Protecting families from contaminated food and water
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Protecting families from contaminated food and water
Posted in Food Safety,Our Blog,Outbreaks & Recalls on March 31, 2023
The Abbott formula plant is under Department of Justice Investigation. Criminal charges will likely follow.
It has been about a year since the baby formula crisis that caused sickened infants and a shortage that rapidly became a national emergency. Has that been swept under the rug, or are those responsible finally feeling the consequences.
In January, the United States Department of Justice’s (DOJ) Consumer Protection branch opened an investigation on the Abbott Laboratories infant formula plant located in Sturgis, Michigan.
Abbott is one of four major companies that control about 90 percent of the infant formula supply in the United States. As a result, it’s closure during the early investigation contributed to severe shortages that continue to affect families.
The DOJ is working towards issuing criminal charges for their role in the outbreak that resulted in the death of 2 infants and sickened at least 2 others with a bacterial infection after consuming formula. Further investigation potentially links another 9 deaths back to this formula. The culprit? Cronobacter sakazakii.
Cronobacter is a sneaky little bacteria. It can live naturally in the environment, but it grows and thrives in starches, herbal teas, powdered milk, and you guessed it. Powdered infant formula.
First, liquid formula is sterile. Powdered formula is not. The dry nature of powdered infant formula exacerbates the issue. This is a well known hurdle among formula producers, food safety scientists, and federal regulators for quite some time. This bacteria loves dry environments, much like the milk powder in powdered infant formula. It is difficult to eradicate and can be introduced at many stages in formula preparations. It could come from the factory floor, at any time it is opened, and even while it is being prepared for the hungry baby’s bottle.
In general, Cronobacter is a pretty bad bug. But an infection in an infant is significantly worse.
Cronobacter infections are rare, but can be life-threatening. Particularly in newborns. The United States Centers for Disease Control and Prevention (CDC) estimates that between 2 and 4 cases are reported to the agency every year, though this could be an underestimate as most hospitals and laboratories aren’t required to report Cronobacter infections to health departments as they do other potentially foodborne bacterial infections.
Cronobacter infection can result in a dangerous blood infection leading to sepsis and can also swell the linings of the brain and spinal cord causing meningitis.
Symptoms often start with a fever, poor feeding, excessive crying, and low energy. Seizures have also been reported during a Cronobacter infection.
Infants under 2 month of age, those born prematurely, and those with weakened immune systems are at highest risk.
Infants with these symptoms should be taken to a medical practitioner as soon as possible.
Cronobacter does not like to cooperate with testing. It is difficult to detect, especially after the child has fallen ill. Scientists have found that the bacteria are known to clump together in tight bunches, making it difficult to find in samples.
Those in charge of the Sturgis Abbott plant held firm that there was no causal relationship established between its products and any of the reported deaths. Per federal requirements, the Abbot plant routinely tests their products.
“Abbot conducts microbiological testing on products before distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility,” Abbott said in a statement at the time.
Additionally, the plant indicated that they conduct microbiological testing on products before distribution and that no Abbott formula distributed to consumers tested positive for either Cronobacter or Salmonella.
The bad bug was, however found in environmental samples on the manufacturing floor. This is what gave authorities cause for pointing the finger at Abbott. That, and a whistleblower report discussing unsanitary conditions on the factory floor.
After reports of sickened and dying babies started hitting the news, a whistle blower submitted a 34-page report of concerns of unsanitary conditions and practices at the factory. This report was not handled and forwarded to the appropriate people right away, which is a topic of heated debate and may contribute to the Abbott’s defense.
In fact, Frank Yiannas, the FDA’s deputy commissioner for food policy and response indicates that he didn’t receive the complaints for at least 4 months. The report got hung up in the agencies departments regulating drugs. As a result, other top FDA officials not as high in the food safety side of things had elected not to send new inspectors to the Sturgis, Michigan plant.
“It wasn’t sent to me,” said Yiannas, who previously ran the food safety program for Walmart. “It wasn’t shared with me internally. How does this happen?” According to Yiannas, there were early signals, and “in any safety profession you want to take those seriously to stop the domino affect,” he said. “That didn’t happen.”
It took another infant death linked to Abbott-produced formula for the plant to close and a recall to be issued.
There are so many areas for the DOJ to look at in order to hold each contributing party accountable.
First, the conditions on the Sturgis plant manufacturing areas that lead to the whistleblower filing a report. Next, the delay in getting the report into the right hands within the FDA that was blamed on a “mail room problem.” And finally, the delayed action.
We trust that those involved in manufacturing and making our food products are keeping safety a priority. Besides choosing particular brands and products, there are a few additional steps to help parents feed their children safely.
According to the CDC, very few cases of Cronobacter infections have been reported among exclusively breast milk fed infants. Of course breastfeeding isn’t possible for all parents and situations, but if it is possible – it is a great risk mitigator.
Cleaning, sanitizing, and storing feeding items safely is another step that can help you keep your baby safe. Adding new formula or breast milk to a partially used or simply rinsed bottle can allow germs to grow quickly. Always clean, sanitize, and store feeding items such as baby bottles, breast pump parts, nipples, caps, rings, valves, and other objects that might enter a baby’s mouth (i.e. pacifiers and teethers). Always take apart bottles and breast pump equipment after use so that they can be cleaned thoroughly.
Take a few moments before preparing and feeding bottles or food to your baby to ensure hands and surfaces are clean. The urgency of a yelling baby may tempt you to skip this important step, but safety also waits for no one. Clean surfaces, like countertops and sinks with soap and water and wash your hands with soap and water for at least 20 seconds.
Always wash your hands before touching your baby’s mouth, before touching things that go into your babies mouth, such as teethers or pacifiers, and after using the toiled or changing diapers.
If soap and water is not available, a hand sanitizer with at least 60% alcohol can be used, but wash your hands with soap and water as soon as possible. While the 60% alcohol hand sanitizer kills Cronobacter, it does not kill all types of germs.
If you feed your baby formula, consider using liquid formula when possible, especially if your baby is at higher risk.
When heating infant formula, never use a microwave. Microwaves heat unevenly, resulting in “hot spots” that could burn your baby’s mouth and throat.
Check the formula container for expiration dates and that it is in good condition without dents, puffy ends, or rust spots.
Never set formula scoop on the counter, in the sink, or on any surface. Keep the lids and scoops clean and completely dry. Always close containers of formula as soon as possible after using them.
In general, it is safe to mix the powdered infant formula according to the manufacturer’s instructions on the container. However, if you baby is in a higher risk category, the CDC indicates a preparation protocol to further reduce risk.
The experienced infant botulism lawyers at The Lange Law Firm, PLLC are dedicated to holding food companies accountable for lapses in food safety that result in illness or injury.
An infant botulism lawyer can:
The Lange Law Firm, PLLC has recovered millions of dollars in product liability and food poisoning cases. They can help you too!
Call (833) 330-3663 for a free, no obligation consultation. Or fill out the online submission form, and someone will get back with you right away.
By Heather Van Tassell (contributing writer, non-lawyer)