A new study found that baby formulas used by millions of parents to nourish their children have little or no high-quality evidence to support health claims, prompting researchers to call for better regulations to protect consumers. 

The February 2023 study published in The BMJ looked at 814 infant formula products marketed in 15 countries, including the U.S. 

Products in the study made an average of two claims each. The most commons claims were:

  • Helps/supports development of brain and/or eyes and/or nervous system
  • Strengthens/supports a healthy immune system
  • Helps/supports growth and development

“We also found that many ingredients were linked to several claims, and some claims were linked to multiple ingredients. It’s essential that the industry provides accurate and reliable information to consumers, rather than using vague or unsupported claims as marketing tools,” Drs. Ka Yan Cheung and Loukia Petrou, the joint first co-authors of the study, told The Guardian media outlet.

Industry Ties Found in Most Studies

When studies and data were provided to support claims, only 56% of the reported findings came from clinical trials. The rest came from opinion pieces, reviews or studies involving animal research, according to the study published in BMJ

Among the clinical trials that were referenced, 90% carried a high risk of bias. Most of the authors of these trials had some type of tie to the baby formula industry, according to researchers. 

About 88% of the registered clinical trials had authors who were directly affiliated with the baby formula industry or who had received formula industry funding. 

The study found existing baby formula regulations are “failing to effectively limit the use of claims in marketing of breast milk substitutes.” 

FDA Doesn’t ‘Approve’ Baby Formula Before Marketing 

In the U.S., the U.S. Food and Drug Administration doesn’t approve baby formulas before they go on sale because they are considered foods not pharmaceuticals. However, the agency said, “all formula marketed in the United States must meet federal nutrient requirements, and infant formula manufacturers must notify the FDA prior to marketing a new formula.” 

The rules FDA sets forth for baby formula labeling and health claims are “nonbinding recommendations.” This means companies don’t have to follow the recommendations in order to market their products. This includes health claims about ingredients and their benefits for any health conditions or disease.  

“There is a clear need for greater regulation and oversight to ensure that these claims are supported by sound scientific evidence and to protect the health and well-being of our youngest and most vulnerable populations,” said Drs. Daniel Munblit and Robert Boyle, senior co-authors for the study.

Abbott, the maker of Similac and the largest baby formula producer in the U.S., is still under scrutiny following quality control issues and potential bacteria contamination at its Sturgis, Michigan, plant. The company issued a baby formula recall after several babies got sick and some died from bacterial infections after consuming baby formula manufactured at the Sturgis plant. 

In addition to the company’s recall woes, Abbott and Enfamil maker Mead Johnson are facing baby formula lawsuits from parents who say the formula makers knew its cow’s milk baby formulas put premature infants at risk for developing necrotizing enterocolitis, or NEC. NEC is a serious and potentially deadly intestinal disease.