Category: food safety

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.

Canadian Norovirus outbreak linked to live spot prawns

The Public Health Agency of Canada (PHAC) is reporting an outbreak of Norovirus gastroenteritis in four Canadian provinces.

The forty-eight confirmed cases occurred in British Columbia (11), Alberta (12), Manitoba (19), and Ontario (6) during the weeks of May 8, 2022, through May 22, 2022.

All of the interviewed victims reported eating spot prawns before their illnesses occurred.

On May 31st, the Canadian Food Inspection Agency (CF’IA) issued a recall notice for several lots of Tri-Star Seafood Supply Ltd live spot prawns. The prawns were  sold in British Columbia, Alberta, Manitoba, and Ontario, and may have been distributed in other provinces and territories.

The recalled prawns were identified as:

Tri-Star Seafood Supply Ltd. live spot prawns:- Lot codes AJ200-021, CA001-1532, and CA001-1540. Variable package size. No UPC.

The CFIA warns that the agency’s ongoing investigation may lead to recalls of other products.

What consumers need to know

  • Acute gastrointestinal illnesses such as norovirus are common in North America and are very contagious, affecting all age groups. However, pregnant women, people with compromised immune systems, young children and the elderly are at risk for developing more serious complications, like dehydration.
  • Spot prawns contaminated with noroviruses may look, smell and taste normal. The following safe food-handling practices will reduce your risk of getting sick:
    • Do not eat, use, sell, or serve the recalled spot prawns. Check to see if you have the recalled spot prawns at home. If you do, throw them out and wash your hands.
    • Avoid eating raw or undercooked spot prawns. 
    • Eat spot prawns right away after cooking and refrigerate leftovers. 
    • Always keep raw and cooked spot prawns separate to avoid cross-contamination.
    • Do not use the same plate or utensils for raw and cooked spot prawns.
    • Wash your hands well with soap before and after handling any food. 
    • Be sure to clean and sanitize cutting boards, counters, knives and other utensils after preparing raw foods.
  • Noroviruses can be transmitted by ill individuals. Cleaning and disinfecting practices are the key to preventing further illnesses in your home.
    • Thoroughly clean contaminated surfaces, especially after an episode of illness.
    • After vomiting or diarrhea, immediately remove and wash clothing or linens that may be contaminated with the virus (use hot water and soap).
    • If you have been diagnosed with norovirus illness or any other gastrointestinal illness, do not prepare food or pour drinks for other people while you have symptoms, and for the first 48 hours after you recover.

Read more about Norovirus 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

Pets, peanut butter and Salmonella – A cautionary tale

Between September 2008 and April 2009, contaminated peanut butter manufactured by the Peanut Corporation of America caused 714 confirmed cases of Salmonella Typhimurium illnesses in the United States. The outbreak claimed nine lives.

3rd Birthday #1 Aug 2005In addition to the human toll extracted by the contaminated peanut butter, the CDC reported one laboratory-confirmed case of Salmonella in a dog from an Oregon household. Salmonella resembling the outbreak strain was recovered by a private laboratory from a sample of Happy Tails Multi-Flavored Dog Biscuits.

Some of the biscuits in the package contained peanut butter.

The Happy Tails biscuits were recalled on January 23, 2009, just a few days after the dog became ill.

In a separate incident, a dog in Georgia died after being fed Austin peanut butter crackers. The crackers were among a long list of products recalled in response to the Salmonella outbreak.

Peanut butter has been associated with several other outbreaks of Salmonella and one E. coli O157:H7 outbreak in the United States since 2009, resulting in ninety-three illnesses and twenty-three hospitalizations.

The Jif peanut butter situation

The CDC is now reporting sixteen confirmed cases of Salmonella Senftenberg across twelve states.

Two people have been hospitalized.

Ten out of ten outbreak victims interviewed by state and local public health officials reported having consumed peanut butter in the week before they fell ill. Nine of the ten reported having eaten Jif peanut butter. The tenth victim did not know what brand of peanut butter was consumed.

The May 20, 2022, recall of Jif peanut butter products already has triggered at least fifteen recalls in the United States by manufacturers who used one of the recalled products as an ingredient.

While no pet foods or pet treats have been recalled so far, the contaminated Jif peanut butters still represent a risk to family pets.

Many dog owners use treat balls smeared with peanut butter to keep their pets occupied when left alone.

Others use peanut butter to make pills more palatable, or to tempt the appetite of a dog that has become disinterested in food.

Although dogs are less susceptible than humans to developing symptoms of a Salmonella infection, they can become symptomless carriers, and shed the bacteria in their stools for several weeks after becoming infected.

Keep yourself, your family and your pets safe

  • If your pet has eaten one of the recalled Jif peanut butter products, watch for symptoms of salmonellosis, including diarrhea, loss of appetite, or vomiting, and take your pet to the veterinarian without delay if these symptoms appear. If possible, bring a fresh stool sample to the veterinary office and ask for a Salmonella test.
  • If your pet is showing symptoms of salmonellosis, take extra precautions to keep young children away, and be alert for signs of salmonellosis among household members.
  • Always wash your hands with soap and water right after handling any pet food or treats.
  • When possible, store pet food and treats away from where human food is stored or prepared and away from reach of young children.
  • Don’t use your pet’s feeding bowl to scoop food. Use a clean, dedicated scoop, spoon, or cup.
  • Always follow any storage instructions on pet food bags or containers.