Infant Formula and Salmonella

In the first months of your new baby’s life a single food source is common.  Breast milk or infant formula.  Sometimes it is a combination of the two depending on your individual circumstances.  While there are pros and cons for each, breast milk is by far the most beneficial and healthy option.  But it isn’t an option for everyone.  In those cases, infant formula provides all the nutrition (except vitamin D in some cases) that your growing baby will need.  But what about Infant Formula and Salmonella?

In our modern world, you expect the food we eat and feed our families is safe.  With all of the safety regulations in place, baby formula, above all others should be safest to consume.  But that isn’t always the case.  In some circumstances, mistakes are made and poor product quality falls through the cracks ultimately making its way into our homes.  When these mistakes occur in our most vulnerable population – ones that cannot speak for themselves, the outcomes can be devastating.

Recent Infant Formula Outbreaks

A Salmonella outbreak in an infant population is heartbreaking at best and tragic at worst.

Salmonella Outbreak in Nursery Leaves 5 Children Ill

Our first example starts in a small town in South Carolina.  An otherwise healthy 5-month-old baby girl began to show symptoms of becoming sick.  A few days later her condition worsened, and she began having blood in her stools.  Like any concerned caregiver, her parents immediately took her to their pediatrician.  A stool sample revealed the presence of Salmonella.

About this same time, another child, an 8-month-old boy in a neighboring town also fell ill.  His symptoms included vomiting, fever, and diarrhea.  After seeking medical attention, his mother was notified that he too had Salmonella infection.

At this point, laboratory results reported to the State of South Carolina were flagged in their FoodCORE database as both children were sickened with the same strain of Salmonella.  FoodCORE is a national foodborne illness organization and database used to identify and track foodborne illness.

A FoodCORE Team was assembled, and an investigator discovered that both children attended the same nursery.  During the course of the investigation, the investigator determined that three other infants from the same classroom were also ill with the same strain of Salmonella.  Subsequent investigation of the nursery’s formula preparation, diaper changing and hand washing procedures, as well as other hygiene practices took place.  While no source for the Salmonella infection was determined, additional hygiene steps were implemented at the nursery after inspection.  Fortunately, all five sick infants recovered from illness and regained health.

Next, we come to an outbreak investigation leading us to the source.  A manufacturing facility linked to a decade of Salmonella cases.

Salmonella Outbreak Leads to European Infant Formula Recall

Reports of Salmonella Poona cases across Europe eventually lead to the recall of several infant formula brands produced at the same facility in Spain.

The original investigation began in early 2019 when 14 French babies between the ages of 2 months and 19 months fell ill with the same strain of Salmonella.  Based on parent interviews of these children who live in 10 different regions of France, all leads pointed to infant formula.  The Modilac brand powdered milk in question was produced by a single plant in Spain.

Soon other cases began linking up with each other and the offending infant formula.  Luxembourg indicated 1 case along with Belgium who also had 1 case.  The Czech Republic indicated 4 cases, Germany came in at 2 cases, and The Netherlands and Switzerland determined 1 case each was also linked to this outbreak.

Turns out, Modilac was not the only product produced at this Spanish facility.  Other infant formula products also decided to recall their products made at that facility out of an abundance of caution.  Sodilac withdrew and recalled their infant nutrition products based on rice proteins and all infant formula produced at the Spanish site.  Lactalis also later recalled 16,300 boxes of their Picot AR milk produced at that site.

More in-depth investigation revealed an even bigger problem.  All in all, this investigation ended up with a sad 31 infant cases in France that resulted in about 50% serious enough for hospitalization.  Additionally, whole genome sequencing analysis linked this outbreak to a 2010 to 2011 Salmonella Poona outbreak traced back to that same manufacturing facility in Spain.  But it doesn’t stop there.  This same facility was also cited as the source of an outbreak of a different strain of Salmonella, Salmonella Give in 2008.

Additional investigation in cases dating back to the original 2008 cases revealed a common thread.  A root cause formula indicated by “Brand A” and a common drying tower was determined to be the source of both the 2010-2011 and 2019 outbreaks based on the results of the epidemiological investigations.  The offending brand is labeled as “Brand A” because despite the overwhelming epidemiologic evidence, there is no confirmed evidence of Salmonella contamination present in “Brand A.”

Investigations remain ongoing at the facility in an effort to identify the source of contamination and mitigate any future contamination events.

Infant Formula-Based Outbreaks: A Historical Perspective

Powdered infant formula, while a seemingly harmless food product is not sterile.  As such, it can be intrinsically contaminated with pathogens along the production process the same as other food products.  In fact, at least 6 recent outbreaks of Salmonella have been linked to consuming infant formula.

While separate events, a few common factors can be identified among the 6 studied in this historical perspective.  First, the strain was a rare serotype.  Being rare helps traceback activities more easily determine the true source as opposed to more common strains that pop up in other food sources simultaneously.  Another common theme among these outbreaks is the low level of contaminants.  With such a low level of Salmonella organisms detected in the infant formula, routine testing may not have indicated a problem until it was too late.

Are Infants More Susceptible?

Are infants more susceptible to Salmonella infection?  It seems to be a question not all that different from the age old  “which came first, the chicken or the egg.”  In the United States, incidence of salmonellosis – the illness associated with Salmonella infection was 121.6 to 100,000 infants.  This comes to about 8 times greater than salmonellosis instances in other age groups.  These numbers are on par with data gathered in other areas of the world with the United Kingdom reporting 181 cases per 100,000 infants and Israel reporting 92.8 cases per 100,000 infants.

