Infant Formula Nutritional Claims Often Have Little or No Scientific Evidence, Researchers Warn

Researchers found clinical trials conducted to confirm infant formula nutritional claims often had a high rate of bias, if any such trials were even conducted.

Yet another study highlights how infant formula manufacturers frequently make unfounded claims about the nutritional and health benefits of food provided to the most vulnerable consumers at the beginning of their lives.

In a report published last week in the medical journal The BMJ, an international team of researchers indicates most infant formula products include health claims not backed up by scientific references, and also noted those health claims have failed to withstand the scrutiny of strong clinical trials.

The findings come on the heels of a series of studies conducted by World Health Organization researchers, who warned earlier this month that the infant formula industry participates in “predatory” marketing, which has resulted in less breastfeeding worldwide and increased the long-term health risks for children.

Growing concerns about the industry’s decision to place profits before the health and safety of infants is also highlighted in hundreds of baby formula NEC lawsuits being pursued against Abbott Laboratories and Mead Johnson, which allege that the companies have continued to promote use of their cow’s milk-based products among premature infants, despite decades of compelling evidence that suggested these vulnerable newborns face an increased risk of developing a devastating gastrointestinal condition known as necrotizing enterocolitis, which can occur suddenly after a baby is switched to formula in the hospital or NICU.

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Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.


In this latest study, researchers conducted an international cross sectional survey of 757 infant formula products, looking at the number and types of health and nutritional claims made for each product. They then looked at references sited and clinical trials conducted to confirm those health claims.

According to the findings, the infant formula products had a median of two claims each, and 31 different types of claims were observed across all of the products. Researchers found that among the 608 infant formula products with one or less claims, the most common was that the formula helped support brain development, eyes or the nervous system. The second most common claim was that the infant formula strengthens or supports a healthy immune system.

Researchers found that many of those claims were made without a reference to a specific ingredient, and the most common groups of ingredients linked to claims of improved health were long chain polyunsaturated fatty acids, prebiotics, probiotics or synbiotics, as well as hydrolyzed protein.

When the products did cite a clinical trial, the researchers found many of those trials carried a high risk of bias, making the findings suspect, and often skewing the results in favor of the manufacturers’ claims. However, many give no supporting data to substantiate claims that their infant formula products provide the health and nutritional benefits they tout on their labels and websites.

“This could suggest that the global regulatory and public health communities, governments, and public policy civil servants are failing to effectively limit the use of claims in marketing of breast milk substitutes,” the researchers concluded. “This can both undermine breastfeeding and increase costs for families, as high prices for infant formula have detrimental effects on families residing in low and middle income countries.”

February 2023 Baby Formula NEC Lawsuit Update

There are currently about 100 Similac lawsuits and Enfamil lawsuits filed throughout the federal court system against Abbott and Mead Johnson by families of children diagnosed with NEC after being fed the formula, which have been centralized before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois, for coordinated discovery and pretrial proceedings.

Each of the NEC lawsuits raise similar allegations, indicating that manufacturers of cow’s milk-based infant formula and human milk fortifier specifically marketing products for use by preterm newborns, without providing warnings to hospitals, doctors or families. However, as lawyers continue to investigate and file claims in the coming year, it is ultimately expected that several thousand lawsuits will be brought by families of infants diagnosed with NEC.

In November 2022, a group of 12 cases were selected for a NEC lawsuit bellwether pool, which will go through case specific discovery and prepared for a series of early trial dates expected to begin in 2024.

Although the outcome of these early bellwether trials will not have any binding impact on other claims, they are expected to have a substantial impact on any baby formula NEC settlements the manufacturers may offer to avoid the need for each individual case to be remanded back to U.S. District Courts nationwide for separate trial dates in the future.


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