Nine baby deaths reported to FDA during Abbott Nutrition investigation

Between December 1, 2021, and March 3, 2022, the US Food and Drug Administration (FDA) received nine (9) reports of infant deaths among babies who were fed powdered infant formula manufactured by Abbott Nutrition in Sturgis, Michigan.

The infant death reports were included in a list of 128 consumer complaints supplied to eFoodAlert by the FDA in response to a Freedom of Information Act (FOIA) request. (see: Abbott Nutrition consumer complaints file, Redacted)

Two of the deaths were numbered among the four confirmed outbreak cases of Cronobacter sakazakii identified by the US Centers for Disease Control and Prevention (CDC).

The other seven deaths were reported to the FDA via the agency’s consumer complaint system. Two of those reports mentioned Salmonella in the complaint description.

In addition to the nine deaths, consumers described twenty-five (25) incidents categorized as “Life Threatening Illness/Injury” and eighty (80) instances of “Non-Life Threatening Illness/Injury.”

Fourteen consumers contacted the FDA to obtain information or clarifications on the Abbott recall.

The complaints were lodged with FDA District Offices across the continental USA.

Salmonella was present in two of the dead babies, and was mentioned in seventeen other illness complaints.

One of the surviving infants was infected with both Salmonella and E. coli.

The symptoms suffered by the infants were mostly consistent with a gastrointestinal infection: fever (31 babies), vomiting (42 babies), diarrhea (47 babies), and blood in stool (6). Most babies suffered from multiple symptoms.

Other reported symptoms included loss of appetite, rash (either localized or spread over entire body), lethargy, dehydration, irritability, weight loss, and difficulty breathing.

Some of the infants suffered from multiple infections:

The FDA did not respond to eFoodAlert‘s request for comment on what was done to follow up on the seven infant death reports that did not involve Cronobacter sakazakii, or on the non-fatal illnesses not involving Cronobacter.

According to an agency spokesperson, the FDA, along with the CDC and state and local partners, investigated consumer complaints and/or reports, received from September 20, 2021 to February 24, 2022, of infant illness.

The spokesperson did not address any of the more than thirty complaints–including three reported deaths–received by FDA district offices between February 25, 2022 and March 3, 2022.

Two of those three reported deaths referred to Salmonella.

The FDA investigation uncovered multiple instances of Cronobacter sakazakii in the environment of Abbott’s manufacturing facility.

None of the cultures retrieved from environmental samples were a genetic match for the strain that infected the two babies for which the CDC received cultures. The CDC did not receive cultures from the other two infected babies for genetic analysis.

Although there is no direct evidence in the form of genome sequencing to link any of the illnesses unequivocally to Abbott’s infant formulas, all of the complaints have one element in common.

Every one of the sick babies was fed an Abbott powdered formula.

The FDA has established an Incident Management Group (IMG) under Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

The IMG is tasked with managing the ongoing investigation and monitoring the infant formula supply chain, and will remain in place at least until the current supply shortage is over, according to the FDA spokesperson.

In Memoriam

With production now having resumed–under close supervision–at the Abbott Nutrition plant in Sturgis, the time has come to acknowledge the lives that were lost.

We know very little about the nine infants who died. For privacy reasons, their names, ages, genders, where they lived, and when they died have been withheld. They are identified only by their unique Complaint ID numbers.

  • Complaint ID #171222, reported December 1, 2021. Infant arrived to the ER in cardiac arrest. Cronobacter sakazakii and Proteus mirabilis. Infant had consumed Similac Pro-Total Comfort (Powder) infant formula, Lot #23495K80.
  • Complaint ID #172435, reported February 22, 2022. Vomiting, swollen organs, trouble breathing. Infant had consumed Similac Advance, Lot #34875K80.
  • Complaint ID #172477, reported February 22, 2022. Screaming. Infant had consumed Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, et al, infant formula powder, Lot #34869K80.
  • Complaint ID #172479, reported February 23, 2022. Fever, diarrhea, loss of appetite, vomiting. Infant had consumed Similac Advanced infant formula. Lot number not available.
  • Complaint ID #172541, reported February 24, 2022. Tested positive for Cronobacter sakazakii. Infant had consumed Similac PM 60/40, Lot #27032K800.
  • Complaint ID #172585, reported February 24, 2022. No details available. Infant had consumed EleCare infant formula, Lot number not available.
  • Complaint ID #172607, reported February 28, 2022. Cause of death and opinion pending further studies (Congenital). Infant had consumed Similac Elecare powdered infant formula, Lot #34771Z21 1306305
  • Complaint ID #172632, reported March 2, 2022. Salmonella meningitis, ventriculitis, vomit, diarrhea, seizures, bradycardia. Infant had consumed Similac Pro Advance infant formula, Lot #25598SHO 0557 015 SIMESPWD.
  • Complaint ID #172636, reported March 2, 2022. Salmonella. Infant had consumed Similac Total Comfort, Lot #26834K80.

May they rest in peace.

Organic strawberries behind hepatitis A outbreak

The FDA, the CDC, the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency, in cooperation with their partner agencies, are investigating a cross-border outbreak of hepatitis A illnesses linked to organic strawberries.

A total of 27 outbreak cases have been confirmed in all, including ten in Canada and seventeen in the United States.

Canadian cases are reported in Alberta (4) and Saskatchewan (6), in individuals between 10 and 75 years of age. Four of the ten victims have been hospitalized.

Cases in the United States have occurred in California (15), Minnesota (1) and North Dakota (1), with 12 hospitalizations reported.

Illness onset dates range from March 28 to April 30, 2022 in the US, and between early and mid-April in Canada.

Patient interviews conducted in both countries linked the outbreak to consumption of fresh organic strawberries sold in the United States between March 5th and April 25th, and in Canada between March 5th and March 9th.

The strawberries, which have passed their shelf life, were sold in Co-op stores in Alberta and Saskatchewan and at the following retailers in the United States under FreshKampo and HEB brand names:

  • Aldi
  • HEB
  • Kroger
  • Safeway
  • Sprouts Farmers Market
  • Trader Joe’s
  • Walmart
  • Weis Markets
  • WinCo Foods

The strawberries were distributed across the United States, but only sold in the two Canadian provinces where hepatitis cases were reported.

Neither the FDA nor the PHAC have indicated in what country the strawberries were grown.

Consumers who may have frozen the strawberries for later use should check their freezer and throw away any suspect product.

What consumers should do

  • Check your freezer for these fresh organic strawberries purchased between March 5 and 9, 2022 at Co-op stores in Alberta and Saskatchewan or between March 5 and April 25th at one of the US retailers listed above. If you froze them to eat later, do not eat them. Throw away any remaining organic strawberries. If you don’t know where the strawberries came from, throw them out.
  • Wash and sanitize any drawers, shelves, or containers where the products were stored using a kitchen sanitizer (follow the directions on the container) or prepare a bleach solution in a labelled spray bottle (you can use a ratio of 5 ml of household bleach to 750 ml of water) and rinse with water.
  • If you have eaten these organic strawberries, purchased fresh and later frozen, or have symptoms consistent with hepatitis A, see your health care provider immediately. Vaccination can prevent a hepatitis A infection if given within 14 days of exposure.
  • Wash your hands before and after preparing or eating food, and after using the washroom or changing diapers.
  • If you have been diagnosed with hepatitis A, do not prepare or serve food and drinks to others.

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