are described in the company’s records as necessitating repairs to a roof.
  • Abbott had never validated the dry-out step for their spray dryers to ensure that the interiors of the dryers are completely dry following cleaning.
  • Abbott’s own records documented a history of internal deterioration of the spray dryers dating back to September 2018, including (but not limited to) pits and cracks inside the dryers’ main chambers.
  • Plant personnel working in the infant formula production area did not always wear necessary protective apparel.
  • The company failed to conduct an adequate investigation into the validity of a complaint that showed a possible health hazard existed, and failed to test any retained samples of the suspect production lot for microbiological contamination.
  • At the completion of the September 2021 inspection, the FDA issued an FDA-483 form, listing several deficiencies. Although Abbott promised to take corrective action, the company did not implement sustained corrections or demonstrate ongoing compliance with statutory requirements.

On behalf of the FDA, the US Department of Justice has petitioned the Court to issue a permanent injunction requiring Abbott to “… cease manufacturing, processing, preparing, packing, labeling, holding, and/or distributing any article of food unless and until Defendants bring their manufacturing, processing, preparing, packing, labeling, holding, and distribution operations into compliance with the Act and its implementing regulations to the satisfaction of FDA.”

The request also includes authorization for FDA to inspect the company’s “… place(s) of business and all records relating to the receipt, manufacture, processing, preparing, packing, labeling, holding, and distribution of any article of food to ensure continuing compliance with the terms of the injunction, and that Defendants bear the costs of such inspections, including testing and sampling …” and to award costs to the government, including the cost of the investigation to date.

A short leash

The conditions stipulated in the Consent Decree under which Abbott Nutrition will be allowed to resume and maintain production will keep the company on a very short leash.

Abbott will be required to retain an independent expert or experts to evaluate all of the facilities and processes at the Sturgis, Michigan, location, and conduct an inspection to determine what will be necessary to bring the operation into compliance with FDA regulations. The company will be required to notify FDA of the identity and qualifications of the expert within two days after retaining him or her.

Abbott will need to verify the dry-out procedures and validate its method of testing for moisture in production equipment and processing environments.

A pre-production cleaning, sanitizing and dry-out followed by environmental testing for pathogens will be required.

Before starting production, Abbott will be required to provide FDA with a report from the expert that documents completion of all of the verification and validation activities and the pre-production review.

Once production has started, a qualified individual within Abbott’s quality unit will be required to review the batch record, product test results and environmental monitoring for every production lot prior to distribution of the lot. The responsible individual must certify in writing to FDA that each lot meets all specifications.

The consent decree also specifies the testing that must be conducted, and that production be halted and FDA be notified immediately in the event that any in-process or finished product test detects Cronobacter and/or Salmonella. Production will only resume after Abbott receives written permission from FDA.

Abbott must maintain a record of all sales and distribution of its products and make those records available to FDA immediately upon request.

Additional details include specifics as to the required environmental monitoring, training of personnel, preparation and submission to FDA of a plan for building and/or equipment repair, hiring of an auditor to conduct audit inspections of the production facility, methods and processes.

Under the provisions of the decree, in the event the FDA determines that Abbott has not lived up to its agreement, the agency has the authority to order the company to cease manufacturing, and to take whatever other corrective actions the agency deems necessary for protection of public health.

The foregoing is just a sample of the details contained in the 33-page Consent Decree and the 21-page Complaint. Nor is this the end of the story.

In his blog post this morning, Bill Marler warns that criminal sanctions may be in the offing.

Let’s hope the FDA and the US Department of Justice don’t consider Abbott Nutrition to be “too big to nail.”

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks 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