The FDA investigated the ongoing baby formula shortage. Here’s what it found.

The FDA investigated the ongoing baby formula shortage. Here’s what it found.

The baby-formula shortage remains a serious problem. However, the United States is looking back at what went wrong in the past year to prevent future problems. On September 20, the Food and Drug Administration (FDA) released an internal report on the fumbles and mishaps that led to a delay in response to the formula crisis. There were many reasons, including insufficient emergency response systems capable to manage multiple public health emergencies and outdated data systems. Consumer education was also lacking on how to prepare and handle infant formula. The agency also acknowledged that there are many unknowns about the bacterial contaminant Cronobacter, which was reportedly found in baby formula products from Abbott Nutrition.

” The baby formula shortage was a perfect storm,” says Jenelle Ferry , neonatologist, director of feeding, nutrition and infant development at Pediatrix Florida. “You had a combination COVID pandemic restrictions and supply chain issues. Now you’re dealing with a situation where Abbott Nutrition, a major manufacturer, of formula products, is involved.”

On February 17, 2022, the FDA sent out a warning to consumers to stop using powdered infant formula from Abbott Nutrition after concerns of bacterial contamination in its products. Shortly thereafter, Abbott voluntarily recalled infant formulations and closed the facility during an ongoing FDA investigation. Before the recall, the company was responsible for 40 percent of infant formula production. Panic buying caused by uncertainty about when products would return to shelves led to them being difficult to find. Ferry says that the situation caused unrest and distrust in the entire process. Ferry believes that families didn’t know what to believe or how safe it was for their babies.

[Related: What the FDA is doing about the US baby formula shortage]

Ferry says that part of the reason there is mistrust is a lack of understanding about what happened to the babies who allegedly consumed formula contaminated by Cronobacter. An initial report indicated that babies got sick with Cronobacter after drinking similar–but not the same–formula from Abbott, she says. “It’s very misleading to say the formulas was contaminated because it’s not clear [if] the two infants that died did because of Cronobacter.” Testing later revealed that Cronobacter was on some surfaces of the manufacturing plant, but tests to identify the bacterial strains in the infants found they did not match those found in the factory. Ferry claims that the results are “muddled” because the strains found within the baby formulas were not the same. This suggests that the origin of the bacteria is unknown.

This is not the first time Cronobacter has been a problem with such products–the bacteria can be a contaminant in infant formula. Richard Martinello, an infectious disease expert at Yale School of Medicine, says that the bacteria is naturally present in the environment and has a preference for very dry environments, such as dry powdered baby formula. It is an opportunistic strain of bacteria that can cause severe infections in vulnerable populations, such as infants with a weaker immune system. While Cronobacter infections rarely happen–two to four cases are reported each year in the US–an infected infant (less than one year old) may experience symptoms ranging from fever, seizures, to meningitis. Untreated, there is a high risk of death or meningitis can lead to long-term neurological problems.

Ferry emphasizes that you must ask where and when the contamination was first discovered. She claims that the Cronobacter was not found in any of these recalled products. This means it is possible that the product was exposed via other environmental conditions or handling, rather than being contaminated with bacteria. The bacteria could also have been spread to other areas, such as countertops, storage, and even the home, if the formula is not properly handled or prepared.

Martinello, one of the FDA’s suggestions for improvement, says it is important that Cronobacter cases be made a reportable disease so that states can identify and treat infections. This will allow scientists to better understand the frequency of the cases and provide more opportunities for them to study the bacteria.

[Related: 3 solutions for when you can’t find your baby’s formula]

Infant formula is regulated as food product. However, experts agree that it is life-saving for babies below six months of age, when milk is the primary source. Arik Alper, a pediatric gastroenterologist and assistant professor of pediatrics at Yale School of Medicine, explains that infants and toddlers with special needs were hit hardest by the low stock of infant formulas. Alper says Abbott is a major manufacturer of special formulas for babies with food allergies, inability to digest certain proteins, or who have a disease that requires non-dairy formulas. He says that if you do not need a special formula, there are many options. However, we are faced with a problem when special formulas cannot be found. It’s difficult for babies to adjust to a new formula. The transition could lead to gastrointestinal problems like vomiting or irregular bowel movements .

Ferry believes that breast milk is the best option to feed a baby who is less than six months old when infant formulas are not available. She points out, however, that infant formula is often chosen by people who are not able to breastfeed. You can also look into other brands of infant formulas. However, this is less feasible for infants with special requirements. Alper does not recommend this, but he has seen parents make their own formulas in a blender at home. This would be more suitable for older children. If a parent insists on making their own stock, a nutritionist should supervise the process to ensure a healthy and balanced diet. He warns against parents diluting existing formula stock to make it last. To provide a growing child 100 percent nutrition, “you need to make sure they get enough calories–they need enough nutrients, vitamins, and fiber,” Alper says.

Production at Abbott’s Michigan plant was resumed in July. The FDA is currently forming groups to address the gaps in the baby shortage investigation. They will then reevaluate their progress within a year.

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