The Food and Drug Administration (FDA) on Tuesday announced new efforts to monitor the U.S. infant formula supply and conduct the first “comprehensive update and review” of formula nutrients since 1998.
Actions to be taken by the FDA include increasing testing for heavy metals and other contaminants in infant formula and foods; improving transparency regarding formula nutrients and related health outcomes; collaborating with the National Institutes of Health (NIH) and other agencies to address research gaps on formula-related health outcomes; and extending the personal importation policy.
Cynthia L. Blanco, M.D., FAAP, of the AAP Committee on Nutrition said continued support of Women, Infants and Children (WIC) and Supplemental Nutrition Assistance Program (SNAP) should remain a priority for the FDA. These programs provide access to good nutrition for breastfeeding mothers and formula for those unable to breastfeed, she said.
“The AAP Committee on Nutrition is very interested in learning more about the efforts to ensure formula safety, quality, nutrient content and supply remain at the forefront of infant nutrition,” Dr. Blanco said. “Ensuring access through the WIC and SNAP programs to decrease barriers we’ve faced in the past is extremely important.”
The FDA also will be encouraging manufacturers to develop new infant formulas and inform consumers about the ingredients used.
“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,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H., in a news release.
Tuesday’s announcement comes a few days after a U.S. circuit court ruled that plaintiffs in a Missouri case concerning specialty formula for premature infants could seek a new trial.
Reuters reported March 14 that a St. Louis judge ruled that the lawyers for defendants Mead Johnson and Abbott Laboratories violated instructions while presenting evidence in an October 2024 trial. The firms were accused of failing to warn of a risk of necrotizing enterocolitis (NEC) associated with specialized formula for premature infants; the jury cleared them of wrongdoing.
Mead Johnson parent company Reckitt Benckiser plans to appeal the latest ruling.
The FDA, NIH and Centers for Disease Control and Prevention issued a consensus statement last October saying there is no conclusive evidence that specialty formulas for preterm infants cause NEC. Rather, evidence supports the hypothesis that the absence of human milk is associated with an increased risk of NEC.
“There are two key points about feeding practices and NEC: 1) There is no conclusive evidence that preterm infant formula causes NEC; and 2) there is strong evidence that human milk is protective against NEC,” the October statement reads.
