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FDA Announces Investigation Into Infant Illness Connected to Powdered Formula

Following multiple reports of infants experiencing serious infections, the Food and Drug Administration (FDA) recently announced an investigation into potential bacterial contamination in a certain type of powdered infant formula.

Dani Alexis Ryskamp, J.D.

Written by
— Updated on March 29, 2022

FDA Announces Investigation Into Infant Illness Connected to Powdered Formula

So far, the infections have been traced back to Similac, Alimentum, and EleCare infant formula products. Abbott Nutrition produced these formulas in their Sturgis, Michigan plant. Abbott announced a recall of the baby formula and of other potentially affected products.

Concerns About Bacterial Contamination in Baby Formula

The FDA investigation is based on four reports of Cronobacter sakazakii infections in infants. Additionally, the investigation is also based on one report of a Salmonella Newport infection. All five cases required hospitalization for the affected infants. Furthermore, Cronobacter may have played a role in the death of two of these patients.

Cronobacter sakazakii and related strains of Cronobacter can cause life-threatening infections, including infections of the brain and spine. The bacteria can live in dry environments including that provided by powdered baby formula, according to a CDC fact sheet.

Salmonella includes a group of related bacteria that can cause gastrointestinal illness, fever, and other symptoms. In severe cases, the infection may prove fatal, according to the FDA.

While Cronobacter infections are generally rare, they can be fatal for infants. The infections can also be fatal for elderly persons and those with weakened immune systems. Early symptoms include fever, poor feeding, crying, and very low energy. Symptoms of Salmonella infection also include fever, as well as diarrhea, abdominal cramps, headaches, and rashes.

The CDC recommends that parents take several steps to reduce the risk of Cronobacter infections in infants. Some steps that help reduce the risk include breastfeeding, properly cleaning and storing feeding items, and using liquid infant formula. Unlike powdered formula, liquid formula is generally sterilized, according to the CDC.

Responses from the FDA and Abbott’s Recall of Baby Formula

Abbott’s initial recall announcement covered several types of infant formula. After news of the fourth case of Cronobacter came out, Abbott added a recall for its Similac PM 60/40 product with lot code 27032K800. This specific product is a specialized formula for infants with low mineral intake, which wasn’t included in the initial recall.

Parents can use the Abbott website to look up lot numbers. By doing so, parents can determine whether any products in their household are part of the recall. So far, the recall affects only powdered formulas, not liquid formulas.

In its recall announcement, Abbott noted that “we found evidence of Cronobacter sakazakii in the plant in non-product contact areas.” However, the company found no evidence of Salmonella Newport. Samples tested by Abbott returned no evidence of either type of bacteria, according to the recall announcement. An FDA investigation likewise found evidence of Cronobacter in the environment at the Sturgis plant. The investigation also found evidence that Abbott had destroyed batches of product after finding evidence of Cronobacter.

U.S. House Appropriations Chair Rosa DeLauro recently asked the Health and Human Services Office of the Inspector General to review the FDA’s actions prior to the infant formula recall. The request comes in the wake of news that the FDA received its first notice about a Cronobacter infection in an infant in September 2021. However, the FDA had not issued the recall until February 2022. 

What to Expect From Potential Infant Formula Litigation

Parents of babies who suffer Cronobacter or Salmonella infections after receiving any type of recalled powdered formula will likely want answers and accountability. Litigation surrounding the Abbott Nutrition formula recall will need to answer a number of questions. For example, attorneys will need to establish a clear causal link between the affected formula and the infants’ infections. Questions will arise regarding the Sturgis, Michigan formula plant’s health and safety procedures. Additionally, questions concerning the plant’s testing regimen and who might have known about potential Cronobacter infections and when will also come up.

As the cases proceed, they are likely to rely upon the input of expert witnesses. Experts in Cronobacter and Salmonella transmission, its management in manufacturing powdered infant formula, and its effects on infants’ health are likely to become involved.

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