Powdered infant formula is not a sterile product and therefore can, and sometimes does, contain harmful bacteria. Currently, a Salmonella and Cronobacter outbreak linked to baby formula includes four Cronobacter illnesses and one Salmonella infection confirmed by the Centers for Disease Control and Prevention (CDC), and an additional Salmonella infection in West Virginia that is likely linked to the outbreak, according to state health officials.
Numerous Salmonella outbreaks have been linked to powdered infant formula, but they likely represent only a fraction of the actual number of Salmonella infections reported among infants who consume powdered infant formula, according to various studies. There are three primary reasons for this, according to a 2008 study in Clinical Infectious Disease:
- The incidence of Salmonella infections among infants is higher than in all other age groups so unless the outbreak strain is somewhat unusual it doesn’t stand out.
- Unless the infection is invasive, symptoms of a Salmonella infection will primarily include diarrhea and vomiting which can be confused with what is considered “normal” for a baby.
- A common feature of Salmonella outbreaks linked to powdered infant formula is a low level of Salmonella found in the product.
And “low levels” means extremely low in some cases. Reviewing 11 Salmonella outbreaks, the Italian researchers found that the infective dose can be less than 1,000 organisms. For reference, about 200,000 average-sized Salmonella can fit on the head of a pin.
“In most of the investigations, the epidemic strain of Salmonella species was isolated from bulk, storage, and/or retail packaged samples. This was not achieved without a great deal of effort. There are no data available to adequately describe the distribution of salmonellae in [powderedinfant formula], but it is considered to be sporadic or heterogeneous, leading to difficulties in detection,” the researchers said.
During a 1985 outbreak in the U.K, for example, 33 laboratories tested 4554 samples of 658 batches of product before one lab isolated the outbreak strain from an opened packet of formula taken from the home of an infected infant, according to the study.
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The Italian researcher team examined six Salmonella outbreaks linked to powdered infant formula between 1985 and 2005.
- 1985 United Kingdom, 48 infants
- 1993 United States, 3 infants
- 1996 Spain, 48 infants
- 1996-1997 United Kingdom and France, 17 infants
- 2000 Korea, 30 infants
- 2004-2005 France, 136
2005 Powdered Infant Formula Salmonella Agona Outbreak in France
According to a 2007 study published in The Pediatric Infectious Disease Journal, a Salmonella Agona outbreak linked to powdered infant formula sickened 136 infants from December 2004 to June 2005. At that time, about 70 percent of Salmonella cases in France were attributed to two Salmonella strains, Typhimurium and Enteritidis, while Salmonella Agona was linked to about 1 percent of all cases. So, reports of a spike in Salmonella Agona cases among infants was notable.
In the first outbreak, 47 cases were linked to a powdered infant formula, Product A, which was withdrawn from the market in March 2005. During their investigations of the facility where product A was made, health officials did not identify any hygiene violations. The maker of Product A said all routine sampling tests were negative for Salmonella. But “extensive sampling of stored samples of formula A yielded Salmonella Agona in one of 176 samples.” The strain was also isolated from six environmental swabs, four from the production area and two from the packaging area.
Reports of Salmonella Agona infections continued after Product A was removed from the market. A total of 94 infants were sickened between March and May 2005. These infants had consumed Product B before they became ill.
Investigators discovered that five batches of Product B had been made in the same facility where Product A was made and packaged at another facility owned by Company B. These lots of infant formula were withdrawn in April 2005.
Just as Company A has said, Company B told outbreak investigators that all random sampling was negative for Salmonella. Yet, Salmonella Agona was isolated from unopened canisters of the affected lots taken from the homes of infected infants.
Before whole genome sequencing, pulsed-field gel electrophoresis (PFGE) was the method of identifying the genetic “fingerprint” of a bacterial strain. Using PFGE, health officials were able to determine that the Salmonella Agona isolated from the sick babies was the same as the one isolated from both formulas and from environmental swabs from the facility where they were made.
The infants sickened in this outbreak suffered symptoms including nausea, vomiting, abdominal pain, fever, and diarrhea that was bloody in 56 percent of cases. Fifty infants, 36 percent, were hospitalized.
This outbreak was the first-ever Salmonella Agona outbreak in France. In the U.S, this strain has been linked to a 1998 oat cereal outbreak and a 2017 outbreak linked to imported papayas.
Company Testing Can Miss Low-grade Contamination that Causes Illness
The researchers of this study found that even low levels of Salmonella contamination in powdered infant formula can cause illness. Reviewing 11 Salmonella outbreaks, researchers found that the infective dose can be less than 1,000 organisms. For reference, about 200,000 average-sized Salmonella can fit on the head of a pin.
This outbreak shows that routine product sampling conducted by manufacturers of powdered infant formula is “insufficient to detect a persistent low-grade contamination,” researchers said.
Salmonella Lawyers with Experience
If your baby has been sickened by baby formula that was contaminated with Salmonella and you would like a free consultation with a Salmonella lawyer, please contact the Pritzker Hageman Salmonella Legal Team. Our attorneys have represented clients in every major Salmonella outbreak in the U.S. You can reach us by calling 1-888-377-8900, sending a text to 612-261-0856, or completing the form below. There is no obligation and we don’t get paid unless we win.
Sources:
- Powdered Infant Formula as a Source of Salmonella Infection in Infants https://academic.oup.com/cid/article/46/2/268/457688?login=false
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Two Consecutive Large Outbreaks of Salmonella enterica Serotype Agona Infections in Infants Linked to the Consumption of Powdered Infant Formula https://pubmed.ncbi.nlm.nih.gov/17259878/