FDA To Conduct More Nutrition Reviews and Heavy Metal Testing for Infant Formula

U.S. Health and Human Services Secretary, RFK Jr., is calling for the first complete infant formula nutritional review since 1998.

Federal regulators have pledged to expand investigations into infant formula products like Similac and Enfamil, to ensure they are meeting nutrient requirements, with a safe and intact supply chain.

According to a press release issued by the U.S. Food and Drug Administration (FDA) on March 18, the newly appointed Secretary of the U.S. Department of Health and Human Services, Robert F. Kennedy, Jr., is calling for increases in the safety, nutritional adequacy and quality of infant formula products and their supply chains. 

The program, Operation Stork Speed, will include new nutrient review processes and testing for heavy metals and other potentially harmful ingredients, which have been found to contaminate several different infant formula products in recent years.

The announcement comes about two years after Abbott Laboratories issued a massive Alimentum, Elecare and Similac recall, following the discovery that powdered formula products manufactured at a Michigan facility were contaminated with Salmonella Newport and Cronobacter sakazakii bacteria, which can be dangerous and life-threatening infections.

At least two infant deaths and hundreds of illnesses were reported by parents who fed the contaminated baby formula to their children, and subsequent investigations have revealed Abbott ignored industry safety standards and best practices at its facility for years, endangering infants for the sake of profits.

It also comes amid concerns over the nutritional value of some cow’s milk-based infant formula products for premature babies, and problems with several popular brands of baby food containing toxic heavy metals, including arsenic, cadmium, lead and mercury.

The plan calls for the FDA to start implementing a nutrient review of infant formula, which will be required by law. The agency will issue a Request for Information in the coming months, which will be the first comprehensive update on infant formula nutritional value since 1998, Kennedy pledged.

The agency plans to also increase testing for heavy metals and other contaminants, work with companies to increase transparency and provide clearer labels, improve communication with consumers and stakeholders, and also intends to collaborate with the National institutes of Health and other scientific organizations to fill in research gaps on short-term and long-term health outcomes linked with formula feeding in infancy and childhood.

“The FDA is deeply committed to ensuring that moms and other caregivers of infants and young children and other individuals who rely on infant formula for their nutritional needs have confidence that these products are safe, consistently available, and contain the nutrients essential to promote health and wellbeing during critical stages of development and life,” Acting FDA Commissioner Dr. Sara Brenner said in the press release. “Whether breastfed, bottle fed or both, the rising generation must be nourished in a way that promotes health and longevity over the course of their lives.”

Infant Formula Health Concerns

Research has regularly shown cow’s milk-based baby formula products do not confer the same benefits as breastfeeding and may increase the risk that premature infants develop necrotizing enterocolitis (NEC), which frequently results in severe, life-long injuries or death.

Necrotizing enterocolitis is a devastating gastrointestinal condition that occurs when harmful bacteria breach the walls of the intestines, causing portions of the tissue to become inflamed or die. It primarily affects premature babies and often results in the need for emergency surgery while the baby is still in the NICU. Many infants do not survive.

A January 2022 study found that nutrients in breast milk play a critical role in helping the intestinal epithelial layer mature in preterm infants, strengthening their resistance to NEC. However, these nutrients are not present in cow’s milk-based infant formula marketed for premature babies, such as the popular Similac and Enfamil product lines.

In July 2022, the American Academy of Pediatrics (AAP) issued a policy statement calling for hospitals and the government to promote breastfeeding as the primary form of nutrition for newborns.

Another study, published last October, even found that preterm infants fed breast milk were less likely to develop asthma later in life.

As a result of the failure of formula manufacturers to disclose the risk of NEC, hundreds of families are now pursuing Similac lawsuits and Enfamil lawsuits, claiming that their premature children could have avoided debilitating and often fatal injuries if earlier warnings had been provided for users and the medical community in recent years.

Baby Food Heavy Metal Contamination

Concerns about toxic metal in baby foods emerged in 2021, when Congress released a report on the widespread presence of high levels of arsenic, lead, cadmium and mercury in a number of popular baby food products. The report warned that infant exposure to these heavy metals may heighten the risk of serious developmental disorders, such as autism and ADHD, as well as other cognitive and behavioral issues that can affect a child’s development and long-term health.

While health experts and regulators have called for manufacturers to remove these contaminants from their products, recent testing has shown that toxic heavy metals in baby foods remain a problem.

A report published last year found that popular baby food brands sold by Gerber, Beech-Nut, Sprout, Walmart and others still have potentially dangerous levels of arsenic, cadmium and lead, all of which can increase the risk of neurological side effects for children.

Hundreds of families with autistic children are now pursuing toxic baby food lawsuits against manufacturers of these products, each raising similar allegations that the manufacturers exploited parents’ trust by marketing baby food products as safe, while concealing the presence of dangerous levels of toxic heavy metals.