With this higher rate of transmission, it is not clear whether the higher incidence is a result of higher exposure or greater susceptibility.  It could be probable that the increase in cases stems from caregivers of this age group are more likely to insist on medical care and stool cultures performed than adults afflicted with the same symptoms that are more likely to ride out the illness without medical intervention.  Which is a good thing, because there is a higher correlation of infants and young children, especially those with immunocompromising conditions or other illnesses, to more likely experience severe illness or death due to Salmonella infection.

Historical Timeline

A few events in the 1960’s and 1970’s created a methodology to look for common links.  Though the link was not all that surprising.  Later outbreaks in the 80’s, early 90’s, and beyond benefited by increased technology and awareness.

Salmonella Nubruswick, Derby, and Bredeney in the 1960’s and 1970’s

Our first case study begins in 1966.  A multistate outbreak of Salmonella Newbrunswick in the United States primarily affected infants.  The investigation linked illnesses to a single dried milk manufacturer, where the same strain was isolated from unopened containers, the manufacturing plant environment, and other milk products sampled on the premises.  The source of contamination was ultimately discovered to originate in the spray driers.

In 1973, a devastating 3000 infants were infected with Salmonella Derby in an island-wide outbreak of salmonellosis occurring on Trinidad.  Later a study linked these illnesses to 7 different brands of powdered milk all packaged at a single processing plant.

In 1977, an Australian outbreak of Salmonella Bredeney was traced to powdered milk-based infant formula contaminated during manufacture.  This outbreak, like the one in 1966, was linked to the spray driers.

Notice the common thread?  It did not escape investigators.  As a result, specific preventative measures, particularly during the drying process were implemented during the 1970’s to minimize the risk of contamination in dehydrated dairy products.  As a result, the prevalence of Salmonella contamination of skim milk decreased from 1.9% in 1976 to 0.01% in 1988.

Salmonella Ealing in 1985

In 1985, a United Kingdom outbreak of Salmonella Ealing was linked to 1 brand of infant formula.  This outbreak was also traced back to problems in the spray drier.  Another key aspect of this outbreak source was the low concentration of Salmonella.  In this case, only 1.6 organisms present per 450g.  At the time, only 50g samples were pulled during their quality-control sampling practice, making it unlikely for contamination to be detected.

Lactose Fermenting-Salmonella Tennessee in 1993 and Lactose-Fermenting Salmonella Virchow in 1994

In 1993, a lactose-fermenting strain of Salmonella Tennessee outbreak in the United States and Canada was linked to a manufacturing plant.  Lactose-fermenting is a key part in this investigation in that one of the major factors in identification of Salmonella genus is the characteristic inability to ferment lactose.

A similar lactose-fermenting strain of Salmonella Virchow outbreak in Spain linked to powdered infant formula affected 48 individuals, mostly children under 7 months old across 14 of the 17 regions of Spain.  This unconventional characteristic may account for a lower reported case count than actual number of cases that were not linked to the outbreak and attributed to some other idiopathic diarrheal illness.  This could also account for reduced numbers in the 1993 Salmonella Tennessee outbreak in the United States.

Salmonella Anatum in 1996-1997

Laboratory-based surveillance became key factors in targeted epidemiologic investigations as technology and awareness increased.  This was the case in the Salmonella Anatum outbreak in the United Kingdom and France in 1996 to 1997.  Molecular subtyping was used to identify specific strains, allowing identification of the specific epidemic strain to be determined.  Additionally, communication and collaboration efforts were bolstered through the regions Salm-Net surveillance network used to identify the international outbreak.

Salmonella Enterica in 2000

In 2000, 30 cases of Salmonella infection in Korea were linked to sporadic contamination of a single brand of powdered infant formula consumed by all the sick infants.  The investigation was stifled because it wasn’t possible to determine whether the contamination occurred during manufacture or after package was opened by the consumer.  Organism was only identified in opened packages of formula.  This case brought to light the potential for contamination of powdered infant formula by the end user in addition to the other likely source, the manufacturer.

Salmonella Saintpaul in 2001

Another outbreak in 2001 took the heat off the manufacturer.  An outbreak of Salmonella Saintpaul in 2001 in a United States hospital was linked back to the facility’s formula preparation room.  It was not possible to link the source to the preparation utensils, the environment, or the actual powdered infant formula.  This case highlighted the underlying potential for reconstituted powdered infant formula to be the vehicle for Salmonella infection in cases where the manufacturer is not the source of infection.

Salmonella Agona in 2004-2005

A series of 2 consecutive Salmonella Agona outbreaks linked to 2 brands of powdered infant formula between 2004 and 2005 manufactured on the same production line were left with a vague origin.  While the source of the contamination and the facility has yet to be identified, a persistent environmental contamination is the suspected source.

Common Infections

Salmonella strains are the most common infant formula outbreaks, as identified in the case studies explored here, but other food-borne illness causing bacteria can be the culprit.  Cronobacter or Enterobacter can live in dry foods, such as powdered infant formula.  E. coli is another food-borne bacteria to look out for.

Has Your Family Been Affected by an Infant Formula Outbreak?

Does your infant appear to be experiencing symptoms related to a powdered infant formula outbreak?  Common symptoms include but are not limited to: diarrhea, bloody diarrhea, watery stools, and/or fever.  Seek medical attention immediately and retain any packaging of food products given to your child.  They, in addition to samples taken by your medical professional may be used in traceback activities to determine the source of infection.

Contact a Skilled Infant Formula Lawyer Today

Have you or a loved one suffered from Infant Formula and Salmonella poisoning after falling prey to unsafe food practices? If so, our experienced Infant Formula lawyer at The Lange Law Firm, PLLC is eager to help. Speak to an Infant Formula lawyer today and receive a free case evaluation to see you have an Infant Formula lawsuit.

By: Heather Van Tassell