Wydeven column: Heavy metals found in infant formulas prompts closer look at production
When I was in high school, I loved listening to bands like Kiss, Van Halen, Metallica, Whitesnake and Dokken. The ‘80s were a magical time for heavy metal.
But heavy metal belongs on the radio – not in baby formula.
Consumer Reports recently tested 41 varieties of infant formula looking for heavy metals and other potentially harmful chemicals. Roughly half of the formulas tested contained dangerous ingredients, including acrylamide, arsenic, BPA, lead and PFAS. The remaining formulas had low or no levels of concerning contaminants.
The study, in part, stemmed from the major shortage of baby formula in the U.S. during 2022, after U.S. Food and Drug Administration inspections discovered Cronobacter sakazakii bacteria in an Abbott Laboratories’ plant in Sturgis, Michigan. The outbreak in the company’s Similac brand of formula was linked to two infant deaths.
About one in five newborns in the U.S. use formula, so the factory’s temporary closure reduced the supply for millions of babies who relied on it as a crucial source of nutrition for their first months of life.
In response to Consumer Reports’ study, the FDA, in a joint announcement with the U.S. Department of Health and Human Services, indicated it will bolster its testing of infant formula for heavy metals and other contaminants. HHS Secretary Robert F. Kennedy Jr. earlier met with the chief executives of companies including Abbott and Reckitt Benckiser, maker of Enfamil, along with Perrigo Co. and Bobbie Baby Inc.
In addition to testing for heavy metals, the agency will also comprehensively examine the nutrients used in infant formula. “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” Kennedy said in a statement.
“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 well-being during critical stages of development and life,” acting FDA Commissioner Sara Brenner said in a statement.
Brian Ronholm, director of food policy at Consumer Reports, responded to the FDA and HHS’s announcement by stating, “We look forward to seeing the details of how they intend to implement the plan, and we hope the FDA is providing adequate resources and staffing to actually follow through with these promises.”
In response, Scott Stoffel, a spokesman for Abbott Laboratories, said, “We look forward to working with the Secretary, the FDA, and the scientific and medical communities to continue to make infant formulas even closer to breastmilk and support the aims of Operation Stork Speed.” He continued, saying, “Each ingredient in our formulas is purposefully chosen for the type of baby we’re feeding and their unique dietary needs.”
Abbott and Reckitt are already defending over 400 lawsuits in both federal and state courts across the country. The lawsuits allege the companies concealed the fact that their formula, including products made specifically for premature infants, increased the risk of necrotizing enterocolitis compared to alternatives like donor milk.
NEC causes the death of bowel tissue, which mostly affects premature newborns, and has a fatality rate of about 15% to 40%. According to the U.S. National Institutes of Health, there is evidence that formula increases the risk of NEC in premature infants compared with breast milk.
Abbott Laboratories and Reckitt Benckiser are obviously looking for the right formula to deal with these legal and regulatory woes.
Reg Wydeven is a partner with the Appleton-based law firm of McCarty Law LLP. He can be reached at pcbusiness@postcrescent.com.