Millions of parents rely on baby formula to feed their children, and a new study says health claims made by formula makers aren’t backed by enough high-quality evidence.  

According to a study published in February in The BMJ, many of the health claims made by manufacturers are prone to bias. Researchers found some clinical trials and studies were authored by people who received funding from the industry or who had industry ties.

“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.

Researchers looked at baby formula products marketed in the U.S., Canada, Germany, Australia, Italy, India, Nigeria, Japan, Norway, Russia, Pakistan, Saudi Arabia, Spain, the U.K. and South Africa.

Each of the 814 products included in the study made an average of two claims. The most common claims advertised by manufacturers were that the products helped or supported the development of the brain and of the eyes and nervous system. Other claims were that the baby formula supported growth, development and a healthy immune system. 

“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,” Drs. Daniel Munblit and Robert Boyle, senior co-authors of the study, said.

Baby Formula Studies Funded by Industry

Only about half the evidence cited by baby formula makers came from actual clinical trials, authors said. The rest came from opinion pieces, reviews or animal studies. Of those clinical trials, only about 14% were registered clinical trials. Authors of most of the clinical trials labeled registered (88%) either took industry money or were directly affiliated with the industry, according to the report. 

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

Unlike pharmaceuticals, baby formulas are treated as foods and don’t have to be approved by the U.S. Food & Drug Administration before being sold. And marketing claims don’t have to be backed by clinical trials or rigorous study. However, all formulas in the U.S. must meet federal nutrient requirements. Companies must also notify the FDA before marketing a new formula. 

The FDA sets forth nonbinding recommendations for marketing baby formula, but it doesn’t enforce these rules. Health claims about the formula’s benefits don’t have to be proven before they’re advertised. 

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Lack of Oversight May Have Led to Baby Formula Recall, Shortage

The lack of oversight of baby formula manufacturers may have led to the baby formula recall that left families scrambling for a way to feed their children. Abbott recalled Similac and other baby formula brands produced at its Sturgis, Michigan, plant after some babies got sick and some died from Cronobacter bacterial infections. 

The plant was forced to close and left parents and caregivers without many alternatives. Because Abbott has the largest share of the baby formula market in the U.S., as well as a contract to provide families in the WIC supplemental nutrition program with formula, the plant’s closure crippled the formula supply. 

After the recall, the FDA investigated Abbott and found deficiencies in operations and surfaces contaminated with potentially deadly bacteria at the company’s Sturgis plant. According to FDA chief Dr. Robert Califf, investigators found “shocking” and “egregiously unsanitary conditions.” 

Now Abbott and Mead Johnson face baby formula lawsuits. Families claim the manufacturers’ cow’s milk baby formulas caused premature infants to develop necrotizing enterocolitis, or NEC. NEC causes intestinal inflammation that can lead to serious complications, including death. 

Abbott also faces a criminal investigation from the U.S. Justice Department for its manufacturing practices.